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The FDA authorized the U.S. Smokeless Tobacco Company, a subsidiary of tobacco giant Altria, to market Copenhagen Classic Snuff as less likely to cause lung cancer than cigarettes.

The loose moist snuff smokeless tobacco product had already been on the market with standard tobacco warning labels; now it can carry this claim: "IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer."

FDA cautioned in its that the authorization is only good for 5 years and requires postmarketing studies to monitor consumer impact.

"No tobacco product is safe or 'FDA approved,' so those who do not use tobacco products shouldn't start," said Brian King, PhD, MPH, director of the FDA's Center for Tobacco Products, in the press release. "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."

While the FDA has had the authority to regulate tobacco since the Tobacco Control Act passed in 2009, it has made halting progress in doing so. After denying or delaying more than a dozen applications for smokeless tobacco products vying for the reduced risk designation, FDA finally granted the first such claims to eight in 2019.

Getting a modified risk tobacco product claim -- issued on a product-by-product basis -- requires that the sponsor prove an overall advantage for public health in helping tobacco users move into lower-risk behaviors without motivating new users to start.

An FDA advisory panel had voted unanimously in 2019 that the evidence supported lower lung cancer risk from Copenhagen Classic Snuff compared with conventional combustible cigarettes. In , snuff had no greater mortality risk from malignant neoplasms than never tobacco users compared with the nearly threefold higher risk among combustible tobacco users. FDA said its review "also found those public health gains are not expected to be offset by nonusers starting to use this product."

Postmarket surveillance and studies that assess users' behavior, understanding, and any previous use of cigarettes are required from the manufacturer, along with a scientific model to assess overall continued impact on population health.

"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 noted in the press release. "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."

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