Tobacco Asia

18 tobaccoasia Issue 5, 2026 September / October By Timothy S. Donahue The US Food and Drug Administration has spent much of the mid- dle of the year sending a series of signals that together offer perhaps the regulatory agency's clearest view yet of where tobacco and nico- tine regulation is headed. Within several weeks, the agency released new enforcement pri- orities for unauthorized electronic nicotine delivery systems (ENDS) and nicotine pouch products, proposed sweeping registration re- quirements for foreign tobacco manufacturers, and authorized the first modified-risk marketing claims for nicotine pouches. Viewed independently, each action targets a distinct segment of the nicotine marketplace. Taken together, however, they illustrate an increasingly coordinated regulatory strategy—one that encour- ages manufacturers to enter the legal pathway while expanding the agency's ability to identify, inspect, and remove products that remain outside it. The message is hard to miss. FDA wants more compliant prod- ucts, greater accountability from manufacturers, and clearer scientific distinctions between authorized reduced-risk products and those that continue to bypass federal review. The following developments highlight how that strategy is be- ginning to take shape. FDA sets ENDS, pouch enforcement priorities The US Food and Drug Administration is shaping new policy on one of the nicotine industry's biggest unresolved questions: what will happen to unauthorized ENDS and nicotine pouch products still on the market that have not submitted a premarket tobacco product ap- plication (PMTA)? The US Food and Drug Administration's Regulatory Reset In a May Federal Register notice, the regu- latory agency announced the availability of final guidance titled "Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Autho- rization." According to the notice, the guidance outlines FDA's "certain enforcement policies" for "certain electronic nicotine delivery systems [ENDS] and oral nicotine pouch products that lack premarket authorization." The framing matters. FDA is again formally stating that "all new tobacco products," including nicotine pouches and vapes, on the market without authorization are illegally marketed. This time, however, the agency seems to be signaling a more structured enforcement approach as it seeks to move the market away from illicit goods and toward prod- ucts with marketing granted orders (MGO). The agency stated that the guidance is intended "to promote transparency" and to help it allocate en- forcement resources by focusing regulatory over- sight on products more likely to meet the agen- cy's "appropriate for the protection of the public health (APPH)" standard. For manufacturers, retailers, and distribu- tors, that is the most important sentence. FDA is not saying unauthorized products are legal. It is saying its enforcement priorities are being or- ganized around whether a product submitted a PMTA that is accepted and filed, and the likeli- hood it would gain marketing orders. Laura Leigh Oyler, vice president of regula- tory affairs for Haypp Group, said that for four years, nicotine pouch manufacturers, suppliers, and retailers have been patiently waiting for autho- rization decisions, and this guidance finally allows them to stop operating in a grey area of regulation. "For an agency that typically operates with- out much clarity, this is mind-blowingly clear — file a PMTA for your product that includes every- thing they have explicitly listed they expect to see, wait 180 days, get an acceptance and filing confir- mation, and then you can launch your product in the market," she said. "This is a ground-breaking announcement for American consumers who de- serve a wealth of options as they try to leave ciga- rettes behind." The enforcement guidance suggests that FDA, through the Department of Justice and the Drug Enforcement Administration, will begin taking tougher action against products on the market that lack an accepted and filed PMTA application. "FDA does not intend to prioritize if a product has a pending application that has been accepted and filed, or when a manufacturer has a pending and accepted supplemental PMTA," the agency wrote, adding that all products will still be subject to marketing restrictions and must not have "presumptively underage-appealing elements FDA guidance brings greater regulatory clarity to nicotine pouch manufacturers, suppliers, and retailers, moving the industry beyond a long-standing gray area. Credit: Jakubdrastich2, CC4.0.

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