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

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

FDA concludes completely switching from cigarettes to these authorized products lowers certain health risks

The U.S. Food and Drug Administration announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name. These products had previously been authorized for U.S. sale without modified risk claims by the FDA in 2015 in response to filings of premarket tobacco applications (PMTAs). Today’s action further authorizes the manufacturer to market these specific products with the 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 FDA made this authorization after reviewing scientific evidence submitted by the company that supports this claim. In an effort to help prevent youth access and...

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