ALEXANDRIA, Va.—The U.S. Food and Drug Administration (FDA) authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product (MRTP), the agency announced.
“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,” Altria, parent of U.S. Smokeless Tobacco Company, said in a statement. “We believe urgently advancing harm reduction remains one of the most powerful steps the agency can take.” Altria added, the “decision reenforces our confidence in our regulatory capabilities. We remain committed to equipping adult tobacco consumers with accurate information to support their transition from smoking.”
Copenhagen’s moist snuff smokeless tobacco product is a preexisting tobacco product that has been marketed in the U.S. for years without modified risk information. Yesterday’s action now allows the product to be marketed 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.”
“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,” said Brian King, Ph.D., M.P.H.
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 concluded that the specific claim related to lung cancer risk is scientifically accurate with respect to Copenhagen Classic Snuff. The data show if current smokers switch completely from cigarettes to this product, they would reduce their risk of getting lung cancer. The review also found those public health gains are not expected to be offset by nonusers starting to use this product.
The risk modification order granted by the agency does not permit the company to market the product with any other modified risk claims—including those related to any other outcomes besides lung cancer risk—or statements that convey or could mislead consumers into believing that the product is endorsed or approved by the FDA, or that the FDA deems the product to be safe for use by consumers.
According to the FDA, Altria is required to conduct postmarket 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; the company must request and receive FDA authorization to continue marketing the product as a modified risk product. If at any point the agency determines that the order no longer benefits the public health, the agency must withdraw the order.