Oct. 23, 2019 -- The maker of eight smokeless tobacco products known as snus can market them as being lower risk than regular cigarettes for giving users cancer, lung disease, and stroke, the FDA said Tuesday.
The smokeless products from Swedish Match, sold under the General brand, were cleared for sale in the U.S. in 2015 but without the claim of lower risk. The FDA says while they are lower risk, it does not mean the products are safe or FDA approved, the agency says.
"All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use,” the agency says in a news release.
The decision drew strong reaction from the Campaign for Tobacco-Free Kids and the American Lung Association.
"We are disappointed that the FDA did not put greater priority around protecting kids from these tobacco products, especially allowing flavored products," says Erika Sward, assistant vice president of national advocacy for the American Lung Association. Among the eight products included as lower risk are mint and wintergreen, flavors thought to appeal to teens.
Matt Myers, president of the Campaign for Tobacco-Free Kids, says in a statement that he also wants the FDA to ensure that the "products are not marketed to or used by kids and are marketed only to adult smokers." He calls for enforcement of the company’s promise to study the impact of its decision as part of its post-marketing research for the FDA. The FDA can also eliminate the modified risk authorization after 5 years if it’s having a negative impact on health.
The FDA says the evidence did not suggest ''significant youth initiation of these products" or that young adults who do not use tobacco currently would start using snus even with the modified risk claim.
Snus is a form of smokeless tobacco. Unlike other smokeless tobacco products, such as chewing tobacco, snuff, and dip, users don't need to spit when using snus.
Snus uses a traditional Scandinavian tobacco method, says Jim Solyst, vice president of federal regulatory affairs for Swedish Match USA. Users place the small packets or pouches of tobacco under their upper lip.
The FDA decision gives the company the ability to make its claims of lower risk in marketing content but not on the product labels, he says.
While cigarette smoking has declined in recent years, smokeless tobacco has not, the American Lung Association says. Nearly 4% of U.S. adults use smokeless tobacco in some form.
FDA spokesperson Jeremy Kahn says while the agency did not quantify the risk difference between snus and cigarettes, the conclusion was based on long-term evidence from Sweden and Norway finding lower risk.
"These General Snus products are manufactured differently from traditional smokeless products and have a different risk profile," Kahn says. Even though the cancer risk is expected to be lower from the products compared to other smokeless tobacco products, ''long-term use of these products is not without health risks."