Following its review, the FDA has issued a renewal of modified risk granted orders to Swedish Match USA Inc. for eight General Snus products.

The products receiving modified risk granted orders are: 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. The modified risk granted orders issued by FDA are specific to the above-mentioned products and expire November 7, 2032.

With this renewal, these products may continue to be marketed—as they have been authorized to do so since 2019—with the following modified risk 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.”

According to the agency, the review determined that this 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 FDA. These products were originally authorized for marketing in the United States via the premarket tobacco product application pathway in 2015. In October 2019, the products were then authorized to be marketed as modified risk tobacco products. Those 2019 orders permitting marketing of General Snus products as modified risk tobacco products were valid for 5 years. To continue marketing the products after the set terms of the 2019 orders, Swedish Match USA Inc. submitted modified risk tobacco product renewal applications.