ATR Supports Rep. Tom Cole’s FDA Deeming Authority Clarification Act of 2015


Posted by Paul Blair on Tuesday, May 19th, 2015, 3:21 PM PERMALINK


Congressman Tom Cole (R-Okla.) recently introduced H.R. 2058, the “FDA Deeming Authority Clarification Act of 2015.” This legislation would prevent the Food and Drug Administration (FDA) from banning tobacco products (like cigars) and 99 percent of the innovative vapor and electronic cigarette products that have hit the market since 2007.

The FDA is finalizing a regulatory framework for premium cigars and vapor products that stands to require pre-market approval for all products that have hit the market since February 15, 2007. Any product on the market prior to that date would largely be exempt and any product that has hit the market since then would be given two years to apply for approval.

H.R. 2058 moves up the 2007 date to the date of the announced “deeming regulation,” which is likely to occur later this year. This would permit products that have hit the market since 2007 to remain on the shelves, pending approval. This is important for a number of reasons. First, nearly every vapor product on the market today did not exist in 2007. The thousands of e-liquids and countless versions of electronic cigarettes available to smokers looking for an effective way to quit would be banned pending FDA approval without a change to the Federal Food, Drug, and Cosmetic Act or subsequent Tobacco Control Act of 2009, which established the 2007 date.

That Act was intended to apply to cigarettes, smokeless tobacco, and roll your own products. The FDA’s attempt to categorize new products under the authority given to them by that legislation lays out two pathways to “legalization” for new products on the market. The first is “substantial equivalence,” whereby a manufacturer must file for a tobacco product application, which includes clinical trials and would be relatively expensive for small and medium sized businesses.

Rep. Cole’s common-sense legislation moves up this substantial equivalence 2007 date to date of deeming regulation in 2015 and would prevent countless companies from having to cease operations given the cost of compliance for products that are already being sold to consumers.

If this legislative change if not made, and for the companies who could afford compliance, the FDA would be inundated with applications that the agency is not equipped to fast-track for approval. For combustible cigarette smokers looking to or considering quitting with e-cigarettes, this would be a tragedy as countless innovative smoking cessation devices would be at risk of never being sold.

The FDA has claimed that it does not have the power to modify the February 15, 2007 date, making a Congressional solution imperative. Americans for Tax Reform supports H.R. 2058 and urges more members to join on as co-sponsors in the coming weeks. This legislation will encourage innovation and teardown an unnecessary federal barrier to the sale of many products that stand to improve public health. 

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