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03/24/2022

FDA Signals Decisions on Major Vapor Brands Could Be Coming Soon

The agency has taken action on the lion's share of PMTAs submitted by the Sept. 9, 2020 deadline.
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SILVER SPRING, Md. —  The Food and Drug Administration (FDA) is moving closer to wrapping up its review of the premarket tobacco applications for vapor products, including those from major companies.

To date, the agency has taken action on approximately 99 percent of the nearly 6.7 million electronic nicotine delivery system (ENDS) products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products.

However, the FDA has yet to take action on the majority of PMTAs submitted by big companies, like Altria Group Inc. and Juul. That could be about to change.

On March 24, the agency said it "is close to making additional decisions on applications for popular ENDS products that account for a large part of the market. The continued marketing of these products has the potential to have a substantial public health impact — either positively or negatively — as they hold an overall large market share and are used by a lot of people."

"We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine," said FDA Commissioner Robert M. Califf.

"The balance of these issues was considered by the agency's career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health," he said.

Under the PMTA regulatory pathway manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. 

Tobacco and vapor companies faced a Sept. 9, 2020 deadline to submit PMTAs for ENDS. Per a court order, the FDA had one year to complete its review of all applications — a deadline it did not meet.

Companies that submitted PMTAs are generally allowed to continue to sell or distribute their products for one year until the FDA completes its review, unless there is a negative action taken by the FDA on the application. 

In October, the agency gave the greenlight for R.J. Reynolds Vapor Co., an operating company of Reynolds American Inc., to market its Vuse Solo electronic nicotine delivery system.

With the nod, Vuse became the first ENDS to receive FDA authorization under the premarket application pathway.

On March 24, the agency authorized several tobacco-flavored ENDS products from Logic Technology Development LLC under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.

However, similar to Vuse, the FDA authorization only covers tobacco flavors. The agency has yet to authorize any flavored ENDS.

"Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn't provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth.

"We are committed to continuing to take the appropriate actions to protect our nation's youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States," Zeller added.