FDA Authorizes Copenhagen Classic Snuff as a Modified-risk Tobacco Product

On March 16, the U.S. Food and Drug Administration ( FDA ) authorized the U.S. smokeless tobacco company's Copenhagen classic snuff ( a smokeless tobacco product with moist bulk snuff ) to be sold as a modified risk tobacco product ( MRTP ). Copenhagen's moist snuff smokeless tobacco is an existing tobacco product sold in the United States for years without modifying risk information. Now it allows the product to be marketed as a corrective risk product and claims, "If you smoke, please consider this. Complete conversion from cigarettes to this product can reduce the risk of lung cancer."

'No tobacco products are safe, and there is no 'FDA approval ', so those who do not use tobacco products should not start using them,' Dr. Brian King, Master of Public Health, said,' But tobacco products do have risks and those that smoke have the most significant threat. In this case, the FDA's scientific review found that if an adult smoker switched completely from cigarettes to this smokeless product, it would reduce their risk of lung cancer. '

After a rigorous review of the available evidence, including the Scientific Advisory Committee on Tobacco Products recommendations, public comments, and other available scientific information, the FDA concluded that specific statements related to lung cancer risk were scientifically accurate for Copenhagen's classic snuff. Data shows that if current smokers switch completely from cigarettes to this product, they will reduce the risk of lung cancer. The review also found that these public health benefits are not expected to be offset by non-users starting to use the product.

The risk modification granted by the agency does not allow the company to make any other modified risk statements when selling the product, including statements related to any other outcome other than lung cancer risk, or mislead consumers into believing that the product is approved or approved by the FDA, or that the FDA considers the product to be safe for consumers.

The company must conduct postmarket supervision and research, including evaluating product users' behavior, understanding previously used cigarettes, and assessing the continuing impact on population health.

This modified risk-awarding order will expire after five years. The company must apply for and obtain FDA authorization to continue to sell the product as a modified risk product. If at any time the agency determines that the order is no longer beneficial to public health, the agency must revoke the declaration.

"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 procedure outlined in the 2009 'Family Smoking Prevention and Tobacco Control Act' allows companies to submit applications for FDA assessment of whether tobacco products can be sold or distributed to reduce the risk of injury or tobacco-related diseases. According to the law, the FDA must also ensure that advertisements and labels for modified risk products enable the public to understand modified risk or exposure information and the significance of this information in terms of overall health and in relation to all tobacco-related diseases and health conditions.

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FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product