FDA Renews Modified Risk Authorization for General Snus Products
Key Insights
The FDA has renewed the modified risk granted orders for eight General Snus (search) products from Swedish Match USA Inc. (search), extending their authorization to be marketed with a reduced risk claim.
The renewal allows these products to continue being marketed with the claim that using General Snus (search) instead of cigarettes lowers the risk of several diseases including mouth cancer (search), heart disease (search), and lung cancer (search).
The FDA's review confirmed that the modified risk claim is supported by scientific evidence and that consumers understand the claim and perceive the relative risk appropriately.
The Food and Drug Administration (FDA) has renewed the modified risk granted orders for eight General Snus (search) products manufactured by Swedish Match USA Inc. (search), allowing them to continue to be marketed with the claim of reduced risk compared to cigarettes. This renewal, announced on November 8, 2024, extends the authorization for these products until November 7, 2032.
The specific products covered by this renewal 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, and General Wintergreen Portion White Large. These products have been authorized to be marketed with the claim: “Using General Snus (search) instead of cigarettes puts you at a lower risk of mouth cancer (search), heart disease (search), lung cancer (search), stroke (search), emphysema (search) and chronic bronchitis (search).”
The FDA's decision to renew the modified risk orders was based on a review of scientific evidence supporting the claim. The agency stated that this review determined that the modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes. This is the first renewal of modified risk granted orders issued by the FDA.
These General Snus (search) products were initially authorized for marketing in the United States through the premarket tobacco product application pathway in 2015. In October 2019, the FDA authorized them to be marketed as modified risk tobacco products. The 2019 orders were valid for five years, and Swedish Match USA Inc. (search) submitted renewal applications to continue marketing the products after the initial term.