The latest round of products brings the total number of FDA-authorized flavored nicotine pouches to 43.


The USFDA authorized the marketing of 11 flavored nicotine pouch products through its premarket tobacco product application (PMTA) pathway, according to an agency news release.

The authorized products from Swedish Match USA Inc are sold under the “Zyn Ultra” brand and include cool mint, citrus, peppermint, spearmint, and other flavors.

According to the agenct, 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.

The FDA said its 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.

“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.”
-FDA

In response, the American Lung Association issued a statement questioning the FDA actions.

“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. 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.”
-Thomas Carr, Director of National Policy at the American Lung Association