November 7, 2024 – Washington, D.C. – The U.S. Food and Drug Administration (FDA) has renewed the modified risk granted orders for eight General Snus products from Swedish Match USA, Inc., extending their authorization to be marketed with specific reduced-risk claims. These products, which were initially authorized in 2019, may continue to carry the claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The eight authorized General Snus products include:
- General Loose
- General Dry Mint Portion Original Mini
- General Portion Original Large
- General Classic Blend Portion White Large-12ct
- General Mint Portion White Large
- General Nordic Mint Portion White Large-12ct
- General Portion White Large
- General Wintergreen Portion White Large
This renewed authorization, which will remain valid until November 7, 2032, follows the FDA’s extensive scientific review. The FDA evaluated long-term epidemiological data, consumer understanding, and population health impacts, ultimately determining that these products, when used as an alternative to cigarettes, present a lower risk of several serious health conditions. The renewal underscores the FDA’s commitment to supporting products that contribute to harm reduction for current adult smokers, while upholding strict regulatory standards to protect public health.
“We are encouraged by the scientific evidence indicating that these modified risk products can help reduce tobacco-related health risks for adult smokers who switch to them,” said an FDA spokesperson. “Our decision is based on rigorous evaluation, and these products will continue to be monitored to ensure they provide a health benefit to the population as a whole.”
While the authorization allows the use of the specific reduced-risk claim, the FDA has emphasized that these products are not risk-free and that the authorization does not equate to FDA endorsement or deem them safe for consumer use. The agency reminds the public that no tobacco product is without risk, and those who do not use tobacco products should not start.
This is the first time the FDA has renewed a modified risk order since these products were initially approved for marketing in 2015 through the premarket tobacco product application process. Following a five-year authorization period beginning in 2019, Swedish Match USA, Inc. submitted renewal applications earlier this year, which were reviewed with input from public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC). The TPSAC convened in June 2024 to discuss these applications, helping to inform the FDA’s decision.
For more detailed information about the modified risk granted orders and the FDA’s review, please visit the FDA website.
