Manufacturer Must Monitor Consumer Impact; FDA May Withdraw Authorization as Needed to Protect Public Health
Today, the U.S. Food and Drug Administration 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). Copenhagen’s moist snuff smokeless tobacco product is a pre-existing tobacco product that has been marketed in the U.S. for years without modified risk information. Today’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.”
“No tobacco product is safe or ‘FDA approved,’ so those who do not use tobacco products shouldn’t start,” said Brian King, Ph.D., M.P.H. “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.”
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.
The company 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.
“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,” said Dr. King. “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.”
The MRTP process outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows companies to submit applications for the FDA to evaluate whether a tobacco product may be sold or distributed for use to reduce harm or the risk of tobacco-related disease. By law, the FDA must also ensure that the advertising and labeling of modified risk products enables the public to understand the modified risk or modified exposure information and to understand the significance that information has in the context of total health and in relation to all tobacco-related diseases and health conditions.
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