The American Association of Public Health Physicians, the national voice of directors of state and local health departments and of other public health physicians, has filed two citizens’ petitions with the FDA regarding regulation of e-cigarettes. Both are available for review and comment at the federal Regulations.gov website.
The first petition urges the FDA to classify and regulate e-cigarettes as tobacco products, rather than drug delivery devices. It presents several justifications for this position, including:
Legal - AAPHP agrees with federal Judge Richard Leon, who recently found that “Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product – whether traditional or not – that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes.” Unfortunately, Judge Leon’s decision was challenged by the FDA and is currently under review by a federal appeals court.
Ethical - The AAPHP observes that “[t]he new FDA/Tobacco law…forces FDA to grandfather-in currently marketed conventional cigarettes – the most hazardous of tobacco products, while placing formidable barriers to lower risk products,” which conflicts “with the ethical responsibility of FDA to protect the health of the American public and FDA commitment to base their decisions on the best available scientific data.”
Medical Science and Epidemiology - The AAPHP observes that “[t]he risk of death attributable to tobacco use from smokeless tobacco products is less than 5%, and, for some products, less than 0.1 % the risk of death from conventional cigarettes. The risk of death from E-cigarettes, as best we can estimate from available data, should be about the same as for long term use of pharmaceutical nicotine replacement therapy products.”
The second petition urges the FDA to correct inaccurate and misleading claims about electronic cigarettes made at its July 22, 2009, press conference, and to truthfully inform the public about these products.
I was also critical of the agency’s press conference, noting in a blog post that “the FDA tested e-cigarettes for TSNAs using a questionable sampling regimen, and methods that were so sensitive that the results may have no possible significance to users. The agency failed to report specific levels of these contaminants, and it has failed to conduct similar testing of nicotine medicines that have been sold in the U.S. for over 20 years.”
The AAPHP petitions urge FDA actions that would enormously benefit public health, but I am not confident that the agency will pay any attention. Over two years ago, New York State Health Commissioner Richard Daines filed a petition requesting minor revisions in package labeling and the sale of pharmaceutical nicotine that would greatly expand consumer awareness and availability. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA never responded.