WASHINGTON -- One week after rumors started that the U.S. Food and Drug Administration (FDA) would soon issue its final “deeming” rule to regulate cigars and electronic cigarettes, the House Appropriations Committee approved a measure that would make it easier for manufacturers to comply with potential regulations.
As reported by Reuters, the bipartisan amendment to the 2017 Agriculture Appropriations bill would move the predicate product date for cigars and vapor products from Feb. 15, 2007 to the effective date the FDA issues its final deeming regulations. The measure, which was proposed by Rep. Tom Cole (R.-Okla.) and Rep. Sanford Bishop (D.-Ga.), passed by a 31-19 vote.
In its proposed deeming rule, the FDA argued it did not have the authority to move the predicate (or grandfather) date established in the 2009 Tobacco Control Act—meaning manufacturers would have to go through the costly and time-consuming pre-market tobacco application (PMTA) for any product that did not have a “substantially equivalent” product on the market on or before the 2007 date. Vaping advocates argued this would effectively ban 99% of vapor products, because the category did not exist in 2007. Pushing back the grandfather date means e-cig and cigar manufacturers could garner new-product approvals through the less costly substantial equivalence (SE) pathway.
Industry advocates called the decision a victory for vaping.
“What happened today is a big boost of momentum for the industry,” Arnaud Dumas de Rauly, treasurer of the Vapor Technology Association, told Reuters. “We're happy to have bipartisan co-sponsors because up until now we only had Republican buy-in. Now we have Democratic buy-in as well.”
“The vapor industry and its consumers do not oppose sensible regulation, but the FDA's proposal is anything but sensible,” said Gregory Conley, president of the American Vaping Association (AVA), in a press release. “Modernizing the predicate date will not interfere with the FDA's ability to regulate vapor products. All this change does is force the agency to regulate the vapor products rather than just ban 99%-plus of products on the market today.”
Conley went on to warn that the fight is far from over: The House and Senate still need to approve the final spending bill, and those votes might not happen until the end of 2016.
“This is only the start of a long fight to keep this provision in the overall budget bill,” Conley said. “The fate of the U.S. vapor product industry is in the hands of Congress.”
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