The head of the FDA’s tobacco division has indicated the agency might approve flavored vapes, a move that could reshape the U.S. market. According to comments made by Bret Koplow, the acting director of the FDA’s Center for Tobacco Products (CTP), the agency may authorize more e-cigarette products in the near future. This suggests a potential shift in the regulatory landscape for adult vapers.

During a tobacco and nicotine policy conference hosted by the Food and Drug Law Institute (FDLI), Koplow expressed support for “promoting tobacco harm reduction approaches to reduce smoking.” This statement was shared via a post on X (formerly Twitter) by Cliff Douglas, a long-time leader in tobacco control. This sentiment hints at a more open-minded approach from the agency, which has historically been restrictive.

The most significant part of this development is the potential for new product approvals. The list of FDA-authorized vape products is currently very short, with no flavors other than tobacco and menthol, and no bottled e-liquids. This limited selection has been a point of frustration for many adult vapers who rely on flavored products to stay away from combustible cigarettes.

A “Significant Shift” in FDA Tone

According to Douglas, Koplow even “cautiously supported the potential for authorizing an increased variety of flavored e-cigarettes for sale.” This is a major departure from the agency’s previous stance. During the Trump administration, the CTP approved only one vape device, the JUUL, along with its tobacco and menthol-flavored pods.

In his post, Douglas also noted that Koplow “emphasized the need for a ‘legal market’ of only authorized, lower-risk products, accompanied by robust enforcement.” For this to be effective, however, Douglas argues that the FDA “must dramatically streamline and accelerate its review and authorization process and allow a truly robust market. Otherwise, the unregulated market will thrive and it will all be lip service.”

It’s important to distinguish between Koplow’s statements and Douglas’s interpretation, as Douglas is a known advocate for providing adults with a wide range of vaping options. Still, the fact that an FDA official is even discussing harm reduction and flavored vapes at a public conference is a positive sign for the industry and for consumers seeking alternatives to smoking. Other attendees at the FDLI conference also confirmed a “significant shift” in the acting director’s tone.

However, it’s wise to remain cautious. The vaping community has been let down before by promises of a “streamlined” FDA process that never materialized. Real change could still be a long way off, even if the intention is there.

Will Commissioner Califf Support Reform?

Koplow’s remarks appear to stand in stark contrast to the public statements of FDA Commissioner Robert Califf. Califf has been a vocal critic of the vaping industry, often spreading misinformation about teen vaping rates and vape shops, and advocating for a crackdown on independent vape businesses. During his Senate confirmation hearing, he promised to bring “the full force of the U.S. government” to bear on illegal vapes, a promise he has delivered on.

Since Donald Trump took office, the FDA has issued at least 40 marketing denial orders (MDOs) to U.S. companies, preventing them from selling e-liquids and other vaping products. The actual number of MDOs is likely much higher, but the FDA stopped publishing a public list of these denials on its CTP website as of August 19.

Industry insiders report that the Trump administration’s crackdown on “illegal Chinese vapes” has expanded into a broader effort against all Chinese-made vaping devices. Customs and FDA border officials have begun seizing any vape products originating from China, including refillable pods and mods intended for use with American-made e-liquids.

In September, Califf authorized raids on five vape distributors and six retailers across seven states. During these operations, the FDA, along with the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) and the U.S. Marshals Service, seized over 2.1 million products deemed “illegal.” The seized items weren’t limited to unauthorized disposable vapes from China, which Califf has described as a “national security threat.” They also included bottled e-liquids from small U.S. manufacturers, some of which had premarket tobacco applications (PMTAs) pending with the agency.

Califf has stated that these raids are just the beginning. “We have to go after everything,” he told a National Press reporter. “We have to hit the distribution networks.” After months of this aggressive anti-vaping stance, it’s hard to imagine Commissioner Califf would suddenly reverse course and approve a streamlined review process for flavored vape applications.

A Future of Uncertainty

For adult vapers, this news creates a complicated picture. On one hand, the acting director of the CTP is openly discussing the possibility of authorizing more flavored products, acknowledging the role of harm reduction. This offers a glimmer of hope that the FDA might finally be listening to the science and the needs of consumers.

On the other hand, the FDA Commissioner seems determined to intensify his crackdown on the industry. The aggressive enforcement actions and anti-vaping rhetoric from the top create a climate of fear and uncertainty for businesses and consumers alike.

Will Bret Koplow’s more measured approach prevail, leading to a more sensible regulatory framework? Or will Commissioner Califf’s hardline stance continue to dominate, pushing more consumers toward an unregulated market? Only time will tell. For now, the vaping community can only watch, wait, and hope that the “significant shift” in tone leads to meaningful action.