FDA grants 1st modified-risk claims for smokeless tobacco

2018 11 15 23 31 5737 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the first time for eight smokeless tobacco products from Swedish Match USA under its modified risk tobacco product (MRTP) pathway.

The authorization covers eight snus smokeless tobacco products sold by Swedish Match under its "General" brand name. These products had previously been authorized for sale in the U.S. without modified risk claims in 2015. WIth today's action, Swedish Match can now also market these 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 said it made this authorization after reviewing scientific evidence from the company that supports this claim. However, the agency has also placed stringent advertising and promotion restrictions on the products; advertising must be limited to adults, and the products' packaging and advertising must also bear the warning statements required for all smokeless tobacco products, according to the FDA.

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