FDA Says Flavored Vapes Don't Need Built-In Age Verification

The FDA says flavored vaping products can receive marketing authorization without built-in age verification, rejecting the idea that electronic age restrictions are a requirement for approval.

Bret Koplow, director of the Food and Drug Administration's Center for Tobacco Products (CTP), explained the agency's position in an Oct. 26 letter to Glas Inc., according to Nicotine Insider. Koplow was responding to a Sept. 14 inquiry from Glas CEO Sean Greenbaum about how the FDA evaluates device access restrictions (DAR), which can prevent a vape from working until its user verifies their age.

The inquiry followed R.J. Reynolds Vapor Company's introduction of flavored Vuse Pro pods compatible with Vuse Alto devices, which lack built-in age verification. Reynolds—part of British American Tobacco—has implemented mandatory identification scanning for retail sales of the flavored Vuse Pro pods, but that does not prevent the pods from being used with an Alto device. The FDA authorized the Vuse Alto power unit and six tobacco-flavored pods in July 2024, but its current list of authorized e-cigarettes does not include the flavored Vuse Pro pods.

Glas had reason to ask. On May 5, the FDA authorized four Glas G2 pods, including two non-tobacco, non-menthol flavors—mango and blueberry—marking its first authorizations of e-cigarette flavors outside the tobacco and menthol categories. The G2 system uses smartphone-based age and identity verification to restrict access.

But Glas's route to authorization is not the only one. The FDA's March draft guidance on flavored e-cigarette applications treats device restrictions as one consideration in assessing youth risk, not as a universal prerequisite. Manufacturers must still demonstrate that marketing their products would be appropriate for the protection of public health, weighing potential benefits for adults who smoke against risks to nonusers, including young people.

That distinction does not make unauthorized flavored pods legal. The agency's May enforcement guidance outlines circumstances in which it may deprioritize action against certain products with pending applications. Such discretion is not marketing authorization. It is not publicly established whether the flavored Vuse Pro pods qualify under that policy.

The agency's evidentiary demands also face a legal challenge. In an Aug. 19 Fifth Circuit decision, judges ruled that the FDA had improperly imposed its comparative-efficacy standard without notice-and-comment rulemaking. The FDA said in September that it intends to consider replacing its 2021 premarket application framework.

For vape manufacturers, the message is straightforward: age-gating technology may help make the case for flavored products, but companies can also try to satisfy the FDA's public-health standard with other evidence. Whether the agency will accept that evidence is a different question.