FDA memo shows fruit vapes no better than tobacco for quitting smoking

WASHINGTON (AP) — Fruit-flavored e-cigarettes authorized last month by the Food and Drug Administration were not significantly better at helping smokers quit than tobacco-flavored e-cigarettes, according to a newly released FDA memo that is likely to intensify scrutiny of the agency’s decision.

The FDA in May gave its first-ever approval to fruit-flavored vapes made by manufacturer Glas Inc., effectively endorsing them as a less-harmful alternative to traditional cigarettes. The decision marked a sharp departure from the agency’s longstanding position that such sweet flavors — known to appeal to children — must demonstrate extra health benefits for adults to warrant approval.

Health groups and members of Washington lawmakers quickly condemned the authorization and called for an explanation.

A six-page FDA memo made public this week provides that explanation. In it, FDA regulators appear to sidestep previous statements the agency had made about the risks of sweet vaping flavors while acknowledging significant shortcomings in the data submitted by Glas Inc.

The memo’s central finding — that the fruit flavors showed no meaningful advantage over tobacco flavors in cessation trials — directly undercuts the core rationale the agency would have needed to grant the authorization under its own stated policy.

The agency did not respond to requests for comment on the memo.

The May authorization was the first time the FDA approved fruit-flavored e-cigarettes, which public health advocates had long resisted out of concern that sweet flavors would attract young people to vaping. The new memo does not explain why the agency moved forward despite the weak cessation data. It instead notes the gaps in Glas’s submission and appears to weigh the potential benefits to adult smokers against the known risks to youth.

The disclosure of the memo comes as the FDA faces multiple controversies over its recent tobacco and nicotine-related decisions. MSI previously reported that the agency authorized the first fruit-flavored e-cigarettes for adult smokers on May 6, and subsequent reports found that FDA staff were blindsided by the new vaping policy, which insiders said was eased through a memo without the usual inter-agency review process. Former FDA Commissioner Marty Makary resigned under pressure from vaping allies and other industry groups in May.