Swedish Match Seeks FDA OK to Label Snus ‘Modified Risk’

Swedish Match Seeks FDA OK to Label Snus ‘Modified Risk’

Has filed application with Food & Drug Administration for General brand

Published in CSP Daily News – http://www.cspnet.com/category-news/tobacco/articles/swedish-match-seeks-fda-ok-label-snus-modified-risk

RICHMOND, Va. — Smokeless tobacco maker Swedish Match is asking the U.S. Food & Drug Administration (FDA) to certify its General-branded pouches of tobacco as less harmful than cigarettes, according to a report by the Associated Press.

The company, with North American headquarters in Richmond, Va., is filing an application with the FDA to approve the snus 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 United States.

Both the public health community and the major tobacco companies are watching closely how the FDA handles the products. The tobacco companies are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.

Swedish Match 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 AP. 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 does not 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 the FDA accepts Swedish Match’s more than 100,000-page application, the agency has one year to evaluate it.

“You would hope that products like General and, for that matter, other alternative, 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% in the United States by 2017.

General snus was first sold in Sweden in mid-1860s and has been sold in the United States since 2007. It is currently available nationwide in more than 20,000 stores, which keep it in small chillers to preserve the product.

AP said the brand has at least a 6% share of the retail market, dominated by Winston-Salem, N.C.-based Reynolds American Inc., which sells the market-leading Camel-branded snus, and Richmond, Va.-based Altria Group Inc., which sells Marlboro-branded snus.

Swedish Match’s snus brands make up 75% of the market in Scandinavia. But in the United States, the company said it only has a 10% share of the overall smokeless category.

The category grew about 5.5% in the United States last year, said the report.


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