FDA Renews Risk Modification for Swedish Match Snus Products: Sales Approved Until 2032
On November 7, 2023, the U.S. Food and Drug Administration (FDA) announced that it had officially renewed the risk modification authorization for eight snus products from Swedish Match. This decision allows these products to continue being sold in the U.S. market, with the authorization extended until 2032. This marks the first time the FDA has renewed a risk modification authorization, and the move holds significant implications for both the tobacco industry and public health.
The Scientific Evidence Behind the Renewal
The FDA emphasized that after a rigorous scientific review, it confirmed that the risk modification statements for these snus products were well-supported by scientific evidence, indicating that they effectively reduce the risk of related diseases. The renewed risk statement reads: “Using these snus products in place of cigarettes may reduce the risk of oral cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
This statement is based on existing scientific research, especially long-term epidemiological studies, which show that, compared to smoking, the exclusive use of these snus products significantly reduces tobacco-related health risks. As a result, the FDA recognizes these snus products as a harm-reducing alternative, benefiting overall public health.
Affected Products
- 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
These products have been FDA-authorized for sale since 2019, and they now continue to meet the modified risk statement. According to the FDA’s approval, these products will remain available for sale until November 7, 2032.
Limitations of the Risk Modification Statement
While the FDA approved the risk modification authorization for these snus products, it does not mean that the products are considered “safe” by the FDA. The FDA specifically emphasized that all risk statements must clearly convey to consumers that these products are not completely harmless, and that the FDA has not approved any statement implying that the products are FDA-approved or considered safe for consumers. The FDA also underscored that no tobacco product is entirely safe, and people who do not use tobacco products should not begin using these products.
Furthermore, the FDA stated that if, at any time, evidence suggests that continuing to sell these products is no longer beneficial to public health, the agency has the authority to withdraw the authorization.
Scientific Background of Snus Products and Risk Reduction
Swedish Match’s snus products are considered a harm-reducing tool within the tobacco product category. Unlike traditional cigarettes, these products significantly reduce harmful substances found in tobacco smoke. By providing nicotine without the harmful effects of smoke, snus products represent a less hazardous alternative.
Existing scientific evidence suggests that using these snus products instead of smoking can effectively reduce the risks of oral cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. This evidence played a key role in the FDA’s approval of the renewal application, ensuring that these harm-reducing products remain legally available in the U.S. market.
FDA’s Review and Industry Impact
The FDA’s approval is a recognition of the scientific and regulatory compliance of Swedish Match’s eight snus products and their risk modification authorization. This decision also serves as an important guide for the tobacco industry, particularly regarding the regulation of harm-reducing products.
As more consumers and the industry focus on health and reducing the risks of
