FDA Renews Reduced-Risk Authorization for Eight Swedish Match Products
WASHINGTON, D.C. — Following scientific review by the U.S. Food and Drug Administration (FDA), the agency issued a renewal of modified risk granted orders to Swedish Match USA Inc., for eight General Snus products.
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."
The products which received the modified risk granted orders include:
- General Loose
- General Dry Mint Portion Original Mini
- General Portion Original Large
- General Classic Blend Portion White Large, 12-count
- General Mint Portion White Large
- General Nordic Mint Portion White Large, 12-count
- General Portion White Large
- General Wintergreen Portion White Large
The FDA orders are specific to only the above-mentioned products and expire on Nov. 7, 2032. If at any point the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.
[Read more: Philip Morris International Ups Its Bid for Swedish Match]
The FDA's 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.
The agency found 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.
The available evidence does not indicate significant youth initiation of these products.
The modified risk granted order does not permit Swedish Match to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that FDA deems the products to be safe for use by consumers.
The agency stated there is no safe tobacco product, and those who do not use tobacco products should not start.