FDA Announces New Restrictions on Flavored Vapes

Nearly four months after announcing it, the FDA has finally issued guidance on the sale of flavored vaping products. 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, cheap vape deals 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.

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