NATO Submits Comments to FDA on Smokeless Products

Supports Swedish Match’s and U.S. Smokeless Tobacco’s MRTP applications.

This week, NATO submitted comments to the Food and Drug Administration (FDA)’s Tobacco Product Scientific Advisory Committee (TPSAC) in support of Swedish Match’s modified risk tobacco product applications for the company’s General Snus products and in support of U.S. Smokeless Tobacco’s modified risk tobacco product application for the Copenhagen Snuff Fine Cut product.

FDA regulations enacted pursuant to the Family Smoking Prevention and Tobacco Control Act prohibit companies themselves from making product health claims, except through a modified risk order issued by the FDA. A modified risk tobacco product application (MRTP) is filed by a manufacturer seeking to obtain approval from the FDA to make a statement about the reduced harm or lessened health-related risk of a particular tobacco product. The application is then reviewed by the TPSAC along with relevant studies and other information supplied by the manufacturer and the TPSAC makes a recommendation to the FDA whether the modified risk statement should be approved. If approved by the FDA, the manufacturer is allowed to use the statement in product advertisements and on product packaging.

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In the Swedish Match MRTP applications, the company is seeking to use the following statement: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

In the U.S. Smokeless Tobacco MRTP application, the company is requesting an order from the FDA to use the following statement for its Copenhagen Snuff Fine Cut product: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

The TPSAC is holding public hearings on Feb. 6-7, 2019 regarding the respective MRTP applications submitted by Swedish Match and U.S. Smokeless Tobacco Co. The TPSAC will then issue its recommendation to the FDA on whether to approve the MRTP applications and the agency will then make a final decision on the applications.