The U.S. FDA authorized the sale of nicotine pouch products for the first time, and 20 ZYN nicotine pouches were approved

The U.S. FDA authorized the sale of nicotine pouch products for the first time, and 20 ZYN nicotine pouches were approved

After a detailed scientific review, the U.S. FDA has approved marketing authorization for 20 Zyn brand nicotine pouch products. This marks an important progress in the FDA's regulation of new tobacco products.

The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine pouch products for sale for the first time, which is the first time that nicotine pouch products have received such authorization. This decision was made after a rigorous pre-market tobacco product application (PMTA) review, marking an important step for the FDA in scientific regulation of new tobacco products.

The FDA determined that these approved ZYN products meet the public health standards set forth in the Family Smoking Prevention and Tobacco Control Act of 2009, which assesses the risks and benefits of products to the overall population. According to the FDA's analysis, ZYN nicotine pouches contain significantly fewer harmful ingredients than cigarettes and most smokeless tobacco products (such as moist snuff and snus), reducing the risk of cancer and other serious health problems. In addition, research data provided by the applicant shows that a large number of adult smokers and smokeless tobacco users have completely switched to ZYN nicotine pouches.

The FDA's review also paid special attention to the potential risks of nicotine pouches to youth. Data from the 2024 National Youth Tobacco Survey showed that although sales of nicotine pouches have increased in recent years, only 1.8% of U.S. middle and high school students reported using nicotine pouches, indicating that youth use rates remain low. However, the FDA emphasizes that companies responsible for product marketing must adopt responsible marketing strategies.

To reduce the likelihood of youth exposure to advertising for these products, the FDA has established strict market restrictions on digital, television and radio advertising, including ensuring that advertising targets adults aged 21 and over and tracking the age and demographics of the audience. In addition, manufacturers have also pledged to take additional measures, such as avoiding mass market advertising, advertising actors must be at least 35 years old, and avoiding the use of youth-oriented themes or images.

Specific approved products: 10 flavors, 2 nicotine strengths, including non-tobacco flavors

The products approved by the FDA this time include 20 ZYN nicotine bags, each offering two nicotine strengths (3 mg and 6 mg), covering 10 flavors: Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen. These authorizations are limited to the specific products listed above and do not apply to other ZYN products. In addition, the company may not make reduced risk claims for these products without further approval.

This authorization is the latest in a series of actions by the FDA to ensure that all novel tobacco products are scientifically reviewed before they are marketed. To date, the FDA has received nearly 27 million product applications and made decisions on more than 26 million of them, including previously approved flavored oral tobacco products (such as nicotine mints and chewing products in 2021) and mint-flavored smokeless tobacco products in 2015.

This FDA decision sets a precedent for the regulation of nicotine pouch products, and this decision follows a series of recent FDA actions to strengthen the regulation of the tobacco and nicotine industry. This indicates that the regulation of novel tobacco in the United States will usher in significant progress in 2025, which will also have a profound impact on the landscape of the novel tobacco market in the United States.

At the industry seminar held by 2Firsts at the end of 2024, Ms. Guo Xiaoyu, co-founder and COO of 2Firsts, said that in 2025, driven by regulation, the new tobacco market in the United States will "change dramatically".

After extensive scientific review, the FDA approved 20 ZYN nicotine pouch products for marketing

Published on January 16, 2025

Today, after extensive scientific review, the U.S. Food and Drug Administration (FDA) approved the sale of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway. This is the first time the agency has approved products commonly known as nicotine pouches, which are small synthetic fiber bags containing nicotine designed to be placed between a person's gums and lips.

The FDA determined that the specific products receiving marketing authorization met the public health standard set forth in the Family Smoking Prevention and Tobacco Control Act of 2009. This standard considers the risks and benefits of a product for the entire population.

In addition, the FDA found that the applicants showed that these nicotine pouch products have the potential to provide benefits to adults who smoke and/or use other smokeless tobacco products that are sufficient to outweigh the risks of these products, including to youth. As part of its evaluation, the FDA reviewed data on youth risks and found that despite the growing sales of nicotine pouch products in recent years, youth use rates remain low. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported current use of nicotine pouch products.

While today's action allows these specific tobacco products to be legally sold in the U.S. to adults 21 and older, it does not mean that these tobacco products are safe or that they are "FDA-approved." There is no safe tobacco product; youth should not use tobacco products, and adults who do not use tobacco products should not start using them.

The FDA will closely monitor the marketing and use of these products. To reduce the potential for youth exposure to advertising for these products, the authorization imposes strict marketing restrictions on digital, television, and radio, including measures to ensure that advertising is carefully targeted to adults 21 and older, and that manufacturers track and measure the demographics of the audiences reached by advertising. The company also said it intends to implement additional measures to limit youth exposure, reduce youth appeal, and limit youth exposure to its labels and advertising, such as: not using mass-market advertising on radio and television; hiring actors/models who are 35 years of age or older or styled to look younger than 35 for marketing; and avoiding any content designed to target youth, including characters, images, or themes. The agency may suspend or revoke a marketing authorization issued under the PMTA pathway for a variety of reasons if the agency determines that continued marketing of a product no longer meets the necessary public health criteria, such as if youth drug use has increased significantly.

The products for which the FDA issued marketing authorizations are as follows, each available in two nicotine strengths (3 mg and 6 mg): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint, and ZYN Wintergreen. Importantly, today's action is only for these products; the authorization does not apply to any other nicotine pouches or other ZYN products. In addition, the authorization does not allow the company to make reduced-risk claims for the authorized products, which would require an amendment to the tobacco product's risk-based application.

Today's action is the latest step the FDA has taken to ensure that all new tobacco products sold in the United States undergo scientific review and receive marketing authorization from the agency. To date, the FDA has received nearly 27 million applications for products and has made decisions on more than 26 million of those applications. This includes the authorization of additional flavored oral tobacco products, including nicotine mints and chews in 2021 and menthol smokeless tobacco in 2015. To find a list of tobacco products that can legally be sold in the United States, visit the FDA's searchable Tobacco Products Database.