By Timothy S. Donahue

Top Takeaways:

• Harm reduction, simply stated: Newly permanent CTP Director Bret Koplow said the FDA must help adults who smoke quit or switch to meaningfully lower-risk products and correct widespread misperceptions about nicotine and relative risk.
• Flavors remain possible: Koplow stressed that the FDA does not have a flavor ban and said that effective age-gating could make a wider range of flavored e-cigarettes available to adult smokers.
• Faster reviews ahead: CTP has cut its application backlog by about 70%, shortened early PMTA review stages, and is quietly piloting a supplemental pathway for minor modifications to already authorized products.

Bret Koplow wants the Center for Tobacco Products (CTP) to leave some old thinking behind.

Just days after being named the permanent director of the U.S. Food and Drug Administration’s CTP, Koplow offered perhaps his clearest description yet of where he wants to take the agency: protect youth, accelerate access to authorized lower-risk products for adults who smoke, and tell consumers and physicians more clearly that not all tobacco and nicotine products carry the same risk.

Speaking at the Global Tobacco & Nicotine Forum in Lisbon, Koplow repeatedly returned to a problem he believes is undermining tobacco harm reduction in the United States: too many smokers and healthcare professionals do not understand the relative risks of cigarettes, e-cigarettes, nicotine pouches, and other noncombustible products.

He also offered new details on CTP’s plans for flavored e-cigarettes, PMTA reviews, nicotine pouches, physician communication, illicit products, and a previously little-publicized supplemental PMTA pilot.

New PMTA pilot quietly underway

Koplow disclosed something CTP “hasn’t really announced” in detail: the agency is piloting a supplemental premarket tobacco product (PMTA) process for minor modifications to already authorized tobacco products.

The logic is simple. The FDA has already reviewed much of the science, manufacturing, and other information associated with the originally authorized product. Therefore, a relatively small change should not necessarily require starting from scratch.

“The fastest way for us to do that is to take a product that has already been authorized, and maybe there are improvements, or maybe there are minor changes that give them a new niche,” Koplow said. “If we’ve already assessed the manufacturing process, we can rely on a lot of the parts of the application that we’ve already reviewed.”

Koplow said CTP is already working with companies in the pilot. “I’m excited about it because I think it will facilitate getting more products authorized faster,” he said.

The supplemental program joins CTP’s nicotine pouch pilot, launched last year to test whether reviews could be tailored to the risk profile of a particular category rather than using what Koplow described as the agency’s previous “one-size-fits-all approach.”

The pouch pilot asked, among other things, whether every application required review by all 12 scientific disciplines typically involved in CTP scientific review and whether individual disciplines could narrow their scope where risks were comparatively lower.

Koplow said the first authorization under the pilot was completed in less than 180 days, marking the first time for CTP.

The pilot has not progressed as quickly as initially hoped because some applications selected for it were less complete than the FDA expected, he said. However, lessons from the program are now being applied to other product categories. “We’re very much mindful that we should not be taking a one-size-fits-all approach,” Koplow said.

Koplow’s permanent appointment was announced on Sept. 8. HHS said he will lead CTP’s “dual priorities” of promoting innovation and access to less harmful alternatives for adult smokers while protecting youth from tobacco and nicotine.

At GTNF, Koplow put considerably more flesh on those bones. “There are three things we’re currently prioritizing,” he said. First is preventing youth initiation, particularly of combustible products. Second is “helping people in the United States who still smoke cigarettes to stop, or to switch to products that pose meaningfully lower health risks.”

The third, he said, is ensuring that consumers and clinicians have accurate information about the relative risks of different tobacco products. “I’m referring here to the continuum of risk,” Koplow said. For an agency that Koplow later acknowledged had been reluctant even to use the term “tobacco harm reduction,” the language was notable.

Correcting the message

Koplow traced some of today’s confusion to the dramatic rise in youth vaping in 2018 and 2019 and to the EVALI outbreak, which was ultimately linked primarily to vitamin E acetate in illicit THC vaping products.

The response to the youth crisis was understandable, he said, but it left a legacy behind. “One of the lasting effects of that period, one we’re still contending with, is a widespread and deeply held misperception about what e-cigarettes are, and what risks they pose for adults who smoke,” Koplow said.

He cited survey data showing that the share of adults who correctly understood that FDA-authorized e-cigarettes are generally less harmful than cigarettes declined from about 51% in 2012 to less than 17% in 2022. “That is a striking reversal and a concerning departure from scientific evidence,” he said.

Koplow said complete cessation of all tobacco use remains the healthiest outcome. “That’s our baseline, and it’s unambiguous,” he said. “But for many adults who’ve tried to quit repeatedly and failed repeatedly, completely switching to a lower-risk, FDA-authorized tobacco product can meaningfully reduce their exposure to the toxic and cancer-causing chemicals that make combusted cigarettes so deadly.

“That’s not a commercial claim,” he added. “It’s a scientific one.”

That message is increasingly moving into mainstream medicine. Koplow highlighted a September JAMA Special Communication from the Society for Research on Nicotine and Tobacco Harm Reduction Network, which offers recommendations for U.S. clinicians discussing nicotine e-cigarettes with adult smokers.

The article recommends that clinicians communicate that nicotine e-cigarettes can help adults quit smoking while explaining their risks and the regulatory distinction between FDA-authorized and unauthorized products.

Koplow said he has been sending the article to people across government and wants CTP to engage federal partners, including Medicare, Medicaid, the Department of Veterans Affairs, and the Department of Defense. “They all address smoking cessation,” he said. “They don’t say anything about the products that CTP regulates.”

In particular, he sees older smokers as a missed opportunity. “Older people who smoke are really not shifting, they’re not switching,” Koplow said. “And so that’s really a lost opportunity.” He said CTP is “actively working on plans” to provide older smokers and healthcare providers with better information on lower-risk alternatives.

Koplow also made an unusually specific observation about nicotine pouches. He described pouches as “generally the lowest-risk category of tobacco products” and said consumers accustomed to faster nicotine delivery may abandon them before they adjust to the slower delivery. “I don’t think anybody’s talking to consumers or people who are starting to use nicotine pouches about stick with it for a while,” Koplow said.

He said that if consumers abandon pouches because they initially do not satisfy cravings and return to higher-risk products, “that’s also a missed opportunity.”

FDA: There is no flavor ban

Koplow was equally direct about flavors. “We don’t have a flavor ban,” he said. “I know that a lot of people think that we do.”

FDA, he said, has a concern about youth risk, not about flavors themselves. “Flavors by themselves are not a problem,” Koplow said. “We don’t have a concern about flavors. We have a concern about protecting youth.”

That distinction could have significant consequences for future flavored-vape applications. In May, the FDA authorized four Glas products, including its first electronic nicotine delivery system (ENDS) products in non-tobacco, non-menthol flavors.

The products use access-restriction technology that includes government-issued ID verification, Bluetooth smartphone pairing, and periodic biometric checks. The FDA said the technology, combined with marketing restrictions, sufficiently mitigated the risk of youth access.

At GTNF, Koplow described the Glas authorization as merely a beginning. “The calculus changes where youth access risk is meaningfully mitigated by robust technology,” he said.

Future approaches do not necessarily have to rely on smartphones, he added. Koplow suggested fingerprint readers programmed for individual users at retail as a possible example. “I am genuinely, genuinely excited about what this could ultimately mean,” he said.

Where effective technology can meaningfully reduce youth access, Koplow said, “an expanded range of e-cigarette flavors might be more readily made available to adults who smoke and want to completely switch from combusted cigarettes.” He stressed that age-gating is not the only path to authorization.

A flavored e-cigarette can still meet the FDA’s “appropriate for the protection of public health” (APPH) standard if an applicant demonstrates that its benefits in helping adults quit smoking outweigh its potential risks. “There is an additional hurdle” for flavored products because of youth risk, Koplow said. Effective access restrictions could substantially alter that equation.

Authorized vs. unauthorized

Koplow also drew a clear line between FDA-authorized and unauthorized nicotine products. “To date, we’ve authorized over 100 tobacco products through the premarket tobacco product application review pathway,” he said, including e-cigarettes, nicotine pouches, heated tobacco products, and snus.

Each authorization, he said, followed a multidisciplinary scientific review and a determination that the benefits to adults who use higher-risk products outweighed the identified risks to the population, including youth. But consumers walking into a convenience store may have no idea which products have undergone that review.

“There’s nothing on the package that tells them which ones are legal for sale and which ones are not, which have been reviewed by FDA and which ones have not,” Koplow said.

CTP, he revealed, is exploring ideas to help consumers better distinguish authorized products. The unauthorized market, he said, undermines not only regulatory compliance but also other aspects. “The unauthorized market is not just a regulatory compliance problem. It’s also a public health problem,” Koplow said. “And for companies that invested in doing things legally, it’s a competitive fairness problem.”

FDA and U.S. Customs and Border Protection have sharply increased enforcement at the border. Koplow said import refusals rose from about 100 in fiscal 2023 to more than 9,000 in fiscal 2025, though he acknowledged that unauthorized products continue to enter the country in significant numbers.

He also issued a warning to companies, demanding tougher enforcement against illicit competitors. Koplow said some companies that ask the FDA to crack down on the unauthorized market are themselves selling unauthorized products. “What they almost always mean is that you need to do something about all of our competitors’ illicit products, but not our illicit products,” he said.

Some companies, he added, have told the FDA they feel compelled to participate in the unauthorized market because competitors are taking market share. “It’s becoming kind of this vicious cycle,” Koplow said.

PMTA reviews get faster

Koplow also provided one of the most detailed public accounts to date of CTP’s efforts to overhaul PMTA review. According to Koplow, more than 99% of the more than 2 million applications lacked basic information necessary for review. “It’s not that we have such a high scientific standard for how we review these studies,” he said.

Regarding flavored products, Koplow said that many applications contained no comparative evidence against tobacco-flavored products and lacked evidence of benefit, pharmacokinetic data, adequate product characterization, or information demonstrating consistent manufacturing.

A significant reason was the enormous number of applications submitted by vape shops that mixed e-liquids, thereby qualifying as manufacturers under federal law. “They don’t know how to do a pharmacokinetic study, let alone a randomized clinical trial or longitudinal cohort study,” Koplow said.

But he acknowledged that CTP shares some responsibility. “Some of that is on us too, to try to be a better educator of what we’re looking for,” he said. “There is a lot of room for improvement there.”

Koplow said CTP is developing guidance, now in a “very late stage,” to help applicants understand common deficiencies that have delayed otherwise successful applications. The agency is also encouraging pre-submission meetings so companies can discuss proposed studies before investing time and money.

“If these products ultimately are APPH, we don’t want to see a waste of time in bringing them to market because it’s our public health mission to make them available,” he said. “When an applicant gets a marketing granted order, it’s a success for the applicant. It’s a success for us.”

FDA previously disclosed that CTP reduced its application backlog by about 70% in 2025. Koplow provided new numbers on how quickly the front end of the process is moving now.

Acceptance review, which until recently could involve applications submitted years earlier, is now generally completed within one to three weeks, he said. Filing review takes about 21 days. “Everything still takes longer than we want,” Koplow acknowledged.

One obstacle is staffing. Koplow said CTP has far too few scientific review teams and would like to more than double their number. Unlike other FDA centers, he said, CTP lacks the Title 21 hiring authority that would allow the FDA to offer more competitive compensation to scientific personnel.

“We’ve been losing some people to some of those other centers,” he said. “That’s been a real challenge for us.”

Changing that hiring authority would require action by Congress.

A different CTP

Perhaps the most consequential part of Koplow’s appearance was not a single policy announcement. It was the new permanent director’s openness in embracing tobacco harm reduction as part of CTP’s mission.

During the audience discussion, Brown University professor Jasjit Ahluwalia, a co-author of the recent JAMA communication, challenged Koplow to leverage the FDA’s credibility to bring major medical organizations into the harm-reduction discussion.

Koplow said CTP is already developing plans to reach the medical community and is exploring partnerships he was not yet able to discuss. “This should be low-hanging fruit for us,” he said.

Then he acknowledged just how much the language in CTP has changed. When he became acting director, Koplow said, “CTP wasn’t really, hadn’t used the term tobacco harm reduction,” something he found frustrating. “We’re going to do a lot more,” he said.

Koplow was also unusually candid about the industry’s damaged credibility. Medical societies often refuse to meet with tobacco companies and frequently discount industry-funded research, he said. “The tobacco industry is doing a lot of work here, but there is an antiquated perception of the tobacco industry that may have been valid years ago when the industry was more of a monolith,” Koplow said.

At the same time, he did not absolve the industry of responsibility. “The tobacco industry in the past earned [its] lack of credibility,” he said. “And we’re all paying a price for that now.” FDA, he argued, has the credibility to bridge that gap. “We have a responsibility to step up.”

Koplow concluded his prepared remarks with another message likely to resonate with companies that have spent years navigating the PMTA process. “Many of you in this room represent companies that have invested in or want to invest in developing products that can genuinely benefit public health,” he said. “Many of these companies may be playing by the rules, submitting applications with real scientific data, perhaps for products with effective youth access restrictions. These companies are partners in the mission that we share.”

That mission, Koplow said, is not company profits. “It’s to reduce the harm that tobacco has caused for centuries,” he said. “We have more tools to do that now than we ever did before.”