Tobacco Asia

12 tobaccoasia Issue 6, 2026 November / December Q&A THE TA Q A By Thomas Schmid The director of the Center for Tobacco Products (CTP) at the US Food and Drug Administration spoke at the Global Tobacco and Nicotine Forum (GTNF) in Lisbon in September 2026. The session was moderated by Beth Oliva, partner at Fox Rothschild, content chair at the GTNF series of events. Q (Beth Oliva): In the US, FDA has to protect youth and meet the population health standard. How can CTP's work put more weight on helping older adults who smoke? A (Bret Koplow): I'm very interested in finding ways to help older smokers. Older people who smoke are largely not switching, and that's a lost opportunity. Medicare and Medicaid, the Veterans Health Administration and the Department of Defense all address smoking cessation, but they say nothing about the products CTP regulates. I'm not sure they know much about them. I've been forwarding the JAMA article to contacts in those agencies, because we want more discussions with our federal partners. In the medical community, physician societies generally won't meet with the tobacco industry and give no weight to industry-funded studies. There's an antiquated perception of the industry from when it was more of a monolith. We authorized the first e-cigarette less than five years ago, so nobody is really talking to these groups about the products, or the people who are [talking to them] don't have credibility. The industry earned its lack of credibility in the past, and we're all paying for it. FDA has credibility, so we have a responsibility to step up. We're actively working on plans to reach older people who smoke, and healthcare providers. I'd add one point about nicotine pouches: smokeless tobacco users switch more effectively because they're used to the rate of delivery, and people who stick with pouches do acclimate to the slower delivery. Nobody is telling new pouch users to stick with it. These are generally the lowest-risk category of tobacco products, and people giving up on them early is a missed opportunity. Q (Beth Oliva): It took a long time for the special communication article in JAMA (Journal of the American Medical Association) by SRNT to be published. Do you think the change in tone from FDA has empowered researchers? A (Bret Koplow): I'd love to think so, but honestly, I don't know. We have a close relation- ship with the Society for Research on Nicotine and Tobacco (SRNT). We meet with them and are a significant sponsor of their annual confer- ence, which excludes representatives of the tobacco industry. I think not hearing from everybody is a missed opportunity. Q (Beth Oliva): Companies have had to produce rigorous science to be authorized. Yet FDA is criticized for authorizing mostly large companies' products and denying most applications. What's behind that? A (Bret Koplow): It's true that we've mostly authorized products from large companies. The legacy companies have the wherewithal, expertise and science to develop applications, and they know how to do the studies. We have no bias either way. It's based on the data in the application. In the last five years or so we've received… applications covering about 27 million products. That's more products than the rest of FDA has received applications for in its entire history. We've refused to accept, refused to file or denied almost all of them. What people don't understand is that 99-point-something percent lacked the most basic information. It's not that our scientific standard is too high. For flavored products, there's no study comparing the product to a tobacco-flavored equivalent. In almost all cases there's no benefit data at all and no pharmacokinetic data. The product isn't characterized, so we don't know what's in the vapor, and there's nothing demon- strating the product can be manufactured consistently. Most of the applications come from vape shops that mix e-liquids in the back room. Under our statute, which is Congress's doing, they're considered manufacturers. They don't know how to do a pharmacokinetic study, let alone a randomized trial or cohort study, for Bret Koplow on Older Smokers, Application Backlogs, and Illicit Trade Bret Koplow. Credit: Thomas Schmid

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