The US Food and Drug Administration announced that it has authorized the marketing of one brand of smokeless tobacco products as safer than cigarettes.
The authorizations are for eight Swedish Match snus smokeless tobacco products. These products had previously been authorized for US sale without modified risk claims by the FDA in 2015 in response to filings of premarket tobacco applications (PMTAs).
The FDA now has further authorized 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 exposure, the agency has also placed stringent advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults. In addition, the products’ packaging and advertising must also bear the warning statements required for all smokeless tobacco products.
While the decision permits the eight General brand snus smokeless tobacco products to be sold in the US with a modified risk claim, it does not mean these products are safe or “FDA approved,” according to a statement from the agency.
The FDA warns that all tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use. The modified risk orders are product-specific and limited to five years.
“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,” acting FDA commissioner Ned Sharpless, MD, says in a statement.