By Timothy S. Donahue

Top Takeaways:

• FDA’s Acting CTP Director Bret Koplow signaled a major shift by explicitly acknowledging tobacco harm reduction as part of the agency’s regulatory framework.
• Industry observers say the remarks mark the clearest indication yet that FDA accepts comparative-risk messaging and switching as legitimate public-health tools.
• The keynote drew strong attention from technical, regulatory and public-health experts, who described the shift in tone as potentially “groundbreaking.”

The U.S. Food and Drug Administration publicly recognized tobacco harm reduction as a key part of its regulatory approach during this year’s Food and Drug Law Institute (FDLI) Tobacco and Nicotine Policy Conference, marking what several industry and scientific stakeholders describe as the most significant statement from the FDA’s Center for Tobacco Products (CTP) in years.

According to Chris Allen, CEO of UK-based scientific consultancy Broughton, the comments from Acting CTP Director Bret Koplow represented a fundamental shift in how the agency interprets the “appropriate for the protection of public health (APPH)” standard under the Tobacco Control Act.

In a LinkedIn analysis, Allen described the speech as “a landmark moment,” adding that “for the first time, FDA publicly acknowledged tobacco harm reduction as a principle embedded in its regulatory framework.”

Allen outlined several implications of Koplow’s keynote, including a direct statement that harm reduction is the natural outcome of applying FDA’s public-health standard. He noted that this recognition reinforces the legitimacy of products that can reduce risk relative to cigarettes—such as nicotine pouches, heated tobacco, snus and e-cigarettes—when supported by scientific evidence.

Allen said the speech also underscored the FDA’s intent to improve communication around comparative risk, especially amid persistent misunderstandings about nicotine safety among both adults and healthcare providers.

Another important change, according to Allen, was FDA’s recognition that health benefits may result from complete switching rather than just cessation. In his summary, he stated that the agency is now explicitly evaluating authorized products based on their ability to promote switching from high-risk combustible cigarettes.

At the same time, Allen highlighted that protecting youth remains a key focus of the agency’s approach, noting that the FDA will consider new flavors only if technologies such as strong age verification can effectively prevent underage access.

Allen also emphasized the FDA’s efforts to update its regulatory processes. Having reviewed over 26 million premarket tobacco product applications (PMTAs) and reported a 60% reduction in the backlog, he stated that the new Nicotine Pouch Pilot Program could become a model for other product categories by establishing more efficient, scientifically rigorous review procedures.

Allen argued that its importance extends beyond just policy details. “It’s not just a policy update, it’s a philosophical evolution,” he wrote, indicating that the agency is now ready to put the continuum-of-risk framework into action, which manufacturers and harm-reduction experts have long maintained is vital for lowering smoking-related diseases.

Public health expert Cliff Douglas also responded to Koplow’s speech on X. Douglas stated that Koplow “voiced support for promoting tobacco harm reduction as a core approach to reduce smoking.” He mentioned that Koplow emphasized the importance of creating a legal marketplace focused on approved reduced-risk products and noted that the acting CTP director called for “strong enforcement.”

Regarding flavors, Douglas noted that Koplow indicated openness to expanding the range of flavored e-cigarettes eligible for approval if they align with public health goals.

Douglas also cited Koplow’s warning that “an unregulated marketplace will thrive” without a significantly streamlined review process—highlighting the agency’s understanding that long PMTA timelines promote the dominance of illegal disposable products. He also noted that Koplow mentioned FDA would provide more information about the range of risks across nicotine and tobacco products to help inform consumers and healthcare providers.

Douglas noted that panelists described the tone of Koplow’s comments as “refreshing and potentially groundbreaking,” especially the recognition of the benefits of switching from cigarettes to pouches or vapes.

For an industry used to uncertainty about whether the FDA accepts a harm-reduction approach, the keynote marks a major shift. The remarks indicate that the agency is increasingly aware that adult smokers need legal, lower-risk options — and that regulatory clarity, easier pathways, and clear communication about relative risk are key to achieving that goal.