Anti-smoking Groups File FDA Petitions to Regulate Tobacco
A group of health organizations yesterday filed petitions with the FDA asking the agency to regulate several new tobacco products, the Wall Street Journal reports (Fairclough, Wall Street Journal, 12/19). The Supreme Court ruled in March 2000 that the FDA does not have the authority to regulate "traditional tobacco products" (Lockwood, Lexington Herald-Leader, 12/19). However, the groups, which include the American Cancer Society, the American Medical Association, the Campaign for Tobacco-Free Kids and the American Legacy Foundation, argued that the new products are "different," and the FDA has the authority to regulate them as "drugs, drug-delivery devices or foods" (Wall Street Journal, 12/19). Petitions were filed against the following companies:
- Vector Tobacco Inc., makers of the Omni cigarette, and Brown & Williamson, makers of the Advance Lights cigarette, for marketing the new brands as "reduced-risk products" (AP/New York Times, 12/19). At issue is the cigarette manufacturers' claims that their products contain "lower levels of various toxic substances" than other brands. Advance Lights are marketed with the slogan, "All of the taste ... less of the toxins" (Wall Street Journal, 12/19). Edward Sweda, senior attorney at the Tobacco Control Resource Center, said "Certainly a very strong case can be made that [these products] are making health claims" (AP/Baltimore Sun, 12/19). Mark Smith, a spokesperson for Brown & Williamson, said "We make no health claim whatsoever." Smith added that his company's ads "clearly state" that there is "not enough medical information to know if Advance with less toxins will lower health risks." A Vector spokesperson declined to comment.
R.J. Reynolds, for its Eclipse cigarette. Since the cigarette "primarily heats tobacco rather than burns it," it is different than a traditional cigarette and can be regulated as a "drug delivery device," the groups argue. David Iauco, a Reynolds vice president overseeing the Eclipse project, said "We're confident that Eclipse does not fit the description of a drug-delivery device" under federal law, since the company does not make any "therapeutic claims" for the cigarette (Wall Street Journal, 12/19).
Star Scientific, for making a mint-flavored tobacco lozenge, and S.F. Garret, for making "nicotine water." According to Matthew Myers, president of the Campaign for Tobacco Free Kids, the lozenges and water should be regulated by the FDA as a drug or food. He added that the products are "no different" from smoking cessation products, which the FDA regulates (AP/Baltimore Sun, 12/19). Paul Perito, chair of Star Scientific, said "[The petition] is totally without merit. It attempts to distort what the Supreme Court said."
The FDA must respond to the petitions within 180 days, the Journal reports, but is not required to "reach a firm decision for or against" the petitions within any time frame (Wall Street Journal, 12/19).
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