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.

“In addition to stringent restrictions to limit youth access and exposure to advertising, this time-limited authorization comes with a number of post-market requirements that will allow us to keep a close watch on the marketplace. Should any information lead us to determine that the marketing of these products as posing less risk no longer benefits the health of the population as a whole, the agency would consider withdrawing this authorization.”

An important piece of scientific evidence that was submitted for review was the including long-term epidemiological studies that showed that relative to cigarette smoking, exclusive use of these specific smokeless tobacco products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. Other evidence demonstrated that consumers are able to understand the claim and the relative risk of the products, and that seeing the claim influenced their intentions to buy the products among smokers 25 years of age or older, a group the FDA feels would benefit the most from the modified risk tobacco products. Evidence also showed that when used exclusively instead of other smokeless tobacco products, General snus products offer potential for reductions in oral cancer risk.

You can read the full press release from the FDA on General snus’ modified risk authorization by clicking here.

For all the latest news from Swedish Match, visit swedishmatch.com.