FDA Releases Draft Rules Restricting E-Cigarette Sales

SILVER SPRING, Md. — The Food and Drug Administration (FDA) is moving closer to removing certain flavored electronic cigarettes and vapor products from the market.

On March 13, FDA Commissioner Scott Gottlieb announced that the agency is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes, and prioritize enforcement of their sale to shut down youth access. The proposal does not include tobacco, mint and menthol flavors.

In addition, the FDA expects manufacturers of all flavored ENDS products — other than tobacco-, mint- and menthol-flavored — that remain on the market under these new conditions to submit premarket applications to the agency by Aug. 8, 2021. This moves up the deadline by one year.

"When we first announced our comprehensive plan for tobacco and nicotine regulation in July 2017, we outlined a framework to better protect kids and to significantly reduce tobacco-related disease and death. We are continuing to implement that framework today. It remains the blueprint for the agency’s tobacco-related policymaking," Gottlieb said.

According to the commissioner, the plan's ultimate goal is "a world where combustible cigarettes no longer create or sustain addiction — making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or transition to potentially less harmful products."

However, the rise of electronic cigarette use by underage users "is threatening the progress we've made in reducing youth tobacco use," Gottlieb said.

The increased use led him to direct the FDA's Center for Tobacco Products to revisit the agency's regulatory policy of e-cigarettes and vapor products in November, as Convenience Store News previously reported.

As a result, the agency published a draft compliance policy on March 13. The full draft guidance can be found here.

According to the commissioner, the agency expects several things to happen as a result in policy shift, including:

• Some flavored e-cigarette products will no longer be sold;
• Other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021; and
• Some flavored cigars will no longer be sold.

The stricter compliance policy would effectively remove the flavored tobacco products from convenience stores, allowing sales only in adult-only, age-restricted outlets like tobacco shops.

"Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: You may be subject to FDA enforcement for selling certain flavored ENDS products without authorization," Gottlieb said.

To read the commissioner's full statement, click here.