WASHINGTON, D.C.—For the first time, a tobacco producer, Swedish Match USA, has received Food and Drug Administration (FDA) authorization to market certain tobacco products as safer than cigarettes, the FDA announced Tuesday in a press release. The authorization includes eight snus products—smokeless tobacco pouches that are tucked under the lip similar to chewing tobacco—sold under the “General” brand name.
FDA said it has authorized Swedish Match 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.”
In 2015, the FDA authorized the smokeless tobacco products for sale in the United States but without the reduced risk claim. The new allowance still requires warning statements on the product packaging and advertising, along with stringent restrictions on advertising to youth and youth access.
“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,” said Acting FDA Commissioner Ned Sharpless, M.D.
Politico reports that the FDA opened the door to companies making such claims of safer tobacco products, or so-called modified risk tobacco products (MRTP), through the 2009 Tobacco Control Act, with the stipulation that companies must demonstrate and produce evidence that the product carried a reduced risk of tobacco-related disease than other commercially marketed tobacco products.
The evidence submitted by Swedish Match included long-term epidemiological studies that demonstrated lower health risks for the smokeless tobacco products relative to smoking tobacco, allowing the MRTP authorization. The authorization is set to last for five years, and Swedish Match can apply for a renewal.