For the first time, the U.S. Food and Drug Administration is allowing a tobacco company to advertise one of its products as less harmful than cigarettes.
The agency on Tuesday gave approval for the Richmond-based tobacco company Swedish Match North America to sell one of its smokeless tobacco products as “modified risk.” The designation means Swedish Match can market eight versions of its General Snus — a brand of oral, smokeless tobacco sold and consumed in small, tea bag-like pouches — as less risky to a user’s health when compared with smoking cigarettes.
General Snus is sold widely at retail stores in the U.S. The FDA authorization enables Swedish Match to claim that “using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
It is the first time the FDA has granted a modified-risk application under rules established when Congress gave the federal agency authority to regulate tobacco products in 2009. Under that law, tobacco companies cannot make health-related claims about their products in the U.S. without FDA authorization.
In a statement, Swedish Match — a Sweden-based company with its North American headquarters in downtown Richmond — called the decision “historic.”
“Today’s decision is a huge accomplishment for public health in the U.S. and another step toward realizing our vision of a world without cigarettes,” said Gerry Roerty, Swedish Match’s vice president and general counsel.
Swedish Match makes various types of smokeless and chewing tobacco and cigars, but not cigarettes. General Snus is made in Sweden.
Even with the modified risk approval, warning labels will remain on the General Snus tobacco cans. Those rotating labels, which have been required on smokeless tobacco products sold in the U.S. since 1986, warn consumers that the products can cause mouth cancer, gum disease or tooth loss.
However, Swedish Match can now use other ways to communicate to consumers that its snus (pronounced snoose) products are less risky than smoking.
“There is a range of marketing opportunities for us, including point-of-sale and websites,” said Jim Solyst, Swedish Match’s vice president for federal regulatory affairs.
“This decision reinforces that a reduction of risk can occur by switching to a product like General Snus,” Solyst said.
The FDA said Tuesday that it approved Swedish Match’s application after reviewing scientific evidence on the company’s snus products, including long-term epidemiological studies showing that using the products led to lower risk of certain diseases when compared with smoking.
However, the agency also warned that a modified-risk designation “does not mean these products are safe or ‘FDA approved.’”
“All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use,” the FDA said in a statement. “The modified risk orders are product-specific and limited to five years.”
The approval for the Swedish Match product comes as U.S. tobacco companies have been seeking to introduce new products to the market as alternatives to smoking conventional cigarettes.
The Henrico County-based tobacco company Altria Group Inc., for instance, has a modified-risk application pending before the FDA for a moist snuff product made by a subsidiary, U.S. Smokeless Tobacco Co.
Altria also is supporting a modified-risk application that Philip Morris International made to the FDA for its iQOS product, a smoking device that heats tobacco instead of burning it. Philip Morris International was spun off as a separate company from Altria in 2008, but Altria has the rights to sell the iQOS product in the U.S., and it recently introduced the product for a test market in the Atlanta area.
“We believe FDA’s modified risk tobacco product pathway is important and that adult tobacco consumers deserve accurate and scientifically grounded communications about tobacco products,” said Altria spokesman Steve Callahan.
In a note to investors, Wells Fargo analyst Bonnie Herzog called the Swedish Match approval “good news for the broader tobacco/nicotine industry, as it demonstrates the FDA’s commitment to a ‘continuum of risk’ strategy and provides a viable pathway/process for manufacturers.”