Key Points
- PMTA and harm reduction: FDA Center for Tobacco Products Director Bret Koplow said the PMTA pathway is “predicated on tobacco harm reduction,” linking product authorization directly to switching from higher-risk tobacco products.
- Four CTP priorities: CTP is focused on youth prevention, helping adults quit or switch to lower-risk products, improving relative-risk understanding, and reducing unauthorized tobacco products.
- Authorized market challenges: Koplow said unauthorized products can undermine the public health value of FDA-authorized products, while public understanding of e-cigarette relative risk has declined sharply.
- More flexible review approach: CTP is applying lessons from its nicotine pouch pilot, including earlier communication with applicants and more product-category-specific review practices.
- Industry credibility: Koplow said industry must invest in science, follow the rules and earn public trust, while healthcare providers and independent researchers have a larger role to play in harm-reduction communication.
2Firsts
NEW YORK, Sept. 25, 2026
Bret Koplow, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), said the premarket tobacco product application (PMTA) pathway is “predicated on tobacco harm reduction,” as he outlined the agency’s approach to building a regulated marketplace that protects youth while giving adults who smoke access to lower-risk alternatives.
Speaking at the 2026 New Approaches Summit in New York, Koplow said every authorization of a new tobacco product through the PMTA pathway relies in part on an assessment of whether users may completely switch from, or significantly reduce their use of, another tobacco product category that generally poses greater health risks.
“If that hasn’t been clearly articulated recently, well, that’s on us,” Koplow said. “I’m saying it now.”
The summit was held under the theme “Dialogue Matters. Collectively We Can End Smoking.” 2Firsts reported from the event in New York.
Koplow was appointed CTP director in September 2026 after serving as acting director since 2025. Before entering law and later joining FDA, he worked as a clinical psychologist in child and adolescent psychiatry. Koplow said that experience continues to shape his focus on both preventing youth initiation and helping adults who smoke access lower-risk alternatives.
A Regulated Marketplace “Protects Youth and Helps Adults”
Koplow identified four current priorities for CTP: preventing youth initiation, particularly with combustible products; helping people who smoke quit or completely switch to products posing meaningfully lower health risks; improving understanding of relative risk among consumers and clinicians; and reducing the prevalence of unauthorized new tobacco products.
“No tobacco product is safe,” he said, adding that complete cessation remains the healthiest outcome. But for adults who have repeatedly tried and failed to quit, completely switching to an FDA-authorized lower-risk tobacco product can meaningfully reduce health risks.
“A regulated marketplace protects youth and helps adults,” Koplow said.
He also pointed to device access restriction technology as one way regulators may better balance adult benefits and youth risks. Koplow said measures including ID verification, smartphone pairing and periodic biometric checks could help restrict product use to verified adults aged 21 and over.
Where youth access risks are meaningfully mitigated, he said, a broader range of e-cigarette flavors could be made available to adults who smoke and want to switch completely from combustible cigarettes.
“It’s not a silver bullet,” Koplow cautioned, stressing that such technology is not the only way a manufacturer could demonstrate that a non-tobacco-flavored e-cigarette meets the public health standard.
Authorization Alone Is Not Enough
Koplow said FDA authorization alone does not guarantee that lower-risk products will deliver their intended public health benefit.
Citing a CDC Foundation study on unauthorized e-cigarette sales, he said nearly 70% of e-cigarette sales in U.S. convenience and grocery channels were estimated to involve unauthorized products as of December 2025. The published study put the figure at 69.4% of e-cigarette product sales in those channels and noted that more complete data from untracked channels, including vape shops, would be needed for a fuller picture of the market.
Koplow argued that unauthorized alternatives appearing alongside FDA-authorized products can undermine the public health value of products that have undergone the agency’s scientific review. He said consumers often cannot distinguish between authorized and unauthorized products.
He also pointed to a shift in public perceptions of relative risk. Koplow cited survey data showing that the share of U.S. adults who perceived e-cigarettes as less harmful than cigarettes fell from about 51% in 2012 to about 17% in 2022.
A study published in Nicotine & Tobacco Research reported a decline from 50.7% to 16.7% over that period.
Healthcare providers, Koplow said, could play a greater role in discussing FDA-authorized lower-risk alternatives with patients who smoke and have repeatedly failed to quit.
“That conversation is not happening nearly enough.”
During the Q&A, Koplow also acknowledged a credibility challenge for the tobacco industry. He noted that manufacturers remain among the most prominent voices discussing tobacco harm reduction, while the industry lacks credibility with many healthcare providers.
CTP Seeks a More Predictable PMTA Process
Koplow also addressed efforts to improve the PMTA review process while maintaining a high scientific standard.
He said the vast majority of PMTA submissions covering more than 26 million tobacco products lacked the scientific information necessary for meaningful review. CTP reduced its application backlog by approximately 70% in 2025, he said, and there is currently no queue for applications pending Acceptance Review.
In a May 2026 statement on product-review efficiency, FDA said CTP had taken action over the previous five years on PMTAs covering nearly 27 million tobacco products and reduced its application backlog by approximately 70% in 2025.
His advice to future applicants was direct:
“Invest in the science.”
“The bar is high. It should be. But it’s achievable,” Koplow said.
During the Q&A, he described how lessons from CTP’s nicotine pouch pilot are being incorporated into broader review practices. Rather than routinely waiting until the end of scientific review to identify deficiencies, Koplow said CTP has begun communicating with applicants more flexibly and earlier in the process, giving companies an opportunity to address some issues sooner.
He also emphasized that different tobacco product categories may require different review approaches.
“For scientific review, one size doesn’t necessarily fit all,” Koplow said.
In closing, Koplow said regulators, researchers, healthcare providers and industry all have roles to play in making tobacco harm reduction work in practice. Industry, he said, needs to “invest in the science, follow the rules and earn the public trust that this work requires.”
Follow 2Firsts for the latest coverage of the 2026 New Approaches Summit.
Cover image: Bret Koplow speaking at the 2026 New Approaches Summit. Photo by 2Firsts.
References
- U.S. Food and Drug Administration. Bret Koplow, Ph.D., J.D. — Director, Center for Tobacco Products. FDA leadership profile
- Schoute V, Kittle A, Crane E, et al. Sales of Unauthorized E-Cigarettes in the United States, December 2025.NEJM Evidence. 2026;5(9):EVIDpha2600137. DOI: 10.1056/EVIDpha2600137. PubMed record
- Wu A, Son S, Lee M, et al. Association of Vaping-Related Events with Relative Harm Perceptions of E-Cigarettes.Nicotine & Tobacco Research. 2026;28(8):1439–. Oxford Academic article
- Koplow B. CTP Acting Director Statement: New Steps Forward in Accelerating Innovation and Efficiency in Product Review. U.S. Food and Drug Administration, May 7, 2026. FDA statement
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