Tobacco Asia

18 tobaccoasia Issue 6, 2026 November / December By Timothy Donahue Bret Koplow isn't dancing around tobacco harm reduction anymore. The new permanent director of the US Food and Drug Ad- ministration's Center for Tobacco Products (CTP) made that clear in Lisbon, outlining a regulatory direction focused on protecting youth while expanding access to lower-risk products for adults who smoke — and ensuring they understand the difference. Speaking at the Global Tobacco and Nicotine Forum (GTNF), Koplow described an agency looking to move faster on product reviews, rethink its approach to flavored e-cigarettes and nicotine pouches, and do something CTP has historically struggled to do: clearly communicate that not all tobacco and nicotine products carry the same risk. He also disclosed something CTP "hasn't really announced" in detail. The agency is already piloting a supplemental premarket to- bacco product application (PMTA) process to streamline authoriza- tion of relatively minor changes to products that have already cleared FDA review. The idea is straightforward. If FDA has already evaluated a product's science, manufacturing, and other information, a manu- facturer making a relatively minor modification, such as adding age- gating technology, should not necessarily have to start the process 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," Ko- plow 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." CTP is already working with companies in the pilot. "I'm ex- cited about it because I think it will facilitate getting more products authorized faster," Koplow said. The supplemental program fol- US FDA Rethinks the Continuum of Risk At GTNF, Koplow outlined CTP's plans to speed up product reviews and rethink its approach to flavors and risk communication. Koplow said misconceptions about e-cigarette risks for adults who smoke persist following the public health response to youth vaping. Credit: Abdullah Asad, Pexels. lows CTP's nicotine pouch pilot, launched to test whether reviews could be tailored to a product category's risk profile rather than continuing what Koplow described as the agency's previous "one- size-fits-all approach." Among the questions CTP considered were whether every application required review by all 12 scientific disciplines typically involved in its sci- entific review and whether individual disciplines could narrow their scope when the relative risks were lower. Koplow said the first authorization under the pilot was completed in less than 180 days, a first for CTP. The program has not progressed as quickly as initially hoped because some ap- plications selected for it were less complete than FDA expected, he said. However, lessons from the program are now being applied to other prod- uct categories. "We're very much mindful that we should not be taking a one-size-fits-all approach," Koplow said. A new set of priorities Koplow's permanent appointment was announced on September 8. At GTNF, he provided consider- ably more detail on where he intends to take the center. "There are three things we are currently prioritizing," he said. The first is preventing youth initiation, par- ticularly of combustible products. The second is "helping people in the United States who still smoke cigarettes to stop or switch to products that pose meaningfully lower health risks." The third is ensuring that consumers and cli- nicians have accurate information about the rela-

• Cover