Research Article: Compromise or Capitulation? US Food and Drug Administration Jurisdiction Over Tobacco Products

Date Published: July 28, 2009

Publisher: Public Library of Science

Author(s): Stanton A. Glantz, Richard Barnes, Sharon Y. Eubanks

Abstract: Stanton Glantz and colleagues critique the recent policy decision in the United States to grant the FDA regulatory authority over tobacco products, a decision that has broad but not unanimous support among health care professionals.

Partial Text: On June 12, 2009, the United States Congress passed the Family Smoking Prevention and Tobacco Control Act (S. 982), granting the US Food and Drug Administration (FDA) authority regulating tobacco products. The idea of FDA regulation of tobacco has broad [1], but not unanimous, support among medical and public health professionals. This law has many strengths (Table 1): it grants the FDA general authority over tobacco products, including the ability to reduce (but not eliminate) nicotine, requires improved warning labels on cigarette and other tobacco packages, and implements the rules limiting marketing of tobacco products to youth that the FDA issued in 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 prohibit the sale, distribution, possession, exposure to, access to, or use of tobacco products.

The FDA Act is not the first time that public health advocates have compromised with tobacco companies to pass legislation. History demonstrates that the tobacco companies think in the long term and, when forced, will accept short-term setbacks to protect long-term interests.

There are many elements of this new legislation that could prove problematic in achieving effective control of tobacco products and their manufacturers (Table 1). The law imposes strong pre-emption (except fire safety standards) of state and local governments with respect to product standards, premarket approval, adulteration, misbranding, labeling registration, and good manufacturing standards. Pre-emption is a key tobacco industry strategy for preventing innovation and development of strong tobacco control policies [9]. Indeed, it was the lack of such pre-emption that permitted states to develop and implement fire safety standards for cigarettes while the industry effectively blocked federal action. This pre-emption could block the emerging movement to regulate cigarette butts as toxic waste [10].

Including the tobacco industry in this committee also violates Article 5.3 of the World Health Organization Framework Convention on Tobacco Control (FCTC) [39], the first global public health treaty, which has been ratified by 164 nations. (The US has signed, but not yet ratified the treaty.) In recognition of the tobacco industry’s corrosive influence on government, FCTC Article 5.3 commits parties to protecting tobacco control policy and development from the tobacco industry. The implementing guidelines for FCTC Article 5.3 are unequivocal: “Parties should not allow any person employed by the tobacco industry or any entity working to further its interests to be a member of any government body, committee or advisory group that sets or implements tobacco control or public health policy” ([40], §23.4.8).

Finally, the basic terms of the bill were negotiated several years ago, in a wholly different political climate. At that time, it appeared that Republicans would dominate government well into the future. The 2008 election represented a sea change in American politics, including a President who has repeatedly emphasized his commitment to respecting science, depoliticizing the role of science in government decision-making, and rejoining the international community. This FDA legislation does not acknowledge this changed political climate or recognize the opportunity it created to accomplish more than when the bill was originally negotiated. Advocates for the bill also did not press the implications of the strong Court of Appeals decision upholding Judge Kessler’s ruling that the tobacco companies were racketeers to remove industry representatives from the Scientific Advisory Committee.



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