On August 21, 2026, the U.S. Food and Drug Administration (FDA) official FDA announcement authorized 11 ZYN ULTRA nicotine pouch products from Swedish Match USA for U.S. marketing through the Premarket Tobacco Product Application (PMTA) pathway.
The authorization covers 10 products labeled with 9 mg of nicotine and one product labeled with 11 mg.
The decision forms part of the FDA’s nicotine pouch PMTA pilot program, which was established to streamline the review process, accelerate the resolution of regulatory issues, reduce the time applicants need to respond to deficiency letters, and improve the efficiency of scientific reviews. Read our guide to the FDA PMTA process.
Following the latest authorization, the FDA has now authorized 43 nicotine pouch products, including 23 products approved through the pilot program. See our full list of FDA-authorized nicotine pouches.
10 Products With 9 mg and One With 11 mg Receive Authorization
The 10 newly authorized 9 mg products are:
- ZYN ULTRA Chill
- ZYN ULTRA Citrus
- ZYN ULTRA Cool Mint
- ZYN ULTRA Deep Freeze
- ZYN ULTRA Menthol
- ZYN ULTRA Peppermint
- ZYN ULTRA Smooth
- ZYN ULTRA Spearmint
- ZYN ULTRA Wintergreen Chill
- ZYN ULTRA Wintergreen
The FDA also authorized ZYN ULTRA Smooth with 11 mg of nicotine.
Swedish Match USA is the U.S. affiliate of Philip Morris International (PMI). Following the FDA’s decision, PMI said that other ZYN ULTRA products containing 11 mg of nicotine remain under scientific review by the agency.
The latest authorization expands the range of nicotine strengths available among ZYN products that have received FDA marketing authorization in the United States. Previously, the FDA had authorized several ZYN nicotine pouch products containing 3 mg and 6 mg of nicotine. Browse our ZYN product guide.
FDA Says Labeled Nicotine Strength Is Not the Only Exposure Factor
In its announcement, the FDA explained how it evaluates nicotine exposure when reviewing nicotine pouch applications under the PMTA process.
The agency considers the nicotine exposure associated with each product as part of a broader assessment of its potential population-level public health risks and benefits. However, actual nicotine exposure is not determined solely by the amount of nicotine stated on the product label.
The FDA also evaluates factors such as:
- Product design
- Formulation
- Materials
- Nicotine delivery characteristics
- Other product features that may influence the amount and speed of nicotine delivery
These factors are considered on a product-by-product basis.
For the newly authorized products, including the 11 mg version, the FDA said that most harmful and potentially harmful constituents (HPHCs) were present at lower levels than those found in other oral and smokeless tobacco products. Many of these constituents were reported at levels below the limit of quantification.
The agency also said the applicant submitted product-specific data indicating that the products could appeal to existing adult cigarette and smokeless tobacco users who are most likely to benefit from completely switching away from those products.
According to the FDA’s assessment, the products may also deliver enough nicotine to help reduce cravings and withdrawal symptoms to some degree, potentially supporting adult tobacco users who switch from more harmful tobacco products.
FDA Emphasizes the Importance of Complete Switching
The FDA stressed that for adults aged 21 and older who currently smoke cigarettes or use smokeless tobacco, completely switching to FDA-authorized nicotine pouch products may reduce exposure to many harmful chemicals associated with cigarettes and smokeless tobacco.
However, PMTA reviews are based on the potential impact of a new tobacco product on the public health of the U.S. population as a whole.
That assessment considers both the potential benefits of existing adult tobacco users switching products and the potential risks to young people and adults who do not currently use tobacco products.
As a result, FDA marketing authorization should not be interpreted as a finding that the products are safe or risk-free.
Instead, the decision means that the FDA determined that the applications met the statutory standard under the Federal Food, Drug, and Cosmetic Act that the products are “appropriate for the protection of the public health.”
PMTA Pilot Program Has Now Authorized 23 Nicotine Pouches
The FDA also provided an update on its nicotine pouch PMTA pilot program.
According to the agency, the pilot has helped improve the efficiency of the review process by speeding up the resolution of issues identified during reviews, reducing the time applicants need to respond to deficiency letters, and improving the efficiency of scientific evaluations.
The FDA said it has also begun applying some of the lessons and efficiency improvements developed through the pilot to other PMTA reviews.
As of August 21, 2026, the FDA had authorized 43 nicotine pouch products, with 23 receiving authorization through the nicotine pouch PMTA pilot program.
ZYN ULTRA PMTA Authorization Is Different From the MRTP Orders
The latest decision should also be distinguished from the FDA’s recent modified risk tobacco product (MRTP) action involving ZYN.
On June 30, 2026, the FDA issued MRTP orders for 20 ZYN nicotine pouch products that had previously received marketing authorization. This marked the first time the FDA had granted MRTP orders for nicotine pouch products.
The August 21 authorization of 11 ZYN ULTRA products, by contrast, was a PMTA marketing authorization.
These are separate regulatory processes with different legal standards and regulatory implications. A PMTA marketing authorization allows a tobacco product to be legally marketed after the FDA determines that it meets the applicable public-health standard, while an MRTP order concerns specific modified-risk claims and requires a separate FDA determination.
The latest ZYN ULTRA authorization expands both the total number and nicotine strength options of ZYN products legally marketed in the U.S., though the FDA stresses that approval does not mean these products are safe or risk-free.