FDA Bans Sale of Most Flavored Prefilled Pods

Mere weeks after Congress said it will raise the legal smoking and vaping age to 21 comes another restriction. The U.S Food and Drug Administration issued a policy on Thursday that will restrict the sale of flavored pre filled pods. This policy will not affect the sale of vaping mods, tanks, bottles of e-juice or unfilled pod products.

The FDA has issued this policy in an effort to curb youth use of vaping products. This policy leaves open vaping systems available for adults trying to quit combustible tobacco — at least for now. 

“The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes. HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” said Secretary of Health and Human Services Alex Azar.

Under this policy, companies will have 30 days to cease manufacture, distribution, and sale of unauthorized pre filled pods in any flavor other than tobacco or menthol. In addition, the policy focuses on any product that may target minors and the FDA will be prioritizing enforcement against the following groups of vaping products:

• Any flavored, pod based vaping product other than tobacco or menthol.
• All other vaping products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minor’s access
• Any vaping product that is targeted to minors or likely to promote the use of vaping products by minors

The first targeted group of vaping products is specific enough. Any pre filled pod with fruit, mint or any other flavor, other than tobacco or menthol, will face enforcement action if it remains on the market after 30 days. But the other two groups aren’t as clear cut.

The FDA could very well say that any other vaping product hasn’t done enough to prevent minor’s access. What exactly constitutes taking adequate measures to prevent minor access? It’s hard to say.

In any case, the FDA has made clear that it will prioritize enforcement towards any products marketed with labeling and/or advertising that resemble kid-friendly foods and drinks such as juice boxes or kid-friendly cereal; products marketed directly to minors by promoting ease of concealing the product or disguising it as another product; and products marketed with characters designed to appeal to youth.

This policy will affect manufacturers of closed, pre filled pods like RELX & MOTI. And while the policy will still apply to JUUL, it won’t have much of an effect —  in October 2019, JUUL suspended the sale of their non-tobacco and non-menthol based flavors in the U.S.

After May 12, 2020, the FDA will also prioritize enforcement against any vaping product for which the manufacturer has not submitted a premarket application. As of today, no premarket applications from independent vaping companies have been accepted by the FDA. 

Manufacturers of open systems and other vaping products will have a one year grace period from the time they submit their premarket application to continue selling their products. However, manufacturers of these pre filled pods will not and will have to have their application approved before they can return their products to market.