ATR Supports Predicate Date Change in the Tobacco Control Act

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Posted by Paul Blair on Monday, April 18th, 2016, 2:36 PM PERMALINK

The U.S. House Committee on Appropriations will begin markup on the 2017 Agriculture Bill tomorrow, representing a significant opportunity to halt the Food and Drug Administration’s (FDA) overregulation of vapor products in the United States. An amendment to the bill, proposed by Rep. Tom Cole (R-Okla.) will change what is known as the “predicate date” for tobacco products that have hit the market since February of 2007.

This is significant for a number of reasons. First, the Tobacco Control Act (TCA) established an arbitrary date of February 15, 2007 of which all tobacco or tobacco-derived products must establish existence in the market in order to avoid an expensive, if not impossible regulatory pre-approval process within the FDA. This was essentially intended to prevent new tobacco products like cigarettes from hitting the market without pre-approval, which would likely not ever occur.

Unfortunately, innovation has encountered an outdated regulatory code and trapped life-saving smoking cessation products in the mix.

Tobacco-free electronic cigarettes and vapor products did not exist in any commercialized form in 2007, signaling that it was not the intent of the Tobacco Control Act to regulate these products in a similar manner. Unfortunately, because the nicotine contained in many vapor products comes from tobacco plants, the FDA has asserted regulatory authority under the TCA covers these products as well.

As such, an effort underway by Rep. Cole would change the arbitrary 2007 date to the date at which the FDA announces its “deeming regulation,” where they deem vapor products as tobacco products, for regulatory purposes. This common sense change to the Tobacco Control Act would ensure that products already being sold to millions of consumers in the United States would remain available and affordable for adults. Absent a change in this date, the most significant advancement in public health in decades will be stifled by government. 

The growing body of scientific evidence suggests that vapor products are at least 95% and as much as 99% less harmful than combustible cigarettes. Both Matt Meyers of the Campaign for Tobacco Free Kids and Mitch Zeller of the FDA’s Center for Tobacco Products have made statements suggesting their understanding of the opportunity for risk mitigation as well.

Matt Meyers, in 2014 testimony to the Senate Commerce Committee: “Responsibly marketed and properly regulated, e-cigarettes could benefit public health if they help significantly reduce the number of people who smoke conventional cigarettes and become sick and die as a result.” He explained further that if properly regulated, “I don’t think there is any doubt that there would be a reduction in harm,” from smokers who switched to e- cigarettes.

Mitch Zeller: “If we could get all of those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.”

Absent a Congressional change in the predicate date, only large tobacco companies will be able to afford the compliance costs associated with obtaining pre-market approval within the FDA to sell electronic cigarettes. The millions of dollars necessary to undergo this expensive regulatory process will halt innovation, and put most small businesses out of business, striking a significant blow to public health.

A change in the predicate date will do nothing to prevent the FDA from regulating the product category with reasonable requirements like ingredient disclosure or the establishment of good manufacturing practices. It will simply permit innovation to exist to the benefit of most consumers and small businesses in the industry.

Click here to read ATR president Grover Norquist’s letter to members of the House Committee on Appropriations. 

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