First set forth by the agency in November, the directives restrict access to flavored e-cigs that have been popular among minors. “We think flavored products represent greater risk to youth appeal, so when we’re looking at the public health value and redeeming qualities of products, we generally feel flavors have more to prove at this point,” Gottlieb said Wednesday in an interview. “They’re the ones driving youth use so we want to do a proper evaluation through our assessment process.”
The restrictions will likely be finalized and implemented over the next few months. Brick-and-mortar retailers will be unable to sell flavored e-cigs other than tobacco, menthol or mint unless minors are restricted from entering the store or if those items are sold in a separate location in the store that minors are prohibited from entering. Websites selling flavored vaping products must utilize third-party age-verification and halt bulk purchases.
In addition, the agency will make all e-cigarette manufacturers with products currently on the market to submit those to the agency for review a year earlier (August 2021) than the previous deadline. The FDA also will forbid the sale of all flavored cigars new since February 2007.
The Trump administration on Tuesday named National Cancer Institute Director Ned Sharpless as acting FDA commissioner. In a statement, Health and Human Services Secretary Alex Azar said there would be “no let-up” in the agency’s efforts to address youth use of e-cigs.
Starting today, comments on this draft guidance may be submitted to the open docket with the same title on Regulations.gov. Comments must be received by April 15, 2019, to ensure that FDA considers them while working on the final guidance.