The Food and Drug Administration on Thursday announced restrictions on the sale and manufacturing of all flavors of e-cigarette pods except tobacco and menthol.
FDA Commissioner Dr. Stephen Hahn said the policy was intended to limit youth e-cigarette use but maximize the potential benefit to adults trying to quit smoking combustible cigarettes. The flavor restrictions do not apply to tank vaping systems found at vape shops that HHS officials said are more often used by adults.
The Trump administration in September indicated it wanted to ban all e-cigarette flavors besides tobacco.
Campaign for Tobacco-Free Kids President Matthew Myers said the exceptions were concessions to the vaping industry and vape shops that had furiously lobbied to water down the flavor ban.
"By leaving menthol flavored e-cigarettes widely available and completely exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic," the group said in a statement.
HHS officials justified leaving menthol-flavored e-cigarette pods on the market by pointing to the 2019 Monitoring the Future survey, which showed less than 1% of frequent youth e-cigarette users surveyed in the 10th grade most often used the classic tobacco flavor, compared to 4.8% who preferred menthol. Mint was the most popular flavor at 52.1%. The survey was funded by a component of the National Institutes of Health.
But former FDA Commissioner Dr. Scott Gottlieb raised concern that youth usage will pivot to menthol- and tobacco-flavored cartridges if more popular flavors are taken off the market. The FDA left the door open to further action if trends change after the ban is enacted.
"Should the FDA become aware of an increase of youth using any other flavored products (both cartridge-based or otherwise), the agency will take additional steps to address youth use of those products if necessary," the FDA said in a statement.
Manufacturers of banned products can apply to the FDA for marketing approval to restore their products to market. E-cigarette manufacturers have to show that the products would provide a net benefit to public health to obtain FDA marketing approval, and no product has yet been approved. All e-cigarette manufacturers will be required to submit a premarket application by May 12 to remain on the market.
"All e-cigarettes currently on the market are illegal," HHS Secretary Alex Azar said on Thursday, adding that the FDA has so far used its enforcement discretion to allow sales.
The FDA also said it would take enforcement action against any manufacturers that market or target e-cigarette products to children.
Congress at the end of 2019 raised the tobacco purchasing age to 21, but House Energy and Commerce Chair Frank Pallone (D-N.J.) called for passage of a bill he introduced with Rep. Donna Shalala (D-Fla.), a former HHS secretary, that would also implement a full flavor ban.
"A so-called flavor ban that exempts menthol and vape shops is no ban at all," Pallone said in a statement.
Uncertainty about the flavor ban was a prominent issue during Hahn's Senate confirmation hearing.
