By Timothy S. Donahue

Top Takeaways:

• Historic authorization: The FDA granted modified risk tobacco product orders for 20 ZYN nicotine pouch products, allowing Swedish Match to market them with reduced disease-risk claims.
• Specific health claim approved: The FDA concluded that completely switching from cigarettes to the authorized ZYN products lowers the risk of major smoking-related diseases.
• Five-year authorization: The MRTP orders require postmarket surveillance and expire in five years unless renewed.

The U.S. Food and Drug Administration has granted Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch products, marking the first time the agency has authorized nicotine pouches 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 U.S. CEO, said the 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 accurate, 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 had previously received Premarket Tobacco Product Application (PMTA) marketing authorization 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 Bret Koplow, acting director of FDA’s Center for Tobacco Products. “Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”

The modified risk orders cover the following ZYN products, each authorized in both 3 mg and 6 mg nicotine strengths:

• ZYN Chill
• ZYN Cinnamon
• ZYN Citrus
• ZYN Coffee
• ZYN Cool Mint
• ZYN Menthol
• ZYN Peppermint
• ZYN Smooth
• ZYN Spearmint
• ZYN Wintergreen

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 Jan. 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 do not mean the products are safe.

The agency also reiterated that completely quitting all tobacco products remains the best option for smokers. However, the FDA said that adults who completely switch from cigarettes to the authorized nicotine pouches “may reduce exposure to many harmful chemicals” found in combustible cigarettes.

“Today the FDA has given ZYN the ability to tell their customers, and consumers at large, that their products have markedly lower risk than cigarettes,” said Laura Leigh Oyler, VP of Regulatory Affairs for Nicokick.com. “While this is not the first MRTP ever granted, it is the first one given to a product with mass consumer appeal, and it is a signal that the truth can and should be a part of public health strategy.

“At a time when misconceptions about the risk of nicotine are high, the ability to communicate this is monumental not just for the alternative nicotine industry, but for policy makers, public health leaders, and responsible retailers who can shift the conversation from fear to fact-based, while keeping youth prevention front and center.

“Americans can finally hear the truth about lower risk nicotine pouches.”

The agency also retains authority to withdraw the orders if continued marketing no longer benefits public health, including if youth uptake increases significantly.

⁩”Being able to use a modified‑risk claim is a meaningful milestone for tobacco harm reduction,” said Shem Baldeosingh, director of the Global Institute for Novel Nicotine (GINN). “It signals growing recognition that non‑combustible nicotine pouches, when appropriately regulated, can help reduce the burden of smoking‑related disease.

“Significantly, the FDA’s post‑market surveillance requirements will strengthen the evidence base even further — generating real‑world insights into usage patterns, behavior, and public‑health impact. This is a clear example of science‑based, proportionate regulation in practice.”

The decision marks another milestone for Swedish Match and its parent company, Philip Morris International, which have positioned ZYN as the leading U.S. nicotine pouch brand. The products first received FDA marketing authorization via the PMTA pathway on Jan. 16, 2025.

“This decision proves that a light-touch, evidence-based approach delivers for consumers,” said David Williams, president of the Taxpayers Protection Alliance. “The FDA’s authorization of Zyn products with an MRTP claim shows that policymakers can embrace harm reduction without resorting to bans or heavy-handed mandates.

“Consumers deserve accurate information about less harmful alternatives to cigarettes. And adults deserve the freedom to choose less harmful alternatives without Washington bureaucrats second-guessing their decisions.”

The FDA has authorized 26 nicotine pouch products for sale in the United States. The ZYN MRTP orders also establish the first FDA-authorized reduced-risk messaging for nicotine pouches, potentially providing a regulatory framework for future MRTP applications from other manufacturers.

Martin Miller, EVP of Business Development for IKE Tech, said that the decision also underscores that product innovation and regulatory innovation must advance together.

“FDA continues to place significant emphasis on youth access prevention and ongoing post-market oversight, reinforcing that compliance doesn’t end at authorization or at the point of sale,” said Miller. “As more products enter the market, the industry will need infrastructure that connects verified users, authenticated products and enforceable compliance throughout the product lifecycle.”

Additional responses have been added.