FDA found 11 Zyn Ultra products contain lower levels of most harmful chemicals than other oral and smokeless tobacco products. Photo credit: Zyn USA
The US Food and Drug Administration has authorized 11 ZYN Ultra nicotine pouch products, including an 11 mg variant, expanding the US portfolio of Philip Morris International's leading oral nicotine brand.
The products, manufactured by Swedish Match USA, received marketing authorization through the premarket tobacco product application (PMTA) pathway. Ten of the ZYN Ultra products contain 9 mg of nicotine per pouch, while ZYN Ultra Smooth contains 11 mg.
The 9 mg products include Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, Wintergreen Chill, and Wintergreen. The decision brings the total number of FDA-authorized nicotine pouch products to 43.
The authorization offers a notable indication of how FDA is evaluating higher-strength nicotine pouches.
The agency said nicotine exposure is influenced not only by labeled nicotine content but also by product design, formulation, materials, and other characteristics that affect the amount and rate of nicotine delivered.
As part of its broader population health assessment, FDA evaluated the nicotine exposure for each ZYN Ultra product individually, including the 11 mg version. According to the agency, the products contain lower levels of most harmful and potentially harmful constituents (HPHC) than other oral and smokeless tobacco products. Many of those constituents were present at levels too low to quantify.
Swedish Match also submitted product-specific data showing that the products appeal most to adults most likely to benefit from completely switching, including current cigarette smokers and users of smokeless tobacco.
The agency said the products may provide enough nicotine to reduce cravings and withdrawal symptoms to a degree that supports substitution among adults who use more harmful tobacco products.
"For adults 21 and older who use smokeless tobacco or smoke cigarettes, switching completely to FDA-authorized nicotine pouches may reduce exposure to many harmful chemicals found in smokeless tobacco or cigarettes," FDA said.
The agency described the authorizations as "another important step toward providing greater access to potentially less harmful alternative tobacco products for existing adult tobacco users."
The 11 products were reviewed under FDA's nicotine pouch pilot program, which is designed to speed up and streamline PMTA reviews. The agency said the pilot has led to faster resolution of regulatory issues, reduced the time applicants need to respond to deficiency letters, and improved the efficiency of scientific reviews.
FDA said it has begun applying lessons from the program to reviews of other PMTAs. Of the 43 nicotine pouch products currently authorized by the agency, 23 were reviewed in the pilot program.
The latest action further strengthens ZYN's regulatory position in the US market.
In January 2025, FDA initially authorized 20 ZYN nicotine pouch products. In June 2026, the agency granted modified risk tobacco product marketing orders for 20 ZYN products, allowing Swedish Match to market them with specified reduced-risk information.
The new ZYN Ultra order authorized the 11 products for marketing under the PMTA pathway, not the modified risk tobacco product (MRTP) pathway. Swedish Match did not confirm that it had submitted an MRTP application to FDA for the ZYN Ultra products.
For the broader nicotine pouch industry, the decision shows that higher labeled nicotine content does not automatically prevent a product from meeting the FDA's appropriate-for-the-protection-of-public-health (APPH) standard. Instead, the agency's review indicates that nicotine delivery, toxicant exposure, adult switching potential, and risks to youth and nonusers are considered together when evaluating individual products.