Latest FDA tobacco panel hearing: same old, same old?

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ACSH s Dr. Gilbert Ross appeared again before the FDA advisory committee on tobacco products regulation. That panel, officially the Tobacco Products Scientific Advisory Committee, is required to meet periodically by the 2009 Tobacco Control Act and get public commentary on various relevant topics.

Collection of E-cigs

Yesterday s meeting was a discussion about how the FDA s Center for Tobacco Products should deal with modified risk tobacco products products supplying nicotine or seeming to provide whatever it is smokers crave without the deadly effects of inhaling combusted tobacco and its smoke. These products include smokeless tobacco (including snus, purified moist snuff-type tobacco in small packets), dissolvable tobacco sticks and orbs, and especially electronic cigarettes (e-cigarettes). All of these products either have substantial evidence of much less harm as compared to smoking, and/or are clearly of reduced risk potential due to their composition (e-cigarettes produce only nicotine-containing water vapor, with propylene glycol providing a smoke-like appearance, and flavorings, from a device that looks like a cigarette, down to a tip that glows but does not burn upon inhalation). Further, the fact that the old school FDA-approved aids for cessation succeed only 10 percent of the time (or less) makes the need for innovative, effective quitting aids urgent to stem the dreadful toll of about 450,000 Americans dead from smoking-related illness each year.

Given the data showing high quitting success among Scandinavians who switch from cigarettes to snus with the commensurate decline in lung cancer and other smoking-related diseases, and the millions worldwide who have switched to e-cigarettes with a contemporaneous historic decline in cigarette sales, you d think the CTP and the TPSAC would have little to discuss. They should not only approve, but encourage and promote the marketing of these products with the advisory that they are not, perhaps, safe but are far safer than inhaling the products of combustible tobacco in cigarettes.

Well, you d be wrong, dead wrong. Again. The panel is packed with opponents of sensible reduced harm products, who hate and fear anything related to tobacco and anything that (like e-cigarettes) resemble a cigarette. They cleave to the tired dogma, there is no safe form of tobacco. Stick to the evidence-based FDA approved aids for quitting.

I told the panel that the evidence-base of the patches, gums and drugs approved by the FDA clearly shows that they do NOT work, said Dr. Ross. I have given the same presentation, more or less, since my first TPSAC appearance in 2010, and they just won t listen. Yesterday s event was the worst one by far, as I was one of only two presenters who advocated for tobacco harm reduction as an important approach to helping addicted adult smokers quit. Aside from one representative of a tobacco company, the others were all zealot anti-harm reduction people, including representatives of nonprofits who happen to benefit from the generous support of pharmaceutical companies that sell a lot of ineffective remedies for smoking cessation. Rather than seeing progress being made, it seems we are regressing, and that means a bleak future for smokers trying to quit. It s a public health travesty, and the FDA and its panel should be ashamed.