Tobacco Asia

20 tobaccoasia Issue 6, 2026 November / December 'We don't have a flavor ban' Koplow was equally direct regarding flavored e- cigarettes. "We don't have a flavor ban," he said. "I know that a lot of people think that we do." FDA's concern, he said, is youth risk rather than the flavors themselves. "Flavors by them- selves are not a problem," Koplow said. "We don't have a concern about flavors. We have a concern about protecting youth." The distinction could have significant impli- cations for future flavored-vape applications. FDA recently authorized its first electronic nicotine delivery system (ENDS) products in non- tobacco, non-menthol flavors, using access-restric- tion technology that includes government-issued identification verification, Bluetooth smartphone pairing, and periodic biometric checks. Koplow described the authorization as a beginning. "The calculus changes where youth access risk is mean- ingfully mitigated by robust technology," he said. Future approaches do not necessarily need to rely on smartphones. Koplow suggested finger- print readers programmed for individual users at retail as another option. "I am genuinely, genuine- ly excited about what this could ultimately mean," he said. Where effective technology can meaningful- ly reduce youth access, Koplow said, "an expand- ed range of e-cigarette flavors might be more read- ily made available to adults who smoke and want to completely switch from combusted cigarettes." But he stressed that age-gating technology is not the sole route to authorization. A flavored e-cigarette can still meet FDA's "appropriate for the protection of the public health" 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. Authorized vs. unauthorized Koplow also drew a sharp distinction between FDA-authorized and unauthorized nicotine prod- ucts. "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 prod- ucts, and snus. Each authorization followed a multidisci- plinary scientific review and a determination that the benefits to adults using higher-risk products outweighed identified risks to the population, in- cluding youth, he said. But consumers entering a convenience store may have no idea which prod- ucts have undergone that review process. "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. Positive changes may be ahead at FDA as Koplow signals support for incorporating tobacco harm reduction into CTP's mission. Credit: FDA Koplow said that the message also needs to reach physicians. He highlighted a recent spe- cial communication published in the Journal of the American Medical Association by the Harm Reduction Network of the Society for Research on Nicotine and Tobacco (SRNT), which recom- mends that US clinicians discuss nicotine e-ciga- rettes with adult smokers and explain both their risks and the distinction between FDA-authorized and unauthorized products. Koplow said he has been sending the article to people across the US government and wants CTP to engage federal partners, including Medi- care, Medicaid, the Department of Veterans Af- fairs, and the Department of Defense. "They all ad- dress smoking cessation," he said. "They don't say anything about the products that CTP regulates." Older smokers are one group Koplow believes is being overlooked. "Older people who smoke are really not shifting; they're not switching," he said. "And so that's really a lost opportunity." CTP is "actively working on plans," he said, to provide older smokers and healthcare profes- sionals with better information on lower-risk alter- natives. Koplow also singled out nicotine pouches, calling them "generally the lowest-risk category of tobacco products." Consumers accustomed to faster nicotine delivery may abandon pouches before they adjust to the slower delivery, he said. "I don't think any- body's talking to consumers or people who are starting to use nicotine pouches about sticking with it for a while," Koplow said. He said that if consumers abandon pouches because they initially fail to satisfy cravings and re- turn to higher-risk products, "that's also a missed opportunity." "Older people who smoke are really not shifting; they're not switching." — Bret Koplow

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