FDA Releases E-cig Guidance, Moves Up Regulation Date

The FDA today rolled out draft guidance to restrict flavored e-cigarette sales and ban new flavored cigars from the market.

The policy hews closely to a plan first laid out by departing FDA Commissioner Scott Gottlieb in November. It would bar e-cigarettes that are not mint, menthol or tobacco flavored from being sold in outlets that youth can access, such as convenience stores and gas stations, as well as websites with no age verification or limits on how much a consumer can buy.

The guidance also bans flavored cigars that launched after a 2016 cutoff date.

Gottlieb had previously pushed the deadline for e-cigarette makers to submit their products for review to August 2022, but the guidance also rolls back the deadline by one year. The FDA said it will begin reviewing manufacturers and retailers on a "case-by-case basis," prioritizing products and outlets that appeal to teens. After August 2021, the FDA will target manufacturers that have not submitted applications for approval.

In a statement, Gottlieb said the FDA expects some flavored e-cigarettes and cigars will be pulled from the market as a result of the guidance.

But anti-tobacco advocates quickly called more action. "While we appreciate that the FDA has recognize the magnitude of the problem, frankly we were underwhelmed by the announcement," American Heart Association CEO Nancy Brown told reporters on a call. "We don't think the FDA has gone far enough to reduce the epidemic of youth e-cigarette use."

Rep. Diana DeGette (D-Colo.), an outspoken critic of the e-cigarette industry, also said that the FDA plan alone would not curb teen vaping. "To end this epidemic, we must ban the sale of these kid-friendly flavors of nicotine that led to its creation in the first place."