The FDA allows the "modified risk" label for several flavored nicotine sachets

The U.S. Food and Drug Administration (FDA) has granted Swedish Match USA a Modified Risk Tobacco Product (MRTP) marketing authorization for 20 ZYN flavored nicotine pouches.[1]. These products, already authorized for sale in the United States since January 2025, can now be marketed with this modified risk label. Public health experts warn that the industry is exploiting these risk claims to sell its new products, particularly to young people and non-smokers.

A regulated and time-limited authorization for products experiencing rapid growth

The products in question are ZYN nicotine sachets with sweet and fruity flavors (cinnamon, coffee, fresh mint, menthol, citrus, etc.). Other products feature more evocative flavors (Chill, Smooth, Wintergreen). With this authorization, these nicotine sachets can now be marketed with the following claim:« Using ZYN instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. ".

This authorization applies exclusively to the ten lines of ZYN nicotine pouches (available in 3 mg and 6 mg strengths) covered by the decision, and not to all tobacco or nicotine products. It is granted for a period of five years and includes the manufacturer's obligation to conduct post-market surveillance and studies that assess the behavior of users of modified-risk tobacco products (MRTPs) and their understanding of risk information. The FDA specifies that it may revoke this authorization if the conditions that justified its granting are no longer met, particularly in the event of a significant increase in use among young people.

Nicotine pouches are the fastest growing nicotine product in the United States and worldwide., With millions of users: Philip Morris alone sold 794 million boxes of its current version of Zyn in the country in 2025, more than double its 2023 sales.[2]. The FDA's 2025 National Youth Smoking Survey found that 1.7% of high school students now use nicotine pouches. More than one in six users reported using them daily, and more than nine in ten chose flavored versions, with mint being the most popular. ZYN was the most frequently cited brand, mentioned by 69% of young users.[3].

An assessment partly based on non-independent manufacturer data

The decision is based on a review of scientific data provided by Swedish Match USA, a subsidiary of Philip Morris International, focusing on the relative health risks of these products for tobacco users, consumer understanding of the warning label, the risk of use among young people, and potential effects on public health. The FDA considers the evidence presented for the products in question to be sufficient, that the warning label is correctly understood by consumers, and that its use is likely to provide a health benefit to the general population.

The FDA also had the recommendations from the meeting of the Scientific Advisory Committee on Tobacco Products on January 22, 2026, as well as the results of the public consultation and other information, including scientific information, gathered from various sources.

The term "modified risk" is being adopted by the industry as "reduced risks."

The FDA reiterates that no tobacco or nicotine product is risk-free and that people who do not currently use tobacco or nicotine products should not start. It emphasizes that complete cessation of all tobacco and nicotine product use remains the best option for health. To date, the agency has authorized 26 nicotine pouches manufactured by Swedish Match US, Inc. and Helix Innovations LLC., after determining that they meet regulatory requirements for public health protection.

This notion of "modified risk" is often misused as "risk reduction" by the tobacco industry in its strategy to promote new products and improve its institutional image. The term "modified risk," granted by the public agency, is thus used by manufacturers in a context of global decline in smoking, where they seek to develop their new products (e-cigarettes, heated tobacco, nicotine pouches, etc.) and cultivate loyalty among a new generation of consumers addicted to nicotine. This year, Tobacco manufacturers have also been lobbying the US president and other key officials to secure the desired changes., including a faster FDA approval process.

Lisa A. Lacasse, president of the American Cancer Society's Cancer Action Network, said this measure undermines the agency's core mission:« The FDA's role is to protect public health, not to increase the profits of large tobacco companies. »", warning against the tobacco industry's use of flavored products to appeal to a new generation. Ms. Lacasse urged the FDA to strengthen its oversight rather than pave the way for increased marketing of addictive products. Countries like France, Belgium And the Netherlands have already banned the marketing of all these nicotine sachets.

©Generation Without Tobacco

AD

[1]FDA Authorizes 20 ZYN Nicotine Pouches to Be Marketed with Specific Modified Risk Claim, FDA, published June 30, 2026, accessed July 6, 2026

[2]FDA allows Philip Morris to market Zyn as less harmful than cigarettes, Reuters, published on June 30, 2026, accessed on July 6, 2026

[3]Gaby Clark, Andrew Zinin, FDA lets 20 ZYN nicotine pouches claim lower risk than cigarettes; critics warn of danger, Medical Xpress, published July 2, 2026, accessed July 6, 2026

National Committee Against Smoking |