WASHINGTON— In a move that will likely face opposition from the vaping industry and multiple retail channels, FDA Commissioner Scott Gottlieb declared guidelines that would effectively ban the sale of flavored vaping products at convenience stores and gas stations, just weeks before his scheduled departure from the agency.
The FDA’s draft guidelines, issued March 13, specifically leave out tobacco, mint and menthol flavors.
The agency also changed internal compliance deadlines, saying it expects manufacturers of flavored electronic, nicotine-delivery devices to submit premarket applications for FDA approval by Aug. 8, 2021, a full year earlier than it initially required as of 2017.
For a retail channel facing heightened scrutiny from the FDA in recent months, the mandate appeared clear. The agency said it intends to “prioritize enforcement” where flavored vaping devices, cigars and similar products are “sold in locations that minors are able to enter at any time (e.g., the entire establishment or an area within the establishment),” officials said in the draft guidance document.
In a press release, the agency said it expects several things to happen because of the policy changes that could emerge from the draft guidance document:
- Some flavored e-cigarette products will no longer be sold at all.
- 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.
- Some flavored cigars will no longer be sold.
For his part, Gottlieb said, “[It] has become clear that a recent surge in e-cigarette use among youth, which had appeared to be leveling off at the time our comprehensive plan was first announced in July 2017, is threatening the progress we’ve made in reducing youth tobacco use.”
In a statement, Gottlieb said recent government data shows more than 3.6 million middle and high school students across the country were current (as of the past 30 days) e-cigarette users in 2018. The statistic represents a “dramatic increase of 1.5 million children since the previous year,” he said, adding that the data also showed that youth who used e-cigarettes also were using them more frequently, and that they were using flavored e-cigarette products more often than in 2017.
“The government should not be picking winner and losers in the market,” said Jeff Lenard, vice president of strategic industry initiatives for NACS. “Plus, FDA’s own data shows that 86% of students who used e-cigarettes did not get them from stores—they came from online retailers or a social source. And, of those who did get them from a store, 76% got them from a vape shop.”