FDA Grants First-Ever Modified Risk Orders to General Snus

FDA Grants First-Ever Modified Risk Orders to General Snus

For the first time ever, the U.S. Food and Drug Administration (FDA) has authorized the marketing of products through the modified risk tobacco product (MRTP) process. The authorization was granted for eight suns smokeless tobacco products manufactured by Swedish Match USA and sold under the “General” brand name.

These products were previously sold in the U.S. without the modified risk claims in response to Swedish Match USA filing premarket tobacco applications (PMTAs) for these products. With the MRTP authorization, Swedish Match USA can now market these eight 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 granted the use of this modified risk claim after reviewing scientific evidence submitted by the company that supported the claim.

Being able to market these snus products with the modified risk claim, Swedish Match USA had to agree to advertise and promote these products with restrictions, including restricting advertising to adults. All packaging must also display a warning statement that’s required for all smokeless products. The FDA cautions that these products are not necessarily safe nor are they “FDA approved.” The modified risk orders are product-specific and limited to five years.

“Today’s action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers, but only following a thorough scientific evaluation by the FDA. Our team of scientific experts examined these applications to ensure that the tobacco products meet the public health standards in the law. While we are authorizing these specific modified risk tobacco products, it’s important for the public to understand that all tobacco products — including these — pose risk. Anyone who does not currently use tobacco products, especially youth, should refrain from doing so,” commented acting FDA Commissioner Ned Sharpless, M.D.