Eight Snus products from Swedish Match recently received renewals of modified risk granted orders from the Food and Drug Administration (FDA), which allows the company to continue marketing these products with the following 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.”
This is the first renewal of modified risk granted orders issued by FDA.
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 these products and expire in 2032. The agency can, however, withdraw the orders if it determines that the products no longer “benefit the health of the population as a whole,” the FDA noted in a statement.
According to the FDA, its review of the products 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.
FDA reported that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
These products were originally authorized for marketing in the U.S. 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 five years.
To continue marketing the products after the set terms of the 2019 orders, Swedish Match submitted modified risk tobacco product renewal applications.
