FDA Announces New Restrictions on Flavored Vapes

Nearly four months after announcing it, the FDA has finally issued guidance on the sale of flavored vape products, including e-liquid and devices like disposable e-cigs. The new guidance could be the last vaping-related policy decision by Commissioner Scott Gottlieb, who recently announced his resignation. The FDA announced yesterday that NCI director Ned Sharpless will take over as acting commissioner in April.

“We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products,” Gottlieb said in a statement. “For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.”

The big news is that the agency has moved up the deadline by one year for manufacturers to submit premarket tobacco applications (PMTA’s) for flavored products other than tobacco, mint and menthol — from Aug. 8, 2022 to Aug. 8, 2021. In 2017, Gottlieb postponed the application deadline from 2018 to 2022.

Since the FDA has still not produced promised standards-based regulations for small manufacturers like e-liquid makers, this could amount to a death sentence for any vaping business that depends on sales of flavored e-liquid. Currently, producing a PMTA requires a manufacturer to spend probably $1 million per product with no guarantee it will be approved. No vaping company has yet submitted an application.

Most of the new requirements were part of Gottlieb’s November guidance announcement. Other components of the new guidance include:

The FDA has already targeted e-liquid brands that use so-called kid-appealing packaging, like labels and boxes that copy candies and fruit drinks. The announcement today seems to indicate further enforcement against such practices.

Forcing flavored products into stores that prohibit entry to minors means that convenience stores will be unable to sell flavored vaping products (other than tobacco, mint and menthol), but will still be allowed to sell cigarettes, beer, liquor, and pornography. Retail trade associations have already announced that they may go to court to challenge the FDA policy.

The FDA guidance document doesn’t mandate specific quantity restrictions, although the final guidance (issued after public comment) might be more specific. Many retailers already have self-imposed limits on the number of refills or pods sold per day.

Gottlieb says that online sellers should be using “independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records.” These are services that many online vaping retailers already use.

The FDA guidance document is long and repetitive, but the evidence it contains to support flavor restrictions is weak. The agency claims that it has the proof that flavored vaping products (other than tobacco, mint and menthol) are uniquely attractive to minors and not important to adults. But the studies cited are old and limited (including a 2014 survey of fewer than 400 Connecticut high school students), and the agency ignored last year’s national survey of almost 70,000 adult vapers that clearly shows that successful ex-smoking vapers prefer fruit and dessert flavors.

The actions didn’t satisfy staunch foes of vaping. “This will fail to solve the e-cigarette epidemic,” a spokesperson for the American Lung Association told the Washington Post. “The FDA is continuing to kick the can down the road rather than doing what it will ultimately take to end this epidemic — removing all flavored tobacco products from the market.”

“A public health crisis of this magnitude demands faster and more forceful action than the steps announced by the FDA,” added Matthew Myers of Campaign for Tobacco-Free Kids. Myers and others are pushing for Congressional action.

The moral panic over youth vaping — fanned by Commissioner Gottlieb’s proclamation of an “epidemic” — has led to incredible pressure to ban vape flavors from tobacco control groups like TFK. The 2021 PMTA deadline may not matter if those activists have their way. There have been flavor ban bills introduced recently in both the U.S. House and Senate.