Tobacco Documents Online

• LONG VERSION February 1, 1994 TOBACCO PRODUCTS AND THE MYTH OF "UNDERREGULATION" A favorite claim of the antitobacco lobby is that tobacco products are virtually unregulated and accordingly should be subject to stringent new regulatory controls. This claim is untenable. At every level of government -- federal, state and local -- there is extensive regulation of tobacco products. Perhaps no other product is regulated in so many ways, or by so many agencies, as tobacco products. From seed-bed to sales-counter, from how the product is produced to where and when it may be used, tobacco products are among the most highly regulated products in the nation. Beyond these more direct forms of regulation, of course, tobacco is subject to exceptionally heavy regulation by taxation. The true aim of the antitobacco lobby is not to ensure that tobacco products are adequately regulated but to put the tobacco industry out of business and eliminate a product that fifty million ~ American adults use and enjoy. Any system of regulation that fails to guarantee these results will be decried by the antitobacco lobby as "underregulation." No additional regulation is warranted. Indeed, Secretary of Health and Human Services, Louis W. Sullivan himself told Congress in 1990 that legislation giving HHS additional regulatory authority would not add measurably to the agency's current or planned efforts and was therefore "unnecessary."t Federal Regulation 1. Production. Federal regulation of tobacco begins with the setting of production quotas and price levels for tobacco leaf by the Agricultural Stabilization and Conservation Service and the Commodity Credit Corporation of the United States Department of Agriculture2. In addition, USDA's Agricultural Marketing Service employs graders who determine the categorization of individual lots of tobacco for auction purposes in accordance with federal regulations.3 All pesticides used on tobacco are registered by the Environmental Protection Agency. USDA also inspects tobacco . imported into the United States4 and regulates the use of pesticides on tobacco in cooperation with the EPA5

2. Labeling and Advertising. The Federal Cigarette Labeling ~ and Advertising Act bans cigarette advertising on television and radio, requires cigarette packages and advertising to carry specified health warnings and directs the Federal Trade Commission to submit annually to Congress a report concerning cigarette advertising and promotion, along with any agency recommendations for legislation.6 To meet those obligations, the Commission has for many years required the cigarette manufacturers to submit annually detailed information concerning cigarette advertising and promotional expenditures. Information concerning "tar" and nicotine is included in cigarette advertising pursuant to a 1970 agreement between the Commission and the major United States cigarette manufacturers. The FTC has authority to address unfair or deceptive cigarette advertising under the Federal Trade Commission Act and has exercised that authority.7 The Bureau of Alcohol, Tobacco and Firearms regulates still other aspects of the packaging of tobacco products. BATF's regulations include provision requiring the disclosure of certain information on every tobacco product carton or package.8 Other BATF regulations govern the type of packaging in which tobacco - products can be marketed and prohibit certain promotional ! practices.9 3. Product Regulation Ingredients. The ingredients used in cigarettes are monitored by the Office on Smoking and Health in the Department of Health and Human Services.10 Under this regulatory system, cigarette manufacturers are required to submit annually to HHS a complete list of all ingredients added to tobacco in the manufacture of cigarettes, and they have sub mitted additional ingredient information at the request of HHS as will. Congress considered this reporting system to be adequate to "permit the federal government to initiate the toxicologic research necessary to measure any health risk posed by the addition of additives and other ingredients to cigarettes during the manufacturing process."11 HHS is required in turn, to sub mit to Congress reports advising Congress of any information pertaining to any such ingredient "which in the judgment of the Secretary poses a health risk to cigarette smokers."12 Constituents. Pursuant to a voluntary agreement with the • FTC, the major cigarette manufacturers, monitored closely by an on- site representative of the Commission , operate the Tobacco Institute Testing Laboratory (TITL), which measures the "tar," nicotine and

carbon monoxide levels of cigarettes sold in the United States, and is the Commission annually publishes these ratings.13 The Commission has told Congress that it is satisfied that its current arrangement with TITL enables it to ensure the accuracy of the "tar," nicotine and carbon monoxide figures.14 With respect to other constituents of tobacco smoke, a representative of the Oak Ridge National Laboratory (ORNL) told Congress in 1988, based on research conducted by ORNL that testing for other constituents would not affect the relative ranking of cigarettes as determined by "tar" and nicotine or provide information that would affect a smoker's choice among the different brands of cigarettes that are available.15 Food and Drug Administration. Notwithstanding claims by some antismoking advocates that tobacco is "egempt" from regulation by the Food and Drug Administration, FDA in fact has asserted jurisdiction over cigarettes as a"drug" when health claims were made by vendors or manufacturers, and the courts have sustained the agency s assertions of jurisdiction.16 Absent such health claims, FDA has concluded that cigarettes are not a"drug" within the meaning of the Federal Food, Drug, and Cosmetic Act, and the U.S. Court of Appeals for the District of Columbia Circuit has upheld FDA's • position. 17 Cigarettes are treated no differently from other products in this regard. Fire Safety. Congress has twice passed legislation establishing research programs to investigate the technological and commercial feasibility of a cigarette with "reduced ignition propensity." Under the Cigarette Safety Act of 1984, an Interagency Committee was given authority to direct, oversee and review the efforts of a Technical Study Group (TSG) focusing on ways to alter 0 cigarettes and little cigars to reduce their ignition propensity. The Interagency Committee transmitted to Congress the conclusion of the TSG that is technically feasible and may be commercially feasible to develop a reduced ignition propensity cigarette. Congress subsequently passed the Fire Safe Cigarette Act of 1990, directing further research into issues left open by the Technical Study Group. In August 1993, the Consumer Product Safety Commission submitted to Congress a report summarizing the result of research conducted under the 1990 Act. Among other things, the report concluded that it may be possible to develop a reduced ignition propensity cigarette but question whether it would affect the number of careless smoking fires. The report made no recommendation that Congress enact f urther legislation.

4. When and Where the Product Can Be Used. Following ~ several years of study, the EPA in January 193 issued a report classifying environmental tobacco smoke ("ETS") as a Group A (known human) carcinogen. EPA intended its report to have a substantial regulatory impact resulting in the restriction of smoking in places of employment and public settings. In addition, the Occupational Safety and Health Administration has published a Request for Information on indoor air quality, including information regarding ETS. OSHA Administrator Joseph Dear has stated that OSHA will address the issue of indoor air quality and ETS this s pring. 18 Congress, of course, has banned smoking on domestic flights.19 This ban is enforced by the Department of Transportation.20 Congress also has required WIC programs to ban smoking as a condition of recieving continued federal funding.21 Meanwhile, smoking in most federal building is severely restricted under regulations issued by the General Services Administration.22 The Department of Defense, as well as other federal agencies, have established additional controls.23 The Postal Service has banned smoking in its facilities and Amtrak has limited smoking on its trains. The House of Representatives recently adopted rules restricting ~ smoking in its building. 5. Research and Public Education. HHS is required by statute to conduct and support research and to inform the public concerning any relationship between tobacco products and health.24 In addition, HHS must submit an annual report to Congress on tobacco and health issues, together with any recommendations for legislation or administrative action.25 In the Comprehensive Smoking Education Act of 1984, Congress took the further step of establishing the Interagency Committee on Smoking and Health, whose members are appointed by the Secretary of HHS or, in some case, by the heads of other federal departments or agencies.26 Representatives of a number of federal agencies and departments -- including HHS, the Federal Trade Commission, the Department of Labor and the Department of Education -- serve on the Interagency Committee. The Interagency Committee's primary functions are to ~ review on an ongoing basis both public and private sector initiatives p with respect to smoking and to recommend to Congress any policy ~ initiatives that are thought to be appropriate.27 In 1990, HHS ~ launched a sever-year, $165 million antismoking program known as ~ • "ASSIST" to fund antismoking campaigns in 17 states. e~ Qo ~ W

STATE AND LOCAL REGULATION - State and local governments have enacted numerous laws restricting or even banning smoking in places of employment and various public settings. All states prohibit the sale or distribution of tobacco products to persons under the age of 18. Legislation passed by Congress in 1990 requires the states, as a condition of receiving federal substance abuse prevention and treatment block grant funding, to enforce these prohibitions conscientiously.28 In addition, a number of state and local governments have adopted restrictions on the sale of cigarettes through vending machines and have limited the distribution of tobacco product samples. Several local governments prohibit retail displays of tobacco products that permit customer access without the assistance of a clerk. OTHER FEDERAL STATUTES Antitobacco advocates complain that cigarettes are not subject to regulation under the Federal Hazardous Substances Act, the Toxic Substance Control Act or the Controlled Substances Act. As discussed below, however, cigarettes in fact either do not fit within the classes of products and substances addressed by these statutes or the ~ agencies responsible for administering them lack the expertise and resources to regulate cigarettes. 1. The Federal Hazardous Substances Act The Federal Hazardous Substances Act ("FHSA")29 provides for the labeling of "hazardous substances which are used in and about the household but which are not regulated by existing law."3o Through this statute, Congress meant to address accidental poisonings caused by "household products, such as furniture polish, bleaches, detergents, cleaners, etc."31 Congress sought to ensure that consumers would be made aware of the dangers presented by such products and that physicians would be better able to treat persons accidentally poisoned by such products. Under FHSA, hazardous substances must bear appropriate warning labels or they will be deemed to be "misbranded." If a hazardous substance is too hazardous to be sold even with a warning label, it is to be treated as a "banned" hazardous substance. Cigarettes clearly are not" household products" of the type addressed by FHSA and do not present the dangers of "accidental r poisoning" to which the statute is addressed. As one U.S. district _ court observed:

S "[I)t is doubtful that cigarettes *** posed the kind of danger that Congress sought to guard against when it passed the FHSA. For while cigarettes are, in literal terms, 'suitable for household use,' the legislative history suggests that the language was meant to evoke a more common-sense understanding of what one thinks of as household chemicals. Put simply, the Act essentially speaks of the kind of product one finds in the 'Household Products aisle in the supermarket. *** The legislative history (also) strongly suggests that it was the problem of household accidents, especially ones that caused injury to children, that prompted Congress to pass the FHSA. `** The aim of Congress -- so the legislative history shows - was to warn consu mers of the dangers of the products that they brought into the house with them, and, of equal importance, to provide physicians treating accident victims with a means to identify the nature of their patients' problems. 32 As noted above, cigarettes sold in the U.S. are required to bear package warning labels as specified by the Federal Cigarette Labeling and Advertising Act. • Congress did not consider it necessary to provide a specific exemption for cigarettes when it enacted FHSA in 1960. However, Congress did amend the statute in 1976 to provide such an express exemption33 after a U.S. district court rejected CPSC's assertion that it lacked jurisdiction to regulate cigarettes.34 The 1976 amendment clarified CPSC's jurisdiction with respect to other products and substances as well. As Senators Hartke, Hollings, Ford, Stevens, and Beall explained with respect to the legislation amending the FHSA: "It would unmistakably reaffirm the clear mandate of the Congress that the basic regulation of tobacco and tobacco products is governed by the legislation dealing with the subject, the Cigarette Labeling and Advertising Act of 1969, and that any further regulation in this sensitive and complex area must be reserved for specific Congressional action. Moreover, the bill reflect[s] the Commission's recognition that its limited resources should be devoted to the many pressing matters plainly within its jurisdiction and that these resources should not be dissipated in any area far from its central responsibilities and in which it possesses no special egpertise."3S

Noting the controversy over its jurisdiction with respect to both - ammunition and cigarettes, CPSC had told Congress that "[t)he - necessary internal procedures and court actions involving the regulation of ammunition and cigarettes are a tremendous drain on the limited resources of the Commission."36 Cigarettes are not the only product currently exempt from the requirements of FHSA. Exemptions are expressly provided for pesticide subject to the Federal Insecticide, Fungicide, and Rodenticide Act; foods, drugs, and cosmetics subject to the Federal Food, Drug and Cosmetic Act; source material, special nuclear material, or byproduct material subject to the Atomic Energy Act of 1954; and substances used as fuels when stored in containers and used in the heating, cooking or refrigeration system of a house.37 2. The Toxic Substances Control Act The Toxic Substances Control Act ("TSCA")38 authorizes EPA to regulate the manufacture, processing, distribution, and use of chemical substances, if the substances are found to present an unreasonable risk to health or to the environment.39 TSCA was Congress' response to the "unreasonable risk of injury to health and the environment posed by many chemical substances." The law • provides for the collection of data regarding the effects of various chemicals, and for the regulation of those chemicals that present an unreasonable risk or imminent hazard to health or to the environment.40 As under FHSA, cigarettes are not the only product exempt from the requirements of TSCA. Also exempt are ( 1)"any migture"; (2) pesticides as defined in FIFRA; (3) source material, special nuclear material or byproduct material as defined in the Atomic Energy Act of 1954; (4) firearms and ammunition; and (5) foods, drugs, cosmetics, and devices as defined in the FD&C Act.41 EPA itself recommended that tobacco and tobacco products be excluded from TSCA: "We *** do not believe that tobacco products should be regulated under the Toxic Substances Control Act."42 ~ Like most of the products and substances exempted from coverage ® under TSCA, cigarettes are addressed by other statutes, principally ~ the Federal Cigarette Labeling and Advertising Act and the ~ cs~ Comprehensive Smoking Education Act but also a host of other ~ federal laws, as discussed above. ~ ~ • c~

3. The Controlled Substances Act i The Controlled Substances Act (CSA"),43 and the Controlled Substances Import and Export Act ("CSIEA"),44 were enacted as part of the Comprehensive Drug Abuse Prevention and Control Act of 1970. Under the CSA controlled substances are listed on one of five schedules based on the potential for abuse of the drug, the existence or absence of any accepted medical uses for the drug, the safety or danger of the drug, and the likelihood of addiction to the drug.45 _ controlled substances are subject to regulations regarding manufacture, distribution, dispensing, labeling and packaging, as well as production quotas.46 The CSIEA provides for the regulation of the export and import of controlled substances.47 These statutes were intended to establish a more workable and effective system for controlling those drugs that were already under control under existing law, including "hard narcotics and opiates, marihuana, all hallucinogens lsuch as LSD), amphetamines, barbiturates, and tranquilizers subject to abuse."48 The focus was on crime. Congress hoped "to meet problems that have arisen under existing narcotic and dangerous drug laws due to recent governmental reorganization, court rulings,.and the changing posture _ of the drug problem facing this country."49 ' Tobacco products and alcoholic beverages understandably were exempted from the definition of controlled substances. Concerned with criminal law issues presented by the emerging drug problem Congress was addressing substances that historically have been illegal(such as narcotics) or that are legally available only under highly restricted conditions (such as prescription drugs). Tobacco products, like alcoholic beverages, do not fall into either of these categories. Moreover, no serious issues of criminal law enforcement were identified with respect to either of these products. CONCLUS ION For the reasons given above, no additional regulation of tobacco products is warranted. tZ ~ . ~ cn CO ~ ' 00 ~

S S 1 2 3 4 5 6 R 9 10 I 12 13 S 14 15 16 Notes Tobacco Product Education and Health Protection Act of 1990: Hearing on S. 1883 before the Senate Comm. on Labor and Human Resources, 101st Cong., 2d Sess ( 1990). 7 U.S.C. 1281 et seq,; 7 U.S.C. 1421 et seq. 29 CFR Part 29. 7 U.S.C. 51 1 r. 7 U.S.C. 136 et seq.; 7 U.S.C. 511r(e); 7 C.F.R. 1464.7(b)(2), 1464.8(e)(2)-(3). 1 5 U.S.C. 1331 et seq. 15 U.S.C. 45. F..Q,,,27C.F.R29542 E.G., 27 C.F.R. 2 9 5.4 1. 15 U.S.C. 1335a. H.R. Rep. yo. 805, 98th Cong., 2d Sess. 21 (1984) 15 U.S.C. 1335a(b)( I )(B). J= e.Q.. Federal Trade Commission, Report of Tar, Nicotine and Carbon Monoxide Content of 475 Varieties of Domestic Cigarettes, 56 Fed. Reg. 8196-202 (Feb, 27, 1991 ). FTC Nicotine Program: Hearing before the Subcomm. on Transportation, Tourism, and Hazardous Materials of the House Comm. on Energy and Commerce, 100th Cong., 1 st Sess. 5-6 (1987) (statement of the Federal Trade Commission): id, at 10-1 1, 47 (testimony of William C. MacCleod, Director, Bureau of Consumer Protection, FTC); id. at 13, 47 (testimony of Daniel Oliver, Chairman, FTC). Cigarettes -- Advertising, Testing, and Liability: Hearing on H.R. 4543 before the Subcomm. on Transportation, Tourism, and Hazardous Materials of the House Comm. on Energy and Commerce, 100th Cong., 2d Sess. 204 (1988) (statement of Michael D. Guerin). 5g United States v. 46 Cartons. More or L.ess. ContaininQ Fairfax Cigarettes. 1 13 F. Supp. 336 (D.N.J. 1953); United States v. 3S4 Bulk Cartons "` Trim Reduction • Aid Ciearettes. 178 Supp.. 847 (D.N.J. 1959) see also =v. Lieett & Myers Tobacco Co.. 108 F. Supp. 573 (S.D.N.Y. 1952, AFF'D. 203 F.2D 955 (2D CIR. 1953).

• 17 18 19 20 21 22 23 24 25 • • 26 27 28 29 30 31 32 33 34 35 36 Action on Smoking and Health v. Harris. 655 F.2d 236 (D.C. Cir. 1989). Washington Post. Jan 16, 1994, p. H2 49 App. U.S.C.A 1374(d)( 1)(A) jl 1374(d)( I )(B). Pub. L. No. 103-111. Title IV, 107 Stat. 1046, 1072 (1993). 41 CFR 101-20,109-10; 5 1 Fed. Reg. 44258 (1986) .E.g,,, 4 1 CFR 10 1-20.1 09-1 0(a) note. 15 U.S.C. 1341, 4407(a). 1 5 U.S.C. 1341(b) I S U.S.C. 13 41 (b) 1 5 U.S.C. 13 41 (a) ADAMHA Reorganization Act of 1992, Pub. L. No. 103-331, 106 Stat. 394 (1992). 15 U.S.C. 1261 et seq. S. Rep. No. 1158, 86th Cong., 2d Sess. 2 (1960). a a t 1: Palmer v. I.iQQett Grouo. Inc.. 635 F. Supp, 392, 396 (D. Mass. 1984). 15 U.S.C. 1261(f)(2). 5gg H. Rep. No. 325, 94th Cong., 1 st Sess. 16 9 1975) (citing American Public Health Ass'n v. CPSC. Civ. No. 74-1222 (D.D.C. 1975). Two other district courts subsequently ruled that FSHA did not cover cigarettes. Palmer, suora. 635 F. Supp. at 397; Giannunzio v, Philio Morris. Inc.. Civ. No. 3-81-921 (D. Minn. 1982) (order of dismissal). The Palmer court also noted that the Federal Cigarette Labeling and Advertising Act "explicitly preempted the field of federal law with respect to cigarette labeling" -after 1965. 635 F. Supp. at 394. S. Rep. No. 251, 94th Cong., 1 st Sess. 43 (1975). See also 121 Cong. Rec. S. 13,018 (daily ed. July 18, 1975) (remarks of Sen. Moss). Consumer Product Safety Act: Hearings on S. 644 before the Subcomm. for Consumers of the Senate Comm. on Commerce, 94th Cong., 2d Sess. 333 (1975).

• • 37 38 39 40 41 42 43 44 45 46 47 48 49 agg 15 U.S.C. 126 1(f)(2), 15 U.S.C. 2601 et. seq. 15 U.S.C. 2605. 15 U.S.C.2601(b). S= 1 5 U S.C. 2602(2)(B). S. Rep. No. 698, 94th Cong., 2d Sess. 83 (1976). 21 U.S.C. 801 et seq. 21 U.S.C. 951 et. seq. 21 USC. 812. 21 US.C.821-830 21 U.S.C.951-956 H.R. Rep. No. 1444, 9 1 st cong., 1 st Sess. 4(1970). j~.,at6 IND ~ ~ C.C Z"D ~ ~