Regulation Rally

The latest word on the street regarding federal regulation is that the vapor industry may be fighting the Food and Drug Administration’s (FDA) final deeming rule in court.

In the last week of October, while the FDA’s final rule on currently unregulated tobacco products — including electronic cigarettes and vapor products — was in the White House Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs for review, the Tobacco Vapor Electronic Cigarette Association (TVECA) leaked what it claimed were the table of contents and guidance on premarket applications for e-cigs and vaping devices. (At press time, the 40 pages were still up on its website,

TVECA CEO Ray Story said the association was sharing the documents to spur action among e-cigarette makers because the final rules, as currently framed, could effectively wipe out the industry. He cited the FDA’s alleged plan to retain the predicate product date of Feb. 15, 2007, calling it a “de facto ban” and an “annihilation of the category,” and added that he is prepared to challenge the final rules in court if the OMB backs “this kill order.”

The FDA’s Center for Tobacco Products responded that it is aware of TVECA’s claim, but said the agency “cannot confirm if TVECA has a copy of the most recent version of the draft final rule, or even if their copy is authentic.” The agency said it remains committed to “an open dialogue with all interested parties.”

Based on analyzing what TVECA obtained, Professor Michael Siegel of Boston University’s School of Public Health said the FDA’s deeming regulations would subject e-cigarette products released after Feb. 15, 2007 to the FDA’s premarket approval process.

In his opinion, the new rules should be called “The Cigarette Protection Act of 2015.” Despite acknowledging that there is a continuum of risk among nicotine-containing products, with e-cigs at the opposite end of the spectrum from tobacco cigarettes, “the FDA has chosen to ignore the risk differences and instead to treat e-cigarettes much more stringently than tobacco cigarettes,” according to his analysis of the documents TVECA obtained. Siegel added that the proposed FDA measure will “decimate” the e-cig industry.

He said by requiring an “unduly expensive and burdensome process” for e-cigs to remain on the market, the FDA is encouraging many e-cig users to return to tobacco cigarettes, while discouraging many smokers from trying to quit use of these products.

According to Siegel, the regulations also do not address issues such as lack of battery safety and the presence of potential carcinogens like formaldehyde in e-cigs. Siegel concluded that there will be a major contraction of the industry as only cigarette companies and perhaps the largest of the independent e-cig companies will be able to file a “prohibitively expensive and resource-intensive” premarket tobacco application.

Mistic Electronic Cigarettes, a manufacturer of vapor products currently sold in convenience stores under the Mistic and Haus brands, told Convenience Store News that its attorney recently review the leaked document. While there were a few positive aspects (flavors are not being banned), the fact that the grandfather date was not moved was “bothersome.”

“But it doesn’t mean we can’t get a statue changed through Congress,” noted John Wiesehan Jr., CEO of Mistic. His company was scheduled to talk with the OMB and the Small Business Administration on behalf of the industry in December.

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