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Roundy was among the vape shop owners who received FDA bans on all of his flavored products Thursday. “They equate to about 1 percent of our sales, if that,” said Jon Roundy, the owner of Tasty Haze, LLC, a vape shop in Rainbow City, Ala. Vape shop owners say that these products make up a small fraction of their business sales compared to other flavors. FDA in the last few days banned some e-cigs that fall into these categories, but has not issued decisions on other companies’ menthol and tobacco flavors. The fate of e-cigarette products with flavors like tobacco and menthol is unclear. As of Thursday, it had issued 132 marketing denial orders that covered roughly 946,000 flavored e-cigarette products. In August, the agency sent a “refused to file” notice to a company whose application covered 4.5 million products but was missing key information. The last tobacco product to receive FDA clearance through this policy - known as premarket review - before the deadline Thursday was Philip Morris International’s IQOS heated tobacco system in 2020.įDA began issuing decisions on e-cigarette applications this summer ahead of its deadline Thursday. FDA said e-cig makers could continue selling their products for one year while the agency reviewed their submissions. The agency told the companies they must demonstrate that their products were “appropriate for the protection of public health” and would be safe for current smokers and unappealing for non-smokers. 15, 2007, or later - including e-cigarettes, cigars, hookah, pipe tobacco, dissolves and nicotine gels - apply to stay on the market.įDA received approximately 6.5 million applications from e-cig makers by its Sept. The policy requires all companies with products introduced by Feb.

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That began to change in 2016, when the agency finalized a rule that gives it full regulatory control over tobacco products, including e-cigarettes. “It was a bloodbath,” she said.Īnd in a statement, American Vaping Association President Gregory Conley said “it is absolutely absurd that the same agency that found time to ban over six million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares.”Į-cigarettes have grown in popularity in recent years, but have operated in a gray area without many of the rules and restrictions FDA applies to traditional tobacco products like cigarettes. He is frustrated that the agency has not decided whether the largest companies’ products meet the regulatory standard - as is Nancy Brown, the chief executive officer of the American Heart Association, who issued a statement calling FDA’s course of action “deeply disappointing.”Īmanda Wheeler, the president of the American Vapor Manufacturers Association, expressed her displeasure bluntly. “The reality is, hasn’t made decisions on the products that have actually fueled the youth e-cig epidemic,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. Cola and Cinnamon Toast Cereal.”īut groups that oppose vaping and those that represent smaller e-cig makers both found fault with FDA’s approach.

They noted that the banned products included flavors such as “Apple Crumble, Dr. “We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review,” acting FDA Commissioner Janet Woodcock and the director of the agency’s Center for Tobacco Products, Mitch Zeller, said in a statement. In its announcement Thursday, FDA said the makers of the banned products “failed to provide sufficient evidence” that the benefits to adult smokers, for whom vapes are a less-damaging alternative to traditional tobacco, outweigh the “documented risks to youth.”