Tobacco Asia

22 tobaccoasia Issue 5, 2026 September / October come. When Big Tobacco and anti-tobacco groups alike are cel- ebrating an FDA proposed rule, you know there is a big prob- lem for the overall marketplace." The rule would also require manufacturers, both large and small, to maintain records of labeling, advertising, and consum- er information for at least four years. Manufacturers would also need to review facility registrations annually and update product listings twice a year. The Troutman attorneys emphasized that establishment registration should not be confused with FDA marketing au- thorization. "Registration and product listing do not constitute marketing authorization; products subject to the premarket re- view requirements remain unauthorized unless and until a mar- keting authorization is in effect," the Troutman team wrote. The proposed rule is open for public comment through September 14, after which FDA will review submissions before determining whether to issue a final regulation. As FDA increases pressure on manufacturers operating outside the regulatory framework, it is also demonstrating the potential benefits available to companies that successfully navi- gate the agency's scientific review process. FDA grants Zyn 'modified risk' marketing orders After years of evaluating the scientific evidence on nicotine pouches, the FDA has authorized the first modified-risk market- ing claims for the category, marking what many observers con- sider an important milestone for tobacco harm reduction. The agency granted modified-risk tobacco product (MRTP) orders for 20 Zyn nicotine pouch products, authorizing Zyn nicotine pouch- es to be marketed with claims that switching completely from cigarettes reduces the risk of major smoking-related diseases. The decision allows Swedish Match USA Inc., a subsidiary of Philip Morris International (PMI), to market the authorized products with the following FDA-approved statement: "Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis." Stacey Kennedy, PMI US c.e.o., said FDA's decision marks an important moment for the more than 45 million legal-age nicotine consumers in America. "Today's news ensures these adults have access to ac- curate, science-based information, including FDA-authorized evidence that switching from cigarettes to Zyn reduces the risk of smoking-related diseases like heart disease and lung cancer," Kennedy said. "More broadly, it reinforces the agency's science- based approach to evaluating products across the continuum of risk and communicating those findings transparently." The products previously received marketing authorization following a review of their PMTA applications in January 2025. The new MRTP orders go a step further by allowing Swedish Match to communicate the products' reduced-risk profile to adult smokers, following FDA's review of scientific evidence supporting the claim. "FDA's review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices," said CTP's Bret Koplow. The modified risk orders cover many Zyn products, each authorized in both 3 mg and 6 mg nicotine strengths. In reaching its decision, FDA said it reviewed Swedish Match's MRTP applications, scientific evidence on the products' relative health risks, consumer perception studies, youth-use data, public comments, and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC), which met on January 22, 2026. The agency concluded that Swedish Match demonstrated: • The modified risk claim is scientifically accurate for the authorized products; • Adult consumers understand the claim; • Marketing the products with the claim is expected to benefit the health of the population as a whole. FDA emphasized that modified risk orders apply only to the specific authorized products—not to nicotine pouches as a category—and that the MRTP order does not mean the prod- ucts are safe. The agency also reiterated that completely quitting all tobacco products remains the best option for smokers. How- ever, adults who completely switch from cigarettes to the autho- rized nicotine pouches "may reduce exposure to many harmful chemicals" present in combustible cigarettes. For nontobacco-flavored ENDS, FDA requires additional data to assess whether the products are appropriate for the protection of public health. Credit: TBEC Review, CC2.0. Klar nicotine pouches. Credit: Klar

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