WASHINGTON — In the days after President Donald Trump tweeted his interest in possible bans on flavored e-cigarettes, convenience-store associations and analysts have focused on the latest much-anticipated guidance document expected from the U.S. Food and Drug Administration (FDA).
That’s because the latest version of the guidance could reveal how the FDA will focus enforcement actions and, more specifically, how flavored nicotine and tobacco products—which could include mint and menthol—will fare in the months to come.
On Sept. 11, the president tweeted his support for a potential ban, saying he liked vaping as an alternative to cigarettes but wanted to make sure the products were “safe” and emphasized the need to get counterfeit products off store shelves.
In reaction, Alex Azar, secretary of the U.S. Department of Health and Human Services, said the FDA would finalize a compliance policy in the coming weeks. Some industry association officials believe that policy will come in the new version of the FDA’s current guidance on e-cigarettes. Azar said the new document will say how the agency would prioritize enforcement of the its authorization requirements for nontobacco, flavored e-cigarettes, before manufacturers file their premarket tobacco applications (PMTAs). Manufacturers introducing new tobacco products to the United States must file a PMTA with the FDA, the agency said.
Unfortunately for retailers reliant on sales of menthol cigarettes, Azar said the effort would also look at mint- and menthol-flavored products.
“The Trump administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” Azar said.
For its part, the FDA said that effective Aug. 8, 2016, all electronic nicotine delivery system (ENDS) products were expected to file premarket tobacco product applications with the FDA within two years. “ENDS products currently on the market are not being legally marketed and are subject to government action,” officials said. “The compliance policy … will outline enforcement policy addressing nontobacco-flavored e-cigarette products that lack premarket authorization moving forward.”
Unfortunately, because the FDA has publicly changed the deadlines for manufacturers to turn in PMTAs on multiple occasions, just about every vaping device on the market today falls in this legal limbo.
Alexandria, Va.-based Society of Independent Gasoline Marketers Association (SIGMA) said the good news for its members is the FDA’s proposals don’t target c-stores or restrict the sale of products to a particular class of trade, such as tobacco shops or 21-and-over retail locations.
The FDA has been under pressure to “do something” about e-cigarettes for some time, said Bonnie Herzog, managing director of consumer equity research for Wells Fargo Securities, New York. What’s different about the agency’s latest announcement is that it mentions mint and menthol, possibly alluding to an inclusion of those products in the larger flavor debate.
Second, the FDA is tying its enforcement actions to actual reductions in reported teenage vaping. “This could result in a potential ban on all e-cigs, regardless of flavor,” Herzog said.
The national debate has spilled over to mandates on the state level, with Michigan and New York enacting bans on flavored e-cigarettes through executive order. California almost became the third state, but officials failed to get the required legislative support.
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