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US Food and Drug Administration Jurisdiction Over Tobacco Products

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US Food and Drug Administration Jurisdiction Over Tobacco Products Policy Forum Compromise or Capitulation? US Food and Drug Administration Jurisdiction Over Tobacco Products Stanton A. Glantz1*, Richard Barnes1, Sharon Y. Eubanks2 1 Center for Tobacco Control Research and Education, University of California San Francisco, San Francisco, California, United States of America, 2 Attorney in private practice, McLean, Virginia, United States of America On June 12, 2009, the United States Congress passed the Family Smoking Summary Points Prevention and Tobacco Control Act (S. 982), granting the US Food and Drug N On June 12, 2009, the US Congress passed compromise legislation granting the Administration (FDA) authority regulating Food and Drug Administration (FDA) jurisdiction over tobacco products, tobacco products. The idea of FDA repealing federal pre-emption of state and local regulation of tobacco advertising, and requiring graphical warning labels on tobacco products. regulation of tobacco has broad [1], but not unanimous, support among medical N Past legislative compromises with the tobacco industry have led to short-term and public health professionals. This law public health gains at the expense of long-term progress. has many strengths (Table 1): it grants the N The law offers the tobacco industry an opportunity to rehabilitate its image and FDA general authority over tobacco products because they are now ‘‘FDA regulated.’’ products, including the ability to reduce N Tobacco interests that have violated US racketeering law are inappropriately (but not eliminate) nicotine, requires represented on the Scientific Advisory Committee that influences FDA improved warning labels on cigarette and regulations. other tobacco packages, and implements N The challenge for the compromise law’s advocates will be to accept the rules limiting marketing of tobacco responsibility for these problems and see that their negative consequences products to youth that the FDA issued in do not materialize. 1996. It also repeals pre-emption of state and local regulation of tobacco marketing and advertising, and grants states and localities broad rights to regulate or Lessons from Past Compromises when forced, will accept short-term set- prohibit the sale, distribution, possession, with the Tobacco Industry backs to protect long-term interests. The first federal health legislation ad- exposure to, access to, or use of tobacco The FDA Act is not the first time that dressing tobacco was the Federal Cigarette products. public health advocates have compromised Labeling and Advertising Act, passed in The new FDA law is a compromise with tobacco companies to pass legislation. 1965. This law, passed in the wake of between tobacco control organizations History demonstrates that the tobacco growing public concern triggered by the and the Philip Morris tobacco company companies think in the long term and, original 1964 Surgeon General’s report that has its origins in the failed 1997 ‘‘global settlement’’ negotiated to settle litigation against the tobacco industry Citation: Glantz SA, Barnes R, Eubanks SY (2009) Compromise or Capitulation? US Food and Drug Administration Jurisdiction Over Tobacco Products. PLoS Med 6(7): e1000118. doi:10.1371/journal.pmed. [2,3]. These organizations and their Con- 1000118 gressional allies believed that the only way Published July 28, 2009 to win regulatory authority over tobacco Copyright: ß 2009 Glantz et al. This is an open-access article distributed under the terms of the Creative products was to compromise with the Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, tobacco industry. Some of the compro- provided the original author and source are credited. mises, such as prohibiting the FDA from Funding: This paper was not prepared as part of any extramurally funded project. eliminating all nicotine from tobacco prod- Competing Interests: The authors do not consider these competing interests, but in the interest of full ucts, requiring a prescription for tobacco transparency declare the following: Dr. Glantz holds two research grants related to tobacco from the National products, or banning them outright Cancer Institute, an endowed chair as American Legacy Distinguished Professor in Tobacco Control, and a grant (Table 1) do not create overly burdensome from the Robert Wood Johns Foundation to assist Ms. Eubanks, who led the US Department of Justice in its successful RICO case against the tobacco industry (United States v. Philip Morris USA, et al.) in writing a book regulatory hurdles or fundamental long- about the case. Dr. Glantz also administers an endowment from the American Legacy Foundation, which term advantages or legitimacy for the supports the UCSF Center for Tobacco Control Research and Education, which Dr. Glantz directs, and the Legacy Tobacco Documents Library. He also has the William Cahan Endowment provided by the Flight industry. Other provisions, however, do. Attendant Medical Research Institute. Mr. Barnes is an attorney in Dr. Glantz’ research group, who is supported in part by Dr. Glantz’ National Cancer Institute grants. Ms. Eubanks retired from the Department of Justice on December 1, 2005 and is now a lawyer in private practice in Washington, D. C. None of these organizations played any role in the preparation of this paper or the decision to submit it for publication. The Policy Forum allows health policy makers Abbreviations: FCTC, Framework Convention on Tobacco Control; FDA, Food and Drug Administration; TWG, around the world to discuss challenges and Tobacco Working Group. opportunities for improving health care in their societies. * E-mail: [email protected] Provenance: Not commissioned; externally peer reviewed PLoS Medicine | www.plosmedicine.org 1 July 2009 | Volume 6 | Issue 7 | e1000118 that concluded that smoking caused lung achieving effective control of tobacco prod- In 1996, Philip Morris implemented cancer (in men), which accelerated calls for ucts and their manufacturers (Table 1). The Project Sunrise, an 11-year-plan to restore restrictions on cigarette marketing at all law imposes strong pre-emption (except fire its reputation as a ‘‘responsible company,’’ levels of government around the country safety standards) of state and local govern- to maintain its political influence (the key ([4], p. 205), mandated now-familiar (and ments with respect to product standards, to survival for any tobacco company), to worn-out) ‘‘Surgeon General’s Warnings’’ premarket approval, adulteration, mis- recruit quality staff, and to maintain its on the side of cigarette packages and, later, branding, labeling registration, and good customer base [13]. Publicizing the death in cigarette advertising. manufacturing standards. Pre-emption is a and destruction the tobacco industry While this legislation was viewed as a key tobacco industry strategy for preventing causes has been a staple of effective step forward, it was the tobacco companies innovation and development of strong tobacco control media campaigns, begin- who emerged as the long-run winners. The tobacco control policies [9]. Indeed, it was ning in California [15] and used to strong price of the law was federal pre-emption of the lack of such pre-emption that permitted effect in the American Legacy Founda- any controls on cigarette advertising ([5], states to develop and implement fire safety tion’s ‘‘truth’’ campaign [16,17,18]. In- pp. 254–257), including at the state or local standards for cigarettes while the industry deed, distrust of tobacco companies is a level. The result was to choke off all effectively blocked federal action. This pre- powerful message to prevent smoking and subsequent local efforts that had anything emption could block the emerging move- to stimulate cessation attempts [19,20]. to do with cigarette advertising. The ment to regulate cigarette butts as toxic A particularly problematic aspect of the warning labels also provided the tobacco waste [10]. law is the Tobacco Products Scientific companies an important defense in court to While nominally giving the Secretary Advisory Committee that is required to fight liability for the disease and death that broad authority to regulate tobacco prod- include nonvoting members from the their products cause. At the time the FDA ucts and their promotion, the law estab- tobacco manufacturers and growers. The bill passed—44 years later—the US still lishes procedures that will make it difficult Committee is charged with advising the had the weakest, least effective warning to issue meaningful regulations. Rather Secretary of Health and Human Services labels in the world [6]. Indeed, one of the than an unequivocal charge to protect the on, among other things, questions regard- arguments for the FDA bill was that it public health, the regulations must consid- ing nicotine dependence, whether menthol required graphical warning labels and er, among other things, ‘‘technical achiev- (present in about 70% of cigarettes smoked repealed this pre-emption [7]. ability’’ and the possibility of ‘‘creating a by African Americans [21]) should be The next compromise came in 1970, significant demand for contraband’’ (Table removed from tobacco products, and on when health advocates worked with tobac- 1). These requirements provide fertile virtually all regulations and health issues co companies to remove cigarette advertis- ground for years of lawsuits against any relating to tobacco products. This commit- ing from television and radio. This com- regulation the industry opposes [11]. tee will
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