By Timothy S. Donahue

Top Takeaways:

• Ultra cleared: FDA authorized 11 ZYN Ultra products.
• Higher strength: The authorizations include a new 11 mg pouch.
• Pilot delivers: FDA has now authorized 23 pouches through the program.

ZYN just got stronger.

The U.S. Food and Drug Administration authorized 11 ZYN Ultra nicotine pouch products from Swedish Match USA, including a new 11 mg product, expanding the regulatory footprint of the country’s leading nicotine pouch brand.

The marketing granted orders (MGOs) cover ZYN Ultra Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, Wintergreen Chill, and Wintergreen at 9 mg, along with ZYN Ultra Smooth at 11 mg.

The products were reviewed under the FDA’s nicotine pouch pilot program, created to speed and streamline PMTA reviews. The agency said the pilot has led to faster issue resolution, shorter applicant response times to deficiency letters and more efficient scientific reviews.

The FDA has now authorized 43 nicotine pouch products, including 23 reviewed under the pilot. The 11 mg authorization is especially notable as manufacturers expand into higher-strength nicotine pouches.

The FDA said that nicotine content alone does not determine the exposure associated with a pouch. Its review also considers product design, formulation, materials, and other characteristics that affect how much nicotine reaches a user and how quickly.

The agency said it evaluated each ZYN Ultra product, including the 11 mg version, individually as part of its overall public health assessment.

The FDA found that the products contained lower levels of most harmful and potentially harmful constituents than other oral and smokeless tobacco products. Many were present at levels too low to quantify.

According to the FDA, Swedish Match also provided product-specific data showing that the pouches appealed to adults who could benefit most from completely switching, including cigarette smokers and smokeless tobacco users.

The agency said the products may provide enough nicotine to reduce cravings and withdrawal symptoms and to support switching 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,” the FDA said.

The agency called Friday’s authorizations “another important step to provide greater access to potentially less harmful alternative tobacco products for existing adult tobacco users.”

The decision also marks another significant outcome of the FDA’s nicotine pouch pilot.

The agency said it has already begun applying efficiencies gained through the program to other pending PMTAs, potentially giving the ZYN Ultra decisions significance beyond the 11 products authorized on Friday.

“Once again, FDA is rolling the dice with the health of kids and young adults by authorizing 11 new flavored nicotine pouches, all with high levels of nicotine,” said Thomas Carr, Director of National Policy at the American Lung Association. “Of kids who use nicotine pouches, 70% reported using Zyn as their brand, and 60.9% use mint, making it the most popular flavor with kids.

“FDA’s continued authorization of nicotine pouches through a pilot program designed to speed up the review process raises serious questions about whether these products are receiving the rigorous scientific scrutiny necessary to protect public health.”

The marketing granted orders do not mean the products are safe or FDA approved. They mean the FDA determined that allowing each product to be marketed is appropriate for the protection of public health, the statutory standard for new tobacco products.