Opinion ID: 2967173
Heading Depth: 4
Heading Rank: 1

Heading: Historical Actions of the FDA

Text: From 1914 until the present rulemaking attempt, the FDA had consistently stated that tobacco products were outside the scope of its jurisdiction. And, as early as 1898, the Supreme Court of Tennessee acknowledged the dangerous nature of tobacco products, characterizing cigarettes as wholly noxious and deleterious to health, inherently bad, and bad only, and widely condemned as pernicious altogether. Austin v. State, 48 S.W. 305, 306 (Tenn. 1898). Yet, the statute preceding the Act, the Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (1906), did not mention tobacco. As early as 1914, the FDA's predecessor agency stated that it had authority to regulate tobacco products if their labeling indicated use for the cure, mitigation, or prevention of a disease, but not if labeled or used for 28 smoking or chewing or as snuff and not for medicinal purposes. Bureau of Chemistry, U.S. Dept. of Agriculture, 13 Service and Regulatory Announcements 24 (Apr. 2, 1914). Enacted in 1938, the present Act expanded the definition of drug from the definition provided in the Pure Food and Drugs Act of 1906 and also granted the FDA new authority to regulate devices. Food, Drug, and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (1938). However, neither the Act nor its legislative history mention tobacco products.15 In the 60 years following the passage of the Act, the FDA has repeatedly informed Congress that cigarettes marketed without therapeutic claims do not fit within the scope of the Act. Ever since its beginning in the 1930s, the FDA has taken the position and made statements indicating that the Act did not apply to cigarettes marketed without specific health claims. FDA/Dep't of Justice Brief in ASH v. Harris (No. 79-1397), at 16. Again, in 1963, an FDA Bureau of Enforcement Guideline stated that [t]he statutory basis for the exclusion of tobacco products from FDA's jurisdiction is the fact that tobacco marketed for chewing or smoking without accompanying therapeutic claims, does not meet the definitions in the Food, Drug, and Cosmetic Act for food, drug, device or cosmetic. Letter to Directors of Bureaus and Divisions and Directors of Districts from FDA Bureau of Enforcement (May 24, 1963), reprinted in Public Health Cigarette Amendments of 1971: Hearings Before the Consumer Subcomm. of the Senate Comm. on Commerce on S. 1454, 92d Cong. 240 (1972). When Congress later examined the issue of the FDA's jurisdiction during its consideration of tobacco-specific legislation, FDA Commissioner Charles Edwards testified regarding the FDA's lack of authority over cigarettes and stated thatif cigarettes were to be classified as drugs, they would have to be removed from the market because it would be impossible to prove they were safe for their intended [use].16 Hearings on S. 1454 at 239. The Commissioner _________________________________________________________________ 15 Two of the main supporters of the Act were representatives from the two leading tobacco States - Senator Bailey (D-NC) and Representative Chapman (D-KY). See 83 Cong. Rec. 9094 (1938). In fact, Sen. Bailey and Rep. Chapman were among Senate and House managers of the Act in the Conference Committee. Had there been any indication that the Act might apply to tobacco products, we can only assume that such members of Congress would have expressed opposition to the Act. 16 The Commissioner cited several cases in support of the FDA's conclusion that it lacked authority over cigarettes as customarily marketed. 29 took the position that the Federal Cigarette Labeling and Advertising Act, discussed in greater detail below, reinforced that the regulation of cigarettes is to be the domain of Congress. Hearings on S. 1454 at 242. The Commissioner then concluded that labeling or banning cigarettes is a step that can be take[n] only by Congress. Any such move by the FDA would be inconsistent with the clear congressional intent. Hearings on S. 1454 at 242. In 1977, Action on Smoking and Health (ASH), a public health group, petitioned the FDA to regulate cigarettes. ASH claimed that cigarettes were drugs because they contain nicotine which produces addiction in many smokers, and particularly in youth. Citizen Petition, FDA Docket No. 77P-0185, at 4-11 (May 26, 1977)[G. Br. Att. 77]. In rejecting ASH's petition,17 the FDA cited a 1953 Second Circuit opinion, FTC v. Liggett & Myers Tobacco Co., 203 F.2d 955 (2d Cir. 1953), affirming on opinion below, 108 F. Supp. 573 (S.D.N.Y. 1952), for the proposition that cigarettes marketed without health claims by the vendor are not within the FDA's jurisdiction. Specifically, the FDA quoted with approval the following language from the court's opinion: 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 _________________________________________________________________ See, e.g., FTC v. Liggett & Myers Tobacco Co. , 203 F.2d 955 (2d Cir. 1953), affirming on opinion below, 108 F. Supp. 573 (S.D.N.Y. 1952); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178 F. Supp. 847 (D.N.J. 1959); United States v. 46 Cartons . . . Fairfax Cigarettes, 113 F. Supp. 336 (D.N.J. 1952). 17 A federal appeals court upheld the FDA's denial of jurisdiction. See ASH v. Harris, 655 F.2d 236 (D.C. Cir. 1980). In upholding the FDA's denial of jurisdiction, the court emphasized the relevance of the remarks of the district court in Liggett. In construing the identical language of the definitions in the Federal Trade Commission Act, the Liggett court stated: [s]urely, the legislators did not mean to be as all-inclusive as a literal interpretation of [the definitions] would compel us to be. ASH, 655 F.2d at 240 (quoting Liggett & Myers, 108 F. Supp. at 576). 30 included as an article intended to affect the functions of the body of man or in any other definition of drug. See Letter from FDA Commissioner Donald Kennedy to John F. Banzhaf, III, at 3 (Dec. 5, 1977) (quoting Liggett & Myers, 108 F. Supp. at 577) (stating that the FDA's consistent position has been that cigarettes marketed without health claims by vendors are not drugs within the Act). In 1978, ASH filed a second petition, claiming that cigarettes were devices under the Act and thus were within the scope of the FDA's jurisdiction. Citizen Petition, FDA Docket No. 78P-0338 (Oct. 2, 1978). After reviewing the legislative history of the Act, the FDA stated that [i]nsofar as rulemaking would relate to cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction under [the definition of device]. Therefore, no rulemaking is permissible as a matter of law. Letter from FDA Commissioner Jere E. Goyan to John F. Banzhaf, III and Peter N. Georgiades, at 12 (Nov. 25, 1980). In considering the effect of the Medical Device Amendments of 1976 which modified the definition of device to its current formulation, the FDA Commissioner stated: 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 weredevices 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. 31 Goyan/Banzhaf Letter, at 3. The FDA's holdings and statements that the Act fails to provide authority suitable to the regulation of cigarettes are consistent with part II.A's conclusion, supra, that the Act's regulatory scheme simply cannot accommodate tobacco products. Again in 1989, the FDA Commissioner stated that:it doesn't look like it is possible to regulate [tobacco products] under the Food, Drug and Cosmetic Act even though smoking, I think, has been widely recognized as being harmful to human health. Hearings Before the Subcomm. on Rural Development, Agriculture, and Related Agencies of the House Comm. on Appropriations, 100th Cong., 2d Sess. 409 (1989). The above statements evidence the FDA's position from 1914 until the present rulemaking attempt that, as a matter of law, it did not have jurisdiction to regulate tobacco products as customarily marketed. The FDA's public, consistent, and longstanding interpretation18 of the Act gains even more significance when viewed in conjunction with the actions of Congress during the same time period.