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.”
“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. “Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency’s highest priorities.”
Woodcock and Zeller also noted that the banned products included flavors such as “Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.”
By the numbers: FDA received approximately 6.5 million applications from e-cig makers, who were required by Sept. 9, 2020, to demonstrate that their products were “appropriate for the protection of public health” and would be safe for current smokers and unappealing for non-smokers. The agency said they could continue selling those products for one year while FDA reviewed their submissions.
FDA said Thursday that it had acted on roughly 93 percent of those applications, but it has not yet issued decisions on products from Juul, Reynolds American’s Vuse and NJoy, which control the largest shares of the market.
Applications still pending with FDA are in the “final stages of review,” the agency said.
Background: E-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.
The agency finalized a rule in 2016 that gives it full regulatory control over tobacco products, including e-cigarettes, but it has taken years to implement. The rule mandates that all companies with products introduced by Feb. 15, 2007, or later — including e-cigarettes, cigars, hookah, pipe tobacco, dissolves and nicotine gels — apply to stay on the market.
FDA began issuing decisions on e-cigarette applications this summer ahead of its deadline Thursday. In August, the agency issued a “refused to file” notice to a company whose application covered 4.5 million products but was missing key information. As of the Sept. 9 deadline, it issued 132 marketing denial orders that covered roughly 946,000 flavored e-cigarette products.
The last product to receive FDA clearance through its premarket review pathway before the deadline Thursday was Philip Morris International’s IQOS heated tobacco system in 2020.
What’s next: FDA is working to complete its review of the remaining e-cig applications. It is also rounding out reviews of applications filed under the “substantial equivalence” standard for products like cigars, pipes and hookah tobacco. In total, the agency has granted marketing orders to 350 of these products.