Tobacco Documents Online

Briefins! Book. The Food and Drug Administration , and Tobacco Regulation The Tobacco Institute September 1995

FDA's proposed rule to regulate cigarettes and smokeless tobacco products On August 11, the Food & Drug Administration published a notice of proposed rulemaking and hundreds of pages of "analysis" for asserting jurisdiction over cigarettes and smokeless tobacco products. The public comment period unless extended ends on November 9, 1995. FDA seeks to regulate tobacco products as "drug 3elivery devices" but only in ways that would, FDA claims, reduce tobacco use among young people. In fact, the regulation's prohibitions, restrictions and censorship of advertising, and burdensome requirements for manufacturers and retailers would severely impact 50 million adult consumers. J

The Food and Drug Administration and Tobacco Regulation Table of Contents 1 FDA Proposed Rule 2 The Case Against FDA Regulation of Tobacco -- An Overview 3 The FDA and Tobacco Regulation -- A Summary of the Arguments 4 Backgrounders ~ 5 Opinion Editorials and News Articles 6 Cigarette Manufacturers' Complaint 7 Smokeless Tobacco Industry Complaint 8 Industry Reaction: Press Releases

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Commissioner Kessler has declared that FDA will regulate cigarettes and smokeless tobacco products as medical device.s. Under his rationale, the cigarette filter, the paper, and even th e tobacco are the "devices" that deliver the "drug" nicotine. He claims that the "device" provisions of FDA's authorizing statute allow the Agency to impose restrictions on cigarette sales, distribution, and proinotion -- just like FDA would with a true medical device. But Comnussioner Kessler's decision to regulate cigarettes and tobacco product; as "devices" is like trying to fit a square peg in a round hole - it just doesn't work. FDA's approach to regulation of cigarettes is just as contorted under FDA law as it is lacking common sense. Indeed, b.-cause cigarettes and tobacco products were never intended by Congress to be regulated as medical devices or drugs, FDA has had to create a wholly new (and unauthorized) regulatory framework for tobacco. In doing so, FDA has ignored its own statutory mandate and usurped Congress's exclusive right to define the limits of an agency's authority. For example, FDA concedes that it cannot require cigarette manufacturers to put any information regarding smoking and health on packages of cigarettes. But dictating the content of package labeling is an integral part of FDA regulation of both "drugs" apd "devices." The bottom line is that FDA has been forced to twi st existing statutory provisions and ignore applicable statutory requirements in order to avoid the plain and unmistakable truth that Congress nev.-r intended FDA to regulate tobacco products - and that this is true whether FDA tries to regulate these products as drugs or medical devices.

August 24, 1995 Summary of Proposed FDA Regulations Advertising and Promotion • Bans all outdoor advertising within 1,000 feet of any playground, elementary school or secondary school (including signs on retail stores) [897.30(b)] • Limits all other advertising to black text on a white background (except for advertising in certain "adult" periodicals) [897.32(a)1 • Limits logos and brand names on race cars, driver uniforms, etc., to a black-on- white format [897.30(a)(2) & 897.32] • Requires all cigarette advertising to include the phrase "CIGARETTES--A NICOTINE DELIVERY DEVICE" [897.32(b)] Requires all cigarette advertising to carry a second warning statement, in addition to the Surgeon General's warning that is already required [897.32(c)I • Bans all cigarette advertising in any media not specifically enumerated in the proposed rule [897.30(a)] • Bans the use of tobacco brand names on non-tobacco products (e.g., t-shirts, caps, lighters) [897.34(a)]. ~ • Bans the use on tobacco products of brand names associated with non-tobacco products (except for brand names used on tobacco products on January 1, 1995) [897.16(a)] • Bans brand-name event sponsorships; allows only corporate sponsorships (if tobacco company name was extant on January 1, 1995) [897.34(c)] • Bans the distribution of free product samples, either in person or through the mails [897.16(d)] • Requires tobacco product manufacturers to undertake $150 million-a-year TV- based national public educational effort to discourage persons under 18 from smoking [897.29] GO ~ N • Gives FDA broad authority to pursue "false or misleading" cigarette advertising ~ and labeling, including "omissions," lack of "balance" and lack of "substantial W evidence" [897.36] b4

-2- Labels • Requires each package to display the word "CIGARETTES" under the brand name in letters at least half as large [897.24 & § 5C2(e)(2) of Actl • Bans all cigarette "labeling" in any media not specifically enumerated in the proposed rule [897.30(a)] Sales • Bans vending machine sales [897.16(c)] • Bans self-service displays [897.16(c)] • Bans sale and distribution by mail [897.16(c)] • Bans sales other than from unopened packages [897.14(c)] • Bans sale of packages containing fewer than 20 cigarettes [897.16(b)] Duties and Responsibilities • Every person who "furthers the marketing of cigarettes or smokeless tobacco products" is a "distributor" -- including, presumably, advertising agencies, publishers and outdoor companies [897.3(c)] • Every "distributor" is "responsible for ensuring that -:he cigarettes or smokeless tobacco products it manufactures, labels, advertises, packages, distributes [or] sells *** comply with the [proposed rules]" [897.101 • Every manufacturer must remove from retail outlets all self-service displays, advertising, labeling and other manufacturer-owned items that do not comply with the proposed rules [897.12(a)] • Every manufacturer must conduct visual inspections, in the normal course of business, to ensure that retailers are complying with the proposed rules [897.12(b)1 • Every retailer must check photo identification to ensure that no one who buys tobacco products is under 18 [897.14(a)] • Every retailer is responsible for ensuring that all sales are "direct, face-to-face"pr) transactions [897.14(b)] ~ N ~ m W W CR

Penalties and Sanctions • Failure to comply with any restriction or requirement in the FDA proposal would result in "misbranding" the cigarette brand(s) involved, which is a"prohibited act" [§§ 301(a)-(c), (k), 502(a), (q), 709 of the Acti. • Prohibited acts.(e.g., violative advertising) may be enjoined by court action [ § 302 of the Act] • Prohibited acts may be punished as misdemeanors uv ithout the requirement of mens rea (guilty intent); intentional acts and second offenses of the same offense are punishable as felonies [§ 303(a) of the Act] • Misbranded articles (cigarettes or labeling) may be seized and condemned by the Government [ § 304(a) of the Act] • Administratively determined civil penalties may be assessed by FDA for violations of the device provisions of the Act, in the amount of $15,000 per violation, and up to $1,000,000 for all violations joired in a single proceeding [§ 303(f) of the Act] (Based on FTC precedents, each individual violative package, piece of labeling, or advertisement in a given magazine is viewed as a separate violation.) • Based on the criteria for "restricted devices," an argument could be constructed that failure to comply with the FDA-imposed restrictions subjects the noncom- plying product or labeling to the notification, replacement-refund, or recall provisions applicable to devices [§ 518 of the Act] F. I

REQUIREMENTS FOR COMMENTING ON PROPOSED FDA REGULATION9 1. Docket numbers: To comment on the onmosed -vending machine ban -free sampling, mail-order sales or self-service display bans -tombstone advertising -ban on outdoor advertiaing within 1,000 feet of a school x playground -ban on the sale or distribution of non-tobacco items (hFits, t shirts, etc.) -restriction on sponsorship of events to corporate name oniy, not brand name -5150 million anti-tobacco education campaign required of the tobacco industry -any other proposed restrictions on saiss, marketing or distribution 0 Submit comments to: 95N-0253- ("Reguiations Restricting the Sale and Di3trih ution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adoioacents") To comm n _ _ -whether nicotine in cigarettes or smokeless tobacco is a drug or -whether these products are drug delivery devices within tite meaning of the Food, Drug and Cosmetic Act Submit comments to: D5N-0Z53J- ("Anaiysis Regarding the Food and Drug Administration's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products") need to appear on the outside enveiope. The docket number should be noted somewhere on the comment for easier processing. It does not 2. Address; Docketa Management Branch (HFA-306) Food and Drug Administration, room 1-23 12420 Parklawn Dr., Rockviiie, MD 20857 3. Form and content: There are no restrictions as to length, typewritten vs. handwrttte.ti, double vs. single-spaced or the size or kind of paper used. Individuals - may submit single copies of comments. FDA will make all additional copias. Corporations, trade assoce., individuals writing on behalf of a group, etc. - are "requested" to submit four copies of all comments.

41314 Fedesal Register, / Vol. e0, No. 155 / Friday, August 11, 1995 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVIM Food and Drug Adtninbtration 21 CFR Parts 801, 8a'i, 804, and 897 (Doetat Na OSN-o28.11 Reg"ladoca bttlon of ~ ~ fyts~s and Dbbi C Smokeiess Tobsooo Products To Protsat C1Wdren and Ado/.sc.nts At3ENCr: Food and Drug Administration, HHS. ACTION: Proposed rtile, summARY: The Food and Drug Administration (FDA) is proposing new regulations goveeaing the sale and distribution of nicotine-containing cigarettes and smokeless tabacco products to children and adolescents in order to address the seriouspub1ic health problems caused by the use of and addiction to these products. The proposed rule would reduce children's and adolescents' easy access to cigarettes and smokeless tobacco as well as significantly decrease the amount of positive imagery that makes these products so appealing to them. The proposed rule would not restrict the use of tobacco products by adults. Spec~fically, the proposed rule would establish 18 years of age as the Federal minimum age of purchase and would prohibit cigarette vending machines, free samples, mail-order sales, and self- service displays. It would also require that retailers comply with certain conditions regarding sales of tobacco, especially verification that the purchaser is at least 18 ysars of age before a tobacco sale is mads. Finally. the proposed rule would limit advertising and labeling to which children and adolescents are exposed to a text-only format; ban the sale or distribution of branded non-tobacco items such as hats and tee shirts; restrict sponsorship of events to the corporate name only; and require manufacxuiers- to establish and maintain a national public education campaign aimed at children and adolescents to counter the pervasive imagery and reduce the appeal created by decades of pro- tobacco messages and thus to help reduce young people's use of tobacco products. The objective of the proposed rule is to meet the goal of the report "Healthy People 2000" by reducing roughly by half children's and adolescents' use of tobacco products. If this objective is not met within seven years of the date of publication of the final rule, the agency will take additional measures to help achieve the reduction in the use of tobacco products by young people. FDA is requesting comment regarding the type of additional measures that would be most effective. DATES: Written comments and recommendations by November 5.1995. ADDRE3sE8: Submit written comments and recommendatioa. to the Doclrets Management Branch (HFA-305). Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.. Rockville, MD 20857. FOR FURTHER INFORMATtON QONTACT: Philip Chao, Office of Policy (HI-23), Food and Drug Administration, 5800 Fishers Iane, Rockville, MD, 20857, 301-827-3380. SUPPLEMENTARRr INFORMATtON: L Introduction Approximately 50 million Americans currently smoke cigarettes and another 6 million use smokeless tobacco products., 1'hese tobacco products are responsible for more than 400.000 deaths each year due to cancer, respiratory illnesses, heart disease, and other health problems.= Cagarettes kill more Americans each year than acquired immune deficiency syndrome (AIDS), alcohol, car accidents, murders, suicides, illegal drugs, and fires combined.3 On average, smokers who die from a disease caused by smoking lose 12 to 15 years of life because of tobacco use.• In a separate document 3 FDA is addressing the issue of its jurisdiction over nicotine-containing cigarettes and smokeless tobacco products. The results of an extensive investigation and comprehensive legal analysis support a finding at this time that the nicotine in these products is a drug and that these products are nicotine-delivery devices within the meaning of the Federal Food. Drug, and Cosmetic Act (the act). FDA proposes to regulate cigarettes and smokeless tobacco products by employing its restricted device authority, which affords the most appropriate and flexible mechanism for regulating the sale, distribution, and use of these products. The primary objective of the proposed rule is to reduce the death and disease caused by tobacco products. Rather than banning tobacco products for the millions of Americans who are currently addicted to them, this regulation focuses on preventing future generations from developing an addiction to nicotine- containing tobacco products. In addition, the scientific evidence strongly suggests that nicotine addiction begins when most tobacco uaers are teenageis or younger and, thus, is a pediatric disease. Therefore, reducing the number of young people who regularly start to use tobacco products will help to prevent future generations of individuals from becoming addicted to nicotine. The goal of the proposed rule is to help the country achieve one of the objectives of "Healthy People 2000: • which is to reduce the number of children and adolescents who use tobacco products by roughly one half by the year 2000. The agency has modi$ed the goal to include a different measurement tool and established 7 years after publication of the final rule as the goal's endpoint. "Healthy People 2000" discussed national health promotion and disease prevention objectives in this country. It was facilitated by the Institute of Medicine of the National Academy of Sciences, with the help of the U.S. Public Health Service, and included almost 300 national membership organizations and all State health departments.6 To determine the most appropriate regulatory measures, the agency reviewed the current patterns of use of tobacco products. According to the 1994 Surgeon General's Report, "Preventing Tobacco Use Among Young People: A Report of the Surgeon General" (the 1994 Surgeon General's Report), more than 3 million American adolescents currently smoke cigarettes and an additional 1 million adolescent males use smokeless tobacco.7 Every day, another 3,000 young people become regular smokers.9 U.S. data suggest that anyone who does not begin smoking in childhood or adolescence is unlikely to ever begin.9 Eighty-two percent of adults who ever smoked had their first cigarette before age 18, and more than half of them had already become regular smokers by that age.1O Moreover, the younger one begins to smoke. the more likely one is to become a heavy smoker. I I Many young tobacco users become addicted to nicotine, a chemical substance in tobacco. Although they ' believe that they will not become addicted to nicotine or become long- term users of tobacco products, they often find themselves unable to quit smoking.12 In fact. among smokers aged 12-17 years. 70 percent already regret their decision to smoke and 66 percent state that they want to quit.13 Those who are able to quit experience relapse rates OD and withdrawal symptoms similar to tG those reported in adults.14 tV Long-term addiction to nicotine can 6.1 result in serious chronic diseases and 00 premature death. An adolescent whose W cigarette use continues into adulthood ~ increases his or her risk of dying from