FDA Action to Address “Epidemic” of Youth E-Cigarette Use Can Make Fundamental Difference, but Agency Follow-Up Is Key

WASHINGTON, D.C. – The actions the U.S. Food and Drug Administration announced today to address an “epidemic” of youth e-cigarette use have the potential to make a fundamental difference, but will only have a major impact if the FDA quickly follows up and requires that flavored e-cigarettes that have not been reviewed by the agency be removed from the market because of their appeal to kids, forces changes in the marketing and sales practices of e-cigarette manufacturers that have fueled this epidemic, and requires that all e-cigarettes undergo review by the FDA without further delay.

FDA Commissioner Scott Gottlieb has rightly recognized that the skyrocketing youth use of e-cigarettes, including Juul and a growing number of products similar to Juul, is a crisis that must be a priority for the FDA to address. Commissioner Gottlieb stated that youth e-cigarette use has reached “an epidemic proportion,” flavors are “one of the principal drivers of the youth appeal of these products,” and “we cannot allow a whole new generation to become addicted to nicotine.” The FDA must match these strong statements with equally strong action.

Critically, while the FDA notes that removing flavored products from the market unless those products have been reviewed by FDA, altering current marketing practices, eliminating online sales and taking significant steps to curtail illegal sales to kids are examples of actions companies can take to reduce youth use, the FDA stops short of requiring these changes. Real change can only be accomplished if the FDA reverses its decision allowing e-cigarettes introduced before August 8, 2016, to stay on the market for years without agency review and enforces current law prohibiting the introduction of new products after August 8, 2016, without such review. Today’s announcement will represent a fundamental turning point if, but only if, the FDA formally requires all manufacturers to comply with these requirements and the FDA reverses its policy and requires that all of these products undergo agency review now, not four years from now.

In March of this year, the Campaign for Tobacco-Free Kids and other leading health organizations filed suit challenging an FDA decision that delayed from 2018 to 2022 a legally required agency review of e-cigarettes that were on the market as of August 8, 2016. However, products introduced after August 8, 2016, are still required to undergo FDA review before they enter the market. The Campaign for Tobacco-Free Kids and other health groups last month urged the FDA to enforce this requirement.