The FDA on Tuesday said it will accept comments on the company's application to market the snus (pronounced "snoose") products as "modified risk" for 180 days. Snus teabag-like pouches or loose tobacco that users stick between their cheek and gum to get their nicotine fix are popular in Scandinavian countries and are part of a growing smokeless tobacco market in the U.S.
The agency's scientific advisory panel also plans to review the application in about 90 days.
The entire review process is expected to take about a year under a 2009 law that gave the FDA authority to evaluate tobacco products for their health risks and lets the agency approve ones that could be marketed as safer than others. None has been given the OK yet, but the agency has noted that some tobacco products could pose less of a health risk to users than smoking.
In an application filed in June, the company, whose North American headquarters is in Richmond, is proposing to say that the snus products are addictive but substantially less risky than smoking. The company also wants permission to remove one of the required health warning labels relating to oral cancer.
Tobacco companies want to market more smokeless tobacco and other alternatives like electronic cigarettes to make up for falling cigarette sales. But they are not allowed to explicitly market them as less risky than cigarettes.
The question remains whether smokers, which total about 42 million adults in the U.S., are willing to switch, even if it means saving their lives.
Total sales of snus are about 50 million cans per year in the U.S., growing from virtually nothing in the mid-2000s, said the subsidiary of Stockholm-based Swedish Match AB.
Market researcher Euromonitor International estimates U.S. sales at $342 million in 2013 and predicts that snus retail volume will grow by about 20 percent in the U.S. by 2017.
General snus was first sold in Sweden in mid-1860s and has been sold in the U.S. since 2007. It is currently available nationwide in more than 20,000 stores and is kept in small chillers to preserve the product. The brand has at least a 6 percent share of the retail market, which is dominated by Winston-Salem, North Carolina-based Reynolds American Inc., which sells the market-leading Camel-branded snus, and Richmond, Virginia-based Altria Group Inc., which sells Marlboro-branded snus.
Swedish Match's snus brands make up 75 percent of the market in Scandinavia. But in the U.S., the company said it only has a 10 percent share of the overall smokeless category.
The category grew about 5.5 percent in the U.S. last year but is still small compared with cigarettes.