FDA Commissioner Dr Marty Makary has claimed that “up to a quarter or more” of U.S. children are “regularly using” vapes – but the agency’s own data puts the figure at just 5.9 per cent.
The inflated statistic came as Makary fronted headlines over the biggest vape bust in U.S. history, a $90 million (€77.2 million) seizure of Chinese-made vapes in Chicago that he called a national security issue. “We have to do it when you have up to a quarter or more of your nation’s children regularly using an addictive product,” he said.
But the real number – from the FDA’s own 2024 National Youth Tobacco Survey – shows regular use among high schoolers has fallen to its lowest level in five years. That disconnect has reignited criticism that the agency is fuelling moral panic while sidelining science and adult smokers seeking safer alternatives.
Crackdown and contradictions
Makary has made tackling “illegal Chinese products” a top priority, warning that the trade is “rooted in organised crime” and that 85 per cent of vapes sold in U.S. shops are illicit. Yet enforcement has come alongside sweeping denials of marketing applications from legitimate U.S. vape makers, effectively freezing the legal, regulated market.
There are roughly 7,000 vaping products sold nationwide; only 39 have been authorised by the FDA.
Former federal agents told 7News that weak port enforcement allowed “port shopping,” where shipments rejected at one dock simply entered through another. Makary said that before the crackdown, “It was a joke. They were laughing at us.”
Small businesses strike back
As the FDA touts record seizures, independent American vape firms are fighting for survival in court. On September 30, a coalition including White Cloud, Vertigo Vapor, Breeze Smoke and others filed a joint appeal at the Fifth Circuit Court of Appeals, challenging the agency’s mass “Marketing Denial Orders” (MDOs).
They argue the FDA unlawfully rejected applications without full scientific review, imposing a new “comparative efficacy” rule that requires proof that flavoured vapes help smokers quit more than tobacco ones. It effectively amounts to a backdoor flavour ban.
The suit also points to internal memos showing menthol and even zero-nicotine products were automatically denied, despite falling outside the FDA’s legal remit. Petitioners say these products are used by adults tapering off nicotine, and that the agency ignored real-world data showing youth use of their products was minimal.
