The House Committee on Appropriations could be the last line of defense against Food and Drug Administration (FDA) regulation that will wreck the e-cigarette industry.
The FDA regulation, expected to be announced imminently, will require all e-cigarette products that came on the market since February of 2007 (predicate date) to undergo a Pre-Market Tobacco Applications (PMTA) process that could cost millions per product.
Since almost all vapor products on the market were released after February, 2007, hardly any will avoid a PMTA and almost no businesses, with the exception of tobacco companies, will be able to bear the regulatory burden. (RELATED: One Imminent FDA Regulation Could Wipe Out 10 Years Of E-Cigarette Innovation)
“The agency’s economic analysis of the rule predicts that the cost of such approvals will be so high that approximately 99 percent of products on the market will not even be put through the application process,” says the American Vaping Association (AVA).
But there could be hope for vapers yet, according to the AVA. The House Appropriations Committee could support an amendment to the FY 2017 Agriculture Appropriations bill to change the predicate date for vapor products by amending the bill April 19.
“Changing the predicate date will not stop the FDA from regulating vapor products,” says Gregory Conley, president of AVA. “The FDA will be free to set rigorous product standards and require disclosure of all ingredients in products already on the market. The FDA just won’t be able to set technology back a decade by banning tens of thousands of products for no reason other than the inability of small manufacturers to pay huge fees.”
“The vapor industry and its consumers are not asking for special treatment,” Conley added. “We are asking that the FDA not treat vapor products far worse than they do Big Tobacco’s deadly cigarettes.”
The FDA’s approach to e-cigarettes has been widely criticized for being poorly planned and damaging to public health. If the FDA continues on the path of near total e-cigarette prohibition it “would give deadly old-school combustible cigarettes an almost insurmountable competitive advantage,” according to the National Center for Public Policy Research Risk Analysis Director Jeff Stier. “The regulation would have the effect, intended or not, of taking e-cigarettes away from former smokers who quit smoking by using these less harmful alternatives.”
“This,” says Stier, “is exactly the opposite of what government should be doing, which is to create a regulatory environment that encourages smokers to switch to e-cigarettes, the dramatically less harmful way to get nicotine.” (RELATED: Wells Fargo: FDA’s Anti-Ecig Regulation Will Be A Bonus For Big Tobacco)
“The House Appropriations Committee can change the predicate date, literally giving everyone more breathing room, but it wouldn’t completely reign in the FDA because the FDA would still seek to hold e-cigarettes that go on the market after that date to innovation-stifling pre-market rules.
“If in the name of public health, federal regulations inhibit much-needed innovation in the e-cigarette market, public health will actually suffer as fewer adult smokers will be likely to switch from smoking.”
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