NATO Supports FDA Applications for Smokeless Products

Tobacco retailing group submits comments on reduced-risk claims during FDA process
Photograph: Shutterstock

LAKEVILLE, Minn. -- Earlier this week, NATO filed two public comments with the U.S. Food and Drug Administration (FDA) regarding modified-risk tobacco product (MRTP) applications the agency is considering related to nine smokeless tobacco products.

Swedish Match North America Inc., Richmond, Va., amended an earlier MRTP application initially submitted in 2014 for eight General snus products; and a subsidiary of Richmond, Va.-based Altria Group Inc., U.S. Smokeless Tobacco Co., filed an MRTP application for its Copenhagen fine-cut moist snuff. NATO filed comments in support of all nine applications and encouraged the FDA to grant modified-risk orders for each.

Under the Family Smoking Prevention and Tobacco Control Act, manufacturers themselves are prohibited from making health claims and are only allowed to do so through modified-risk orders issued by the FDA. Previously, both FDA Commissioner Scott Gottlieb and Center for Tobacco Products (CTP) Director Mitch Zeller have recognized that delivery of nicotine through various means exists on a “continuum of risk.” It is widely accepted within the scientific community that combustible tobacco products are on the higher end of the spectrum of risk while noncombustible nicotine products such as electronic cigarettes or smokeless tobacco fall on the lower end of the spectrum, closer to nicotine-replacement therapies.

While many experts recognize that switching from combustible to noncombustible tobacco and nicotine can provide health benefits, the public, and smokers specifically, are often unaware of potential benefits. In its public comments, NATO urged the FDA to consider that the American public and adult tobacco consumers (who buy products from our member businesses) deserve accurate information upon which to make informed health choices. Making such information accessible not only benefits individuals, but also benefits our population’s health overall.

The MRTP application from U.S. Smokeless Tobacco for its Copenhagen fine-cut moist snuff is receiving its first consideration by the agency. The applications for the eight General snus products from Swedish Match are a continuation of a process begun with the filing of initial MRTP applications in 2014.

In regard to the Swedish Match applications, the CTP previously provided Swedish Match with specific, written recommendations to correct deficiencies it found in the applications and suggested it file amended applications. In response, Swedish Match changed its proposed claims, supplemented the requested evidence and conducted new scientific studies as recommended by the agency.

Swedish Match indicated its willingness to retain a label statement requested by CTP that reads, “WARNING: This product is not a safe alternative to cigarettes.”

Swedish Match requests a modified-risk order to make the following claim about its General snus products: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”

The MRTP application filed by U.S. Smokeless Tobacco’s Copenhagen is seeking approval of the modified-risk claim for Copenhagen Snuff Fine Cut that reads: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

Reynolds American Inc., Winston-Salem, N.C., is also awaiting approval from the FDA for MRTP applications related to six of its Camel Snus products. Reynolds filed initial MRTP applications in March 2017 and the Tobacco Products Scientific Advisory Committee (TPSAC) considered the applications in September 2018. FDA takes TPSAC recommendations under consideration but makes its determination based on its own review.

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