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BROWN AND WILLIAMSON TOBACCO CORP., et al.

No. 98-1152.

United States Supreme Court Petitioner's Brief.

July 12, 1999.

PETITIONER'S BRIEF, U.S.S.CT.

ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FOURTH

CIRCUIT

BRIEF FOR THE PETITIONERS

Margaret Jane Porter Chief Counsel Karen E. Schifter Patricia J. Kaeding Associate Chief Counsel Food and Drug Administration Rockville, MD. 20857

Seth P. Waxman Solicitor General Counsel of Record David W. Ogden Acting Assistant Attorney General Edwin S. Kneedler Deputy Solicitor General William B. Schultz Deputy Assistant Attorney General Irving L. Gornstein Assistant to the Solicitor General Eugene Thirolf Douglas Letter Gerald C. Kell Scott R. McIntosh Christine N. Kohl Attorneys Department of Justice Washington, D.C. 20530-0001 (202) 514-2217

*I QUESTION PRESENTED

The Federal Food, Drug, and Cosmetic Act authorizes the Food and Drug Administration (FDA) to regulate products as "drugs" or "devices" when they are "intended to affect the structure or any function of the body." 21 U.S.C. 321(g)(1)(C) and (h)(3). FDA has found that the nicotine in tobacco products is intended by tobacco manufacturers to cause and sustain a user's addiction to nicotine and to act as a sedative, stimulant, and appetite suppressant. The question presented is whether, given that finding, tobacco products are subject to regulation under the Act as "drugs" and "devices."

*II PARTIES TO THE PROCEEDING

The petitioners are: Food and Drug Administration, and Jane E. Henney, Commissioner of Food and Drugs.

The respondents are: Brown and Williamson Tobacco Corp.; Lorillard Tobacco Company; Philip Morris, Incorporated; RJ Reynolds Tobacco Company; Coyne Beahm, Incorporated; National Association of Convenience Stores; ACME Retail, Incorporated; United States Tobacco Company; Conwood Company, LP; National Tobacco Company, LP; Pinkerton Tobacco Company; Swisher International, Incorporated; Central Carolina Grocers, Incorporated; J.T. Davenport, Incorporated; North Carolina Tobacco Distributors Committee, Incorporated; The American Advertising Federation; American Association of Advertising Agencies; Association of National Advertisers, Incorporated; Magazine Publishers of America; the Outdoor Advertising Association of America, Incorporated; and Point of Purchase Advertising Institute.

*III TABLE OF CONTENTS

Opinions below ... 1

Jurisdiction ... 1

Statutory and regulatory provisions involved ... 2

Statement ... 2

Summary of argument ... 13

Argument:

FDA validly determined that tobacco products are "drugs" and "devices" within the meaning of the Act ... 16

A. FDA's interpretation is supported by the plain language, structure, and drafting history of the drug and device definitions ... 17

B. FDA's interpretation is also supported by FDA's prior regulatory practice and the public health purposes of the Act ... 23

C. FDA's interpretation is consistent with the structure of the Act as a whole ... 30

D. FDA's prior statements, unenacted tobacco bills, and the tobacco-specific statutes enacted long after 1938 do not detract from the reasonableness of FDA's interpretation ... 37

Conclusion ... 49

Appendix ... 1a

TABLE OF AUTHORITIES

Cases:

Action on Smoking and Health v. Harris, 655 F.2d 236 (D.C. Cir. 1980) ... 5, 28, 40

Adams Fruit Co. v. Barrett, 494 U.S. 638 (1990) ... 17

Agnew v. United States, 165 U.S. 36 (1897) ... 4

*IV Banzhaf v. FCC, 405 F.2d 1082 (D.C. Cir. 1968), cert. denied, 396 U.S. 842 (1969) ... 45

Busic v. United States, 446 U.S. 398 (1980) ... 35

Central Bank v. First Interstate Bank, 511 U.S. 164 (1994) ... 42

Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) ... 13, 16, 17, 38

Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992) ... 44

Commodity Futures Trading Comm'n v. Schor, 478 U.S. 833 (1986) ... 17

County of Oneida v. Onieda Indian Nation, 470 U.S. 226 (1985) ... 37

H.J. Inc. v. Northwestern Bell Tel. Co., 492 U.S. 229 (1989) ... 22, 35

INS v. Chadha, 462 U.S. 919 (1983) ... 42

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ... 47, 48

Mississippi Power & Light Co. v. Mississippi ex rel. Moore, 487 U.S. 354 (1988) ... 17

Motor Vehicle Mfrs. Ass'n v. State Farm Mut., 463 U.S. 29 (1983) ... 38, 39, 43

NLRB v. City Disposal Sys., Inc., 465 U.S. 822 (1984) ... 17

National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325 (2d Cir. 1977) ... 28

Oncale v. Sundowner Offshore Servs., Inc., 523 U.S. 75 (1998) ... 22, 35

Pension Benefit Guar. Corp. v. LTV Corp., 496 U.S. 633 (1990) ... 42

Posters 'N' Things v. United States, 511 U.S. 513 (1994) ... 27

Rust v. Sullivan, 500 U.S. 173 (1991) ... 38, 39, 42

Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735 (1996) ... 38, 39

TVA v. Hill, 437 U.S. 153 (1978) ... 35, 37, 44

*V United States v. 354 Bulk Cartons *** Trim Reducing-Aid Cigarettes, 178 F.Supp. 847 (D.N.J. 1959) ... 24

United States v. 46 Cartons, More or Less, Containing Fairfax Cigarettes, 113 F. Supp. 336 (D.N.J. 1935) ... 24

United States v. 789 Cases *** of Latex Surgeons' Gloves, 799 F.Supp. 1275 (D.P.R. 1992) ... 28

United States v. An Article *** Consisting of *** 216 Cartoned Bottles, 409 F.2d 734 (2d Cir. 1969) ... 28

United States v. An Article of Device *** "Cameron Spitler Amblyo- Syntonizer'', 261 F.Supp. 243 (D. Neb. 1966) ... 28

United States v. Bacto-Unidisk, 394 U.S. 784 (1969) ... 21, 22, 23, 29, 34

United States v. Estate of Romani, 523 U.S. 517 (1998) ... 42

United States v. Ron Pair Enters., Inc., 489 U.S. 235 (1989) ... 20

United States v. Rutherford, 442 U.S. 544 (1979) ... 32, 34

United States v. Storage Spaces Designated Nos. "8" & "49", 777 F.2d 1363 (9th Cir. 1985), cert. denied, 479 U.S. 1086 (1987) ... 28

Statutes and regulations:

Alcohol and Drug Abuse Amendments of 1983, Pub. L. No. 98-24, 97 Stat. 178, 42 U.S.C. 290aa et seq. ... 46

42 U.S.C. 290aa-2(b) ... 46

Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act, Pub. L. No. 102-321, 106 Stat. 394 ... 47

Endangered Species Act of 1973, 16 U.S.C. 1531 et seq. ... 37

*VI Energy and Water Development Appropriation Act, Pub. L. No. 96-69, 93 Stat. 449 ... 37

Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 ... 27

Pure Food and Drug Act of 1906, ch. 3915, s 6, 34 Stat. 769 ... 20

Saccharin Study and Labeling Act, Pub. L. No. 95-203, 91 Stat. 1451 ... 36

Federal Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq. ... 2

21 U.S.C. 321(g)(1) ... 2, 18

21 U.S.C. 321(g)(1)(C) ... 13, 18, 21, 25, 35

21 U.C.C. 321(h)(3) ... 2, 13, 18, 21, 25, 35

21 U.S.C. 321(i) ... 18

21 U.S.C. 321(n) ... 26

21 U.S.C. 321(s) (1994 & Supp. III 1997) ... 18

21 U.S.C. 321(ff)(1) ... 18

21 U.S.C. 331(a) ... 31

21 U.S.C. 348(c)(3) ... 36

21 U.S.C. 352(a) ... 26

21 U.S.C. 352(c) ... 26

21 U.S.C. 352(f)(1) ... 36

21 U.S.C. 352(f)(2) ... 36

21 U.S.C. 352(j) ... 31

21 U.S.C. 353(g)(1) ... 2, 36

21 U.S.C. 355(a) ... 31

21 U.S.C. 355(d) ... 31

21 U.S.C. 360c ... 31

21 U.S.C. 360c(a)(2)(C) ... 31-32, 33

21 U.S.C. 360h(e)(1) ... 31

21 U.S.C. 360k(a) ... 47

21 U.S.C. 360k(a)(1) ... 47

21 U.S.C. 360k(b) ... 47

21 U.S.C. 360j(e)(1) ... 3, 10, 11, 31

21 U.S.C. 371(a) ... 16

21 U.S.C. 393(b)(1) ... 2

*VII 21 U.S.C. 393(b)(1) ... 2

21 U.S.C. 393(b)(2)(B) ... 2, 32, 35

21 U.S.C. 393(b)(2)(C) (Supp. III 1997) ... 2, 32, 35

21 U.S.C. 393(d)(2) (1994 & Supp. III 1997) ... 16

Comprehensive Smokeless Tobacco Health Education Act of 1986, 15 U.S.C. 4401 et seq. ... 46

15 U.S.C. 4402(a) ... 46

15 U.S.C. 4402(b) ... 46

15 U.S.C. 4406(a) ... 46

Consumer Products Safety Act, 15 U.S.C. 2052(a)(1)(B) ... 19

Controlled Substances Act, 21 U.S.C. 802(6) ... 19

Fair Packaging and Labeling Act, 15 U.S.C. 1459(a)(1) ... 19

Federal Cigarette Labeling and Advertising Act, 15 U.S.C. 1331 et seq. ... 44

15 U.S.C. 1331 ... 45

15 U.S.C. 1333 ... 44

15 U.S.C. 1334(a) ... 44

Federal Hazardous Substance Act, 15 U.S.C. 1261(f)(2) ... 19

Toxic Substances Control Act, 15 U.S.C. 2602(2)(B)(iii) ... 19

42 U.S.C. 300x-26(a) ... 47

21 C.F.R.:

Section 201.5 ... 27

Section 201.128 ... 27

Section 801.4 ... 27

Section 801.5 ... 27

Section 808.1(d)(2) ... 47

Miscellaneous:

17 Fed. Reg. (1952):

p. 6818 ... 27

*VIII 60 Fed. Reg. (1995):

p. 41,314 ... 3

p. 41,527 ... 30

pp. 41,528-41,531 ... 29

61 Fed Reg. (1996):

p. 44,396 ... 3

p. 44,398 ... 9

p. 44,399 ... 9

p. 44,421 ... 9

p. 44,619 ... 3

pp. 44,400-44,403 ... 2, 36

pp. 44,406-44,407 ... 9

pp. 44,412-44,413 ... 8, 32

p. 44,413 ... 32

p. 44,441 ... 46

p. 44,465 ... 36, 37

p. 44,480 ... 9

p. 44,489 ... 9

pp. 44,544-44,548 ... 8

p. 44,547 ... 47

p. 44,550 ... 48

pp. 44,616-44,617 ... 9

p. 44,617 ... 9

pp. 44,617-44,618 ... 10

p. 44,628 ... 24

p, 44,630 ... 3

p. 44,632 ... 4, 23

pp. 44,634-44,635 ... 4

pp. 44,635-44,636 ... 4

p. 44,636 ... 5

pp. 44,636-44,640 ... 5

pp. 44,664-44,685 ... 3

p. 44,665 ... 23

p. 44,666 ... 3

pp. 44,666-44,670 ... 4

pp. 44,667-44,678 ... 23

pp. 44,686-45,204 ... 3

p. 44,691 ... 4

p. 44,693 ... 27

*IX pp. 44,698-44,701 ... 4

p. 44,700 ... 3

pp. 44,701-44,739 ... 4

p. 44,721 ... 3

pp. 44,739-44,744 ... 4

p. 44,807 ... 5

pp. 44,807-44,846 ... 4

pp. 44,812-44,813 ... 4

pp. 44,826-44,827 ... 5

pp. 44,847-45,097 ... 5

p. 44,851 ... 5

pp. 44,854-44,915 ... 5

p. 44,855 ... 5

p. 44,856 ... 5

p. 44,857 ... 6

p. 44,858 ... 6

p. 44,867 ... 6

p. 44,868 ... 6

p. 44,871 ... 6

p. 44,882 ... 6

p. 44,884 ... 6

p. 44,890 ... 7

p. 44,951 ... 7

pp. 44,951-44,952 ... 7

pp. 44,954-44,957 ... 7

p. 44,963 ... 7

pp. 44,963-44,967 ... 7

pp. 44,970-44,971 ... 7

p. 44,976 ... 7

p. 45,120 ... 7

p. 45,153 ... 27

p. 45,154-45,155 ... 26

p. 45,157 ... 27

p. 45,167 ... 29

p. 45,184 ... 27

pp. 45,172-45,178 ... 7

p. 45,175 ... 8

p. 45,178 ... 8

p. 45,184 ... 27

*X pp. 45,203-45,204 ... 8

p. 45,207 ... 8

pp. 45,208-45,216 ... 8

pp. 45,219-45,252 ... 8

p. 45,222 ... 41

pp. 45,233-45,234 ... 39

pp. 45,234-45,235 ... 39

pp. 45,235-45,236 ... 39

p. 45,237 ... 39

p. 45,228 ... 38

Charles W. Dunn, Federal Food, Drug, and Cosmetic Act (1938) ... 21

H.R. Rep. No. 2139, 75th Cong., 3d Sess. (1938) ... 20

H.R. Rep. No. 853, 94th Cong., 2d Sess. (1976) ... 28

H.R. Rep. No. 2283, 104th Cong., 1st Sess. (1995) ... 43

S. Rep. No. 493, 73d Cong., 2d Sess. (1934) ... 21

S. Rep. No. 361, 74th Cong., 1st Sess. Pt. 1 (1935) ... 20

S. Rep. No. 1295, 104th Cong., 1st Sess. (1995) ... 43

The American Heritage Dictionary of the English Language (2d ed. 1991) ... 5

*1 OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 1a-75a) is reported at 153 F.3d 155. The opinion of the district court (Pet. App. 76a-136a) is reported at 966 F.Supp. 1374. The Food and Drug Administration's jurisdictional determination and final rule concerning tobacco products are published at 61 Fed. Reg. 44,396 (1996), and 61 Fed. Reg. 44,619 (1996). [FN1]

FN1. Copies of the Federal Register notices containing the final rule and jurisdictional determination have been lodged with the Court.

JURISDICTION

The judgment of the court of appeals was entered on August 14, 1998. A petition for rehearing was denied on November 10, 1998. Pet. App. 137a-146a. The petition for a writ of certiorari was filed on January 19, 1999, and was granted on April 26, 1999. The jurisdiction of this Court rests on 28 U.S.C. 1254(1).

*2 STATUTORY AND REGULATORY PROVISIONS INVOLVED

The relevant provisions of the Federal Food, Drug, and Cosmetic Act appear in an appendix to this brief. The tobacco product regulations appear in the appendix to the petition for a writ of certiorari.

STATEMENT

1. The Federal Food, Drug, and Cosmetic Act (Act), ch. 675, 52 Stat. 1040, 21 U.S.C. 301 et seq., confers authority on the Secretary of Health and Human Services, through the Food and Drug Administration (FDA), to regulate """drugs" and "devices" for the purpose of protecting the public health. See 21 U.S.C. 393(b)(1), (2)(B) and (C). The Act defines "drug" as, inter alia, """articles (other than food) intended to affect the structure or any function of the body of man or other animal." 21 U.S.C. 321(g)(1). The Act similarly defines "device" as, inter alia, "an instrument, apparatus, *** contrivance, *** or other similar or related article, including any component, part, or accessory, *** intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body *** and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. 321(h)(3).

The Act recognizes that certain products may constitute a combination of a drug and a device. 21 U.S.C. 353(g)(1). FDA may regulate drug/device combination products by using its authority to regulate drugs, its authority to regulate devices, or both. 61 Fed. Reg. 44,400-44,403 (1996). One provision relating to devices authorizes FDA, by regulation, to "require that a device be restricted to sale, distribution, or use *** upon such *** conditions as [FDA] may prescribe in such regulation, if, because of its potentiality for *3 harmful effect or the collateral measures necessary to its use, [FDA] determines that there cannot otherwise be reasonable assurance of its safety and effectiveness." 21 U.S.C. 360j(e)(1).

2. In response to petitions requesting that FDA regulate tobacco products, FDA conducted an extensive investigation, issued a proposed rule and """jurisdictional" analysis, and invited public comment. 60 Fed. Reg. 41,314 (1995). In August 1996, FDA determined that tobacco products constitute a combination of a "drug" and a "device" and issued regulations directed to those products. 61 Fed. Reg. at 44,396; id. at 44,619.

FDA based its determination that tobacco products are "drugs" and "devices" on two key findings: (a) extensive scientific documentation establishes that the nicotine in tobacco products "affects the structure or any function of the body" because it causes and sustains addiction, and acts as a sedative, stimulant, and appetite suppressant, 61 Fed. Reg. at 44,630, 44,664-44,685; and (b) those effects are "intended" by the manufacturers of tobacco products. Id. at 44,630, 44,686-45,204.

a. In finding that the nicotine in tobacco products affects the structure and function of the body, FDA relied on scientific evidence that nicotine directly affects a part of the brain known as the mesolimbic system, which rewards the repeated consumption of certain pleasurable substances. By increasing the activity of dopamine within that system, nicotine causes the compulsive drug- seeking behavior of drug addiction. 61 Fed. Reg. at 44,700, 44,721. In some circumstances, and in some doses, nicotine in tobacco products acts as a sedative, while in other circumstances and doses, it acts as a stimulant. Id. at 44,666. Studies also show that nicotine can cause weight loss. Ibid. FDA found that those effects on the structure and function of the body are quintessentially drug-like, identical to those FDA has found in numerous *4 other products that it regulates under the Act, including stimulants, tranquilizers, appetite suppressants, nicotine replacement products, and narcotics used to treat addiction. Id. at 44,632, 44,666-44,670.

b. In finding that the effects of tobacco products on the structure and function of the body are "intended," FDA drew on three categories of evidence.

First, FDA found that nicotine's widely recognized addictive properties make it foreseeable to any reasonable manufacturer that a substantial proportion of users of tobacco products will consume them to satisfy their addiction. 61 Fed. Reg. at 44,701-44,739. FDA also found that nicotine's mood-altering effects and its effects on weight are so well established that a reasonable manufacturer would foresee that tobacco products would be used by a substantial proportion of consumers for those purposes as well. Id. at 44,63 4- 44,635, 44,698-44,701, 44,739-44,744. Those findings, FDA determined, are sufficient in themselves to meet the statutory standard of "intended" effects, because "[i]t is a widely accepted legal principle that persons can be held to '"intend' the reasonably foreseeable consequences of their actions." Id. at 44,691 (citing, inter alia, Agnew v. United States, 165 U.S. 36, 53 (1897) ( """The law presumes that every man intends the legitimate consequence[s] of his own acts.")).

Second, FDA found that consumers do in fact use tobacco products predominantly for pharmacological purposes. 61 Fed. Reg. at 44,635-44,636, 44,807-44,846. As many as 92% of all cigarette smokers and 75% of all young persons who regularly use smokeless tobacco consume those products because they are addicted to the nicotine in them. Id. at 44,635-44,636. Indeed, the percentage of smokers addicted to nicotine is higher than the percentage of heroin and cocaine users addicted to those drugs. Id. at 44,812-44,813. More than 70% of young daily smokers and 50% of young *5 daily smokeless tobacco users consume tobacco products to obtain their mood-altering effects. Id. at 44,636. As many as one-half of young persons who smoke do so to control their weight. Ibid. Although some people also use tobacco products for their taste or because they like the ritual, those purposes are clearly secondary. Id. at 44,807, 44,826-44,827. FDA determined that, "[w]here consumers use a product predominantly or nearly exclusively to obtain any of the effects on the structure or function of the body produced by a substance, such evidence would alone be sufficient to establish manufacturer intent." Id. at 44,807 (citing Action on Smoking & Health v. Harris, 655 F.2d 236, 239-240 (D.C. Cir. 1980)).

Third, FDA relied on statements, research, and actions of the manufacturers themselves, which showed that the manufacturers intend their products to affect the structure and function of the body. 61 Fed. Reg. at 44,847-45,097. That extensive evidence, FDA concluded, satisfies the standard dictionary definitions of "intend," because it shows that manufacturers "have in mind" the pharmacological effects and uses of their tobacco products and "design" them to enhance those effects and uses. Id. at 44,851 & n.413 (quoting, inter alia, The American Heritage Dictionary of the English Language 668 (2d ed. 1991)).

FDA cited recently discovered evidence that the leading tobacco manufacturers have long known that consumers use tobacco products to obtain the pharmacological effects of nicotine. 61 Fed. Reg. at 44,636-44,640, 44,854- 44,915. For example, as early as 1969, the vice president for research and development for Philip Morris informed the board of directors that "the ultimate explanation for the perpetuated cigaret habit resides in the pharmacological effect of smoke upon the body of the smoker." Id. at 44,855. In the ensuing decades, Philip Morris researchers described a cigarette as "a dispenser for a dose unit of nicotine," id. at 44,856, *6 observed that cigarettes serve as "a narcotic, tranquilizer, or sedative," id. at 44,857, characterized nicotine as "a powerful pharmacological agent with multiple sites of action," ibid., and reported that "it is well recognized within the cigarette industry that there is one principal reason why people smoke --to experience the effects of nicotine, a known pharmacologically active constituent in tobacco," id. at 44,858.

Similarly, a memorandum from the early 1970s shows that R.J. Reynolds (RJR) scientists regarded nicotine as a "potent" and "habit-forming" drug, considered cigarettes to be "a vehicle for delivery of nicotine," and conceived of the tobacco industry itself as "a specialized, highly ritualized and stylized segment of the pharmaceutical industry." 61 Fed. Reg. at 44,867. The memorandum also stated that "the confirmed user of tobacco products is primarily seeking the physiological 'satisfaction' derived from nicotine," and that "what we are really selling [is] nicotine satisfaction." Id. at 44,868. RJR researchers later reiterated that "[w]ithout any question, the desire to smoke is based on the effect of nicotine on the body," that "a confirmed smoker attempts to get a certain desired level of nicotine," and that "[t]he nicotine in the blood acts upon the central nervous system and produces in the average smoker a sensation one could describe as either stimulating or relaxing." Id. at 44,871.

In the 1960s, a senior advisor to the board of British American Tobacco Company (BATCO), the parent company of Brown & Williamson, stated that "smoking is a habit of addiction," and that "nicotine is a very remarkable beneficent drug that both helps the body to resist external stress and also can as a result show a pronounced tranquillising effect." 61 Fed. Reg. at 44,882. During the same period, Brown & Williamson's general counsel stated that """nicotine is addictive" and that "[w]e are, then, in the business of selling nicotine, an addictive drug." Id. at 44,884. BATCO researchers also stated that "puffing behaviour is the means *7 of providing nicotine dose in a metered fashion." Id. at 44,890.

FDA further found that cigarette manufacturers acted on the basis of their statements and research concerning the pharmacological effects of tobacco products. In particular, FDA found that "[m]anufacturers of commercially marketed cigarettes commonly manipulate nicotine deliveries to provide remarkably precise, pharmacologically active doses of nicotine to consumers." 61 Fed. Reg. at 44,951. Such manipulation is especially evident in low-tar cigarettes, which make up 80% of the cigarette market. Id. at 44,951-44,952. As tar levels are reduced, nicotine levels naturally fall. Id. at 44,976. To counteract that effect and to provide an active dose of nicotine in low-tar cigarettes, manufacturers use tobacco blends with higher nicotine content, id. at 44,954-44,957, ventilation systems that remove more tar than nicotine from smoke, id. at 44,963-44,967, and chemical additives that increase the amount of pharmacologically active nicotine in the smoke, id. at 44,970-44,971.

FDA likewise found evidence that manufacturers of smokeless tobacco manipulate nicotine deliveries. They market "starter" brands that have a low level of nicotine, so that new users may develop a tolerance for nicotine without experiencing nausea or vomiting. 61 Fed. Reg. at 44,643. They also market regular brands to experienced users that are engineered to deliver the level of nicotine necessary to sustain addiction. Ibid. Through marketing and advertising, manufacturers encourage those who have developed a tolerance for starter brands to graduate to regular brands. Id. at 45,120. [FN2]

FN2. FDA also relied on evidence that tobacco manufacturers advertise that tobacco products will provide "satisfaction." 61 Fed. Reg. at 45,172-45, 178. FDA found that, to the users of tobacco products, the "promise of ' ' 'satisfaction' implies that the product will fulfill their craving for the pharmacological effects of nicotine--satisfying their addiction and providing the sought after mood-altering effects of nicotine." Id. at 45,175. In effect, "manufacturers use 'satisfaction' as a code-word for the pharmacological effects of nicotine." Id. at 45,178.

*8 Finally, although FDA concluded that each of the three categories of evidence just discussed independently supports its determination that manufacturers intend the pharmacological effects and uses of their tobacco products, the cumulative effect and convergence of the evidence "convincingly establishes that cigarettes and smokeless tobacco are 'intended' to affect the structure and function of the body within the meaning of the Act." 61 Fed. Reg. at 45,203-45,204.

c. Having concluded that tobacco products fall squarely within the "drug" and """device" definitions, FDA next examined the structure of the Act as a whole, prior agency statements concerning its authority to regulate tobacco products, Congress's failure to pass legislation that would have expressly authorized FDA to regulate tobacco products, and Congress's enactment of certain tobacco- specific statutes. After carefully evaluating each of those considerations, FDA concluded that none of them detracts from the conclusion that tobacco products are "drugs" and "devices" under the Act. See, e.g., 61 Fed. Reg. at 44,412- 44,413 (structure of the Act); id. at 45,219-45,252 (prior statements); id. at 45,255-45,259 (unenacted legislation); id. at 44,544-44,548, 45,261-45,265 (tobacco-specific statutes).

d. In sum, FDA concluded that the nicotine in tobacco products is a "drug," 61 Fed. Reg. at 45,207, that tobacco products contain "device components" for the delivery of that drug, and that cigarettes and smokeless tobacco therefore are "combination products" under the Act. Id. at 45,208-45,216.

*9 3. a. FDA next determined that tobacco use is the largest cause of preventable death in the United States. 61 Fed. Reg. at 44,398. Tobacco kills more Americans annually than AIDS, car accidents, alcohol, homicides, illegal drugs, suicides, and fires combined. Ibid. FDA also found that tobacco use is a "pediatric disease," id. at 44,421, because most people who use tobacco as adults began smoking regularly during childhood. If adolescents can be kept tobacco-free, most will never start using tobacco as adults. Id. at 44,399. Efforts to prevent childhood tobacco use, however, have not been successful thus far. Approximately one million children begin to smoke every year. Id. at 44,568. One of every three young people who become regular smokers will die prematurely from a tobacco-related disease. Id. at 44,399.

b. Because most tobacco-related addiction begins in childhood, FDA issued regulations aimed at reducing the use of tobacco products by young people. It adopted access restrictions that, inter alia: (1) prohibit the sale of tobacco products to persons under age 18; (2) require retailers to check the identification of persons under age 27; and (3) prohibit vending machine sales and self-service displays of tobacco products except in adult-only locations. 61 Fed. Reg. at 44,616-44,617. FDA also issued regulations requiring tobacco product labeling to bear the established name of the product (e.g., """cigarettes") and the statement, "Nicotine-Delivery Device for Persons 18 or Older." Id. at 44,617.

Based on evidence that "advertising plays a material role in the decision of children *** to engage in tobacco use," 61 Fed. Reg. at 44,489, and internal company documents showing the industry's concerted efforts "to attract young smokers" and "presmokers" through advertising, id. at 44,480, FDA concluded that restrictions on the forms of advertising that are most effective in attracting young smokers are necessary to complement the access restrictions. Id. at 44,406-44,407. FDA's advertising and promotion *10 restrictions include: (1) a requirement that advertisements appear in black-and-white, text- only format, except in adult publications and adult-only facilities; (2) a ban on outdoor advertising within 1000 feet of schools and public playgrounds; (3) a prohibition on the sale or distribution of hats, t-shirts, and other similar promotional products that bear a tobacco product brand name or logo; and (4) a prohibition on sponsorship of athletic, cultural, or other events in a tobacco brand name. Id. at 44,617-44,618. In adopting its access, labeling, and advertising restrictions, FDA invoked its authority under 21 U.S.C. 360j(e)(1) to place conditions on the sale, distribution, and use of a device if FDA determines that "there cannot otherwise be reasonable assurance of its safety and effectiveness."

4. Respondents (tobacco companies, advertisers, and retailers) brought suit in the United States District Court for the Middle District of North Carolina, challenging the validity of FDA's tobacco product regulations. Respondents moved for summary judgment, arguing that: (1) FDA lacks statutory authority to regulate tobacco products that are marketed without claims of therapeutic value; (2) FDA lacks statutory authority to regulate advertising of tobacco products; and (3) FDA's advertising restrictions violate the First Amendment. For purposes of their summary judgment motion, respondents accepted as true the facts found by FDA concerning the effects of tobacco products on the human body, and the intent of the manufacturers to cause those effects. Pet. App. 77a-78a n.1.

The district court granted in part and denied in part respondents' motion for summary judgment. Pet. App. 76a-134a. The district court first held that FDA had lawfully concluded that tobacco products are subject to regulation as """drugs" and "devices." Id. at 80a-126a. The court reasoned that, given FDA's finding that tobacco products are intended to cause and sustain addiction and to act as a stimulant, *11 sedative, and weight regulator, tobacco products fit squarely within the Act's definitions of "drug" and "device." Id. at 81a, 104a-116a. The court concluded that FDA's previous statements concerning its authority to regulate tobacco products, Congress's failure to enact bills that would have expressly authorized FDA to regulate tobacco products, and the tobacco-specific statutes enacted after 1938 do not detract from the reasonableness of FDA's conclusion that tobacco products are drugs and devices under the Act. Id. at 84a-101a.

The district court upheld FDA's restrictions on minors' access to tobacco products as a valid exercise of FDA's authority under 21 U.S.C. 360j(e)(1) to impose conditions on the "sale, distribution, or use" of "devices." Pet. App. 133a. It also upheld FDA's labeling requirements. Id. at 134a. The court concluded, however, that FDA's advertising and promotion restrictions are not authorized by Section 360j(e). Id. at 127a-133a. The district court certified all of its rulings for interlocutory appeal, id. at 135a, and the court of appeals accepted that certification, id. at 11a.

5. a. In a 2-1 decision, a panel of the Fourth Circuit reversed, Pet. App. 1a- 75a, holding that "FDA lacks jurisdiction to regulate tobacco products," and that "all of the FDA's August 28, 1996 regulations *** are thus invalid," id. at 11a-12a. The majority acknowledged that the plain meaning of the drug and device provisions "may appear to support the government's position that tobacco products fit within the Act's definitions of drugs or devices." Id. at 19a. The majority determined, however, that FDA could not rely on the definitional provisions, because, in its view, tobacco products do not fit into the Act's overall regulatory scheme. Id. at 20a-30a.

The majority concluded that, under 21 U.S.C. 360j(e), FDA has a responsibility to determine that there is a reasonable assurance of safety of a product that it declines to *12 ban completely from the market. Pet. App. 21a-22a. Because FDA found tobacco products to be dangerous, the majority concluded, FDA's failure to prohibit the sale of such products does not "comply with the terms of the very statutory provision it has chosen as its basis for regulation." Id. at 23a. The majority further concluded that, given FDA's finding that tobacco products are not safe, several other provisions of the Act would require FDA to ban the sale of tobacco products, a result the majority found to be in conflict with what it perceived to be Congress's intent. Id. at 23a-30a. The majority concluded that "FDA's need to maneuver around the obstacles created by the operative provisions of the Act reflects congressional intent not to include tobacco products within the scope of the FDA's authority." Id. at 29a-30a. The majority also concluded that FDA's previous statements concerning the circumstances in which it would regulate tobacco products, Congress's failure to enact bills that would have expressly authorized FDA to regulate tobacco products, and the tobacco-specific statutes enacted since 1938 all corroborate that Congress did not intend the original grant of authority to FDA to include regulation of tobacco products. Id. at 31a-52a.

b. Judge Hall dissented. Pet. App. 55a-75a. Observing that the "record contains voluminous evidence of the pharmacological effects of nicotine," id. at 57a, and that such effects are "intended" by tobacco manufacturers, id. at 57a-59a, he concluded that "[t]obacco products fit comfortably into the [Act's] definitions of 'drug' and 'device,"DD' id. at 55a. Judge Hall rejected the majority's view that FDA's failure to prohibit the sale of tobacco products, despite finding them to be dangerous, demonstrates that tobacco products are not covered by the Act. Id. at 60a-61a. He reasoned that "[h]ow the FDA has chosen to regulate tobacco has no bearing on the question of whether the agency has the authority to regulate it at all." Ibid. Judge Hall similarly disagreed with *13 the majority's reliance on FDA's prior decisions and statements regarding its authority to regulate tobacco products. Id. at 63a-65a. He pointed out that "an agency can change its view of what action is possible or necessary, particularly when new facts come to light." Id. at 64a. Here, he explained, FDA had a strong basis for changing its position because of new evidence that "nicotine is extremely addictive and that a large majority of tobacco users use the product to satisfy that addiction," and, even more important, because of new evidence that "manufacturers design their products to sustain such addiction." Id. at 65a. Judge Hall also disagreed with the majority's reliance on unenacted bills, concluding that any inference that could be drawn from that experience was offset by Congress's inaction following FDA's announcement of its proposed rule to regulate tobacco products. Id. at 61a n.1. Finally, Judge Hall concluded that the "tobacco-specific" statutes cited by the majority address narrow subjects and fall far short of showing that Congress intended to prevent FDA from exercising regulatory authority over tobacco products. Id. at 65a-70a.

SUMMARY OF ARGUMENT

The Food and Drug Administration reasonably concluded that tobacco products are drugs and devices subject to regulation under the Act. Under Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), FDA's conclusion is entitled to controlling weight.

A. The Federal Food, Drug, and Cosmetic Act defines "drug" and "device" to include products "intended to affect the structure or any function of the body," 21 U.S.C. 321(g)(1)(C) and (h)(3), and it does not exempt tobacco products from those definitions. Given FDA's finding that the nicotine in tobacco products is intended by manufacturers to sustain addiction and to act as a sedative, stimulant, and *14 appetite suppressant, tobacco products plainly qualify as drugs and devices under the Act.

B. Tobacco products also have the classic characteristics of drugs and devices subject to regulation under the Act: They are taken within the human body, they deliver a pharmacologically active substance to the bloodstream, and they have potentially dangerous effects. Moreover, the intended pharmacological effects of tobacco products mirror those of numerous other products that FDA regulates, including tranquilizers, stimulants, weight-loss products, nicotine replacement products, and narcotics used to treat addiction.

Respondents' argument that tobacco products cannot be drugs or devices unless they are accompanied by express claims of therapeutic value is without merit. The text of the Act makes "intended" effects, not "market claims," the decisive factor. When, as here, consumers use a product predominantly for its pharmacological effects, manufacturers know that is why consumers use their products, and manufacturers manipulate the content of the product in order to promote those uses, an intent to affect the structure or function of the body is clearly established. FDA has regulated other products intended to affect the structure or function of the body, despite the absence of explicit market claims, and there is no principled basis for treating tobacco products differently.

C. The court of appeals' view that tobacco products cannot be drugs or devices, because if they were, they would have to be banned, is incorrect. The Act authorizes FDA to permit the continued marketing of drugs and devices, subject to regulation, when it finds that the dangers of banning the product outweigh the benefits. FDA reasonably determined that, with respect to adults, the dangers of banning tobacco from the market outweigh the benefits, because a ban would leave many users with untreatable *15 symptoms of withdrawal, and would predictably lead to the use of more dangerous black market products. If the Court were to overturn FDA's judgment concerning the risks and benefits of leaving tobacco products on the market, however, that would simply mean that the Act, as presently written, requires tobacco products to be banned. That consequence would in no way undermine FDA's conclusion that tobacco products are intended to affect the structure or function of the body and are therefore drugs and devices subject to regulation under the Act.

D. Until FDA issued the regulations at issue here, the only instances in which it had found that tobacco products were intended to affect the structure or function of the body involved cases in which there were express market claims of therapeutic value. An agency is always free to change its position on an issue, however, as long as it provides a reasoned explanation justifying the change, and FDA provided such a reasoned explanation here. FDA's conclusion that tobacco products are intended to affect the structure or function of the body, regardless of whether manufacturers make express claims of therapeutic value, is based on overwhelming new evidence that nicotine is addictive, that consumers use tobacco products primarily to satisfy addiction and for its mood- altering effects, that manufacturers know that consumers use their products primarily for those purposes, and that manufacturers have engineered their products to deliver pharmacologically active doses of nicotine.

Nor is it significant that Congress has failed to enact bills that would have expressly authorized FDA to regulate tobacco products. The Constitution requires Congress to express its will through enacted legislation, not unenacted bills. Congress's failure to enact bills that would have expressly authorized FDA to regulate tobacco products therefore has no more bearing on the question presented in this case than does Congress's failure to enact other bills *16 that would have excluded tobacco products from the reach of the Act.

Finally, the tobacco-specific statutes enacted long after 1938 do not affect the question presented here. Those statutes address narrow issues, such as what warning labels should be placed on cigarette packages. None of those statutes exempts tobacco products from the reach of the Federal Food, Drug, and Cosmetic Act, and none of them remotely implies that FDA altogether lacks authority to regulate tobacco products.

ARGUMENT

THE FOOD AND DRUG ADMINISTRATION VALIDLY DETERMINED THAT TOBACCO PRODUCTS ARE """DRUGS" AND "DEVICES" WITHIN THE MEANING OF THE ACT

After the most extensive rulemaking hearing in its history, the Food and Drug Administration determined that the nicotine in tobacco products is intended by tobacco manufacturers to cause and sustain addiction and to act as a stimulant, sedative, and appetite suppressant. The sole question presented in this case is whether, given that finding, FDA validly determined that tobacco products are subject to regulation as "drugs" and "devices" under the Act.

Because Congress has conferred on FDA the authority to administer the Act, 21 U.S.C. 393(d)(2) (1994 & Supp. III 1997), and to issue regulations to carry out its purposes, 21 U.S.C. 371(a), FDA's conclusion that tobacco products are drugs and devices is subject to review under the standard set forth in Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). Under Chevron, unless Congress has "unambiguously expressed [its] intent" and "directly addressed the precise question at issue," the question for a court is whether the agency's view is based on *17 a """permissible construction" of the Act. Id. at 843. That means that "a court may not substitute its own construction of a statutory provision for a reasonable interpretation made by the administrator of an agency." Id. at 844. Rather, when the agency "fills a gap or defines a term in a way that is reasonable in light of the legislature's revealed design," a court must give the agency's view "controlling weight." Ibid. As we now demonstrate, FDA reasonably concluded that tobacco products are subject to regulation under the Act as "drugs" and "devices." The Court should therefore give FDA's interpretation controlling weight. [FN3]

FN3. The court of appeals appeared to question the applicability of Chevron for two reasons. First, the court noted (Pet. App. 16a) that, under Adams Fruit Co. v. Barrett, 494 U.S. 638, 649 (1990), "[a] precondition to deference under Chevron is a congressional delegation of administrative authority," suggesting that the court believed that such a delegation is absent here. Adams Fruit holds that an agency is not entitled to deference when it does not have authority to enforce the statutory provision at issue. Ibid. Because Congress has conferred authority on FDA to regulate drugs and devices, Adams Fruit is inapplicable here. Second, the Fourth Circuit suggested (Pet. App. 16a) that an agency is entitled to diminished deference when it attempts "to expand the scope of its jurisdiction." As long as an agency is reasonably interpreting a statutory provision it enforces, however, Chevron deference applies. It is not relevant whether the agency's proposed interpretation can be said to affect its jurisdiction. Chevron, 467 U.S. at 844 (an agency is entitled to deference on the "reach of a statute" it is authorized to enforce). See Commodity Futures Trading Comm'nv. Schor, 478 U.S. 833, 844-845 (1986); NLRB v. City Disposal Sys., Inc., 465 U.S. 822, 830 n.7 (1984); see also Mississippi Power & Light Co. v. Mississippi ex rel. Moore, 487 U.S. 354, 380-382 (1988) (Scalia, J., concurring) (collecting cases).

A. FDA's Interpretation Is Supported By The Plain Language, Structure, And Drafting History Of The Drug And Device Definitions

1. Rather than identifying specific products that FDA may regulate as "drugs" and "devices," Congress enacted *18 comprehensive definitions of those terms. Products that fall within those definitions, unless expressly exempted, are subject to the Act's regulatory regime. The Act defines "drug" as:

(A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph.

21 U.S.C. 321(g)(1) (emphasis added). The Act similarly defines "device" as, inter alia, "an instrument, apparatus, *** contrivance, *** or other similar or related article, including any component, part, or accessory, *** intended to affect the structure or any function of the body of man or other animal, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. 321(h)(3).

Significantly, the Act does not exempt tobacco from the drug and device definitions. In contrast, the Act does specifically exclude "food" from the very "structure-function" definition of "drug" at issue here, 21 U.S.C. 321(g)(1)(C), and exempts "tobacco" itself from the definition of "dietary supplement," 21 U.S.C. 321(ff)(1). See also 21 U.S.C. 321(i) (exempting """soap" from the definition of "cosmetic"; 21 U.S.C. 321(s) (1994 & Supp. III 1997) (exempting "pesticides" in certain circumstances from the definition of *19 "food additive"). Congress has also specifically exempted tobacco products from many other laws, including the Federal Hazardous Substances Act, 15 U.S.C. 1261(f)(2), the Fair Packaging and Labeling Act, 15 U.S.C. 1459(a)(1), the Consumer Products Safety Act, 15 U.S.C. 2052(a)(1)(B), the Toxic Substances Control Act, 15 U.S.C. 2602(2)(B)(iii), and the Controlled Substances Act, 21 U.S.C. 802(6). Accordingly, the overwhelming implication from the text and structure of the "drug" and "device" definitions is that tobacco products, like all other products not specifically exempted, are subject to regulation as "drugs" and "devices" if they are "intended to affect the structure or any function of the body." 21 U.S.C. 321(g)(1)(C) and (h)(3).

2. Given the extensive evidence before FDA, and FDA's findings based on that evidence, tobacco products plainly qualify as "drugs" and "devices" under that statutory standard. The evidence established that: (1) nicotine in tobacco products causes and sustains addiction and acts as a sedative, stimulant, and appetite suppressant; (2) most persons who use tobacco products do so in order to obtain those effects; (3) tobacco manufacturers know that most consumers use their products for those purposes; (4) tobacco manufacturers themselves characterize nicotine as a powerful drug and cigarettes as a vehicle for delivering nicotine; (5) the manufacturers design their products to deliver pharmacologically active doses of nicotine; and (6) the manufacturers market their products with claims that they will provide "satisfaction," a "code-word" for the pharmacological effects of nicotine. See pp. 3-8, supra. Based on that compelling evidence, FDA found that the nicotine in tobacco products is intended by manufacturers to cause and sustain addiction, and to act as a sedative, stimulant, and appetite suppressant. In light of that critical finding, tobacco products fit squarely within the "drug" and "device" definitions--they are, without question, "intended to affect the structure or any function *20 of the body." 21 U.S.C. 321(g)(1)(C) and (h)(3). Thus, the plain language of the Act, which is the starting point in resolving any question of statutory construction, United States v. Ron Pair Enters., Inc., 489 U.S. 235, 241 (1989), provides powerful support for FDA's conclusion that tobacco products are "drugs" and "devices" under the Act.

3. The history of the Act provides additional support for FDA's conclusion. Before the Act was passed in 1938, the Pure Food and Drugs Act defined "drug" to include "articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them," and "any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals." Pure Food and Drugs Act of 1906, ch. 3915, s 6, 34 Stat. 769. In the 1938 Act, Congress expanded the definition of """drug" to include "articles (other than food) intended to affect the structure or any function of the body of man or other animals." s 201, 52 Stat. 1041. The new Act also added a parallel definition of "device." Ibid. Congress enacted the new definitions because existing law "contain[ed] serious loopholes" and was "not sufficiently broad in its scope to meet the requirements of consumer protection under modern conditions." H.R. Rep. No. 2139, 75th Cong., 3d Sess. 1 (1938). Congress was particularly concerned about dangerous and ineffective weight-loss products that had escaped regulation under the old drug definition. S. Rep. No. 361, 74th Cong., 1st Sess. Pt. 1, at 239 (1935). Congress understood, however, that the Act would reach well beyond weight-loss products and cover other products intended to affect the structure or function of the body. See H.R. Rep. No. 2139, supra, at 2 ("Drugs intended for diagnosing illness or for remedying underweight or overweight or for otherwise affecting bodily structure or function are subjected to regulation.").

*21 The drafting history of the drug and device definitions provides compelling evidence that the definitions were intended to have a scope that is as broad as their language prescribes. Early versions of the bill had included """devices intended to affect the structure or function of the body" within the definition of "drug." S. Rep. No. 493, 73d Cong. 2d Sess. 2 (1934). In hearings on one of those bills, a Member of Congress asked the FDA Administrator whether the drug definition would include "ultraviolet lights and various instruments of that sort." Charles W. Dunn, Federal Food, Drug, and Cosmetic Act, App. B at 1053 (1938). The Administrator responded that it would, because the portion of the "drug" definition that encompassed "devices" was "admittedly an inclusive, *** wide definition." Ibid. The Administrator added that the definition would also encompass belts used for therapeutic purposes, explaining that "[t]his definition of 'drugs' is all-inclusive." Id. App. C at 1126-1127. Members of Congress later expressed concern that the device portion of the drug definition was so broad as to reach shoulder braces, radium belts, electrical devices, bathroom weight scales, hospital air conditioners, and crutches. United States v. Bacto-Unidisk, 394 U.S. 784, 795-796 (1969) (citing relevant debates). The members did not object to the regulation of such products under the Act; instead, they objected to the characterization of such products as drugs. Id. at 796-797. In response to that narrow concern, the bill was amended to remove devices from the drug definition and to create a separate definition of "device" that paralleled the new definition of drug. Ibid. That solution eliminated the awkwardness of referring to electric belts and therapeutic lamps as drugs, while preserving the bill's broad scope. Ibid.

The statutory background and drafting history of the Act show that Congress understood that the definitions of "drug" and "device" would determine what products would *22 be subject to regulation under the Act, and that the scope of those definitions was intended to be coextensive with their plain language, reaching many products that had not been subject to regulation before. Accordingly, they firmly support FDA's reliance on the plain language of the "drug" and "device" definitions in concluding that, given their intended pharmacological effects, tobacco products are subject to regulation under the Act. [FN4]

FN4. As the court of appeals noted (Pet. App. 32a), there is no discussion in the legislative history of the 1938 Act concerning whether tobacco products would or would not be covered as drugs or devices. But that is hardly surprising. At the time, there was not public evidence that the nicotine in tobacco products was intended by manufacturers to cause and sustain addiction and to act as a sedative, stimulant, and appetite suppressant. Moreover, as the discussion in the text demonstrates, Congress deliberately drafted comprehensive definitions of drug and device, and it is that intent, rather than Congress's understanding of the specific products that would be encompassed by those definitions, that is controlling. See Oncale v. Sundowner Offshore Servs., Inc., 523 U.S. 75, 79 (1998) (Since "it is ultimately the provisions of our laws rather than the principal concerns of our legislators by which we are governed," it is irrelevant whether the members of Congress who enacted Title VII would have regarded male-on-male sexual harassment as a form of discrimination prohibited by Title VII.); H.J. Inc. v. Northwestern Bell Tel. Co., 492 U.S. 229, 248 (1989) (While "[t]he occasion for" the enactment of the RICO statute was "the perceived need to combat organized crime," Congress "chose to enact a more general statute."). See also note 7, infra.

4. This Court's decision in Bacto-Unidisk also provides significant support for FDA's analysis. The question in that case was whether an antibiotic sensitivity disc used to determine which antibiotic should be used in treatment of a particular patient was a "drug" under the Act. 394 U.S. at 784. The disc satisfied the literal definition of "drug," because it was intended for use in the cure, mitigation, or treatment of disease. Id. at 792. The lower courts had held, however, that the drug definition should be construed to *23 reach only those products that satisfy the medical definition of a drug. Ibid. This Court squarely rejected that interpretation and held that the disc was a "drug" within the meaning of the Act. Relying on the text of the Act and the drafting history discussed above, the Court concluded that "the word 'drug' is a term of art for purposes of the Act, encompassing far more than the strict medical definition of that word." Id. at 793. The Court further explained that "[t]he historical expansion of the definition of drug, and the creation of a parallel concept of devices, clearly show *** that Congress fully intended that the Act's coverage be as broad as its literal language indicates--and equally clearly broader than any strict medical definition might otherwise allow." Id. at 798. Bacto-Unidisk therefore fully supports FDA's reliance on the plain language of the drug and device definitions for its conclusion that, in light of their intended pharmacological effects, tobacco products are drugs and devices under the Act.

B. FDA's Interpretation Is Also Supported By FDA's Prior Regulatory Practice And The Public Health Purposes Of The Act

1. FDA's conclusion that tobacco products are subject to regulation as drugs and devices is also supported by FDA's prior regulatory practice and the public health purposes of the Act. As FDA has explained, the intended pharmacological effects of tobacco products mirror those of numerous other products that FDA regulates, including tranquilizers, stimulants, weight-loss products, and narcotics used to treat addiction. See 61 Fed. Reg. at 44,632, 44,667- 44,678. FDA also regulates the sale of other products containing nicotine, such as nicotine patches, nicotine chewing gum, and nicotine nasal spray, and the pharmacological effects of nicotine in tobacco products are far more powerful than those in the other nicotine-containing products. Id. at 44,665.

*24 Significantly, moreover, tobacco products have the classic characteristics of drugs and devices subject to regulation under the Act: Tobacco products are taken within the human body, they deliver a pharmacologically active substance to the bloodstream, and they have potentially dangerous effects. 61 Fed. Reg. at 44,628. The resemblance of tobacco products to other products regulated as drugs and devices by the FDA has not escaped the attention of tobacco manufacturers. In their own research, market planning, and deliberations, the manufacturers have referred to the nicotine in tobacco as a drug, to cigarettes as a vehicle for the delivery of nicotine, and to the tobacco industry as a segment of the pharmaceutical industry. See pp. 5-7, supra. Because of the similarity between tobacco products and other products regulated by FDA, it is not surprising that FDA has previously regulated tobacco products when it has found sufficient evidence that they were intended to affect the structure or any function of the body, see United States v. 354 Bulk Cartons *** Trim Reducing-Aid Cigarettes, 178 F. Supp. 847, 851 (D.N.J. 1959), or that they were intended to treat or prevent disease, see United States v. 46 Cartons, More or Less, Containing Fairfax Cigarettes, 113 F. Supp. 336, 338-339 (D.N.J. 1953).

2. Respondents have sought to distinguish the products regulated by FDA that have pharmacological effects similar to those of tobacco products on the ground that those products are sold with express therapeutic claims. That distinction, in respondents' view, also explains why it was appropriate for FDA to regulate tobacco products in the two cigarette cases cited above. Under respondents' theory, tobacco products would be subject to FDA regulation only if tobacco manufacturers suddenly decided on a policy of full public disclosure and made express representations that their products cause and satisfy addiction and are intended to be used as a sedative, stimulant, and appetite suppressant.*25 But as long as they refrain from making such claims, respondents argue, tobacco products are not subject to the Act. That remains true, under respondents' theory, even when, as here, there is overwhelming evidence that consumers use tobacco products as sedatives, stimulants, and appetite suppressants and to maintain addiction; that those characteristics of tobacco products are so well known as to render them unquestionably foreseeable to the manufacturers of the products; and that the manufacturers of the products in fact act keenly aware of those effects and uses and manipulate the nicotine content of their products to promote them.

In these circumstances, the pervasive knowledge and conduct on the part of both manufacturers and consumers serve the same function as labeling or other express representations by the manufacturers in identifying the intended effects and uses of the product, thereby rendering any such representations unnecessary. It would be ironic indeed, and contrary to the fundamental public health purposes of the Act, to conclude that a product is altogether excluded from regulation under the comprehensive terms of the Act precisely because its basic drug-like qualities are so well documented, widely known, and thoroughly embedded in the behavior of consumers and manufacturers as to render express claims to that effect superfluous. And, not surprisingly, respondents' view that FDA must blind itself to compelling evidence that a product is intended to affect the structure or function of the body simply because a manufacturer has not made any express claims of therapeutic value is at odds with the text of the Act, longstanding FDA regulations, the legislative history of the Medical Devise Amendments of 1976, lower court decisions, and FDA's regulatory practice.

The text of the Act makes "intended" effects, not "market claims," the decisive factor. 21 U.S.C. 321(g)(1)(C) and (h)(3). *26 While market claims are one important way in which a product's intended effects may be established, they are not the only way. As the present case so clearly shows, other circumstances can establish that a product is intended to affect the structure or function of the body. Nothing in the text of the operative definitions bars FDA from relying on such evidence. Moreover, if Congress had wished to establish the statutory standard respondents propose, it could have used terms such as "promoted to," "labeled to," "advertised to," or """represented to" instead of "intended to." Congress used such terms in other provisions of the Act. 21 U.S.C. 321(n) (misbranding may result from """representations" made in "labeling or advertising"); 21 U.S.C. 352(a) (a drug is misbranded if its "labeling" is false or misleading); 21 U.S.C. 352(c) (a drug is misbranded unless its "advertisements and other descriptive printed matter" contain certain true statements). Congress's failure to use those terms in the drug and device definitions is therefore significant: It shows that Congress understood the difference between intended effects and claimed effects, and that it deliberately chose the more comprehensive """intended to affect" formulation to define the products subject to coverage under the Act. See 61 Fed. Reg. at 45,154-45,155.

Consistent with that understanding, FDA regulations that have been in effect for more than four decades provide that "intended use" (or words to that effect) refer to "the objective intent of the persons legally responsible for labeling," and may be determined not only by "labeling claims" and "advertising matter," but also by (1) other "oral or written statements" made by persons legally responsible for the labeling; (2) "the circumstances surrounding the distribution of the article"; (3) "the circumstances that the article is, with the knowledge of [the responsible persons], *** offered and used for a purpose for which it is neither labeled nor advertised"; and (4) evidence that "a manufacturer *27 knows, or has knowledge of facts that would give him notice" that a drug or device "is to be used" for purposes other than those for which the manufacturer offered the products. 21 C.F.R. 201.128 (drug); 21 C.F.R. 801.4 (device). [FN5] FDA has further explained that its "objective intent" standard means that FDA will consider all relevant evidence of intent from the perspective of a reasonable fact-finder, and that it is not bound by the intent a manufacturer claims to have. 61 Fed. Reg. at 45,153, 45,184 n.1133. Compare Posters 'N' Things v. United States, 511 U.S. 513, 519-522 (1994) (holding that the phrase "primarily intended for use [with illegal drugs]," which is the definition of "drug paraphernalia" in 21 U.S.C. 857(d), "is to be understood objectively and refers generally to the item's likely use").

FN5. The regulatory definitions quoted in the text, which were first promulgated in 1952 (see 17 Fed. Reg. 6818 (1952)), define "intended use" for purposes of FDA's labeling regulations. The product labeling regulations require adequate labeling for all "intended uses" of a drug or device. See 21 C.F.R. 201.5 (drugs), 801.5 (devices). As FDA explained in its jurisdictional determination concerning tobacco products (61 Fed. Reg. at 44,693 n.23, 45,157), however, it regularly uses the definitions in the product-labeling regulations not only to identify the intended uses of products that are already classified as drugs or devices, but also to determine whether products should be classified as drugs or devices in the first place.

The legislative history of the Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539, in which Congress revised and reenacted the definition of "device" in its current form, see s 3(a)(i)(A), 90 Stat. 575, confirms the soundness of FDA's interpretation of that definition (and the parallel definition of "drug") as not limiting the "intended" effects of a product to those the manufacturer expressly claims. The House Report stated that, although the major new authorities to be conferred on FDA should be limited to devices intended for human use,

*28 [t]his is not to say *** that a manufacturer of a device that is banned by the Secretary [for human use] can escape the ban by labeling the device for veterinary use. The Secretary may consider the ultimate destination of a product in determining whether or not it is for human use, just as he may consider actual use of a product in determining whether or not it is a device.

H.R. Rep. No. 853, 94th Cong., 2d Sess. 14 (1976) (emphasis added).

Lower courts likewise have agreed that a manufacturer's intent with respect to effects or use may be determined on the basis of all relevant circumstances, including consumer use, not simply a manufacturer's market claims. National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325, 334 (2d Cir. 1977) (intent may be determined from any relevant source, including consumer use); United States v. An Article *** Consisting of *** 216 Cartoned Bottles, 409 F.2d 734, 739, 742 (2d Cir. 1969) (the intended use of a product may be determined from its label, accompanying labeling, promotional material, advertising and any other relevant source, including consumer use); United States v. Storage Spaces Designated Nos. "8" & "49", 777 F.2d 1363, 1366 (9th Cir. 1985), (manufacturer intent may be derived from any relevant source), cert. denied, 479 U.S. 1086 (1987); Action on Smoking & Health v. Harris, 655 F.2d 236, 239-240 (D.C. Cir. 1980) (ASH) (consumer use can be relevant in determining manufacturer intent); see also United States v. 789 Cases *** of Latex Surgeons' Gloves, 799 F. Supp. 1275, 1285, 1294-1295 (D.P.R. 1992); United States v. An Article of Device *** "Cameron Spitler Amblyo-Syntonizer'', 261 F. Supp. 243, 245 (D. Neb. 1966). From a public health perspective, no other result could be justified. The risks to the public health and the appropriateness of regulation under the Act exist regardless of whether intended effects *29 are established through market claims or by other evidence. See Bacto-Unidisk, 394 U.S. at 798 (the Act is to be given a construction "consistent with the Act's overriding purpose to protect the public health").

Finally, in its administration of the Act, FDA has treated products intended to affect the structure or function of the body as drugs or devices, despite the absence of express market claims of therapeutic value. For example, FDA took enforcement action against "caine," a product that contained anesthetic powders and that was often marketed as incense. FDA found that "caine" was intended to be used as a drug, based on a laboratory analysis of its ingredients, its sale in "head shops," and "street" information that it provided a "cheap high." 61 Fed. Reg. at 45,167. Similarly, FDA took enforcement action against "khat," a shrub whose leaves act as a stimulant when chewed or used as tea, even though its vendors did not make any market claims. FDA determined that "khat" was intended for use as a drug based on its actual effects and widely known uses. Ibid.

FDA has also treated other products as drugs or devices, despite the absence of explicit market claims. Among other products, FDA has treated as drugs or devices: (1) cosmetics containing hormones based on the absence of any legitimate cosmetic purpose for the hormones; (2) toothpaste containing fluoride because fluoride is widely accepted as an anti-cavity agent and affects the structure of the tooth; (3) thyroid-containing food supplements based on the recognized physiological effects of thyroid products; (4) interferon based on media coverage touting it as a possible miracle cure; (5) novelty condoms based on their likely use as prophylactics; (6) non-corrective tinted contact lenses based on their effects on the eye; (7) sunscreen products based on consumer expectations that they will provide protection against the sun; and (8) tanning booths based on the known effects of ultraviolet rays. 60 Fed. Reg. at 41,528-41,531. In each of the above *30 cases, FDA found that the product was intended for use as a drug or a device based on the inherent nature of the product, its predominant use or effects, or both. Id. at 41,527. There is no principled basis for treating tobacco products differently, especially in light of the compelling evidence that tobacco manufacturers have known for decades that nicotine is addictive and has mood-altering effects and that those are the main reasons that people use tobacco products. Tobacco products should not escape regulation for the protection of the public health simply because tobacco manufacturers re-rain from making express claims about the pharmacological effects and uses they so clearly intend and from which they so clearly profit.

C. FDA's Interpretation Is Consistent With The Structure Of The Act As A Whole

The court of appeals rejected FDA's conclusion that tobacco products are drugs and devices in large part because it believed that regulation of tobacco products is inconsistent with the structure of the Act as a whole. The court essentially reasoned as follows: (1) If tobacco products are drugs or devices within the meaning of the Act, the regulatory provisions of the Act would require them to be banned; (2) Congress did not intend for tobacco products to be banned; therefore (3) tobacco products are not drugs and devices. See generally Pet. App. 18a-30a. That analysis is seriously flawed. FDA reasonably concluded that the operative regulatory provisions of the Act do not require a ban of tobacco products. Even if the operative provisions of the Act were to require a ban, however, that would not detract from the reasonableness of FDA's conclusion that tobacco products are drugs and devices.

1. In concluding that tobacco products would have to be banned if they are drugs and devices, the court of appeals cited provisions of the Act that either directly prohibit the *31 marketing of drugs and devices that FDA has found not to be sufficiently "safe," or contemplate that FDA will prevent or otherwise regulate the marketing of such products. [FN6] Because FDA determined that tobacco products are dangerous, the court reasoned, those provisions would require tobacco products to be banned if they were "drugs" and "devices." See generally Pet. App. 18a-30a.

FN6. See 21 U.S.C. 393(b)(2)(B) and (C) (Supp. III 1997) (FDA shall protect the public health by ensuring that "drugs are safe and effective," and that "there is a reasonable assurance of the safety and effectiveness of devices."); 21 U.S.C. 360j(e)(1) (FDA "may by regulation require that a device be restricted to sale, distribution, or use *** upon such *** conditions as [FDA] may prescribe by regulation, if, because of its potentiality for harmful effect ***, [FDA] determines that there cannot otherwise be reasonable assurance of its safety and effectiveness."); 21 U.S.C. 355(a) and (d) (No person may introduce any "new drug" absent FDA approval, and, if FDA finds that the drug "is unsafe for use," it "shall issue an order refusing to approve the application."); 21 U.S.C. 331(a), 352(j) (The introduction of a "misbranded" drug or device is prohibited, and a drug or device is "misbranded" when "it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling."); 21 U.S.C. 360c (FDA must classify devices into one of three categories based on what controls are necessary to provide a reasonable assurance of the safety and effectiveness of the device.); 21 U.S.C. 360h(e)(1) (If FDA "finds that there is a reasonable probability that a device *** would cause serious, adverse health consequences or death," FDA "shall issue an order requiring the appropriate person *** to immediately cease distribution of such device.").

In deciding whether a drug or device is sufficiently "safe" within the meaning of the provisions cited by the court of appeals, however, FDA's role is not confined to determining whether the product is unsafe as that term is most commonly used. FDA also generally weighs the risk presented by a product against countervailing health benefits. That balancing of risks and benefits is expressly required when FDA classifies devices into regulatory categories. 21 U.S.C. *32 360c(a)(2)(C) ("the safety and effectiveness of a device are to be determined by weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use"). FDA also follows the same general balancing approach in applying and enforcing other provisions of the Act. See United States v. Rutherford, 442 U.S. 544, 555 (1979). For example, as FDA has explained, several products used in the treatment of cancer are highly toxic and therefore are not "safe" as that term is most commonly understood. 61 Fed. Reg. at 44,413. FDA has nonetheless approved such products for use in cancer treatment after finding that the danger of not treating the cancer outweighs the risks of the drugs. Ibid.

FDA applied a similar analysis here. It found that, while "tobacco products are unsafe as that term is conventionally understood," the Act contemplates """consideration of not only the risks presented by a product but also any of the countervailing effects of use of that product, including the consequences of not permitting the product to be marketed." 61 Fed. Reg. at 44,412-44, 413. After undertaking that balancing process, FDA concluded that, with respect to adults, "the sudden withdrawal from the market of products to which so many millions of people are addicted would be dangerous" for several reasons. Id. at 44,413. First, as a result of withdrawal symptoms, "[t]here could be significant health risks to many of these individuals." Ibid. Second, the health care system could be "overwhelmed by the treatment demands that these people would create, and it is unlikely that the pharmaceuticals available could successfully treat the withdrawal symptoms of many tobacco users." Ibid. Finally, because of the strength of the addiction and the difficulty of quitting, "a black market and smuggling would develop to supply smokers with these products," and the black market products would likely "be even more dangerous than those currently marketed, in that they could contain *33 even higher levels of tar, nicotine, and toxic additives." Ibid. FDA therefore reasonably concluded that, "on balance, an approach that prohibits the sale and promotion of cigarettes and smokeless tobacco to children and adolescents, while permitting the sale to adults seems most appropriate, *** is consistent with the statutory standard of reasonable assurance of safety[,] and is more effective in achieving public health goals than a ban on all tobacco products." Ibid.

The Fourth Circuit rejected FDA's analysis on the ground that FDA had applied the wrong legal standard for determining the safety of a product. In the court's view, the Act requires FDA "to strike a balance between the risks and benefits of the use of a product, not to weigh the risks of leaving a product on the market against the risks of taking a product off the market." Pet. App. 21a. The statutory text, however, does not impose any such limitation on the agency's discretion. The "benefit to health from the use" of a product, 21 U.S.C. 360c(a)(2)(C), readily encompasses the prevention of the harmful health consequences that would ensue if a product were removed from the market. Tobacco products thus "benefit" the "health" of many users because they relieve otherwise untreatable symptoms of nicotine withdrawal, and because they are safer than black market products that would predictably be used for that purpose if tobacco products could no longer be lawfully marketed to adults.

FDA's interpretation, moreover, best comports with the public health purposes of the Act. From a public health perspective, it would make no sense to require removal of a product from the market when that would cause more harmful health consequences than leaving the product on the market. This Court's decision in Rutherford also supports FDA's interpretation. There, the Court affirmed FDA's conclusion that laetrile, while inherently harmless, was unsafe *34 within the meaning of the Act and should be removed from the market, because its availability could lead persons to reject more beneficial conventional treatments. 442 U.S. at 556. FDA's conclusion here--that the continued marketing of tobacco products to adults should be allowed because their removal could leave those users without treatment alternatives for their addiction and lead them to use more dangerous products--is the mirror image of the analysis approved in Rutherford. Thus, FDA's conclusion that the Act does not require tobacco products to be banned is based on a reasonable construction of the Act. Under Chevron, the court of appeals should have deferred to it. The court of appeals, however, did not even advert to the question of Chevron deference when it rejected FDA's conclusion that the Act does not require it to impose a complete ban on tobacco products. See Pet. App. 20a-30a.

2. Even assuming the regulatory provisions of the Act would require tobacco products to be banned, however, that would not affect the reasonableness of FDA's conclusion that tobacco products are drugs and devices within the meaning of the Act. As Judge Hall stated in his dissent in this case, "[h]ow the FDA has chosen to regulate tobacco has no bearing on the question of whether that agency has the authority to regulate it at all." Pet. App. 60a-61a. See also Bacto-Unidisk, 394 U.S. at 792 (while the parties have debated the wisdom of subjecting antibiotic sensitivity disks to premarket review, the only relevant inquiry "is whether the statute's definition of 'drug' authorizes the disc regulations contested here").

The court of appeals' contrary conclusion rests on the premise that a ban on tobacco products would be a consequence that the enacting Congress did not contemplate and that therefore would conflict with Congress's intent, so that, if the regulatory provisions of the Act would require tobacco products to be banned, they cannot be drugs or devices. No *35 provision of the Act as passed in 1938, however, suggests that a ban on the sale of tobacco products, or indeed any other products--based on powerful evidence that might later came to light establishing the addictive and other intended pharmacological effects of such products--would conflict with congressional intent. Nor is there any other sound basis for reaching that conclusion.

Congress expresses its operative intent in the text of the laws it enacts, see Oncale, 523 U.S. at 79-80; H.J. Inc., 492 U.S. at 248, and that intent is not difficult to discern here: When FDA finds that a product is """intended to affect the structure or any function of the body", 21 U.S.C. 321(g)(1)(C) and (h)(3), and that the product is not sufficiently, "safe," 21 U.S.C. 393(b)(2)(B) and (C)--i.e., the risks of the product outweigh its benefits--Congress intended for the product not to be marketed. [FN7]

FN7. What is dispositive for purposes of statutory construction is the statute itself, not whether the Congress that enacted the statute could have anticipated a specific application of the general standards that it prescribed, or whether that Congress would have desired the particular consequences of one such natural application. "It is not for us to speculate, much less act, on whether Congress would have altered its stance had the specific events of this case been anticipated." TVA v. Hill, 437 U.S. 153, 185 (1978); accord Busic v. United States, 446 U.S. 398, 404- 405 (1980).

If this Court were to overturn FDA's judgment that the risks of tobacco products are outweighed by the countervailing benefits of continued marketing to adults, that would simply mean that the Act, as presently written, requires tobacco products to be banned. That consequence, however, would in no way undermine FDA's conclusion that tobacco products are intended to affect the structure or function of the body and are therefore drugs and devices subject to regulation under the Act. In those circumstances, then, it would properly be for Congress, after weighing the competing considerations, to decide whether the ban that was *36 (by hypothesis) required by the Act in its current form should remain in effect, or whether the Act should be amended to permit the continued marketing of cigarettes and other tobacco products, under whatever conditions Congress might then prescribe. That result would not be at all anomalous in the working of a comprehensive, prophylactic statute designed to protect the public health and safety. It is, for example, the way in which the Food, Drug, and Cosmetic Act itself operated and Congress responded after FDA concluded that saccharin is an animal carcinogen, the continued sale of which as a food additive would be unlawful under the Act, a conclusion that was dictated by the Delaney Clause, 21 U.S.C. 348(c)(3). Congress enacted legislation that imposed an 18-month moratorium on FDA's proposed rule. Saccharin Study and Labeling Act, Pub. L. No. 95-203, 91 Stat. 1451. [FN8] That moratorium has been extended repeatedly, *37 and it remains in effect today. See Pub. L. No. 104-180, s 602, 110 Stat. 1594; 21 U.S.C. 348 note. [FN9]

FN8. The court of appeals concluded that FDA's regulatory scheme does not comport with three other provisions of the Act. Those additional criticisms are also misguided. FDA's determination that the "primary mode" of tobacco products is that of a "drug" does not mean that FDA must regulate tobacco products as drugs rather than devices. Pet. App. 24a. A finding concerning the primary mode of a combination product only determines which component of FDA will have principal responsibility to conduct premarket review. See 21 U.S.C. 353(g)(1). Regardless of which component has that responsibility, FDA may regulate a combination product by using its authority to regulate drugs, its authority to regulate devices, or both. 61 Fed. Reg. at 44,400-44,403. Nor does 21 U.S.C. 352(f)(1) automatically require tobacco manufacturers to include directions for use on their product labels. Pet. App. 25a-26a. FDA may grant an exemption from that requirement when the information is "not necessary for the protection of public health." 21 U.S.C. 352(f)(1). Because the way in which tobacco products are used is common knowledge, FDA reasonably determined that an exemption was appropriate. 61 Fed. Reg. at 44,465. Finally, 21 U.S.C. 352(f)(2) does not require tobacco manufacturers to include additional warnings for children on the labels of tobacco products. Pet. App. 26a-27a. FDA reasonably concluded that the familiar Surgeon General's warnings required by other federal statutes are sufficient to satisfy that provision's requirement that a label bear adequate warnings against use by children. 61 Fed. Reg. at 44,465. In any event, as discussed above, the sole question presented here is whether tobacco products are drugs and devices within the meaning of the Act. Whether FDA is required to take further steps, in addition to the regulations it has prescribed, does not have any bearing on the resolution of that question.

FN9. Congress responded in a similar manner to the holding in TVA v. Hill, 437 U.S. 153 (1978), that the Endangered Species Act of 1973 (ESA), 16 U.S.C. 1531 et seq., prohibited the completion of the Tellico Dam because the project would destroy the snail darter, by directing the completion of the dam, "notwithstanding" the ESA. See Energy and Water Development Appropriation Act, Pub. L. No. 96-69, 93 Stat. 449. See also County of Oneida v. Oneida Indian Nation, 470 U.S. 226, 253 (1985).

D. FDA's Prior Statements, Unenacted Tobacco Bills, And Certain Tobacco- Specific Statutes Enacted Long After 1938 Do Not Detract From The Reasonableness Of FDA's Interpretation

In rejecting FDA's conclusion that tobacco products are drugs and devices, the court of appeals also relied on FDA's prior statements concerning its authority to regulate tobacco products, unenacted bills that would have specifically authorized FDA to regulate tobacco products, and certain tobacco-specific statutes enacted long after the Federal Food, Drug, and Cosmetic Act was passed. FDA carefully examined each of those sources and reasonably determined that they do not detract from the conclusion that tobacco products are drugs and devices under the Act.

1. Until FDA issued the regulations at issue here, the only instances in which the agency had found that tobacco products were drugs involved cases in which there were express market claims of therapeutic value. FDA's prior position on the subject was authoritatively expressed in decisions in 1977 and 1980 rejecting petitions filed by Action *38 on Smoking in Health (ASH) to regulate cigarettes as drugs or devices. See J.A. 44-49 (Letter from FDA Commissioner Kennedy to ASH Executive Director Banzhaf (Dec. 5, 1977)); J.A. 50-68 (Letter from FDA Commissioner Goyan to ASH Executive Director Banzhaf (Nov. 25, 1980)). Focusing on those decisions, and some earlier statements made by FDA officials, the court of appeals treated FDA's current position as not warranting deference. Pet. App. 31a-37a. The court of appeals erred both in its understanding of FDA's prior position and in its approach to reviewing FDA's current regulation of tobacco products.

An agency's position on any given issue is not "carved in stone." Chevron, 467 U.S. at 863. To fulfill its assigned responsibilities, an agency "must be given ample latitude to 'adapt [its] rules and policies to the demands of changing circumstances,"DD' Motor Vehicle Mfrs. Ass'n v. State Farm Mut., 463 U.S. 29, 42 (1983), and "must consider varying interpretations and the wisdom of its policy on a continuing basis." Chevron, 467 U.S. at 863-864. For those reasons, and because "the whole point of Chevron is to leave the discretion provided by the ambiguities of a statute with the implementing agency," Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735, 742 (1996), an agency is always free to change its position on an issue or its interpretation of a statute, as long as it offers a "reasoned analysis" that justifies the change. Rust v. Sullivan, 500 U.S. 173, 187 (1991); Chevron, 467 U.S. at 863-864; Motor Vehicle Mfrs. Ass'n, 463 U.S. at 42.

FDA provided such a "reasoned analysis" here. Specifically, FDA explained that three key developments led to its change in position. First, while no major health organization had determined that nicotine was an addictive drug before 1980, by 1994, every leading scientific panel or organization had concluded that nicotine is addictive. 61 Fed. Reg. at 45,228. Second, since 1980, scientific evidence has shown *39 that an overwhelming percentage of users of tobacco products do so to satisfy their addiction and to obtain nicotine's mood-altering effects. Id. at 45,233-45,234. In contrast, before 1980, there was no evidence regarding the proportion of users who were addicted, and the evidence was insufficient to conclude that tobacco products were consumed primarily for their pharmacological effects. Id. at 45,234-45,235. Third, recently released internal industry documents show that tobacco manufacturers have long known that consumers use tobacco products to sustain addiction and for other pharmacological effects, and that manufacturers have deliberately engineered their products to deliver active doses of nicotine. Id. at 45,235- 45,236. Almost none of that evidence was publicly available in 1980. Id. at 45,237. FDA's finding that tobacco products are intended to affect the structure and function of the body, regardless of whether they are accompanied by express market claims of therapeutic value, is therefore "based on an overwhelming body of new evidence that ha[d] become available since FDA last considered this issue." Id. at 45,237. Because FDA provided a reasoned explanation for its change in position, that position is entitled to full Chevron deference. Rust, 500 U.S. at 186-187; Motor Vehicle Mfrs. Ass'n, 463 U.S. at 42; see also Smiley, 517 U.S. at 742.

The court of appeals concluded that FDA's prior decisions not to regulate tobacco products were based on a categorical view that tobacco products cannot be subject to regulation under the Act absent specific health claims, rather than the absence of the kind of evidence of intended effects discussed above. Pet. App. 36a. The court's understanding of the ASH decisions is incorrect. In the 1977 decision, FDA rejected ASH's assertion that cigarettes could be regulated as drugs because consumers use them for their effects on the body, on the ground that ASH's evidence was not sufficient to establish such an intent by the manufacturers or vendors of cigarettes. *40 J.A. 48-49. The government's brief defending FDA's decision in the court of appeals explained that FDA had concluded that cigarettes could not be regulated as drugs "in the absence of health claims by the manufacturers or vendors or other evidence of the manufacturers' or vendors' intent to affect the bodily structure or functions.'' Gov't Br. at 14, Action on Smoking & Health v. Harris, 655 F.2d 236 (D.C. Cir. 1980) (emphasis added). In affirming FDA's decision, the D.C. Circuit stated that "we do not read [FDA's decision] to mean either that the Commissioner will never consider evidence of consumer intent on this question or that he simply ignored the evidence presented to him in this petition." ASH, 655 F.2d at 239. Instead, the petition failed because ASH had failed to "meet the high standard established in cases where the statutory 'intent' is derived from consumer use alone." Ibid.

In the 1980 "device" decision, FDA stated that the relevant inquiry under the Act is whether there "is objective evidence that the manufacturer or vendor intends that the article is to affect the structure or a function of the body." J.A. 56. FDA further explained that a finding of such an intent could be based not only on a manufacturer's market claims, but also on "the circumstances surrounding [a product's] distribution," and the "consumer intent in using a product." Ibid. FDA determined, however, that ASH's evidence, including ASH's evidence of consumer use, "fails to establish that cigarettes are intended "to affect the structure or any function of the body."DD' J.A. 57; accord J.A. 61- 63. FDA's prior rulings on formal petitions to regulate tobacco products therefore rested on the absence of sufficient evidence at the time that such products were intended to affect the structure or function of the body--not on a categorical view that tobacco products can satisfy the drug and device *41 definitions only if manufacturers make express market claims of therapeutic value. [FN10]

FN10. The court of appeals also relied upon a 1914 opinion letter by FDA's predecessor agency. Pet. App. 32a. That letter, however, supports the proposition that labeling claims are not dispositive and that consumer use is relevant to the question of "intent":

Under the Food and Drugs Act, a drug is defined as any substance, or mixture of substances, intended to be used for the cure, mitigation, or prevention of disease of either man or other animals. It, therefore, follows that tobacco and its preparations, when labeled in such a manner as to indicate their use for the cure, mitigation, or prevention of disease, are drugs within the meaning of the act, and, as such, are subject to the provisions thereof.

On the other hand, tobacco and its preparations which are not so labeled and are used for smoking or chewing or as snuff and not for medicinal purposes are not subject to the provisions of the act.

USDA Bureau of Chemistry, 13 Service and Regulatory Announcements 24 (Apr. 1914) (Feb. 1914 Announcements p 13, Opinion of Chief of Bureau C.L. Alsberg). As the letter makes clear, labeling can be sufficient to establish the requisite intent. But if the absence of labeling were sufficient to negate intent, the italicized ("and are used") clause would have been superfluous. The final sentence of the opinion simply states that tobacco products could escape regulation under the 1906 Act as drugs if they were not labeled to indicate their use for the cure, mitigation, or prevention of disease and they were not used for such purposes. See 61 Fed. Reg. at 45,222 n.1160.

The court of appeals also relied on letters or statements by FDA officials to Members of Congress during hearings at various times after the Act was passed in 1938, to the effect that FDA did not have authority to regulate tobacco products as customarily marketed. See, e.g., Pet. App. 32a-34a. Those statements are best understood as reflecting FDA's view on those occasions that there was insufficient evidence that tobacco products as customarily marketed were intended to affect the structure or any function of the body.

Even if FDA's prior decisions not to regulate tobacco products could be understood as resting on such a categorical view, however, that would not affect the validity of FDA's *42 present determination that tobacco products are drugs and devices under the Act. An agency is not only free to alter its view of the underlying facts; it is also free to change its view of the appropriate legal standard for evaluating the facts. See Rust, 500 U.S. at 186-187. Regardless of whatever uncertainty there might have been about FDA's position in the past, FDA has now unambiguously concluded that the drug and device definitions encompass products that are intended by manufacturers to affect the structure or function of the body, irrespective of whether the manufacturer makes express claims of therapeutic value. FDA has also concluded that there is no basis for creating an exception to that legal standard for tobacco products. Because that interpretation of the Act is supported by a """reasoned analysis," it is entitled to full Chevron deference. Ibid.

2. Over the years, Congress has failed to enact bills that would have expressly authorized FDA to regulate tobacco products. The court of appeals viewed such congressional inaction as strong evidence that FDA lacks authority to regulate tobacco products under the Act. Pet. App. 37a-39a. Failed legislative proposals, however, do not furnish a sound basis for determining the meaning of a prior statute. See, e.g., United States v. Estate of Romani, 523 U.S. 517, 533-535 (1998); Central Bank v. First Interstate Bank, 511 U.S. 164, 187 (1994). The Constitution requires Congress to express its will through enacted legislation, not unenacted bills. INS v. Chadha, 462 U.S. 919, 945-959 (1983). Congressional inaction also "lacks persuasive significance because several equally tenable inferences may be drawn from such inaction, including the inference that the existing legislation already incorporated the offered change." Central Bank, 511 U.S. at 187 (quoting Pension Benefit Guar. Corp. v. LTV Corp., 496 U.S. 633, 650 (1990)). For those reasons, Congress's failure to enact bills that would have expressly authorized FDA to regulate tobacco products has no more bearing on the *43 question presented in this case than does Congress's failure to enact bills that would have excluded tobacco products from the reach of the Act, e.g., S. Rep. No. 1295, 104th Cong., 1st Sess. (1995); H.R. Rep. No. 2283, 104th Cong., 1st Sess. (1995), or Congress's failure during the past three years to overturn FDA's decision to regulate tobacco products.

The court of appeals' reason for attributing significance to the legislative inaction at issue here is particularly unconvincing. In the court's view, such inaction amounted to congressional "ratification" of FDA's prior statements and decisions that tobacco products are not subject to regulation under the Act. Pet. App. 37a. As we have explained, however, FDA's prior position was based on the absence of sufficient evidence showing that tobacco products were intended by manufacturers to affect the structure or any function of the body. Ratification of that position would not reflect any congressional view on whether tobacco products would be covered by the Act if new evidence established that they are intended by manufacturers to be used for sustaining addiction and for sedation, stimulation, and weight control.

More fundamentally, congressional inaction can never affect the authority of an agency under Chevron to alter its position on an issue. Motor Vehicle Manufacturers Ass'n, supra, is controlling on that point. In that case, the Court held that Congress's failure to overturn an agency regulation did not affect the scope of the agency's authority to rescind the regulation. 463 U.S. at 44-45. The Court explained that the standard for reviewing agency action is not "enlarged or diminished by subsequent congressional action," and that "even an unequivocal ratification--short of statutory incorporation--*** would not connote approval or disapproval of an agency's later decision to rescind the regulation." Id. at 45. Under the analysis in Motor Vehicle Manufacturers Ass'n, Congress's failure to overturn FDA's prior position *44 has no bearing on the validity of FDA's present position that tobacco products are drugs or devices under the Act.

3. Since the Surgeon General issued his well-known report in 1964, Congress has enacted several statutes that deal with tobacco products in certain specific respects. See Pet. App. 39a-42a. None of the statutes, however, expressly exempts tobacco products from the reach of the Act. Nor is there any irreconcilable conflict between the subsequent statutes and the conclusion that tobacco products fall within the reach of the Act. TVA, 437 U.S. at 189-190 (implied repeal occurs only when there is an irreconcilable conflict between the old and the new laws). Those statutes therefore do not affect the reasonableness of FDA's conclusion that tobacco products are drugs and devices under the Act.

a. The Federal Cigarette Labeling and Advertising Act (FCLAA), 15 U.S.C. 1331 et seq., requires cigarette packaging and advertising to bear specific warnings from the Surgeon General concerning the adverse health effects of smoking. 15 U.S.C. 1333. FCLAA also contains a specific preemption section that provides that "[n]o statement relating to smoking and health, other than the statement required by section 1333 ***, shall be required on any cigarette package." 15 U.S.C. 1334(a). That statutory text makes clear that FDA may not require warning labels on cigarettes that are different from those required by FCCLA. The text of FCCLA does not remotely suggest, however, that it altogether deprives FDA of any authority to regulate tobacco products. As this Court explained in Cipollone v. Liggett Group, Inc., 505 U.S. 504, 518 (1992), FCLAA "merely prohibit[s] state and federal rulemaking bodies from mandating particular cautionary statements on cigarette labels."

The court of appeals derived a broader preemptive scope from FCLAA's statement of policy, which is, inter alia, "to establish a comprehensive Federal program to deal with *45 cigarette labeling and advertising with respect to any relationship between smoking and health, whereby *** commerce and the national economy may be protected to the maximum extent consistent with this declared policy and *** not impeded by diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health." 15 U.S.C. 1331. From that statement, the court concluded that Congress had a broad purpose to protect the national economy by allowing the continued marketing of cigarettes if the packages bear sufficient warning labels--a goal the court believed would be undermined if tobacco products were "drugs" and "devices" subject to regulation under the Act. Pet. App. 43a-44a.

As we have already explained, however, treatment of tobacco products as drugs or devices does not lead to the conclusion that such products must be banned, and the regulations at issue here permit the continued sale of tobacco products to adults. In any event, FCLAA does not seek to protect the national economy by shielding tobacco products from laws that would restrict their marketing. Instead, as the text of FCLAA's policy statement makes clear, and as its narrow preemption provision confirms, Congress's goal was far more limited: It wanted to "protect[] the national economy from the burden imposed by diverse, nonuniform, and confusing cigarette labeling and advertising regulations." Cipollone, 505 U.S. at 514; see Banzhaf v. FCC, 405 F.2d 1082, 1089 (D.C. Cir. 1968) ("[n]othing in the [FCLAA] Act indicates that Congress had any intent at all with respect to other types of regulation by other agencies--much less that it specifically meant to foreclose all such regulation"), cert. denied, 396 U.S. 842 (1969). FCLAA does not limit the authority of FDA to ban the sale of tobacco products, any more than it limits the authority of a State to do so (as indeed all States have done with respect to sales to minors, *46 61 Fed. Reg. at 44,441). The enactment of FCLAA therefore does not affect the validity of FDA's conclusion that tobacco products are drugs and devices under the Act.

b. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act), 15 U.S.C. 4401 et seq., requires warnings on smokeless tobacco packages that are similar to the warnings required on cigarette packages. 15 U.S.C. 4402(a) and (b). It also contains a similar express preemption provision, which states: "No statement relating to the use of smokeless tobacco products and health, other than the statements required by section 4402 of this title, shall be required by any Federal agency to appear on any package or in any advertisement." 15 U.S.C. 4406(a). Like FCCLA, the Smokeless Tobacco Act simply requires certain warning labels on packages and precludes federal agencies, including FDA, from requiring different ones. Like FCCLA, the Smokeless Tobacco Act does not in any way suggest that tobacco products cannot be drugs or devices under the Act.

c. The Alcohol and Drug Abuse Amendments of 1983, Pub. L. No. 98-24, 97 Stat. 178, 42 U.S.C. 290aa et seq., direct the Secretary of Health and Human Services to report to Congress every three years on "the health consequences *** of drug abuse in the United States [and] *** current research findings made with respect to drug abuse, including current findings on *** the addictive property of tobacco," and to include the Secretary's recommendations for "legislation and administrative action as the Secretary may deem appropriate." 42 U.S.C. 290aa-2(b). Those reporting requirements do not conflict with FDA's conclusion that tobacco products are drugs and devices under the Federal Food, Drug, and Cosmetic Act. As Judge Hall explained, the reporting obligations do no more than acknowledge the important role that the Secretary has in determining policy in the complex field of drug abuse, and require the Secretary *47 "to ask Congress for any additional tools *** needed to *** perform that role effectively." Pet. App. 69a.

d. The Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act (ADAMHA), Pub. L. No. 102-321, 106 Stat. 394, created separate block grants for state mental health services and drug and alcohol abuse programs. One condition for receiving a block grant is that a State must have in effect a law making it illegal to sell or distribute tobacco products to children under age 18. 42 U.S.C. 300x-26(a). Neither the ADAMHA as a whole nor that specific requirement implies that FDA has no authority to regulate tobacco products as a drug or a device.

The court of appeals concluded that, if tobacco products are "drugs" or """devices" subject to regulations under the Federal Food, Drug, and Cosmetic Act, then one provision of that Act, 21 U.S.C. 360k(a) "would prohibit States from addressing the problem of youth access," in conflict with the congressional intent evident in ADAMHA. Pet. App. 51a. Under Section 360k(a), a State may not establish "any requirement" with respect to devices that is ""different from, or in addition to, any requirement applicable under" the Act. 21 U.S.C. 360k(a)(1). Section 360k(a), however, "does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act." Medtronic, Inc. v. Lohr, 518 U.S. 470, 496-497 (1996) (quoting 21 C.F.R. 808.1(d)(2)). Since ADAMHA's "age 18" restriction is the same as the access restriction imposed by FDA's regulations, the regulations will not prevent States from complying with their block grant obligations under ADAMHA. In fact, by providing an additional level of enforcement against the sale of tobacco products to children, the regulations will "facilitate the end result that Congress sought" in ADAMHA. 61 Fed. Reg. at 44,547.

FDA's regulations could potentially preempt state regulations that impose stricter conditions on the sale of tobacco *48 products than those set forth in the regulations. But that result does not suggest that there is any inherent or irreconcilable conflict between ADAMHA and FDA's conclusion that tobacco products are covered under the Federal Food, Drug, and Cosmetic Act. ADAMHA does not provide a protective shield for all state regulations of tobacco. It simply establishes one condition for receiving a block grant, and, as noted above, FDA's regulations do not prevent States from complying with that condition. In any event, under 21 U.S.C. 360k(b), States may apply for an exemption from the preemptive force of the Act, and FDA has substantial discretion to grant such an exemption. See 61 Fed. Reg. at 44,550; Medtronic, 518 U.S. at 482 n.5, 496. Thus, like the other later-enacted statutes, ADAMHA does not impose any impediment to FDA's thoroughly documented and reasoned conclusion that tobacco products are "drugs" and "devices" within the meaning of the Federal Food, Drug, and Cosmetic Act.

*49 CONCLUSION

The judgment of the court of appeals should be reversed.

Respectfully submitted.

*1a APPENDIX

1. 21 U.S.C. 321(g)(1) provides as follows:

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

2. 21 U.S.C. 321(h) provides as follows:

(h) The term "device" (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

*2a (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

3. 21 U.S.C. 352(f) and 352(j) provide as follows:

s 352. Misbranded drugs and devices.

A drug or device shall be deemed to be misbranded--

*****

(f) Directions for use and warnings on label

Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users, except that where any requirement of clause (1) of this paragraph, as applied to any drug or *3a device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations exempting such drug or device from such requirement. *****

(j) Health-endangering when used as prescribed

If it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.

4. 21 U.S.C. 353(g) provides as follows:

(g) Regulation of combination products

(1) The Secretary shall designate a component of the Food and Drug Administration to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of--

(A) a drug (other than a biological product), the persons charged with premarket review of drugs shall have primary jurisdiction,

(B) a device, the persons charged with premarket review of devices shall have primary jurisdiction, or

(C) a biological product, the persons charged with premarket review of biological products shall have primary jurisdiction.

*4a 5. 21 U.S.C. 355(a) provides as follows:

(a) Necessity of effective approval of application

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.

6. 21 U.S.C. 355(d) provides in relevant part as follows:

(d) Grounds for refusing application; approval of application; "substantial evidence" defined

If the Secretary finds, after due notice to the applicant in accordance with subsection (c) of this section and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; *** (4) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; *** he shall issue an order refusing to approve the application. ***

*5a 7. 21 U.S.C. 360c(a) provides as follows:

s 360c. Classification of devices intended for human use

(a) Classes of devices

(1) There are established the following classes of devices intended for human use:

(A) Class I, GENERAL CONTROLS.--

(i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device.

(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it--

(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and

(II) does not present a potential unreasonable risk of illness or injury,

is to be regulated by the controls referred to in clause (i).

*6a (B) Class II, SPECIAL CONTROLS.--A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 360(k) of this title), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.

(C) Class III, PREMARKET APPROVAL.--A device which because--

(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and

*7a (ii)(I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or

(II) presents a potential unreasonable risk of illness or injury,

is to be subject, in accordance with section 360e of this title, to premarket approval to provide reasonable assurance of its safety and effectiveness.

If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information.

(2) For purposes of this section and sections 360d and 360e of this title, the safety and effectiveness of a device are to be determined--

(A) with respect to the persons for whose use the device is represented or intended,

(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and

(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use.

*8a 8. 21 U.S.C. 360c(d)(1) provides as follows: (d) Panel recommendation; publication; priorities

(1) Upon receipt of a recommendation from a panel respecting a device, the Secretary shall publish in the Federal Register the panel's recommendation and a proposed regulation classifying such device and shall provide interested persons an opportunity to submit comments on such recommendation and the proposed regulation. After reviewing such comments, the Secretary shall, subject to paragraph (2), by regulation classify such device.

9. 21 U.S.C. 360f(a) provides as follows:

s 360f. Banned devices

(a) General rule

Whenever the Secretary finds, on the basis of all available data and information that--

(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and

(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the *9a deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;

he may initiate a proceeding to promulgate a regulation to make such device a banned device.

10. 21 U.S.C. 360h(e)(1) provides as follows:

(e) Recall authority

(1) If the Secretary finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the device)--

(A) to immediately cease distribution of such device, and

(B) to immediately notify health professionals and device user facilities of the order and to instruct such professionals and facilities to cease use of such device.

*****

11. 21 U.S.C. 360j(e) provides as follows:

(e) Restricted devices

(1) The Secretary may by regulation require that a device be restricted to sale, distribution, or use-- *10a (A) only upon the written or oral authorization of a practitioner licensed by law to administer or use such device, or

(B) upon such other conditions as the Secretary may prescribe in such regulation,

if, because of its potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness. No condition prescribed under subparagraph (B) may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless the Secretary determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board. A device subject to a regulation under this subsection is a restricted device.

(2) The label of a restricted device shall bear such appropriate statements of the restrictions required by a regulation under paragraph (1) as the Secretary may in such regulation prescribe.

*11a 12. 21 U.S.C. 360k provides as follows:

s 360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

(b) Exempt requirements

Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if--

(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or

*12a (2) the requirement-- (A) is required by compelling local conditions, and

(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.

13. 21 U.S.C. 371(a) provides as follows:

s 371. Regulations and hearings

(a) Authority to promulgate regulations

The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary.

14. 21 U.S.C. 393(a) & (b) provide as follows:

s 393. Food and Drug Administration

(a) In general

There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the """Administration").

(b) Mission

The Administration shall--

(1) promote the public health by promptly and efficiently reviewing clinical research and *13a taking appropriate action on the marketing of regulated products in a timely manner; (2) with respect to such products, protect the public health by ensuring that--

*****

(B) human and veterinary drugs are safe and effective;

(C) there is reasonable assurance of the safety and effectiveness of devices intended for human use ***.

JOINT APPENDIX

*Iaa TABLE OF CONTENTS

Page

Revelant docket entries, United States District Court Middle District of North Carolina (Greensboro) (Civil No. 95-CV-591) ... 1

Relevant docket entries, United States District Court Middle District of North Carolina (Greensboro) (Civil No. 95-CF-593) ... 6

Relevant docket entries, United States District Court Middle District of North Carolina (Winston-Salem) (Civil No. 95-CV-665) ... 11

Relevant docket entries, United States Distrrict Court Middle District of North Carolina (Greensboro) (Civil No. 95-CV-706) ... 16

Relevant docket entries, United States Court of Appeal for the Fourth Circuit (No. 97-1581) ... 21

Relevant docket entries, United States Court of Appeals for the Fourth Circuit (No. 97-1604) ... 26

Relevant docket entrie, United States Court of Appeals for the Fourth Cicuit (No. 97-1605) ... 31

Relevant docket entries, United States Court of Appeals for the Fourth Circuit (No. 97-1606) ... 35

Relevant docket entries, United States Court of Appeals for the Fourth Circuit (No. 97-1614) ... 40

Letter to Mr. Banzhaf (date December 7, 1997) ... 44

Letter to Mr. Banzhaf and Mr. Georgiades (date November 25, 1980) ... 50

*1aa UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF NORTH CAROLINA

(GREENSBORO)

Civil No. 95-CV-591 Coyne Beahm, Inc., Brown & Williamson Tobacco Corporation,

Liggett Group, Inc., Lorillard Tobacco Company, Philip Morris, Incorporated, R.

J. Reynolds Tobacco Company, Plaintiffs

v.

United States Food & Drug Administration, David A. Kessler, M.D., Commissioner

of Food and Drugs, Defendants

DOCKET ENTRIES

ATE       DOCKET     ROCEEDINGS

            NUMBERS

--------  ---------  ----------------------------------------------------------

-------------------------------------------------------------------------------

                     *****

8/23/96   27         MOTION by COYNE BEAHM, INC., BROWN & WILLIAMSON, LIGGETT

                       GROUP, INC., LORILLARD TOBACCO CO, MORRIS, PHILIP, INC.,

                       REYNOLDS, R. J., TOB for Leave to File Second Amended

                       Complaint w/proposed Second Amended Complaint attached.

                       (ww) [Entry date 08/26/96]

                     *****

10/1/96   34         ANSWER by US FOOD & DRUG ADMIN, DAVID A. KESSLER to second

                       amended complaint (ww) [Entry date 10/02/96]

                     *****

10/15/96  36         MOTION FOR SUMMARY JUDGMENT by plaintiff COYNE BEAHM,

                       INC., plaintiff BROWN & WILLIAMSON, plaintiff LORILLARD

                       TOBACCO CO, plaintiff MORRIS, PHILIP, INC., plaintiff

REYNOLDS, R. J., TOB (rh)

                     *****

2/10/97   --         Motion hearing held before Jd. Osteen, G'boro. Beck Rptr.

                       re: [36-1] motion FOR SUMMARY JUDGMENT by REYNOLDS, R.

                       J., TOB, MORRIS, PHILIP, INC., LORILLARD TOBACCO CO,

                       BROWN & WILLIAMSON, COYNE BEAHM, INC., Ct will enter

                       findings in 5-10 weeks. (jm) [Entry date 02/11/97]

                     *****

4/25/97   70         MEMORANDUM OPINION (signed by Judge William L. Osteen Sr.)

                       Re: [36-1] motion for summary judgment. Ccs. to counsel.

                       (cg)

4/25/97   71         ORDER (signed by Judge William L. Osteen Sr.) [36-1]

                       motion for summary judgment is granted as to the

                       regulations' restrictions on the promotion and

                       advertising of tobacco products and denied as to the

                       Regulations access restrictions and labeling

                       requirements. An immediate appeal from this order may

materially advance the ultimate termination of the

                       litigation. Therefore the court certifies this order for

                       an interlocutory appeal purs. to 28 USC 1292(b). The

                       Regulations heretofore implemented prohibiting the sale

                       of tobacco products to minors shall remain in full force

                       and effect pending appeal by pltfs. The Food and Drug

                       Administration shall not implement any of the additional

                       Regulations set for implementation on 8/28/97, pending

                       further orders by the court. Nothing set forth in this

                       order concerning the time of implemetation of the

                       Regulations shall prohibit either side from presenting

                       motions to the court for a reconsideration as to the

                       implementation of the regulations pending appeal.

                       Further ordered that absent a timely appeal or absent

                       permission of the Court of Appeals for the Fourth

                       Circuit to proceed with an interlocutory appeal, this

                       matter shall proceed for ultimate disposition by the

                       court. Ccs. to counsel. (cg) [Edit date 04/25/97]

5/2/97    72         NOTICE OF APPEAL from order entered 4/25/97 to USCA 4th

                       Circuit by US FOOD & DRUG ADMIN, DAVID A. KESSLER. (rh)

*****

*6aa UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF NORTH CAROLINA

(GREENSBORO)

Civil No. 95-CV-593

American Advertising Federation, American Association of Advertising Agencies,

Association of National Advertisers, Inc., Magazine Publishers of America,

Outdoor Advertising Association of America, Point of Purchase Advertising

Institute, plaintiffs

v.

David A. Kessler, M.D., Commissioner, Food and Drug Administration, United

States Food & Drug Administration, defendants

DOCKET ENTRIES

DATE      DOCKET     PROCEEDINGS

            NUMBERS

--------  ---------  ----------------------------------------------------------

-------------------------------------------------------------------------------

                     *****

9/16/96   39         SECOND AMENDED COMPLAINT by AMERICAN ADVERTISING, AMERICAN

                       ASSOCIATION, ASSN. OF NATL. ADVT., MAGAZINE PUBLISHERS,

                       OUTDOOR ADVERTISING, POINT OF PURCHASE amending [1-1]

                       complaint (kd) [Entry date 09/19/96]

                     *****

10/1/96   41         ANSWER by DAVID A. KESSLER, US FOOD & DRUG ADMIN to second

                       amended complaint. (kd) [Entry date 10/02/96]

                     *****

10/15/96  45         MOTION FOR SUMMARY JUDGMENT by plaintiff AMERICAN

                       ADVERTISING, plaintiff AMERICAN ASSOCIATION, plaintiff

                       ASSN. OF NATL. ADVT., plaintiff MAGAZINE PUBLISHERS,

                       plaintiff OUTDOOR ADVERTISING, plaintiff POINT OF

                       PURCHASE (kd) [Entry date 10/16/96]

                     *****

2/10/97   --         Motion hearing held before Jd. Osteen, G'boro. Beck Rptr.

                       re: [45-1] motion FOR SUMMARY JUDGMENT by plaintiffs. Ct

will enter findings in 5-10 weeks. (jm) [Entry date

                       02/11/97]

                     *****

4/25/97   66         MEMORANDUM OPINION (copy - original filed in 2:95CV591)

                       (signed by Judge William L. Osteen Sr.) [45-1] motion

                       for summary judgment. Ccs. to counsel. (cg)

4/25/97   67         ORDER (copy - original filed in 2:95CV591) (signed by

                       Judge William L. Osteen Sr.) [45-1] motion for summary

                       judgment is granted as to the Regulations' restrictions

                       on the promotion and advertising of tobacco products and

                       denied as to the Regulations access restrictions and

                       labeling requirements. An immediate from this order may

                       materially advance the ultimate termination of the

                       litigation. Therefore, the court certifies this order

                       for an interlocutory appeal purs. to 28 USC 1292(b). The

                       Regulations heretofore implemented prohibiting the sale

                       of tobacco products to minors shall remain in full force

                       and effect pending appeal by pltfs. The Food and Drug

Administration shall not implement any of the additional

                       Regulations set for implementation on 8/28/97, pending

                       further orders by the court. Nothing set forth in this

                       order concerning the time of implementation of the

                       Regulations shall prohibit either side from presenting

                       motions to the court for a reconsideration as to the

                       implementation of the Regulations pending appeal.

                       Further ordered that absent a timely appeal or absent

                       permission of the Court of Appeals for the Fourth

                       Circuit to proceed with an interlocutory appeal, this

                       matter shall proceed for ultimate disposition by the

                       court. Ccs. to counsel. (cg) [Edit date 04/25/97]

5/2/97    68         NOTICE OF APPEAL from order entered 4/25/97 (copy-original

                       filed in 2:95CV591) to USCA 4th Circuit by DAVID A.

                       KESSLER, US FOOD & DRUG ADMIN (rh)

                     *****

*11aa UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF NORTH CAROLINA

(WINSTON-SALEM)

Civil No. 95-CV-665

United States Tobacco Company, Brown & Williamson Tobacco Corporation, Conwood

Company, L.P., National Tobacco Company, L.P., The Pinkerton Tobacco Company,

Swisher International, Inc., Central Carolina Grocers, Inc., J. T. Davenport,

Inc., N. C. Tobacco Distributors Committee, Inc., plaintiffs

v.

United States Food & Drug Administration, David A. Kessler, M.D., Commissioner

of Food And Drugs, Defendants

DOCKET ENTRIES

DATE      DOCKET     PROCEEDINGS

            NUMBERS

--------  ---------  ----------------------------------------------------------

                     *****

8/23/96   21         FIRST AMENDED COMPLAINT by ALL PLAINTIFFS amending [1-1]

                       complaint (cmh) [Entry date 08/26/96]

                     *****

10/1/96   25         ANSWER by US FOOD & DRUG ADMIN, DAVID A. KESSLER to

                       amended complaint (cmh) [Entry date 10/02/96]

*****

10/15/96  27         MOTION For Summary Judgment invalidating and permanently

                       enjoining enforcement of the FDA Regulations Restricting

                       the Sale and Distribution of Cigarettes and Smokeless

                       Tobacco to protect Children and Adolescents by ALL

                       PLAINTIFFS. (cmh)

                     *****

2/10/97   --         Motion hearing held before Jd. Osteen, G'boro. Beck Rptr.

                       re: [27-1] motion For Summary Judgment invalidating and

                       permanently enjoining enforcement of the FDA Regulations

                       Restricting the Sale and Distribution of Cigarettes and

                       Smokeless Tobacco to protect Children and Adolescents by

                       ALL PLAINTIFFS.Ct will enter findings in 5-10 weeks.

                       (jm) [Entry date 02/11/97]

                     *****

4/25/97   60         MEMORANDUM OPINION (copy-original filed in 2:95CV591)

                       (signed by Judge William L. Osteen Sr.) Re: [27-1]

motion for summary judgment. Ccs. to counsel. (cg)

4/25/97   61         ORDER (copy - original filed in 2:95CV591) (signed by

                       Judge William L. Osteen Sr.) [27-1] motion for summary

                       judgment is granted as to the Regulations restrictions

                       on the promotion and advertising of tobacco products and

                       denied as to the Regulations Access restrictions and

                       labeling requirements. An immediate appeal from this

                       order may materially advance the ultimate termination of

                       the litigation. Therefore, the court certifies this

                       order for an interlocutory appeal purs. to 28 USC

                       1292(b). The Regulations heretofore implemented

                       prohibiting the sale of tobacco products to minors shall

                       remain in full force and effect pending appeal by pltfs.

                       The Food and Drug Administration shall not implement any

                       of the additional Regulations set for implementation on

                       8/28/97, pending further orders by the court. Nothing

                       set forth in this order concerning the time of

                       implementation of the Regulations shall prohibit either

                       side from presenting motions to the court for a

reconsideration as to the implementaion of the

                       regulations pending appeal. Further ordered that adsent

                       a timely appeal or absent permission of the Court of

                       Appeals for the Fourth Circuit to proceed with an

                       interlocutory appeal, this matter shall proceed for

                       ultimate disposition by the court. Ccs. to counsel. (cg)

5/2/97    62         NOTICE OF APPEAL from order entered 4/25/97 (copy-original

                       filed in 2:95CV591) to USCA 4th Circuit by US FOOD &

                       DRUG ADMIN, DAVID A. KESSLER(rh)

                     *****

*16aa UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF NORTH CAROLINA

(GREENSBORO)

Civil No. 95-CV-706

National Association of Convenience Stores, Acme Retail, Inc., plaintiffs

v.

David A. Kessler, M.D., Commissioner, Food and Drug Administration, United

States Food & Drug Administration, defendants

DOCKET ENTRIES

DATE      DOCKET     PROCEEDINGS

            NUMBERS

--------  ---------  ----------------------------------------------------------

-------------------------------------------------------------------------------

                     *****

8/30/96   13         FIRST AMENDED COMPLAINT by NATL. ASSN. CONV., ACME RETAIL,

                       INC. amending [1-1] complaint. (cmh)

                     *****

10/1/96   17         ANSWER by DAVID A. KESSLER, US FOOD & DRUG ADMIN to

                       amended complaint (cmh) [Entry date 10/02/96]

                     *****

10/15/96  20         MOTION For Summary Judgment invalidating and permanently

                       enjoining enforcement of the FDA Regulations Restricting

                       the Sale and Distribution of Cigarettes and Smokeless

                       Tobacco by plaintiff NATL. ASSN. CONV., plaintiff ACME

RETAIL, INC. (cmh) [Entry date 10/16/96]

                     *****

2/10/97   --         Motion hearing held before Jd. Osteen, G'boro. Beck Rptr.

                       re: [20-1] motion For Summary Judgment invalidating and

                       permanently enjoining enforcement of the FDA Regulations

                       Restricting the Sale and Distribution of Cigarettes and

                       Smokeless Tobacco by ACME RETAIL, INC., NATL. ASSN.

                       CONV. Ct will enter findings in 5-10 weeks. (jm) [Entry

                       date 02/11/97]

                     *****

4/25/97   52         MEMORANDUM OPINION (copy - original filed in 2:95CV591)

                       (signed by Judge William L. Osteen Sr.) Re: [20-1]

                       motion for summary judgment. Ccs. to counsel. (cg)

4/25/97   53         ORDER (copy - original filed in 2:95CV591) (signed by

                       William L. Osteen Sr.) [20-1] motion for summary

                       judgment is granted as to the Regulations restrictions

                       on the promotion and advertising of tobacco products and

denied as to the Regulations access restrictions and

                       labeling requirements. An immediate appeal from this

                       order may materially advance the ultimate termination of

                       the litigation. Therefore, the court certifies this

                       order for an interlocutory appeal purs. to 28 USC

                       1292(b). The Regulations heretofore implemented

                       prohibiting the sale of tobacco products to minors shall

                       remain in full force and effect pending appeal by pltfs.

                       The Food and Drug Administration shall not implement any

                       of the additional Regulations set for implementation on

                       8/28/97, pending further orders by the court. Nothing

                       set forth in this order concerning the time of

                       implementation of the Regulations shall prohibit either

                       side from presenting motions to the court for a

                       reconsideration as to the implementation of the

                       regulations pending appeal. Further ordered that absent

                       a timely appeal or absent permission of the Court of

                       Appeals for the Fourth Circuit to proceed with an

                       interlocutory appeal, this matter shall proceed for

                       ultimate disposition by the court. Ccs. to counsel. (cg)

5/2/97    54         NOTICE OF APPEAL from order entered 4/25/97 (copy-original

                       filed in 2:95CV591) to USCA 4th Circuit by DAVID A.

                       KESSLER, US FOOD & DRUG ADMIN (rh)

                     *****

*21aa UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 97-1581

Coyne Beahm, Incorporated, Brown & Williamson Tobacco Corporation, Philip

Morris, Incorporated, R. J. Reynolds Tobacco Company, National Association of

Convenience Stores, Acme Retail Incorporated, United States Tobacco Company,

Conwood Company, L.P., National Tobacco Company, L.P., Pinkerton Tobacco

Company, Swisher International, Incorporated, Central Carolina Grocers,

Incorporated, J. T. Davenport, Incorporated, North Carolina Tobacco

Distributors Committee, Incorporated, The American Advertising Federation,

American Association of Advertising Agencies, Association of National

Advertisers, Incorporated, Magazine Publishers of America, The Outdoor

Advertising Association of America, Incorporated, Point of Purchase Advertising

Institute, Lorillard Tobacco Company, plaintiffs-appellees and Liggett Group,

Incorporated, Plaintiff

v.

Food & Drug Administration, David A. Kessler, M.D., Commissioner of Food and

Drugs, defendants-appellants

*22aa DOCKET ENTRIES

DATE      PROCEEDINGS

--------  ---------------------------------------------------------------------

-------------------------------------------------------------------------------

                                     *****

8/11/97   Oral argument heard. Courtroom Deputy: Richard Sewell, Joseph

            Coleman, Diane Burke. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614]

            (psc) [97-1581 97-1604 97-1605 97-1606 97-1614]

4/16/98   COURT ORDER filed for reargument of appeal [2754116-1] Copies to all

            counsel. [97-1604, 97-1581, 97-1605, 97-1606, 971614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

6/9/98    Oral argument heard. Courtroom Deputy: JLC, DHB, RHS. [97-1604,

            97-1581, 97-1605, 97-1606, 97-1614] (rhs) [97-1581 97-1604 97-1605

            97-1606 97-1614]

                                     *****

8/14/98   Published, authored opinion filed. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

8/14/98   Judgment order filed. Decision: REVERSED. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

9/25/98   Petition filed by Appellee FDA in 97-1604, Appellee David A. Kessler

            in 97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessle in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 for rehearing. Number copies filed: 20 [2851942-1]., for

            suggestion for rehearing in banc. Number of copies filed: 20

            [2851942-2]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

[97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

11/10/98  PUBLISHED COURT ORDER filed denying motion for rehearing [2851942-1]

            in 97-1614, 97-1581, 97-1605, 97-1606, 97-1614, denying motion for

            suggestion for reh in banc [2851942-2] in 97-1614, 97-1581,

            97-1605, 97-1606, 97-1614 Copies to all counsel. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606

            97-1614]

11/16/98  Motion filed by Appellee FDA, et al in 97-1604, Appellant FDA, et al

            in 97-1581, Appellee FDA, et al. in 97-1605, Appellant FDA, et al.

            in 97-1606, Appellee FDA, et al. in 97-1614 to stay the mandate

            [2882616-1]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

11/18/98  COURT ORDER filed granting motion to stay mandate [2882616-1] until

            for a period of 30 days from the date of the filing of this order

            pending the filing of a petition for certiorari by the government.

Judge Hall dissented. 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

12/14/98  Motion filed by Appellee FDA in 97-1604, Appellee David A. Kessler in

            97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 to stay the mandate [898734-1]. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

12/17/98  COURT ORDER filed granting motion to stay mandate [2898734-1] until

            January 18, 1999 in 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1605, 97-1606,

            97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

*26aa UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 97-1604

Brown & Williamson Tobacco Corporation, Lorillard Tobacco Company, Philip

Morris, Incorporated, R. J. Reynolds Tobacco Company, plaintiffs-appellants and

Coyne Beahm, Incorporated, Liggett Group, Incorporated, plaintiffs

v.

Food & Drug Administration, David A. Kessler, M.D., Commissioner of Food and

Drugs, defendants-appellees

DOCKET ENTRIES

DATE      PROCEEDINGS

--------  ---------------------------------------------------------------------

-------------------------------------------------------------------------------

                                     *****

8/11/97   Oral argument heard. Courtroom Deputy: Richard Sewell, Joseph

            Coleman, Diane Burke. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614]

            (psc) [97-1581 97-1604 97-1605 97-1606 97-1614]

4/16/98   COURT ORDER filed for reargument of appeal [2754116-1] Copies to all

            counsel. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

[97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

6/9/98    Oral argument heard. Courtroom Deputy: JLC, DHB, RHS. [97-1604,

            97-1581, 97-1605, 97-1606, 97-1614] (rhs) [97-1581 97-1604 97-1605

            97-1606 97-1614]

                                     *****

8/14/98   Published, authored opinion filed. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

8/14/98   Judgment order filed. Decision: REVERSED. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

9/25/98   Petition filed by Appellee FDA in 97-1604, Appellee David A. Kessler

            in 97-1604,

          Appellant FDA in 97-1581, Appellant David A. Kessler in 97-1581,

            Appellee FDA in 97-1605, Appellee David A. Kessler in 97-1605,

Appellant FDA in 97-1606, Appellant David A. Kessler in 97-1606,

            Appellee David A. Kessler in 97-1614, Appellee FDA in 97-1614 for

            rehearing. Number copies filed: 20 [2851942-1]., for suggestion for

            rehearing in banc. Number of copies filed: 20 [285194-22].

            [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb) [97-1581

            97-1604 97-1605 97-1606 97-1614]

                                     *****

11/10/98  PUBLISHED COURT ORDER filed denying motion for rehearing [2851942-1]

            in 97-1614, 97-1581, 97-1605, 97-1606, 97-1614, denying motion for

            suggestion for reh in banc [2851942-2] in 97-1614, 97-1581,

            97-1605, 97-1606, 97-1614 Copies to all counsel. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606

            97-1614]

11/16/98  Motion filed by Appellee FDA, et al in 97-1604, Appellant FDA, et al

            in 97-1581, Appellee FDA, et al. in 97-1605, Appellant FDA, et al.

            in 97-1606, Appellee FDA, et al. in 97-1614 to stay the mandate

            [2882616-1]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

[97-1581 97-1604 97-1605 97-1606 97-1614]

11/18/98  COURT ORDER filed granting motion to stay mandate [2882616-1] until

            for a period of 30 days from the date of the filing of this order

            pending the filing of a petition for certiorari by the government.

            Judge Hall dissented. 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

12/14/98  Motion filed by Appellee FDA in 97-1604, Appellee David A. Kessler in

            97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 to stay the mandate [2898734-1]. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606

            97-1614]

12/17/98  COURT ORDER filed granting motion to stay mandate [2898734-1] until

            January 18, 1999 in 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

Copies to all counsel. [97-1604, 97-1581, 97-1605, 97-1606,

            97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

*31aa UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 97-1605

United States Tobacco Company, Brown & Williamson Tobacco Corporation, Conwood

Company, L.P., National Tobacco Company, L.P., Pinkerton Tobacco Company,

Swisher International, Incorporated, Central Carolina Grocers, Incorporated, J.

T. Davenport, Incorporated, North Carolina Tobacco Distributors Committee,

Incorporated, plaintiffs-appellants

v.

Food & Drug Administration, David A. Kessler, M.D., Commissioner of Food and

Drugs, defendants-appellees

DOCKET ENTRIES

DATE      PROCEEDINGS

--------  ---------------------------------------------------------------------

-------------------------------------------------------------------------------

                                     *****

8/11/97   Oral argument heard. Courtroom Deputy: Richard Sewell, Joseph

            Coleman, Diane Burke. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614]

            (psc) [97-1581 97-1604 97-1605 97-1606 97-1614]

4/16/98   COURT ORDER filed for reargument of appeal [2754116-1] Copies to all

            counsel. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

6/9/98    Oral argument heard. Courtroom Deputy: JLC, DHB, RHS. [97-1604,

            97-1581, 97-1605, 97-1606, 97-1614] (rhs) [97-1581 97-1604 97-1605

            97-1606 97-1614]

                                     *****

8/14/98   Published, authored opinion filed. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

8/14/98   Judgment order filed. Decision: REVERSED. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

9/25/98   Petition filed by Appellee FDA in 97-1604, Appellee David A. Kessler

            in 97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 for rehearing. Number copies filed: 20 [2851942-1]., for

            suggestion for rehearing in banc. Number of copies filed: 20

            [2851942-2]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

11/10/98  PUBLISHED COURT ORDER filed denying motion for rehearing [2851942-1]

            in 97-1614, 97-1581, 97-1605, 97-1606, 97-1614, denying motion for

suggestion for reh in banc [2851942-2] in 97-1614, 97-1581,

            97-1605, 97-1606, 97-1614 Copies to all counsel. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606

            97-1614]

11/16/98  Motion filed by Appellee FDA, et al in 97-1604, Appellant FDA, et al

            in 97-1581, Appellee FDA, et al. in 97-1605, Appellant FDA, et al.

            in 97-1606, Appellee FDA, et al. in 97-1614 to stay the mandate

            [2882616-1]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

11/18/98  COURT ORDER filed granting motion to stay mandate [2882616-1] until

            for a period of 30 days from the date of the filing of this order

            pending the filing of a petition for certiorari by the government.

          Judge Hall dissented. 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

12/14/98  Motion filed by Appellee FDA in 97-1604, Appellee David A. Kessler in

            97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 to stay the mandate [2898734-1]. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606

            97-1614]

12/17/98  COURT ORDER filed granting motion to stay mandate [2898734-1] until

            January 18, 1999 in 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1605, 97-1606,

            97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

*35aa UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 97-1606

Coyne Beahm, Incorporated, Brown & Williamson Tobacco Corporation, Lorillard

Tobacco Company, Philip Morris, Incorporated, R. J. Reynolds Tobacco Company,

United States Tobacco Company, Conwood Company, L.P., National Tobacco Company,

L.P., Pinkerton Tobacco Company, Swisher International, Incorporated, Central

Carolina Grocers, Incorporated, J. T. Davenport, Incorporated, North Carolina

Tobacco Distributors Committee, Incorporated, The American Advertising

Federation, American Association of Advertising Agencies, Association Of

National Advertisers, Incorporated, Magazine Publishers of America, The Outdoor

Advertising Association of America, Incorporated, Point Of Purchase Advertising

Institute, National Association of Convenience Stores, Acme Retail,

Incorporated, Liggett Group, Incorporated, plaintiffs-appellees

v.

Food & Drug Administration, David A. Kessler, M.D., Commissioner of Food And

Drugs, defendants-appellants

*36aa DOCKET ENTRIES

DATE      PROCEEDINGS

--------  ---------------------------------------------------------------------

-------------------------------------------------------------------------------

                                     *****

8/11/97   Oral argument heard. Courtroom Deputy: Richard Sewell, Joseph

Coleman, Diane Burke. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614]

            (psc) [97-1581 97-1604 97-1605 97-1606 97-1614]

4/16/98   COURT ORDER filed for reargument of appeal [2754116-1] Copies to all

            counsel. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

6/9/98    Oral argument heard. Courtroom Deputy: JLC, DHB, RHS. [97-1604,

            97-1581, 97-1605, 97-1606, 97-1614] (rhs) [97-1581 97-1604 97-1605

            97-1606 97-1614]

                                     *****

8/14/98   Published, authored opinion filed. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

8/14/98   Judgment order filed. Decision: REVERSED. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

9/25/98   Petition filed by Appellee FDA in 97-1604, Appellee David A. Kessler

            in 97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 for rehearing. Number copies filed: 20 [2851942-1]., for

            suggestion for rehearing in banc. Number of copies filed: 20

            [2851942-2]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

11/10/98  PUBLISHED COURT ORDER filed denying motion for rehearing [2851942-1]

            in 97-1614, 97-1581, 97-1605, 97-1606, 97-1614, denying motion for

            suggestion for reh in banc [2851942-2] in 97-1614, 97-1581,

            97-1605, 97-1606, 97-1614 Copies to all counsel. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606

            97-1614]

11/16/98  Motion filed by Appellee FDA, et al in 97-1604, Appellant FDA, et al

            in 97-1581, Appellee FDA, et al. in 97-1605, Appellant FDA, et al.

            in 97-1606, Appellee FDA, et al. in 97-1614 to stay the mandate

            [2882616-1]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

[97-1581 97-1604 97-1605 97-1606 97-1614]

11/18/98  COURT ORDER filed granting motion to stay mandate [2882616-1] until

            for a period of 30 days from the date of the filing of this order

            pending the filing of a petition for certiorari by the government.

            Judge Hall dissented. 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

12/14/98  Motion filed by Appellee FDA in 97-1604, Appellee David A. Kessler in

            97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 to stay the mandate [2898734-1]. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606

            97-1614]

12/17/98  COURT ORDER filed granting motion to stay mandate [2898734-1] until

            January 18, 1999 in 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1605, 97-1606,

            97-1614] (dhb) [971581 97-1604 97-1605 97-1606 97-1614]

                                     *****

*40aa UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 97-1614

National AssociationofF Convenience Stores, Acme Retail, Incorporated,

Plaintiffs-Appellants

v.

David A. Kessler, Commissioner of the Food & Drug Administration, FOOD & DRUG

ADMINISTRATION, Defendants-Appellees

DOCKET ENTRIES

DATE      PROCEEDINGS

-------------------------------------------------------------------------------

                                     *****

8/11/97   Oral argument heard. Courtroom Deputy: Richard Sewell, Joseph

            Coleman, Diane Burke. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614]

            (psc) [97-1581 97-1604 97-1605 971606 97-1614]

4/16/98   COURT ORDER filed for reargument of appeal [2754116-1] Copies to all

            counsel. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

6/9/98    Oral argument heard. Courtroom Deputy: JLC, DHB, RHS. [97-1604,

            97-1581, 97-1605, 97-1606, 97-1614] (rhs) [97-1581 97-1604 97-1605

            97-1606 97-1614]

                                     *****

8/14/98   Published, authored opinion filed. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

8/14/98   Judgment order filed. Decision: REVERSED. [97-1604, 97-1581, 97-1605,

            97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606 97-1614]

9/25/98   Petition filed by Appellee FDA in 97-1604, Appellee David A. Kessler

            in 97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

            97-1614 for rehearing. Number copies filed: 20 [2851942-1]., for

            suggestion for rehearing in banc. Number of copies filed: 20

            [2851942-2]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

11/10/98  PUBLISHED COURT ORDER filed denying motion for rehearing [2851942-1]

            in 97-1614, 97-1581, 97-1605, 97-1606, 97-1614, denying motion for

suggestion for reh in banc [2851942-2] in 97-1614, 97-1581,

            97-1605, 97-1606, 97-1614 Copies to all counsel. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606

            97-1614]

11/16/98  Motion filed by Appellee FDA, et al in 97-1604, Appellant FDA, et al

            in 97-1581, Appellee FDA, et al. in 97-1605, Appellant FDA, et al.

            in 97-1606, Appellee FDA, et al. in 97-1614 to stay the mandate

            [2882616-1]. [97-1604, 97-1581, 97-1605, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

11/18/98  COURT ORDER filed granting motion to stay mandate [2882616-1] until

            for a period of 30 days from the date of the filing of this order

            pending the filing of a petition for certiorari by the government.

            Judge Hall dissented. 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1606, 97-1614] (dhb)

            [97-1581 97-1604 97-1605 97-1606 97-1614]

12/14/98  Motion filed by Appellee FDA in 97-1604, Appellee David A. Kessler in

            97-1604, Appellant FDA in 97-1581, Appellant David A. Kessler in

            97-1581, Appellee FDA in 97-1605, Appellee David A. Kessler in

            97-1605, Appellant FDA in 97-1606, Appellant David A. Kessler in

            97-1606, Appellee David A. Kessler in 97-1614, Appellee FDA in

97-1614 to stay the mandate [2898734-1]. [97-1604, 97-1581,

            97-1605, 97-1606, 97-1614] (mst) [97-1581 97-1604 97-1605 97-1606

            97-1614]

12/17/98  COURT ORDER filed granting motion to stay mandate [2898734-1] until

            January 18, 1999 in 97-1604, 97-1581, 97-1605, 97-1606, 97-1614

            Copies to all counsel. [97-1604, 97-1581, 97-1605, 97-1606,

            97-1614] (dhb) [97-1581 97-1604 97-1605 97-1606 97-1614]

                                     *****

*44aa [SEAL OMITTED]

Department of Health Education and Welfare

Public Health Service

Food and Drug Administration

Rockville, Maryland 20452

December 05, 1997

Mr. John F. Banzhaf, III

Executive Director and General Counsel

Action on Smoking and Health

2000 H Street, N.W.

Washington, D.C. 20006

Dear Mr. Banzhaf:

This is in reply to your petition dated May 26, 1977, requesting that the Food and Drug Administration (FDA) take the following action:

1. Recognition of the FDA's jurisdiction over cigarettes containing nicotine (or nicotine separately) as a "drug" or, in the alternative, as a "device" pursuant to 21 U.S.C. 321.

2. Regulation of cigarettes no less strictly than saccharin.

3. Restriction of the sale of cigarettes containing nicotine to pharmacies pursuant to 21 U.S.C. 353.

At a meeting on July 28, 1977, between you and Dr. Luther Terry, representing the petitioner, and several *45aa employees of FDA and me, the petition was discussed. You stated that the petitioners planned to submit additional material supplementing the petition, and that the supplement would be filed with FDA in September 1977. This supplement was submitted on November 15, 1977.

The petition submitted on May 26, 1977, and the supplemental memorandum of November 15, 1977, have been reviewed. Your requests that FDA assert jurisdiction over cigarettes containing nicotine (or nicotine separately) as a drug under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. s 321 et seq., and that FDA restrict the sale of cigarettes to pharmacies under 21 U.S.C. s 353 are denied. However, FDA can assert jurisdiction over cigarettes containing nicotine (or nicotine separately) as a drug when a jurisdictional basis for doing so exists, e.g., health claims made by the vendors Fairfax Cigarettes, infra and Trim Reducing Cigarettes, infra.

The request in your petition that FDA regulate the sale of cigarettes no less strictly than saccharin is withdrawn in your supplemental memorandum; therefore, no response to this request is necessary. The request in your petition that FDA assert jurisdiction over cigarettes as a device pursuant to 21 U.S.C. s 321 will be responded to by FDA in connection with your planned separate petition, on FDA regulation of cigarette filters as devices, to which you refer on page five of your supplemental memorandum. The Agency will respond to the separate petition and to your request for FDA regulation of cigarettes as a device within 180 days of the receipt of your separate petition, (21 C.F.R. s 10.30(e)).

*46aa The petitioners state in the supplemental memorandum that the serious health hazard posed by the extensive variety of additives in cigarettes and the clear absence of regulatory authority in any other Federal Agency are compelling reasons for the FDA to exercise its jurisdiction and strong evidence that such jurisdiction has not been precluded. Petitioners themselves answer these contentions by admitting at pages 9 and 10 of the supplemental memorandum that no law controls the additives to cigarettes.

Insofar as ASH is aware, there is no law which would prohibit cigarette manufacturers from adding to their products additional additives or tobacco substitutes, whether these contain natural products like lettuce leaves, chemical compounds such as Cytrel or NSM, or even known or suspected carcinogens. Moreover, no law appears to require the manufacturers to report such changes in the compositions of their products either to the consumers or to any federal or state agency.

FDA cannot assert jurisdiction over additives in cigarettes unless FDA has statutory jurisdiction over the cigarettes. FDA has asserted jurisdiction over cigarettes when a jurisdictional basis for so doing has existed (Fairfax Cigarettes, infra and Trim Reducing Cigarettes, infra).

Two court decisions in the 1950's demonstrate that FDA has regulated cigarettes when health claims were made by the manufacturers. In United States v. 46 Cartons, More or Less, Containing Fairfax Cigarettes, 113 F. Supp. 336 (D. N.J., 1953), the Court held that the cigarettes were a drug within the meaning of the *47aa Federal Food, Drug, and Cosmetic Act (the Act) because the advertising suggested that the cigarettes were effective in preventing respiratory and other diseases. These drug claims brought the cigarettes within the term "drug" as used in the Act. The other case, United States v. 354 Bulk Cartons Trim Reducing Cigarettes, 178 F. Supp. 847 (D. N.J., 1959), involved cigarettes containing tartaric acid, which were represented to be effective for combatting [sic] obesity. On the basis of the weight-reducing claims made on the packages and in other advertising, the Court held that these cigarettes constituted a drug.

One decision that has been discussed frequently in connection with the conclusion that cigarettes are not a drug under the Act is Federal Trade Commission v. Liggett & Myers Tobacco Co., 108 F. Supp. 573 (S.D. N.Y., 1952), affirmed 203 F.2d 955 (2nd Cir., 1953). The Court construed the definition of the term "drug" in the Federal Trade Commission Act--which is the same definition as in the Federal Food, Drug, and Cosmetic Act--not to include cigarettes. At page 577, the Court stated: "The legislative history, such as it is, coupled with indications of contemporaneous administrative interpretation leads me to the conclusion that Congress, had the matter been considered, would not have intended cigarettes to be included as an article 'intended to affect the functions of the body of man' or in any other definition of 'drug'.'DD'

No court has held that cigarettes are a drug under the Act. The interpretation of the Act by FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors.

*48aa Your petition focused the argument that cigarettes are a drug under the Act of the statutory definition of the term "drug" in 21 U.S.C. 321(g)(1)(C):

articles (other than food) intended to affect the structure or any function of the body of man or other animals...

The meaning of the word "intended" in 21 U.S.C. s 321 was construed in a 1977 appellate court decision, National Nutritional Foods Ass'n. v. Mathews, 557 F.2d 325 (2nd Cir, 1977). The Court stated: "The vendors' intent in selling the product to the public is the key element in this statutory definition" (557 F.2d at 333). The court stated that the Commissioner of Food and Drugs had acted arbitrarily and capriciously in proposing to regulate high potency Vitamin A and D preparationa [sic] as drugs under the Act.

The determination that an article is properly regulated as a drug, however, is not left to the Commissioner's unbridled discretion to act to protect the public health but must be in accordance with the statutory definition. Toxicity is not included as an element in the statutory definition of a drug. It is relevant as a factor supporting the Commissioner's classification under s 201(g)(1)(B), but only to the extent that it constitutes objective evidence of therapeutic intent. 557 F.2d at 334-335.

The petitioners have presented no evidence that manufacturers or vendors of cigarettes represent that the cigarettes are "intended to affect the structure or any function of the body of man...'' 21 U.S.C. s 321(g)(1)(C). Statements by the petitioners and citations in the petition that cigarettes are used by smokers to affect the structure or any functions of their bodies *49aa are not evidence of such intent by the manufacturers or vendors of cigarettes, as required under the provisions of 21 U.S.C. s 321(g)(1)(C) (see National Nutritional Foods Ass'n, supra, at 355).

The petitioners cite United States v. An Article of Drug ... Bacto-Unidisk, 394 U.S. 784 (1968), for a liberal construction of the Act consistent with its overriding purpose to protect the public health. In evaluating this contention, the court in National Nutritional Foods Ass'n., supra at 336, stated:

The drug definition is to be given a liberal interpretation in light of the remedial purposes of the legislation, see, United States v. An Article of Drug ... Bacto-Unidisk (citation omitted), but when an FDA determination that an article is a "drug" is so directly in conflict with the statutory definition, it must be invalidated as arbitrary and capricious and not in accordance with law.

Therefore, your request that FDA regulate cigarettes as a drug under the Act is denied. Based upon this conclusion, your requests that FDA restrict the sale of cigarettes to pharmacies pursuant to the Act and that FDA assert its jurisdiction over additives in cigarettes are also denied. Upon receipt of a separate petition requesting FDA regulation of cigarette filters as devices, the Agency will respond to that additional request.

Sincerely yours,

/s/ DONALD KENNEDY

Donald Kennedy

Commissioner of Food and Drugs

*50aa [SEAL OMITTED]

Department of Health Education and Welfare

Public Health Service

Food and Drug Administration

Rockville, Maryland 20857

November 25, 1980

John F. Banzhaf, III

Peter N. Georgiades

Action on Smoking and Health

2000 H St., NW

Washington, DC 20006

Re: Docket Nos. 77P-0185

78P-0338/CP

Dear Messrs. Banzhaf and Georgiades:

This replies to the pending requests in the petitions filed by Action on Smoking and Health (ASH), et al., on May 26, 1977 (Petition No. 1) and on October 2, 1978 (Petition No. 2), and supplements to them. Your petitions request the Food and Drug Administration (FDA) to recognize its jurisdiction over the following as medical devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h):

*51aa (1) Cigarettes containing nicotine (Petition No. 1);

(2) Cigarette filters, which you describe as basically "the 'detached' filter, which is purchased separately from the cigarettes and is installed by the smoker on the end of the cigarette" and "the 'attached' filter [which] ... is an integral part of many brands of cigarette" (Petition No. 2, pp. 5-6).

ASH also requests that FDA commence rulemaking to determine an appropriate scheme for regulating cigarettes and cigarette filters as medical devices.

We will respond first to Petition No. 1 concerning cigarettes containing nicotine and next to Petition No. 2 concerning cigarette filters. Because we agree with your statement (Petition No. 2, p. 6) that "it is conceptually easier to discuss detached and attached filters separately," we will respond separately with respect to "attached" and "detached" filters. Finally, we will respond to your request that FDA commence rule-making to determine an appropriate regulatory scheme. In preparing our response, we have considered the comments and other documents filed with the respective petitions in the Dockets Management Branch (formerly the Hearing Clerk's office) as well as the petitions themselves.

I. Cigarettes Containing Nicotine

For the reasons discussed below, we are denying the pending requests in Petition No. 1 concerning cigarettes containing nicotine as "devices."

*52aa Petition No. 1 (p. 31) sets forth your view that "cigarettes containing nicotine could be regulated either as 'drugs' or as 'devices."DD' As you know, on December 5, 1977, we denied your request to recognize jurisdiction over cigarettes containing nicotine under the definition of "drug" in section 201(g) of the Act, 21 U.S.C. 321(g). That denial has been extensively briefed, both before the District Court and the United States Court of Appeals for the District of Columbia, where the matter is presently pending. (ASH v. Harris, D.C. Cir., No. 79-1397). The "drug" issue will not be further discussed here.

Petition No. 1 broadly requests (e.g., p. 31) that FDA recognize jurisdiction over cigarettes as a "device" under section 201(h) of the Act, but does not specifically assert or present evidence that cigarettes are a "device" under the provisions of clauses (1) or (2) of section 201(h), 21 U.S.C. 321(h)(1) or (2). We find that cigarettes are not recognized in the official National Formulary or the United States Pharmacopeia, or any supplement to them, and that there is no evidence in the petition that cigarettes are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Accordingly, insofar as Petition No. 1 may be deemed to request that FDA regulate cigarettes containing nicotine as a "device" under section 201(h)(1) or (2) of the Act, we deny your request.

With respect to the application of section 201(h)(3) of the Act, 21 U.S.C. 321(h)(3), Petition No. 1 asserts that when the definition of "device" was enacted in 1938 it was intended to expand the agency's jurisdiction beyond that provided over "drugs" (p. 30) and that the *53aa "device" category is a far broader category than that of "drug" (p. 31).

The legislative history of the development of the definitions of "drug" and """device" as enacted in 1938 is discussed at length by the Supreme Court in United States v. An Article of Drug ... Bacto-Unidisk, 394 U.S. 784, 794- 800 (1969), where the Court treats the interpretation of the "intended use" portion of both definitions as presenting the same issues when considered under either section 201(g) or then 201(h). The language of current section 201(h)(3) was contained in the "device" definition prior to the "Medical Device Amendments of 1976," (the amendments), Pub. L. 94295. Petition No. 1 fails to establish that there are any differences between the scope of "device" jurisdiction before and after the amendments that are pertinent to determining whether cigarettes containing nicotine are "intended to affect the structure or any function of the body of man" within the meaning of section 201(h)(3) of the Act. Also, there is no suggestion in the legislative history of the amendments that Congress intended that portion of the definition to be interpreted in a different manner than it had been previously or than the identical language found in the "drug" definition in section 201(g)(1)(C) of the Act, 21 U.S.C. 321(g)(1)(C).

The report on the amendments by the House Committee on Interstate and Foreign Commerce (H.R. Rep. No. 94-853, 94th Cong., 2d Sess., p. 14 (1976)) notes that the purpose of amending the definition is "to draw a clear distinction between a 'device' and a 'drug';'DD' that the definition generally retains provisions of existing law concerning intended use; that those characteristics are also used in the definition of a "drug" in section *54aa 201(g) of the Act; but, adds the chemical action and metabolism modification to "remov[e] the gray area that exists under present definitions."

Specifically, there is no evidence in the legislative history that Congress intended to include cigarettes within the definition of "device" nor does the legislative history contain any discussion of a possibility that cigarettes were "devices" within the prior definition.

The amendments were thoroughly considered, and the legislative history discusses the types of products intended to be regulated and the types of health hazards with respect to which the amendments were intended to provide authority. Cigarettes are not mentioned even though Congress was aware of the considerable public discussion of the health hazards of cigarette smoking. It is, therefore, not reasonable to consider cigarettes as "devices" when there was no discussion in the legislative history of congressional intent to provide jurisdiction over cigarettes or to provide authority suitable to the regulation of cigarettes.

FDA has long believed and has repeatedly advised inquirers that cigarettes as customarily marketed are intended solely for smoking purposes or smoking pleasure and are not within FDA's jurisdiction under the Act. Indeed, this interpretation is involved in the pending appeal in ASH v. Harris. FDA's longstanding interpretation that it has no jurisdiction over cigarettes, absent evidence of the requisite intended use which brings cigarettes within the Act, is well known. That "statutory construction has been 'fully brought to the attention of the public and the Congress,' and the latter has not sought to alter that *55aa interpretation although it has amended the statute in other respects, [thus,] presumably the legislative intent has been correctly discerned." United States v. Rutherford, 99 S.Ct. 2470, 2476 n.10 (1979).

As stated, Congress has long been aware of the agency's interpretation. See, e.g., Hearings Before the Committee on Interstate and Foreign Commerce, House of Representatives, 89th Cong., 2d Sess., on Bills Regulating the Labeling and Advertising of Cigarettes and Relating to Health Problems Associated with Smoking, pp. 13-19 (1964); Hearings Before the Committee on Interstate and Foreign Commerce, House of Representatives, 89th Cong., 1st Sess., on H.R. 2248, etc., Cigarette Labeling and Advertising-1965 (1965); Hearings Before the Consumer Subcommittee of the Committee on Commerce, United States Senate, 92d Cong., 2d Sess., on S. 1454, Public Health Cigarette Amendments of 1971, 239- 252 (1972). Although bills have been introduced to amend the Act to include cigarettes, these attempts have failed. See, e.g., H.R. 11280, 84th Cong., 2d Sess. (1956) (to establish standards of purity, quality and fitness for human consumption); S. 2554, 85th Cong., 1st Sess. (1957) (label warning requirement); H.R. 592, 85th Cong., 1st Sess. (1957); S. 1682, 88th Cong., 1st Sess. (1963); H.R. 5973, 88th Cong., 1st Sess. (1963). H.R. 2248, 89th Cong., 1st Sess. (1965); H.R. 279, 96th Cong., 1st Sess. (1979). Evidence in the legislative history of those bills indicates that the bills were intended to expand, and not merely to clarify, FDA's jurisdiction under the Act. For example, when Senator Moss introduced S. 1682, he explained that "this amendment simply places smoking products under FDA jurisdiction along with foods, drugs, and cosmetics." 109 Cong. Rec. 10322 (1963).

*56aa FDA has, however, occasionally had evidence that cigarettes have been represented as effective for the prevention or treatment of respiratory and other diseases or for weight reduction. FDA has regarded cigarettes which were so represented by manufacturers or vendors as "drugs". See, e.g., United States v. 46 Cartons ... Fairfax Cigarettes, 113 F. Supp. 336 (D. N.J. 1953); United States v. 354 Bulk Cartons ... Trim Reducing-Aid Cigarettes, 178 F. Supp. 847 (D. N.J. 1959).

An article may be within FDA's jurisdiction if there is objective evidence that the manufacturer or vendor intends that the article is to affect the structure or a function of the body. In determining the intended use of a product, FDA considers the expressions of the person legally responsible for its labeling and the circumstances surrounding its distribution. Petition No. 1 does not contain examples of any representations by the manufacturers or vendors of cigarettes establishing that cigarettes are intended to affect the structure or any function of the body of man.

Petition No. 1 (p. 5) asserts that cigarettes per se affect the structure and functions of the body. However, effects alone do not establish jurisdiction under section 201(h)(3) of the Act. Even assuming the accuracy of the assertions as to the effects of cigarettes, the petition does not establish that these effects are intended.

Evidence of consumer intent in using a product can be relevant in determining the intended use of the product, and we have considered the evidence of consumer intent presented in Petition No. 1. ASH asserts *57aa that consumers use cigarettes with the intent of affecting the structure or functions of their bodies but the petition does not establish this contention. Indeed, petitioners admit (e.g., Petition No. 1, p. 2) that consumers smoke for a variety of reasons.

After a review of all the evidence on Petition No. 1, we conclude that the evidence presented by petitioners fails to establish that cigarettes are intended "to affect the structure or any function of the body" within the meaning of section 201(h)(3) of the Act.

In addition, we have considered whether granting your request to assert jurisdiction over cigarettes as "devices" would require action precluded by another act of Congress, specifically the Federal Cigarette Labeling and Advertising Act (FCLAA), 15 U.S.C. 1331-1340, as amended (Petition No. 1, pp. 20-30 and Exhibit IX).

In enacting the FCLAA, Congress was aware that FDA does not consider cigarettes, absent evidence of the requisite intended use, to be within FDA's jurisdiction under the Act. See, e.g., Hearings on H.R. 2248, etc., at 193 (1965). In a March 22, 1965, letter to the Chairman of the Senate Committee on Commerce concerning cigarette labeling and advertising, the Secretary of then Department of Health, Education, and Welfare (HEW) Anthony J. Celebrezze recommended that regulatory authority concerning cigarette labeling be vested in HEW. Secretary Celebrezze argued that HEW should be authorized to require statements on the labeling of cigarette packages and to prohibit or regulate the use of statements that might give consumers the misleading impression that a given *58aa cigarette is safer than others. Hearings Before the Committee on Commerce, United States Senate, 89th Cong., 1st Sess., on S. 559 and S. 547, Bills to Regulate Labeling of Cigarettes and For Other Purposes, pp. 22-26 (1965). Secretary Celebrezze recommended that the preferable manner for vesting regulatory responsibility would be by way of amendment to the federal Hazardous Substances Act (FHSA). Rather than providing the regulatory authority recommended by HEW, Congress mandated a specific warning, and preempted the imposition of a requirement of any other statement relating to smoking and health on cigarette packages. Similarly, Congress opted for the requirement of reports to Congress concerning smoking and cigarette labeling, including recommendations for legislation. We believe that the FCLAA, as amended, and its legislative history is strong evidence that Congress did not intend cigarettes as customarily marketed, and absent evidence of the requisite intended use, to be regulated by FDA under the Act.

We are also mindful of the fact that Congress has specifically excluded tobacco or tobacco products from the coverage of other statutes that otherwise might have applied to them. Thus, tobacco or tobacco products were excluded from the definition of "hazardous substance" under the FHSA, 15 U.S.C. 1261(f)(2); from the definition of "consumer product" under the Consumer Product Safety Act, 15 U.S.C. 2052(a)(1)(B); from the definition of """chemical substance" under the Toxic Substances Control Act, 15 U.S.C. 2602(2)(B)(iii); from the definition of "controlled substance" under the Controlled Substances Act, 21 U.S.C. 802(6); and from the definition of """consumer commodity" under the Fair Packaging and Labeling Act, 15 U.S.C. 1459(a)(1).

*59aa Those actions are indicative of the policy of Congress to limit the regulatory authority over cigarettes by Federal agencies. This is particularly true of the amendment of the FHSA to specifically exclude tobacco and tobacco products from the definition of "hazardous substance," 15 U.S.C. 1261(f)(2), encated in response to American Public Health Ass'n v. Consumer Product Safety Comm'n, Civil Action No. 94-1222 (D.D.C. April 23, 1975) (Exhibit IX to Petition No. 1). That case had held that the Consumer Product Safety Commission (CPSC) had jurisdiction to consider the promulgation of a rule banning high tar cigarettes from interstate commerce. S. Rep. No. 94-251, 94th Cong., 2d Sess. 5 (1976). See also the letter from Elmer B. Staats, Comptroller General, to the Hon. Sam J. Ervin, Jr., Chairman, Senate Committee on Government Operations, 120 Cong. Rec. S. 6225, 6227 (daily ed. April 24, 1974), advising that, although the definition of "hazardous substance" might literally include tobacco products, the FCLAA and its amendments "preempt the field of cigarette smoking and its relation to health."

For the above reasons, FDA is denying your request to assert jurisdiction over cigarettes containing nicotine as "devices" under the Act.

II. Attached Cigarette Filters.

Petition No. 2 requests that FDA recognize jurisdiction over attached cigarette filters, which ASH describes as an "integral part of many brands of cigarette" (p. 6), as "devices" under section 201(h)(2) of the Act. For the reasons discussed below, we are denying this request.

*60aa ASH asserts that the manufacturers of cigarettes are making implied claims that bring attached filters within the definition of device. Petition No. 2 provides examples of filter cigarette labeling and advertising, all of which include representations as to the level of tar, nicotine, or other constituents of cigarettes or of cigarette smoke. ASH contends (Petition No. 2, p. 3) that "... cigarette filters, which are designed and sold to remove tar, nicotine or harmful gases from tobacco smoke fall squarely within th[e] literal language" of the statutory definition of "device." In addition, ASH asserts that "cigarette manufacturers are using a wide variety of filters and each is making express or implied claims that the use of its filter will mitigate, treat or prevent smoking-related diseases by removing the 'tar,' nicotine or gases from the tobacco smoke" (Petition No. 2, p. 14).

In this connection, we have also reviewed the cigarette advertisements presented to the Anesthesiology Device Section of the Respiratory and Nervous System Devices Panel (formerly the Anesthesiology Device Classification Panel). In addition, we have considered the transcript of the Panel's deliberations concerning cigarette filters and the conclusion of the Panel that attached cigarette filters are "devices." We do not agree with the Panel's assessment of advertisements for filtered cigarettes and find that the advertisements presented to the Panel are of the same nature as the filter cigarette advertisements attached to Petition No. 2.

Representations in cigarette labeling or advertising of the nature of those in the record of Petition No. 2 as to the absolute or relative quantity of hazardous *61aa constituents of cigarette smoke or as to the safety of the cigarettes do not make the cigarettes or their filters intended for use in the mitigation, treatment, or prevention of disease.

The representations in the filtered cigarette labeling and advertising in Petition No. 2 are made in the context of long-standing public discussion of potential health hazards of smoking and, in recent years, of warnings which have been statutorily required on cigarette packages. ASH provided in Petition No. 2 as "good examples" (p. 11) of implied claims a series of advertisements (Exhibits H-O) (see also pp. 11-14 and Exhibits P-W). ASH itself admits that the advertisements do not imply that there is a health benefit for which purpose the filter cigarettes should be used, absent the desire to smoke (p. 12; see also Petition No. 1, p. 34).

Where, as here, attached filters are at most represented as making the cigarettes to which they are attached less hazardous to smoke, neither the cigarettes nor the filters are thereby intended for use in the mitigation, treatment, or prevention of disease.

FDA or its employees may have previously responded in a different manner to inquiries about cigarettes. FDA's position concerning representations of the types discussed above for cigarettes with attached filters is set forth herein and any inconsistent prior statements or opinions issued by or on behalf of FDA or any of its employees are hereby rescinded.

ASH asserts that objective evidence other than manufacturers' claims can be material to a determination *62aa of intended use under the statutory definition, and that National Nutritional Food Ass'n v. Food and Drug Administration, 504 F.2d 761 (2d Cir. 1974), cert. denied, 420 U.S. 946 (1975), is authority for this interpretation (Petition No. 2, p. 21). We agree. However, the court there held that the vendor's intent is the crucial element in the statutory definition and that objective evidence sufficient to pierce the manufacturer's subjective claims must be presented (504 F.2d at 789).

As Petition No. 2 also discusses, in National Nutritional Foods Ass'n v. Weinberger, 512 F.2d 688 (2d Cir. 1975), the court indicated that a finding that the product was used by consumers almost exclusively for therapeutic purposes could support a determination that the product was intended for use in the cure, mitigation, prevention, or treatment of disease (512 F.2d at 703). In National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325 (2d Cir. 1977), the court reiterated that vendor intent in selling a product to the public is the key element in the statutory definition (557 F.2d at 333). Those cases support FDA's position that it is the intent of the manufacturers or vendors that objective evidence must establish and that evidence of consumer use can be one element of objective evidence to be weighed in determining if the intended purpose of a product subjects it to regulation under the Act. ASH has not established that consumers use attached cigarette filters for the prevention, mitigation, or treatment of disease to the extent necessary to allow FDA to impute the requisite intended uses to manufacturers or vendors.

*63aa The evidence presented in Petition No. 2 concerning consumer intent regarding attached filters establishes at most that many consumers may regard attached filters as reducing exposure to hazardous constituents of cigarettes and creating a "safer" cigarette. As noted above, this will not bring attached filters within the definition of "device".

Because attached filters are necessarily used with the cigarettes of which they are constituent parts, the intent of consumers in using attached filters is reasonably understood and assessed together with consumer intent with respect to filtered cigarettes. ASH has not asserted that cigarettes with filters are intended to prevent, mitigate, or treat disease. Petition No. 1 expressly disclaims reliance on such an assertion when it discusses FTC v. Liggett & Myers Tobacco Co., 180 F. Supp. 573 (S.D.N.Y. 1952), aff'd, 203 F.2d 955 (2d Cir. 1953). Petition No. 1 characterizes as "tenuous" the very line of reasoning that Petition No. 2 relies upon in asserting that attached cigarette filters are intended to mitigate, treat, or prevent disease (Petition No. 1, p. 17).

We have also considered ASH's arguments concerning the intent of researchers, and find that the material in Petition No. 2 concerning that intent does not lead to different conclusions than does the evidence of consumer intent regarding attached filters.

For these reasons, FDA is denying your request to assert jurisdiction over attached filters as "devices" under the Act. We believe that congressional consideration of cigarettes included filter cigarettes and, as discussed in Section I, supports our conclusion that *64aa attached filters, as customarily marketed, are not within FDA's jurisdiction.

III. Detached Filters

ASH contends that detached filters, which are purchased separately from cigarettes and "installed by the smoker on the end of the cigarette" (Petition No. 2, p. 6), are subject to FDA's jurisdiction because:

1. Detached filters are advertised as useful in the mitigation, treatment, or prevention of disease (p. 6); or

2. Detached filters are advertised as useful aids in efforts to stop smoking and, therefore, are articles intended to affect the structure or function of the body or to mitigate, treat, or prevent disease (p. 8); or

3. Consumers use detached filters intending to mitigate, treat, or prevent disease (p. 16).

For the reasons stated below, the requests in Petition No. 2 with respect to detached filters are granted in part and denied in part.

We have reviewed the labeling and advertising submitted in Petition No. 2 concerning detached filters to determine whether representations for these products establish that detached filters are intended to be used to mitigate, treat, or prevent disease or to affect the structure or function of the body. We agree that some of that labeling and advertising establishes that manufacturers of certain detached filters, i.e., One Step At A Time, Venturi, and Nu Life Smokers Kit, have made *65aa representations that would bring these products under the device definition and, thus, FDA's jurisdiction.

The labeling and advertising submitted for other detached filters, i.e., Aquafilter and Medico Charcoal Filters, do not establish that these products are intended for a purpose that would bring them within the definition of device.

We would point out that all of the detached filters for which labeling and advertising were submitted in Petition No. 2 are intended to reduce the amount of tar, nicotine, or gases inhaled by the smoker or to aid the smoker to reduce or stop smoking. This does not establish manufacturer intent to mitigate, treat, or prevent disease, or to affect the structure or function of the body. As noted in Section II, we do not agree with the assertion in Petition No. 2 that "cigarette filters which are designed and sold to remove tar, nicotine or harmful gases from tobacco smoke" fall squarely within the literal definition of "device." Manufacturers of detached filters which are intended to remove tar, nicotine, and gases or to aid the smoker to reduce or stop smoking may be responding to consumer demand for a low tar, low nicotine, low gas cigarette, or a stop smoking aid to enable them to reduce the costs of smoking or eliminate the odor associated with smoking, etc. Only if detached filters intended for these purposes are coupled with other evidence that, when viewed together, establish the requisite intended use, will the products come within FDA's jurisdiction.

As noted in Section II, a claim of general or comparative safety, without more, will not usually cause a product to be subject to the Act. Many products are *66aa designed and sold to be used to reduce the exposure of humans to hazardous substances. For example, catalytic convertors and lead-free gasoline for use with automobiles are designed to reduce the exposure of humans to lead and hazardous by-products of gasoline combustion. These products, however, are not deemed to be within the Agency's jurisdiction. The determination that a product is properly regulated under the Act is not left to FDA's unbridled discretion but must be in accordance with the statutory definition. United States v. 62 Cases of Jam, 340 U.S. 593 (1950).

ASH's contention that consumer use of (or researchers' intent with respect to) detached filters brings these products within FDA's jurisdiction is identical to petitioner's discussion of attached filters. Our position is the same as discussed under Section II of this letter, as supplemented by our discussion above of evidence of intended use.

Therefore, Petition No. 2 has not provided evidence establishing FDA's jurisdiction over all detached filters. As stated above, we have concluded that FDA has jurisdiction over particular detached filters for which the evidence of the requisite intended use has been shown in Petition No. 2. The evidence in Petition No. 2 has also established that detached filters have been marketed with labeling and advertising which do not provide evidence of the requisite intended use.

FDA may have previously responded to inquiries regarding detached cigarette filters intended to aid the smoker to reduce or stop smoking. As noted under Section II with respect to attached filters, this response sets forth FDA's position and rescinds any earlier *67aa correspondence or opinions concerning detached filters that may be in conflict.

IV. Rulemaking

ASH has requested that FDA commence rulemaking proceedings to establish the means by which FDA should exercise its jurisdiction over cigarettes and attached and detached filters as medical devices. In the FEDERAL REGISTER of November 2, 1979, FDA stated that it was not issuing a proposed regulation to classify cigarette filters pending action on ASH's petition (44 FR 63292 at 63299). ASH's request to commence rulemaking is granted in part and denied in part.

Insofar as rulemaking would relate to cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction under section 201(h) of the Act. Therefore, no rulemaking is permissible as a matter of law.

Insofar as rulemaking would relate to detached filters, we have concluded that FDA has jurisdiction under section 201(h) of the Act over some, but not all, detached filters. We are granting your request that FDA institute rulemaking with respect to those detached filters over which FDA has jurisdiction.

In accordance with 21 CFR Part 860, FDA will propose to classify detached filters that are medical devices. FDA currently does not intend to institute other rulemaking proceedings specifically for these detached filters. However, rulemaking that FDA institutes with respect to other articles may also be applicable to detached filters that are devices.

*68aa Sincerely yours,

/s/ [ILLEGIBLE]

For Jere E. Goyan

Commissioner of Food and Drugs

DIGEST

Food and Drug Administration v. Brown and Williamdson Tobacco Corp.

138 DRUGS AND NARCOTICS

138I Drugs and Druggists in General

138k2 Federal Regulation

138k3 k. Drugs or devices within regulations.

Are tobacco products subject to regulation under Federal Food, Drug, and Cosmetic Act as "drugs" and "devices," given Food and Drug Administration's (FDA) finding that nicotine in tobacco products is intended by tobacco manufacturers to cause and sustain a user's addiction to nicotine and to act as a sedative, stimulant, and appetite suppressant? Federal Food, Drug, and Cosmetic Act, ss 201(g)(1)(C), (h)(3), as amended, 21 U.S.C.A. ss 321(g)(1)(C), (h)(3).

U.S.Pet.Brief,1999.

1999 WL 503874 (U.S.Pet.Brief)

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2078162 - AUBURN UNIVERSIT

Date and Time Printing Started: 10/11/1999 05:56:46 pm (Central)

Date and Time Printing Ended: 10/11/1999 05:56:54 pm (Central)

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