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Food and Drug Administration regulation of tobacco products: introduction
  1. S Shatenstein
  1. Correspondence to:
 Stan Shatenstein

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This past July, the US Senate voted 78 to 15 to grant the Food and Drug Administration (FDA) authority to regulate tobacco products. The proposed, precedent setting legislation is part of a larger tax bill and is also tied to a controversial tobacco growers’ buyout. In order to become law, the Senate version of the Bill, sponsored by Republican Senator Mike DeWine of Ohio and Democrat Edward Kennedy of Massachusetts, must be harmonised with a proposed, far weaker House of Representatives Bill that does not include FDA regulation. Ultimate passage of a revised Bill is not likely to occur until some time in 2005, if at all. If key senators carry out their threat to block passage of watered down House legislation, the regulatory debate may have to wait for another day, or year.

Among its many provisions, the Senate version of the Bill:

  • empowers FDA to approve products that make exposure-reduction claims (PREPS)

  • grants FDA authority to ban sale and distribution of any product not pre-approved by the agency and to apply nationwide product standards; states cannot impose conflicting standards

  • authorises FDA to require new, larger pack warnings labels

  • empowers the FDA to combat the existence of counterfeit, contraband, and other illicit tobacco products and to restrict advertising and promotions that appeal to children

  • requires that FDA publish, three years after enactment, an annual list indicating “harmful and potentially harmful constituents to health” in each brand

  • forbids FDA from banning tobacco sales to adults age 18 and over or from requiring that nicotine yields be reduced to zero

  • prohibits manufacture of cigarettes containing additives that would be the characterising flavour other than tobacco or menthol

  • allows states to regulate “time, place and manner” of cigarette advertising, but not content

  • prevents manufacturers from using terms “low tar” and “light” absent advance FDA approval.

A joint statement from the American Cancer Society, the American Lung Association, the American Heart Association, and the Campaign for Tobacco-Free Kids, hailed the Senate vote “historic action”. Altria, parent company of Philip Morris USA claimed the Bill would give the FDA “comprehensive, meaningful and effective authority”. A New York Times editorial, by contrast, called it a “stinky deal” because of the “unseemly $12 billion handout to tobacco growers”. Other US tobacco companies are also opposed, fearing that the FDA regulation of the industry will be a de facto “Marlboro Monopoly Act”, cementing Altria’s market leadership by stifling marketplace competition and blocking development of arguably innovative products.

Matt Myers, president, Campaign for Tobacco-Free Kids, and Dr Michael Siegel, Social and Behavioral Sciences Department, Boston University School of Public Health, argue, respectively, for and against the merits of FDA regulation of tobacco products, looking at the specifics of the Senate Bill and the general regulatory concept.

As this edition of Tobacco Control went to press, congressional tax negotiators blocked the plan to allow FDA tobacco regulation, but the issue is certain to be raised again soon.