An advisor to the Food and Drug Administration (FDA) claimed Tuesday he hasn’t seen any evidence that the agency’s imminent crackdown on e-cigarettes amounts to prohibition, despite the FDA’s own contradicting data.
Dr. Thomas Eissenberg, a project director at the Center for the Study of Tobacco Products and a member of the Tobacco Products Scientific Advisory Committee, said on a radio program he has seen no proof that FDA’s regulations of vapor products will result in de facto prohibition.
The FDA’s rules, likely to be implemented in 2016, will require all e-cigarette products released after Feb. 15, 2007 to undergo the costly Pre-Market Tobacco Applications (PMTA) process. The PMTA process for each individual product can run between $2-10 million. E-cigarette advocates and trade association groups argue this will mean the vast majority of products will be taken off the market.
Speaking to radio host Jennifer Rooks, Eissenberg spent 50 minutes discussing issues surrounding e-cigarettes and vaping Tuesday. He was asked by the President of the American Vaping Association Gregory Conley:
Are you concerned that if the FDA regulation of e-cigarettes is actually prohibition and this removes 98.5 percent-plus of e-cigarette products from the market due to the costs involved – which is what the FDA’s economic impact analysis suggests – are you at all worried that the FDA’s worried that the FDA’s regulation could harm public health by dissuading smokers from quitting by making these products boring and unappealing to smokers?
Eissenberg responded:
With regard to prohibition, I don’t think I have seen anything from the FDA that suggests that they’ll be prohibiting electronic cigarettes.
This answer is surprising, given the FDA’s own economic impact analysis estimates that out of the 1,675 products on the market (at the time of publication), only 25 will go through the PMTA process during the two-year window.
In this scenario, 98.5 percent of e-cigarette products would be made illegal, essentially introducing e-cigarette prohibition.
The prohibition of the majority of vapor products would not only destroy most of the industry, but could spawn a huge black market. (RELATED: FDA Could Trigger Massive E-Cig Black Market, Turn Vapers Back To Smoking)
Eissenberg’s response as an expert in the field of tobacco control is even more mystifying since not only does the FDA’s own document show the devastating impact of its deeming rules, independent experts have publicly criticized the agency’s approach.
Dr. Michael Siegel, a professor in the Department of Community Health Sciences at Boston University School of Public Health and has 25 years of experience in the field of tobacco control, wrote on his blog in 2015 that the FDA “is essentially making a decision to prohibit these products, or at very least, to prohibit 99 percent of these products.”
“This is not a valid regulatory approach, especially when compared to the FDA’s regulatory approach for real cigarettes, which is to do nothing!”
When asked by The Daily Caller News Foundation whether he stood by the remarks and if the FDA’s rules amounted to prohibition in light of the of the agency’s own economic impact analysis, Eissenberg said, “A good question for FDA.”
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