The FDA may not regulate tobacco products as "drugs" or as "medical devices"

Duke Law Journal

Volumn 47, Issue 6, 1998, Pages 1071-1072

  Merrill, Richard A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ADVERTIZING; ARTICLE; DRUG CONTROL; FOOD AND DRUG ADMINISTRATION; HUMAN; LEGAL ASPECT; PLANT; TOBACCO; UNITED STATES;

ADVERTISING; DRUG AND NARCOTIC CONTROL; HUMANS; PLANTS, TOXIC; TOBACCO; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032035383     PISSN: 00127086     EISSN: None     Source Type: Journal    
DOI: 10.2307/1373031     Document Type: Article

References (9)

1. Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374, 1393-1400 (M.D.N.C. 1997).
2. Brown & Williamson Tobacco Corp. v. FDA, Nos. 97-1604, 97-1581, 97-1606, 97-1614 and 97-1605, 1998 WL 473320 (4th Cir. Aug. 14, 1998).
3. See Appellees' Petition for Rehearing, Brown & Williamson (No. 97-1604).
4. See Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, 61 Fed. Reg. 44,396 (1996) (to be codified at 21 C.F.R. pts. 801, 803, 804, 807, 820, 897 (1997)) [hereinafter FDA Regulations].
5. 21 U.S.C. §§ 301-397 (1994 & Supp. II 1997).
6. See Nicotine in Cigarettes and Smokeless Tobacco Is a Drug and These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act: Jurisdictional Determination, 61 Fed. Reg. 44,619, 45,208 (1996) [hereinafter FDA Jurisdictional Determination].
7. See 21 C.F.R. pt. 897 (1997).
8. See Ceci Connolly & John Mintz, 3 Unlikely Allies Built a Broad Anti-Tobacco Wave, WASH. POST, Mar. 31, 1998, at A1 (detailing Kessler's antipathy toward the tobacco industry, and his role in convincing President Clinton of the political advantage of supporting the FDA's attempt to regulate tobacco products).
9. See 21 C.F.R. §§ 897.2, 897.14(a) (1997). The FDA estimated that "1 million youngsters become new smokers each year." FDA Regulations, supra note 4, at 44,573. The FDA predicted that its regulations would help achieve the goal of reducing underage tobacco use by one-half. See id. at 44,423. Regulations previously adopted by the Department of Health and Human Services which provide funding incentives to states to enforce their laws against sale to persons under eighteen should also help achieve that goal. See id. at 44,498 (citing the