41314 Federal Register / Vol. 60, No. 155 / Friday, August 11, 1995 / Proposed Rules DEPARTMENT OF HEALTH AND achieve the reduction in the use of pediatric disease. Therefore, reducing HUMAN SERVICES tobacco products by young people. FDA the number of young people who is requesting comment regarding the regularly start to use tobacco products Food and Drug Administration type of additional measures that would will help to prevent future generations be most effective. of individuals from becoming addicted 21 CFR Parts 801, 803, 804, and 897 DATES: Written comments and to nicotine. [Docket No. 95N±0253] recommendations by November 9, 1995. The goal of the proposed rule is to ADDRESSES: Submit written comments help the country achieve one of the Regulations Restricting the Sale and and recommendations to the Dockets objectives of ``Healthy People 2000,'' Distribution of Cigarettes and Management Branch (HFA±305), Food which is to reduce the number of Smokeless Tobacco Products To and Drug Administration, rm. 1±23, children and adolescents who use Protect Children and Adolescents 12420 Parklawn Dr., Rockville, MD tobacco products by roughly one half by 20857. the year 2000. The agency has modified AGENCY: Food and Drug Administration, the goal to include a different FOR FURTHER INFORMATION CONTACT: HHS. measurement tool and established 7 Philip Chao, Office of Policy (HF±23), ACTION: Proposed rule. years after publication of the final rule Food and Drug Administration, 5600 as the goal's endpoint. ``Healthy People SUMMARY: The Food and Drug Fishers Lane, Rockville, MD, 20857, 2000'' discussed national health 301±827±3380. Administration (FDA) is proposing new promotion and disease prevention regulations governing the sale and SUPPLEMENTARY INFORMATION: objectives in this country. It was distribution of nicotine-containing I. Introduction facilitated by the Institute of Medicine cigarettes and smokeless tobacco of the National Academy of Sciences, products to children and adolescents in Approximately 50 million Americans with the help of the U.S. Public Health order to address the serious public currently smoke cigarettes and another Service, and included almost 300 health problems caused by the use of 6 million use smokeless tobacco national membership organizations and 1 and addiction to these products. The products. These tobacco products are all State health departments.6 proposed rule would reduce children's responsible for more than 400,000 To determine the most appropriate and adolescents' easy access to deaths each year due to cancer, regulatory measures, the agency cigarettes and smokeless tobacco as well respiratory illnesses, heart disease, and reviewed the current patterns of use of as significantly decrease the amount of other health problems.2 Cigarettes kill tobacco products. According to the 1994 positive imagery that makes these more Americans each year than Surgeon General's Report, ``Preventing products so appealing to them. The acquired immune deficiency syndrome Tobacco Use Among Young People: A proposed rule would not restrict the use (AIDS), alcohol, car accidents, murders, Report of the Surgeon General'' (the of tobacco products by adults. suicides, illegal drugs, and fires 1994 Surgeon General's Report), more Specifically, the proposed rule would combined.3 On average, smokers who than 3 million American adolescents establish 18 years of age as the Federal die from a disease caused by smoking currently smoke cigarettes and an minimum age of purchase and would lose 12 to 15 years of life because of additional 1 million adolescent males prohibit cigarette vending machines, tobacco use.4 use smokeless tobacco.7 Every day, free samples, mail-order sales, and self- In a separate document,5 FDA is another 3,000 young people become service displays. It would also require addressing the issue of its jurisdiction regular smokers.8 U.S. data suggest that that retailers comply with certain over nicotine-containing cigarettes and anyone who does not begin smoking in conditions regarding sales of tobacco, smokeless tobacco products. The results childhood or adolescence is unlikely to especially verification that the of an extensive investigation and ever begin.9 Eighty-two percent of adults purchaser is at least 18 years of age comprehensive legal analysis support a who ever smoked had their first before a tobacco sale is made. Finally, finding at this time that the nicotine in cigarette before age 18, and more than the proposed rule would limit these products is a drug and that these half of them had already become regular advertising and labeling to which products are nicotine-delivery devices smokers by that age.10 Moreover, the children and adolescents are exposed to within the meaning of the Federal Food, younger one begins to smoke, the more a text-only format; ban the sale or Drug, and Cosmetic Act (the act). FDA likely one is to become a heavy distribution of branded non-tobacco proposes to regulate cigarettes and smoker.11 items such as hats and tee shirts; restrict smokeless tobacco products by Many young tobacco users become sponsorship of events to the corporate employing its restricted device addicted to nicotine, a chemical name only; and require manufacturers authority, which affords the most substance in tobacco. Although they to establish and maintain a national appropriate and flexible mechanism for believe that they will not become public education campaign aimed at regulating the sale, distribution, and use addicted to nicotine or become long- children and adolescents to counter the of these products. term users of tobacco products, they pervasive imagery and reduce the The primary objective of the proposed often find themselves unable to quit appeal created by decades of pro- rule is to reduce the death and disease smoking.12 In fact, among smokers aged tobacco messages and thus to help caused by tobacco products. Rather than 12±17 years, 70 percent already regret reduce young people's use of tobacco banning tobacco products for the their decision to smoke and 66 percent products. millions of Americans who are currently state that they want to quit.13 Those who The objective of the proposed rule is addicted to them, this regulation focuses are able to quit experience relapse rates to meet the goal of the report ``Healthy on preventing future generations from and withdrawal symptoms similar to People 2000'' by reducing roughly by developing an addiction to nicotine- those reported in adults.14 half children's and adolescents' use of containing tobacco products. In Long-term addiction to nicotine can tobacco products. If this objective is not addition, the scientific evidence result in serious chronic diseases and met within seven years of the date of strongly suggests that nicotine addiction premature death. An adolescent whose publication of the final rule, the agency begins when most tobacco users are cigarette use continues into adulthood will take additional measures to help teenagers or younger and, thus, is a increases his or her risk of dying from Federal Register / Vol. 60, No. 155 / Friday, August 11, 1995 / Proposed Rules 41315 cancer, cardiovascular disease, or lung associate the ``Joe Camel'' cartoon figure The proposed rule would prohibit the disease.15 In addition, smokeless with cigarettes.24 Studies also show that distribution of free samples and would tobacco use has been linked to oral most young people buy the most heavily allow the exchange of coupons and cancer and other adverse effects.16 advertised cigarette brands, whereas other non-cash certificates only by Although most segments of the many adults buy generic or ``value individuals 18 or older and only in face- American adult population have category'' cigarette brands, which have to-face transactions. Currently, young decreased their use of cigarettes, the little or no image advertising.25 people, including children in prevalence of smoking by young people In proposing this regulation, FDA elementary school, are often able to has failed to decline for more than a examined many domestic and foreign obtain free samples despite industry- decade. Recently, smoking among young tobacco control statutes, regulations, imposed age restrictions on such people has begun to rise.17 Between and legislation, as well as numerous distributions. 1991 and 1994, the prevalence of studies and reports. FDA also reviewed The proposed rule would also smoking by eighth graders increased 30 recommendations from various public prohibit the sale of single cigarettes percent, from 14.3 percent to 18.6 health organizations, including the (``loosies'') and ``kiddie packs (less than percent. Among 10th grade students, it World Health Organization, the Office of 20 to a pack) which, due to their increased from 20.8 percent to 25.4 the Surgeon General, the Centers for relatively low price and easy percent and for 12th grade students, it Disease Control and Prevention (CDC), concealment, have been shown to be rose from 28.3 percent to 31.2 percent.18 the National Cancer Institute (NCI), and particularly appealing to children and Between 1985 and 1994, smoking the Institute of Medicine (IOM). Two adolescents. among college freshmen increased from reports, the 1994 Surgeon General Further, the proposed rule would 9 percent to 12.5 percent.19 Report and the 1994 IOM Report prohibit manufacturers from using a Millions of American children and ``Growing Up Tobacco Free: Preventing trade name or brand name of a non- adolescents can easily buy or obtain Nicotine Addiction in Children and tobacco product for a cigarette or cigarettes and smokeless tobacco Youths,'' were especially helpful and smokeless tobacco product. This will products. The large number of young informative. prevent a manufacturer from people who use these products is The agency has examined many transferring the images, good will, and especially noteworthy because all States options for reducing tobacco use by appeal of a popular non-tobacco product prohibit the sale of tobacco products to children and adolescents, and believes to a tobacco product.