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Swedish Match seeks FDA approval to sell product as 'modified risk' tobacco

RICHMOND, Va. - Smokeless tobacco maker Swedish Match is asking the Food and Drug Administration to certify its General-branded pouches of tobacco as less harmful than cigarettes.

The company with its North American headquarters in Richmond, Virginia, is filing an application with the FDA to approve the snus (pronounced "snoose") products as "modified risk."

Snus — teabag-like pouches 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.

How the FDA handles the products is being closely watched by both the public health community and bigger tobacco companies, which are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.

The company is proposing to say that the product is addictive but is "substantially less risky than smoking," Jim Solyst, director of federal government affairs for Swedish Match North America, said in an interview with The Associated Press. Swedish Match also wants permission to remove one of the required health warning labels because Solyst said there's "excellent scientific evidence" that the product doesn't cause oral cancer.

The application also highlights a philosophical debate over how best to control tobacco. One camp says there's no safe way to use tobacco and pushes for people to quit above all else. Others embrace the idea that lower-risk alternatives like smokeless tobacco or electronic cigarettes can improve public health, if they mean fewer people smoke.

A 2009 law gives 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. Once Swedish Match's more than 100,000-page application is accepted by the agency, the FDA has one year to evaluate it.

Tobacco companies want to market more smokeless tobacco and other alternatives like electronic cigarettes to make up for falling cigarette sales. But they can't 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.

"You would hope that products like General and, for that matter, other alternative products would encourage people to move from smoking to the alternative products," Solyst said.

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 per cent in the U.S. by 2017.

General (pronounced gen-er-AHL) 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 per cent 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 per cent of the market in Scandinavia. But in the U.S., the company said it only has a 10 per cent share of the overall smokeless category.

The category grew about 5.5 per cent in the U.S. last year but is still small when compared with cigarettes.

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Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.

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