Opinion ID: 2967173
Heading Depth: 4
Heading Rank: 3

Heading: Congress' Tobacco-Specific Legislation

Text: Under Chevron's instruction to apply the traditional rules of statutory construction, it is also appropriate to consider the provisions of the whole law, and . . . its object and policy in ascertaining the will of Congress. Dole v. United Steelworkers of America, 494 U.S. 26, 35 (1990) (quoting Pilot Life Ins. Co. v. Dedeaux , 481 U.S. 41, 51 (1987)). Having examined the Act and prior actions of the FDA and Congress, we now take a closer look at three statutes and related amendments (collectively referred to as the tobacco-specific legislation) enacted by Congress for the purpose of addressing public health concerns about the use of tobacco products. The issue is not, in the words of the stalking horse set up by the government, whether these three statutes partially repeal or amend the Act to withhold jurisdiction over tobacco products from the FDA. FDA Red Br. at 57. Rather, we examine the tobacco-specific legislation as a part of our inquiry into congressional intent. As discussed above, we are of opinion that the statutory text, viewed as a coherent whole, clearly indicates that Congress did not intend the FDA's original jurisdictional grant to include tobacco products. Thus, the subsequent enactment of tobacco-specific legislation provides corroborating evidence of established congressional intent. In January 1964, the publication of the first Surgeon General's report on smoking and health called the federal government's attention to the dangers of tobacco products. Dept. of Health, Education and Welfare, Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service (1964); see also H.R. Rep. No. 289, 91st Cong., 1st Sess., at 5 (characterizing the 1964 Surgeon General's Report as the principal basis for regulatory efforts). Shortly thereafter, the House Committee on Interstate and 34 Foreign Commerce initiated a series of hearings regarding the federal government's role in dealing with smoking-related health problems. Committee Chairman, Representative Oren Harris, stated that: The purpose of these hearings will be, if we can reach that point, to determine the extent of authority under existing law to deal with the various aspects of this general field, and to determine whether any action of the Congress is warranted in the interest of public health. In other words, we want to find out under our responsibility whether or not legislative action is necessary, and if so, what kind. Hearings Before the Comm. on Interstate and Foreign Commerce on Bills Regulating the Labeling and Advertising of Cigarettes and Relating to Health Problems Associated with Smoking, 88th Cong., 2d Sess. 23 (1964). During the course of these hearings, Congress considered and rejected the option of granting the FDA jurisdiction over tobacco products. Of the eleven bills submitted to the Committee, two would have expressly amended the Act to make it applicable to tobacco products. 1964 Hearings at 2-12. These two bills proposed expansion of the Act to cover tobacco products by creating a new category of products subject to FDA jurisdiction. See 1964 Hearings at 4-7 (suggesting creation of new category entitled smoking products). These two bills also proposed new operative provisions applicable only to smoking products.20 1964 Hearings at 4-7. As part of the hearings, Surgeon General Terry was asked whether the Department of Health, Education, and Welfare (HEW), the FDA's parent department, had authority to regulate tobacco products. Dr. Terry's unqualified response was that his department did not believe that it had such authority in existing laws governing the Public Health Service and Food and Drug Administration. 1964 Hearings at 56. Similar testimony was later provided by the Deputy Commissioner of the FDA. See Cigarette Labeling and Advertising: Hearings Before the House _________________________________________________________________ 20 The fact that the two proposed bills created a new jurisdictional category and new operative provisions for tobacco products is consistent with our analysis in part II.A, supra, which concludes that the current structure of the Act cannot accommodate tobacco products. 35 Comm. on Interstate and Foreign Commerce, 89th Cong., 2d Sess. 193 (1965) (statement of Deputy Commissioner Rankin that [t]he Food and Drug Administration has no jurisdiction under the Food, Drug, and Cosmetic Act over tobacco, unless it bears drug claims); see also 111 Cong. Rec. 13431 (1965). In addition, the Secretary of HEW, Anthony J. Celebrezze, warned the Committee that giving the FDA jurisdiction over tobacco products might well lead to a ban and that such a ban would be contrary to the intent of Congress and the will of the American public. See 1964 Hearings at 18 (stating that a ban would be contrary to what, we understand, is intended or what, in the light of our experience with the 18th amendment, would be acceptable to the American people). Following the hearings and consideration of the various bills, Congress responded to the Surgeon General's report by enacting The Federal Cigarette Labeling and Advertising Act (Cigarette Labeling Act), Pub. L. No. 89-92, 79 Stat. 282 (1965) (codified at 15 U.S.C. §§ 1331 et seq.). In general, the Cigarette Labeling Act required manufacturers to place specific health-hazard warnings from the Surgeon General on cigarette packaging, advertising, and billboards. 15 U.S.C. § 1333. The Cigarette Labeling Act also set forth congressional policy regarding regulation of tobacco products: It is the policy of the Congress, and the purpose of this chapter, to establish a comprehensive Federal program to deal with cigarette labeling and advertising with respect to any relationship between smoking and health, whereby - (1) the public may be adequately informed about any adverse health effects of cigarette smoking by inclusion of warning notices on each package of cigarettes and in each advertisement of cigarettes; and (2) commerce and the national economy may be (A) protected to the maximum extent consistent with this declared policy and (B) not impeded by diverse, nonuniform, and confusing cigarette labeling and advertising regulations with respect to any relationship between smoking and health. 36 15 U.S.C. § 1331. Thus, the express goal of the Cigarette Labeling Act is to warn consumers about the health hazards of smoking while also protecting the national economy. The district court apparently considered that the plaintiffs claimed that the separate preemption provision of the Cigarette Labeling Act precluded any further regulation of tobacco products except by Congress. See Coyne Beahm, 966 F. Supp. at 1385-1386. We do not think that the claim was so broad then, certainly it is not so broad now. While it is true that 15 U.S.C. § 1334, requires that no statement relating to smoking or health other than the statement required by § 1333, shall be required on any cigarette package, that is not a statement excluding other regulation of tobacco products. But the fact that Congress has, some 27 years after the establishment of the FDA in its present form, enacted the Cigarette Labeling Act, is strong evidence that Congress has reserved for itself the regulation of tobacco products rather than delegating that regulation to the FDA. Congressional policy, as set out in the Cigarette Labeling Act, cannot be harmonized with the FDA's assertion of jurisdiction over tobacco products. First, by enacting the Cigarette Labeling Act rather than other proposed legislation, Congress clearly rejected the proposed regulatory role for the FDA. Next, the Act charges the FDA with protecting the public health, but does not authorize the FDA to consider protection of commerce and the national economy. Thus, by the terms of its enabling statute, the FDA is not capable of complying with Congress' stated policy regarding the regulation of tobacco products. In addition, the congressionally-established regulatory plan of the Cigarette Labeling Act directly contradicts the FDA's mandatory requirements set forth in the Act. As discussed supra in part II.A, the Act prohibits the sale or distribution of unsafe devices. See, e.g., 21 U.S.C. §§ 331(a), 352(j). In contrast, the Cigarette Labeling Act recognizes the unsafe and dangerous nature of cigarettes, but permits continued marketing with consumer warnings. 15 U.S.C. §§ 1331, 1333. The decision by Congress to allow continued marketing of unsafe products cannot be reconciled with the operative provisions of the Act, primarily because the Act does not allow FDA consideration of the factors involved in Congress' policy determination. See 15 U.S.C. § 1331(2) (establishing policy of protecting commerce and the national economy). 37 Finally, in developing the Cigarette Labeling Act, Congress clearly considered and rejected a role for the FDA. The government does not produce any legislative history to the contrary. The legislative history of the Cigarette Labeling Act is thus important to understanding congressional intent because it reflects the historical context in which the Cigarette Labeling Act was developed. See Radowich v. United States Att'y, 658 F.2d 957, 961 (4th Cir. 1981) (stating that courts should look at the clearly expressed intention as expressed without dissent in the legislative history to be certain that their construction of a statute is consistent with the manifest purpose as clearly mirrored in the legislative history). Thus, the Cigarette Labeling Act and the context in which it was enacted provides evidence of Congress' intent that the FDA not have jurisdiction over tobacco products. Subsequent legislation by Congress reinforces our understanding of this expressed congressional intent. The Cigarette Labeling Act's advertising and labeling regulations originally were set to expire on June 30, 1969. In response, the Federal Communications Commission (FCC) introduced a proposal to ban all television and radio cigarette advertising. 34 Fed. Reg. 1959 (1969). In addition, the Federal Trade Commission (FTC) renewed its proposed rule from 1964. See 34 Fed. Reg. 7917 (1969) (citing health hazards of smoking and proposing warning statements for cigarette packages and advertisements).21 Again, Congress debated the role of administrative agencies in the regulation of tobacco products. See generally Cigarette Labeling and Advertising: Hearings Before the House Comm. on Interstate and Foreign Commerce, 91st Cong., 1st Sess. (1969). The House Report stated: The regulations [proposed by the FCC and the FTC] raise basic constitutional questions and would affect the growing, sale, and manufacturing of tobacco for cigarettes and the persons involved in or affected by those activities. These activities cut across the whole spectrum of commercial and social life in the United States. It is therefore an area where the Congress, if anyone, must make policy. _________________________________________________________________ 21 We note that the FDA took no action at this time. 38 ... Aside from the questions of constitutional and statutory law which the two agencies' proposed rules raise, they are an assumption by these agencies of policymaking with respect to a subject matter on which the Congress has made policy . . ., [and] has stated its intention to be the exclusive policymaker on the subject matter . . . . H.R. Rep. No. 289, at 4-5. Following these debates and hearings, Congress amended the Cigarette Labeling Act by enacting the Public Health Cigarette Smoking Act of 1969, Pub. L. No. 91-222, 84 Stat. 87 (1970). Basically, the 1969 Act reenacted the Cigarette Labeling Act, but with several amendments.22 Notably, Congress did not amend or replace 15 U.S.C. § 1331, the provision setting out its policy determination regarding the regulation of tobacco products. Congress showed a continuing interest in the regulation of tobacco products with the Alcohol and Drug Abuse Amendments of 1983, Pub. L. No. 98-24, 97 Stat. 175, 178 (1983) (codified at 42 U.S.C. §§ 290aa et seq.). These amendments require the Secretary of HHS, FDA's parent agency, to submit certain reports to Congress every three years. 42 U.S.C. § 290aa-2(b). The statute directs the Secretary to report to Congress current findings on the addictive property of tobacco and to recommend legislation and administrative action as the Secretary may deem appropriate. 42 U.S.C.§ 290aa-2(b)(2)-(3). This statute evidences Congress' awareness of the addictive nature of tobacco products and its intent to retain control over further regulatory action. In 1984, Congress again amended the Cigarette Labeling Act, but retained the basic regulatory approach established in 1965. See Com_________________________________________________________________ 22 For example, the 1970 amendments changed the wording of the warning to be included on cigarette packages, 15 U.S.C. § 1333; revised § 1334's express preemption provision; and made it unlawful to advertise cigarettes on electronic communications subject to FCC jurisdiction, 15 U.S.C. § 1335. 39 prehensive Smoking Education Act (Smoking Education Act), Pub. L. No. 98-474, 98 Stat. 2200 (1984) (amending the Cigarette Labeling Act). The Smoking Education Act required rotating warnings on cigarette packaging and advertising, 15 U.S.C. § 1333; established an Interagency Committee on Smoking and Health, including members from the FTC, the Department of Education, and the Department of Labor, but not from the FDA, 15 U.S.C. § 1341(b); and required annual disclosure of tobacco ingredients to the Secretary of HHS, 15 U.S.C. § 1335a. Quoting U.S. Surgeon General Dr. C. Everett Koop, the House Report recommending this legislation described cigarette smoking as the most important public issue of our time. H.R. Rep. No. 805, 98th Cong., 2d Sess., at 12 (1984). Consistent with the prior actions of Congress discussed above, the House Report recognized that [f]ederal laws that protect the public from hazardous food, drugs and consumer products do not apply to cigarettes. H.R. Rep. 805, at 12. In 1986, Congress created a similar regulatory program for smokeless tobacco, but with some additions.23 Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco Act), Pub. L. No. 99-252, 100 Stat. 30 (1986) (codified at 15 U.S.C.§§ 4401-4408). In general, the Smokeless Tobacco Act required specific health warnings in smokeless tobacco advertising and on packaging, 15 U.S.C. § 4402(a),(b); authorized the FTC to issue specified regulations regarding the content and form of label warnings, 15 U.S.C. § 4402(c); banned advertising on electronic communications subject to FCC jurisdiction, 15 U.S.C. § 4402(f); and required annual ingredient and nicotine-level reporting to the HHS Secretary, 15 U.S.C. § 4403. In addition, the Smokeless Tobacco Act authorized the Secretary of HHS to develop a program for informing the public of the health hazards caused by use of smokeless tobacco. 15 U.S.C. § 4401(a). Specifically, the Secretary is instructed to make this information available to school systems for educational purposes. 15 U.S.C. § 4401(a)(1)(B). The statute also provided for technical and financial assistance to States for their development of educational programs about the dangers of smokeless tobacco and for establishing _________________________________________________________________ 23 It is worth noting that Congress adopted a very similar approach to the one taken in the Cigarette Labeling Act, even though it had expressly recognized the addictive nature of tobacco. 42 U.S.C. § 290aa-2(b)(2). 40 18 as the minimum age for purchasing smokeless tobacco. 15 U.S.C. § 4401(b).24 Finally, the Smokeless Tobacco Act requires the Secretary of HHS to submit biennial reports to Congress containing a description of the effects of health education efforts, an evaluation of the health effects of smokeless tobacco products, and recommendations for legislation and administrative action. 15 U.S.C. § 4407(a). Like the Cigarette Labeling Act, the Smokeless Tobacco Act also contains an express preemption provision. See 15 U.S.C. § 4406 (providing that [n]o 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). However, as discussed in relation to the Cigarette Labeling Act, this express preemption provision does not detract from our examination of the statute as a tool for determining congressional intent. In recommending passage of the Smokeless Tobacco Act, the House Report cited particular concerns about the popularity of smokeless tobacco with minors. See S. Rep. No. 209, 99th Cong., at 4 (1985), reprinted in 1986 U.S.C.C.A.N. 7, 10 (stating that a major reason for the development of a legislative proposal is the alarming incidence of use by children). Thus, in 1986, Congress considered the very issues that the FDA now purports to address in its proposed regulations. Within the context of the FDA's repeated stated positions that it had no jurisdiction, Congress enacted comprehensive legislation addressing many of the activities that the FDA now attempts to regulate, based on the same concerns relating to youth use now cited by the FDA. The enactment of the Smokeless Tobacco Act in no way supports a conclusion that Congress intended to give the FDA jurisdiction over tobacco products. To the contrary, the detailed scheme created by Congress evidences its intent to retain authority over regulation of smokeless tobacco. Cf. Patterson v. McLean Credit Union, _________________________________________________________________ 24 As discussed below, Congress built on the youth education and age limit provisions of the Smokeless Tobacco Act in the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992 (1992 Amendments), Pub. L. No. 102-321, 106 Stat. 394 (codified at 42 U.S.C. § 300x-26). 41 491 U.S. 164, 181 (1989) (stating that courts should be reluctant . . . to read an earlier statute broadly where the result is to circumvent the detailed remedial scheme constructed in a later statute). The FDA may not, without empowerment by Congress, construct what it believes is a better regulatory scheme. MCI, 512 U.S. at 234. If the FDA believed that additional regulation was needed, the Secretary should have recommended such action to Congress, as directed in the Smokeless Tobacco Act. 15 U.S.C. § 4407(a)(4). In 1992, Congress again addressed the problem of youth access to tobacco products. The Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992 (1992 Amendments), Pub. L. No. 102-321, 106 Stat. 394, focused on regulation at the state level by providing financial incentives to States which enact and enforce access restrictions for individuals under age 18. 42 U.S.C. § 300x-26.25 The 1992 Amendments express clear congressional intent that States exercise their traditional police powers and take a primary role in attacking the problem of youth access to tobacco products. However, the FDA's proposed regulatory scheme would preempt much state regulation in this area, including more stringent regulations than those proposed by the FDA. The Act prohibits States from imposing on devices any requirements different from, or in addition to those imposed by the FDA. 21 U.S.C. § 360k(a). Thus, if the Act applied to tobacco products, § 360k(a) would prohibit States from addressing the problem of youth access. The FDA responds, FDA Red Br. p. 67, n. 16, that States might qualify for exemptions from preemption under § 360k(b). However, the possibility of a discretionary exemption does not take away the inherent conflict between the state regula_________________________________________________________________ 25 More specifically, States are eligible for the financial incentives only if they: (1) prohibit sales to individuals under age 18, 42 U.S.C. § 300x26(a)(1); (2) enforce the prohibition in a way thatcan reasonably be expected to reduce the extent to which tobacco products are available to individuals under the age of 18, 42 U.S.C. § 300x-26(b)(1); (3) conduct random, unannounced inspections of retailers to check compliance, 42 U.S.C. § 300x-26(b)(2)(A); and (4) make annual reports to the HHS Secretary regarding the manner and success of state enforcement activities, 42 U.S.C. § 300x-26(b)(2)(B). 42 tory role established by Congress and the FDA's proposed scheme. In developing its regulatory scheme for tobacco products, Congress made a policy determination that state participation was necessary for effective regulation of youth access. Allowing the FDA to override this decision would be contrary to congressional intent. Over the last 60 years, Congress has enacted numerous statutes and amendments for the regulation of tobacco products. Throughout this period, Congress was well aware of the dangers of tobacco products and of the FDA's consistent position that it had no jurisdiction over tobacco products. Yet, Congress took no steps to overturn the FDA's interpretation of the Act, that it had no jurisdiction over tobacco products as customarily used. In fact, Congress deliberately rejected a role for the FDA during its consideration of various legislation from 1965 through 1993.26 Instead, Congress developed a regulatory scheme whereby it retained the position of policymaker for the industry.27 In addition, it developed a scheme whereby designated agencies would periodically report any new information and recommendations for legislation or regulation to Congress.28 Taken together, these actions by Congress are relevant and corroborative evidence that Congress never intended to give the FDA jurisdiction over tobacco products.