FDA grants first modified risk orders to smokeless tobacco products
WHITE OAK, Md., U.S.: For the first time, the U.S. Food and Drug Administration (FDA) has authorized the marketing of products through the modified risk tobacco product pathway. The authorizations were granted to eight Swedish Match snus smokeless tobacco products sold under the General brand name in the U.S. The products will now be marketed under the assumption that using General Snus instead of cigarettes decreases the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
The FDA’s decision to authorize the products came after a thorough scientific analysis and is limited to five years. The agency has imposed severe advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults. In addition, the products’ packaging and advertising must bear the warning statements required for all smokeless tobacco products. The advertising regulations are planned to help prevent youth access to snus use and exposure.
The decision permits the aforementioned products to be sold in the U.S. with a modified risk claim, but it does not guarantee product safety or imply that the product has obtained the FDA’s stamp of approval. According to the FDA, all tobacco products pose risks and people who do not use tobacco products should continue to resist tobacco use.
“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,” said Dr. Norman E. Sharpless, acting Commissioner of Food and Drugs at the time.
“In addition to stringent restrictions to limit youth access and exposure to advertising, this time-limited authorization comes with a number of postmarket 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,” he concluded.
The use of the smokeless tobacco product snus—finely ground tobacco typically packaged in a pouch that is placed under the upper lip—remains controversial. In Sweden, where snus originated, widespread use of the product has helped the country to almost stub out cigarette use. Just 5% of adults in Sweden smoke cigarettes daily, but the opinions of public health researchers differ on whether snus is safer than lighting up.
The sale of snus has been banned in all European Union member states except Sweden since 1992, and the Court of Justice of the European Union dismissed a challenge to the ban in November 2018.