An FDA adviser stated last week that he has yet to see any evidence that the coming crackdown on e-cigarettes is going to amount to prohibition. Still, this seems to contradict data that has been made public by the agency.
According to 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, he has not seen any evidence that the new FDA regulations on vaping products is going to prohibit the sale of the items.
FDA e-cigarette rules will probably be rolled out in 2016, and will mandate that any e-cig manufacturer product released after Feb. 15, 2007 must under go the expensive Pre-Market Tobacco Applications process, or PMTA. This process for each product can cost as much as $10 million. E-cigarette companies argue that this means that most vaping products will disappear from the market.
The doctor’s comments on a radio program recently are interesting because FDA’s economic impact analysis on e-cigarette regulations being considered estimated that of the 1675 products that are on the market now, just 25 will go through the expensive PMTA process. That means that 98% or more of e-cigarette products will be illegal.
A doctor outside of FDA, Dr. Michael Siegel, a professor in the Department of Community Health Sciences at Boston University School of Public Health, wrote recently that FDA’s pending vaping rules will essentially prohibit most e-cigarettes, or at least 99% of the products. He argues that this is a poor regulatory approach, especially when compared to what FDA does to regulate real cigarettes, which are much more harmful to health.
Many in the vaping industry think that FDA does enact an essential ban on e-cigs, this will just result in a huge e-cigarette black market. The hope in the vaping community is that FDA’s regulatory approach will be more reasonable than the rumors suggest.