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On behalf of our activist community, I urge you to contact your representative and ask him or her to cosponsor the FDA Deeming Authority Clarification Act, H.R. 1136, introduced by Rep. Tom Cole (R-Okla.) and Rep. Sanford Bishop (D-Ga.). The bill would save e-cigarette and vaping producers from a Food and Drug Administration rule finalized by the agency in May 2016.
The Food and Drug Administration (FDA) deemed authority under the Food, Drug, and Cosmetics Act and the Family Smoking Prevention and Tobacco Control Act to retroactively regulate e-cigarette and vapor products that entered the market on February 15, 2007 and after. Given that this is a relatively new market, the rule would subject virtually all e-cigarette and vapor products to a costly $1 million approval process. Pre-market tobacco applications for every available e-cigarette-related product are required.
This rule threatens e-cigarette and vapor manufacturers, particularly the latter, whose businesses will be virtually wiped out in August 2018, when the two-year compliance window closes.
While the FDA has claimed the authority to regulate e-cigarettes and vapor products in the interest of public health, there is scant evidence that shows these products increase the consumption of traditional cigarettes. In fact, a study conducted by Public Health England, a government agency in the United Kingdom, concluded that e-cigarettes are 95 percent less harmful than traditional cigarettes and serve as a successful cessation method.
Unfortunately, the message that the FDA is sending to Americans who wish to kick or curb their smoking habit through the use of e-cigarettes or vapor products is “quit or die.” Thankfully, the FDA Deeming Authority Clarification Act would address this particular instance of regulatory overreach.
The FDA Deeming Authority Clarification Act would change the predicate statutory date under the Family Smoking Prevention and Tobacco Control Act of February 15, 2007 to 21 months after its enactment. Products already on the market would be grandfathered in, which the FDA rule did not do.
E-cigarette and vapor products represent a $3.5 billion industry that employs thousands of Americans. These products are safer than traditional cigarettes and help many Americans kick or curb smoking. For these reasons, I urge you to contact your representative and ask him or her to cosponsor the FDA Deeming Authority Clarification Act, H.R. 1136.
Adam Brandon, President and CEO, FreedomWorks