FDA grants first-ever modified risk orders to eight smokeless tobacco products

November 2019 – Vol. 38, No. 10

Even as citizens of the United States deal with previously unrecognized significant dangers related to vaping of many substances and aggressive marketing of Juul-type products, the FDA, on October 22, 2019, for the first time authorized the marketing of products through the modified risk of tobacco product (MRTP) pathway outlined in the 2009 Family Smoking Prevention and Tobacco Control Act.

This action authorizes the manufacturer to market these products with the following claim, “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 ruling limits marketing to adults, and the FDA placed stringent advertising and promotion restrictions on the products. This ruling affects eight products, and the modified risk orders are product-specific and limited to five years.

The FDA rightfully states, “All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use.” Unfortunately, while the packaging must also include the warning statements required for all smokeless tobacco products, those reading the package warning will not have access to the FDA’s full press release and will miss the message that no tobacco product has any positive health benefit.

The AAO-HNS opposes support of snus or any other tobacco or vaping product. This has significant potential to increase tobacco usage in the youth population as well as adults and give first-time users an unwarranted feeling of security in using these flavored tobacco products. We urge repeal of this MRTP for snus products.

Read the full release from the FDA at https://www.fda.gov/news-events/press-announcements/fda-grants-first-ever-modified-risk-orders-eight-smokeless-tobacco-products