Smokeless, Harm Reduction Under New Focus

FDA to hold hearing on reduced-risk debate in 2019
Photograph: Shutterstock

LAKEVILLE, Minn.-- Most who have followed stories about tobacco legislation and regulation in recent years would recognize that the concepts of “relative risk” and “harm reduction” have received considerable attention and been the subject of fierce debate.

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, FDA Center for Tobacco Products Director Mitch Zeller, experts and advocates from public health and tobacco control, businesses and consumers have debated potential benefits (or risks) of applying proven harm-reduction strategies from other health fields toward reducing risks associated with tobacco consumption.

In early 2019, the FDA Tobacco Products Scientific Advisory Committee (TPSAC) will hold a hearing directly related to these concepts and the outcome will provide a clearer picture of where the committee stands on the issue.

The concepts themselves are not particularly complicated. Different tobacco and nicotine products, whether traditional combustible cigarettes, cigars, a wide variety of smokeless tobacco products or electronic vapor products, possess different product attributes, are used differently and pose different risks for consumers.

Long-term scientific data clearly demonstrates that smokeless tobacco poses less health risks. Smokeless tobacco users’ health risks are generally lower than compared to the use of other tobacco products. The questions soon to be considered by TPSAC relate to how this information about lower health risks may, or may not, be provided to the public.

Under current law, tobacco product manufacturers are prohibited from making health claims about their products. One exception provided in the Tobacco Control Act is if the FDA approves claims under what is known as the modified-risk tobacco product (MRTP) pathway. Under this regulatory pathway, the FDA must refer applications submitted by manufacturers to make various health claims to the TPSAC to review MRTP applications concerning scientific issues, including safety, dependence and health issues, and then provide advice, information and recommendations to the FDA to use in its evaluation.

The FDA makes the final determinations about whether to authorize the MRTP to allow specific health-related claims and is under no burden to follow recommendations or votes provided by TPSAC.

Richmond, Va.-based Altria Group Inc., on behalf its subsidiary U.S. Smokeless Tobacco Co., has submitted an MRTP claim for its Copenhagen brand fine-cut moist snuff product.  The application asks the TPSAC and FDA to consider allowing the health claim that states, “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”

Years of data and science support this claim. And on Feb. 6-7, 2019, TPSAC will meet at the FDA in Silver Spring, Md., to consider this new MRTP submitted by Altria and amended versions of previously submitted MRTP applications from Swedish Match North America Inc., Richmond, Va., for eight snus smokeless tobacco products sold under the General brand.

Earlier this year, in regard to MRTP applications for Winston-Salem, N.C.-based Reynolds American Inc.’s Camel Snus products, TPSAC recognized that the available science supports that switching completely from cigarettes to Camel Snus can reduce risks of lung cancer and respiratory disease. The TPSAC has not has yet issued an MRTP marketing order on Camel Snus.

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