FDA Authorizes 11 New Nicotine Pouches
August 21, 2026
Today, the U.S. Food and Drug Administration (FDA), authorized the marketing of 11 new nicotine pouch products through the premarket tobacco product application (PMTA) pathway. The authorized products, made by Swedish Match USA, Inc., are sold under the “ZYN ULTRA” brand name and include the following:
- ZYN ULTRA Chill 9 mg
- ZYN ULTRA Citrus 9 mg
- ZYN ULTRA Cool Mint 9 mg
- ZYN ULTRA Deep Freeze 9 mg
- ZYN ULTRA Menthol 9 mg
- ZYN ULTRA Peppermint 9 mg
- ZYN ULTRA Smooth 9 mg
- ZYN ULTRA Smooth 11 mg
- ZYN ULTRA Spearmint 9 mg
- ZYN ULTRA Wintergreen Chill 9 mg
- ZYN ULTRA Wintergreen 9 mg
As part of its thorough scientific review of new tobacco products, the FDA considers the risks and benefits to the U.S. population as a whole — including the benefits to adults who currently use tobacco products and switch to a potentially lower-risk product, as well as the risks posed to youth and non-users of tobacco products. To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.
The review of these products was part of the agency’s nicotine pouch pilot program, which aims to increase efficiency and streamline the review process for nicotine pouches through the PMTA pathway. The pilot streamlined the FDA’s review processes, which has led to faster resolution of issues, decreased time needed for applicants to respond to deficiency letters, and more efficient scientific reviews. The FDA has begun implementing efficiencies learned from the pilot to the review of other PMTAs. To date, the FDA has authorized 43 nicotine pouch products overall, 23 as part of the pilot program.
In reviewing nicotine pouch applications, the FDA considers the nicotine exposure associated with each product as part of its assessment of the product’s potential risks and benefits to the population as a whole. Nicotine exposure is influenced not only by a product’s labeled nicotine content, but also by its design, formulation, materials, and other characteristics that can affect the amount and rate of nicotine delivered to the user. Consistent with this approach, the FDA evaluated the nicotine exposure associated with each of the products authorized today based on its individual characteristics and as part of the product’s overall public health assessment.
The FDA’s evaluation found that the new products, including the 11 mg product authorized today, contain lower levels of most harmful and potentially harmful constituents (HPHCs) when compared to other oral and smokeless tobacco products, many of which were too low to be quantified in the new products. The applicant provided product-specific data showing that the new products appeal to adults who would benefit most from completely switching to them (i.e. current cigarette and smokeless tobacco users). Additionally, the review discussed that the new products may deliver sufficient nicotine to the user to reduce craving and withdrawal symptoms to a degree that can support behavioral change (e.g., product substitution) among adults who currently 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. Today’s authorizations are another important step to provide greater access to potentially less harmful alternative tobacco products for existing adult tobacco users.
To date, the FDA has authorized 43 nicotine pouches. These products are listed at www.fda.gov/authorizednicotinepouches.