UNITED STATES
Vaping industry deems FDA final rule “cost prohibitive”

US vaping industry regulations announced 5 May amount to “an enormously cost-prohibitive regulatory process” that will cripple the sector and harm the effort to wean smokers away from cigarettes, an industry association said.

Smoke-Free Alternatives Trade Association (SFATA) issued a call to move back the 15 Feb, 2007 cut-off referred to in the final rule released by the Food and Drug Administration as the “predicate date”. Two initiatives to do this are before Congress. Nearly all vapour products were not on the market in 2007, and therefore must undergo a more costly approval process, SFATA said.
“Although the FDA states it has found a vapour product on the market in 2006, it has yet to be determined whether the far more technologically advanced vapor products on the market today can be considered substantially equivalent to that product,” SFATA said. Nine million former US smokers have switched to vaping products, and the new rule could push them back into a smoking habit, the organisation said.
FDA’s rule extends its authority to e-cigarettes, cigars, hookah and pipe tobaccos and some smokeless products not already regulated in the 2009 Family Smoking Prevention and Control Act.
Cigar Association of America President Craig Williamson said "the association is undertaking an extensive review of the FDA's final rule and guidance documents, which tally well over 500 pages, to determine how the rule will impact cigar manufacturers, retailers, and consumers. We are evaluating our next steps."

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