The Food and Drug Administration, for the first time ever, will allow a tobacco company to advertise products as less harmful than smoking cigarettes.
The agency on Tuesday authorized Swedish Match to say eight of its General snus smokeless tobacco products "puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis" than smoking. This marks the first time the FDA has approved this type of request, known as a modified-risk tobacco product application.
"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," acting FDA Commissioner Ned Sharpless said in a statement.
While the FDA's review found using snus instead of cigarettes poses a lower risk of developing some tobacco-related diseases, it does not mean the products are safe. Snus is a type of smokeless tobacco. The ground tobacco is typically sold inside a pouch that users place inside their mouths.
For General snus-maker Swedish Match, the FDA's decision ends a five-year regulatory saga. For the broader tobacco industry, it will likely give companies hope they can win regulators' permission to advertise new tobacco products as less harmful alternatives to smoking cigarettes.
"Now that we know this pathway works, we'd want to look at it as a possibility for other products," Gerry Roerty, vice president of legal and general counsel of Swedish Match's U.S. division, said in an interview.
The FDA has embraced the idea that tobacco products exist on a continuum of risk, where cigarettes are on the most harmful end and other ways to consume nicotine are on the less harmful end. This idea has come under scrutiny amid an outbreak of a deadly vaping-related lung disease that has sickened nearly 1,500 people and killed at least 33.
Jefferies analyst Owen Bennett called Tuesday's decision positive for the industry because it shows the FDA is committed to allowing less harmful alternatives on the market. He told clients in a research note that the designation could also comfort consumers as they question the safety of e-cigarettes.
"It is essentially the FDA endorsing the product as a less harmful alternative to cigarettes, while also giving the consumer comfort the product meets strict standards," Bennett wrote. "Such endorsement could prove very valuable in the current environment where there is an increasing consumer demand for less harmful products, while at the same time there are many fears around the safety of vaping."
Swedish Match first petitioned the FDA in 2014 to exempt its General snus products from the standard warning label that says smokeless tobacco products can cause gum disease and tooth loss. The FDA denied the request in 2016 and encouraged Swedish Match to modify its application.
Swedish Match often touts what it calls "the Swedish Experience." Snus is popular in Sweden, though the country reports relatively low rates of tobacco-related illnesses. Yet snus is banned in every European Union nation except Sweden.
In the U.S., the landmark 2009 Family Smoking Prevention and Tobacco Control Act created an application for tobacco companies seeking to market their products as less harmful than cigarettes. The FDA scrutinizes the scientific evidence and evaluates the company's suggested claims before ultimately making its decision.
A handful of companies have submitted applications to advertise products as safer than cigarettes. Reynolds American, a unit of British American Tobacco, filed one for its Camel snus. Philip Morris International filed one for its heated tobacco product Iqos, which was recently cleared for sale. These marketing applications are still pending.
The FDA said its review of Swedish Match's application found science supported the claim and understood it. Relative to cigarette smoking, exclusive use of the snus products "poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis," the agency said in a press release.
The agency did not find evidence of minors using snus. Still, it set restrictions that prevent Swedish Match from marketing to youth, particularly online.
The FDA's authorization only lasts for five years. The company can apply to renew the current order.
U.S.-listed shares of Swedish Match rose 2.7% Tuesday.