FDA tobacco chief backs wider vape flavour choice if youth access is controlled

The comments come as the agency confirms it will consider replacing the regulatory framework used to assess new tobacco products, citing the growth of the illicit market and the need for clearer rules. 

Bret Koplow, director of the FDA’s Center for Tobacco Products, put harm reduction at the centre of the agency’s approach during the New Approaches Summit in New York on 25 September.

Koplow described the agency’s premarket tobacco product application pathway, which companies use to seek marketing authorisation, as “predicated on tobacco harm reduction”.

“If that hasn’t been clearly articulated recently, well, that’s on us,” he said. “I’m saying it now.”

Koplow said effective controls on youth access could allow more flavours to become available to adults seeking to switch completely from cigarettes. He also stressed that access-restriction technology was one possible route to meeting the agency’s public health requirements.

His priorities include helping smokers quit or move to lower-risk products, preventing youth uptake and improving understanding of the relative risks.

Flavour choice with safeguards

The approach already has a practical example. In May, the FDA authorised four Glas vape pods, including its first authorisations for flavours beyond tobacco and menthol.

The agency said the company’s technology, combined with marketing restrictions, was expected to effectively limit young people’s ability to use the products.

Users must verify their age and identity with government-issued identification and connect the device to a smartphone through Bluetooth. The vape stops working when separated from the phone, while random biometric checks help establish that the registered user is still operating it.

The decision showed how age controls could support greater choice for adult smokers. The FDA also said a non-tobacco flavour could qualify for authorisation where evidence showed its benefits in helping adults stop smoking outweighed its potential risks.

Glas must target advertising at adults aged 21 and over and report on the effectiveness of its youth-prevention measures. The FDA can withdraw authorisation if the balance of benefits and risks changes.

Adult quitters enter the Senate debate

Flavours also featured at the 24 September confirmation hearing for Heidi Overton, President Donald Trump’s nominee to lead the FDA.

According to Reuters, Republican senator Susan Collins challenged recent authorisations for flavoured vapes and nicotine pouches, arguing they could undermine progress on youth vaping.

Overton defended the decisions by pointing to adults who had stopped smoking. She said career FDA staff had recommended the authorisations because many adults who quit cigarettes use flavoured products.

FDA confirms plans to review the rules

In a press release issued on 28 September, the FDA said it intended to evaluate changes to the application system, including starting a rulemaking process to replace the current framework.

It pointed to its experience implementing the 2021 rule, the pace of new product introductions and a federal lawsuit challenging the existing system.

The agency said a modern framework offering “greater clarity and predictability” was critical to protecting public health.

The announcement follows reporting by Reuters and the Wall Street Journal that changes were being prepared. It doesn’t set new review deadlines or confirm changes to scientific evidence requirements.

Applications will continue to be assessed under the existing statutory public health standard while changes are considered. The FDA said future reforms would include opportunities for public input.

Making alternatives available sooner

Some changes are already documented. In a May update, Koplow said the agency had reduced its application backlog by around 70 per cent during 2025 and eliminated the queue for the initial acceptance stage.

That first stage checks whether applications can proceed. It doesn’t amount to permission to sell a product.

The FDA also outlined an approach allowing products ready for authorisation to move forward while others in the same submission awaited further evidence.