FDA Authorizes Copenhagen Classic Snuff as Modified Risk Tobacco Product

U.S. Smokeless Tobacco must conduct postmarket surveillance, studies on consumer effect
U.S. Smokeless Tobacco Co.
Logo/U.S. Smokeless Tobacco Co.

U.S. Smokeless Tobacco Co.’s Copenhagen Classic Snuff can now be marketed as a modified risk tobacco product (MRTP). The Food and Drug Administration’s classification allows the Altria-owned company to market the product with this claim: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

The agency said, however, that there is no safe or “FDA-approved” tobacco product.

“Those who do not use tobacco products shouldn’t start,” said the FDA’s Center for Tobacco Products Director Brian King. “But tobacco products do exist on a spectrum of risk, with those that are smoked having the greatest risk. In this case, the FDA’s scientific review found that if an adult smoker completely switched from cigarettes to this smokeless product, it would reduce their risk of getting lung cancer.”

Copenhagen’s moist snuff smokeless tobacco is a pre-existing tobacco product that has been sold in the United States for years without modified risk information, the FDA said. The agency reached its MRTP decision after a rigorous review of evidence including recommendations from the Tobacco Products Scientific Advisory Committee, public comments and other scientific information.

The data showed if current smokers switched completely from cigarettes to Copenhagen Classic Snuff, they would reduce their risk of getting lung cancer, and the public health gains are not expected to be offset by nonuser initiation, the FDA said.

We are pleased that FDA has authorized this science-based claim recognizing the harm reduction potential of smoke-free products, but we’re disappointed it took FDA nearly half a decade after our original application to make this determination, David Sutton, director of media relations with Altria, said.  We believe urgently advancing harm reduction remains one of the most powerful steps the agency can take. Today’s decision re-enforces our confidence in our regulatory capabilities. We remain committed to equipping adult tobacco consumers with accurate information to support their transition from smoking.

The MRTP application was submitted in March 2018, Altria said. 

The modified risk granted order will expire in five years, and at that time, the company must receive FDA authorization to continue marketing the product as an MRTP. U.S. Smokeless Tobacco Co. must also conduct postmarket surveillance and studies to assess product users’ behavior, understanding and any previous use of cigarettes, and continue to assess impact on population heath.

“The ball is now in the company’s court to conduct postmarket studies and surveillance on consumer impact, and to submit this information to FDA annually,” King said. “If scientific evidence indicates that the net gains of these products no longer outweigh the risks at the population level—or if the company fails to conduct the required postmarket surveillance and studies—the FDA is committed to taking action as appropriate, including withdrawing the order, to protect public health.”

U.S. Smokeless Tobacco Co., owned by Richmond, Virginia-based Altria, in an oral tobacco product company. Copenhagen leads its moist smokeless tobacco product portfolio, and its other brands include Skoal, Red Seal and Husky.

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