FDA E-Cig ‘Deeming’ Rule Imminent

Tobacco industry expecting final rule this month

WASHINGTON -- Tobacco industry and anti-tobacco groups are expecting the U.S. Food & Drug Administration (FDA) this month to release its long-awaited final rule “deeming” whether it can regulate cigars and electronic cigarettes, according to a report by The Hill. Electronic E-cigarette

While FDA spokesperson Michael Felberbaum told the newspaper that he did not have any update to share on the timing of the deeming rule’s release, most industry observers believe a final rule is imminent.

“The proposed rule came out in April 2014, and last spring they said they would be done by summer,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, told the Hill. “Then last June, they said they’d be done by the end of the summer. I guess they never said which year.”

Myers said the delays in releasing the final rule have damaged the agency’s credibility.

The delay has prompted speculation on what could be holding up the rule.

Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association (TVECA), believes the agency is hung up on one provision--a mandate that requires any nicotine delivery devices that hit stores after Feb. 15, 2007, to apply retroactively for approval, the Pre-Market Tobacco Application (PMTA) process.

Story argues that provision alone will wipe out the e-cigarette industry, which didn’t take off until after 2007.

The FDA has said it does not have the authority to alter or amend that date, set by statute in the Family Smoking Prevention & Tobacco Control Act signed into law by President Obama in 2009.

Story said Rep. Duncan Hunter (R-Calif.) is working on legislation to change the date. Duncan’s chief of staff Joe Kasper dismissed the FDA’s claims that the agency’s hands are tied by statute, calling the argument “bunk.”

The legislation is intended to ensure e-cigarettes are not regulated like traditional tobacco products.

“Vaping is not the same as smoking traditional tobacco, and it shouldn’t be treated that way,” Kasper said. “Vaping is really a proxy war for anti-tobacco forces, and there’s nothing they want more than to continue associating vaping with regular tobacco.”

In a separate statement, another group, the Vapor Technology Association (VTA), said, “The FDA’s U.S. regulatory policy … will only serve to eliminate products that have high acceptance among adult cigarette smokers, and ultimately harm the broader public health goal of deterring tobacco use.”

“Despite an overabundance of distorted and misleading information propagated by some in the public health community, the science is clear--responsibly manufactured vapor products are not only a safer alternative to traditional combustible products, but also provide smokers with a viable path to reducing their tobacco consumption and quitting altogether,” said Tony Abboud, VTA’s national legislative director. “The FDA’s actions will not improve our nation’s public health objectives. To the contrary, they will yank responsibly manufactured vapor products from the hands of adult smokers and replace them with the cigarettes they had been trying to give up.”

“Moreover, by simply dumping vapor technology products into an already antiquated federal regulatory scheme, the FDA will, in one stroke, wipe out nearly a decade of widespread consumer acceptance of these products. At the same time, the FDA will kill nearly a decade of innovation in the vapor technology industry and the many thousands of small and mid-size businesses in communities across this country who have invested in establishing retail stores and developing new technologies. … If enforced as drafted, the unreasonable and excessive regulations proposed by the FDA will only serve to put these innovators out of business, their employees out of work, and will hand deliver Big Tobacco a monopoly on vapor products.”


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