Modified-Risk Orders for Copenhagen Snuff
U.S. Smokeless Tobacco Co.’s manufacturing facility in Tennessee.
The U.S. Food and Drug Administration has authorized U.S. Smokeless Tobacco Co.’s (UST) Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified-risk tobacco product (MRTP). Copenhagen’s moist snuff smokeless tobacco product has been marketed in the U.S. for years without modified-risk information.
The FDA’s action now allows UST to market the product as a modified-risk product with the claim: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”
After a rigorous review of the available evidence, including recommendations from the Tobacco Products Scientific Advisory Committee, public comments and other available scientific information, the FDA says it concluded that the specific claim related to lung cancer risk is scientifically accurate with respect to Copenhagen Classic Snuff. The review also found the public health gains are unlikely to be offset by nonusers starting to use the product.
UST will be required to conduct post-market surveillance and studies that include an assessment of product users’ behavior, understanding and any previous use of cigarettes as well as a scientific model to assess continued impact on population health.
This modified-risk granted order will expire in five years.