FDA Commissioner Marty Makary Resigns Over Agency’s Approval of Flavored Nicotine Vapes

The U.S. Food and Drug Administration (FDA) recently approved the marketing of electronic nicotine delivery systems (ENDS) produced by Glas, a Los Angeles-based company specializing in devices with built-in age verification technology. The authorized pods include Classic Menthol, Fresh Menthol, Gold, and Sapphire. This decision marked the FDA’s first authorization of non-tobacco and non-menthol ENDS products, a significant shift from its previous stance that had restricted flavored vaping products, citing concerns over youth appeal.

FDA Commissioner Marty Makary resigned on Tuesday, reportedly in protest of the policy change. Makary’s departure followed his vocal opposition to the FDA’s approval of these flavored products, despite President Donald Trump’s 2024 campaign promise to "save vaping again." During a May 2025 Senate appropriations subcommittee hearing, Makary emphasized the risks of underage vaping, claiming in a post on his official X account that "there are high schools in America now where kids are saying half of the kids in high school are addicted to these vaping products."

Makary’s assertion, however, starkly contrasts with data from the National Youth Tobacco Survey (NYTS). The 2024 NYTS reported that only 7.8% of high school students had used e-cigarettes in the past 30 days. His claim of 50% addiction rates at certain schools is more than six times the national average and roughly 22 times the rate of daily use, assuming 30% of past-month users were daily users, as indicated in the 2023 survey.

Contrary to Makary’s warnings, underage vaping has declined significantly in recent years. Past-month use among high school students dropped from 10% in 2023 to 7.8% in 2024, a 72% decrease from the peak of 27.5% in 2019. The trend continued in 2025, with rates falling further to 5.2%. Makary did not acknowledge this downward trend in his statements.

He added,

"There are kids in America today who are addicted, they know they're addicted, they come from good families, they're good kids, and they can't stop. And that is something that we have to address."

The Glas approvals included products designed with safeguards to prevent underage use. The FDA stated,

"The FDA's rigorous, scientific review of these products found that the applicant sufficiently demonstrated that Glas's device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product."