FDA panel wary of snus label request

WASHINGTON – Government health advisers have serious reservations about a proposal by Swedish Match to market its smokeless tobacco pouches as less harmful than cigarettes and other tobacco products.

The company is seeking Food and Drug Administration permission to remove or revise several warning labels on the pouches, called snus. It’s the first formal request the FDA has considered publicly since it gained authority to regulate tobacco products in 2009.

But a panel of FDA advisers said overwhelmingly Friday that company data do not support several key changes.

The eight-member panel voted unanimously that the company’s application does not show snus lacks the same risks of gum diseases and tooth loss as other smokeless tobacco products. Swedish Match has asked the FDA to drop those warnings from its U.S. offerings.

Snus are teabag-like pouches of loose tobacco that users stick between their cheek and gum to absorb nicotine. They are popular in Scandinavian countries and are part of a growing smokeless tobacco market in the U.S. Swedish Match holds about 9 percent of the U.S. market.

Swedish Match also wants the FDA to certify new language that its snus has “substantially lower risks to health than cigarettes.” The company points to studies showing snus is not associated with lung cancer, lung disease and other ailments tied to cigarettes.

But panelists said the company’s language oversimplifies the issue, since some snus users also smoke, exposing themselves to negative health effects from both products. Panelists voted unanimously that the company’s language does not adequately describe the health risks of snus, including pregnancy complications.