Swedish Match AB has failed to get a green light from U.S. advisers to ease warning labels on its snus tobacco packaging, though the panel was divided over whether the products are less risky than cigarettes.
Snus, the tiny packets of tobacco that fit between users’ lips and gums made by Stockholm-based Swedish Match, represent the first tobacco product to seek Food and Drug Administration clearance to make a modified-risk claim. A 2009 law that gave the FDA authority over tobacco products banned cigarette companies from using words such as “light” or “mild” on their products and required the agency to clear any labels that claim lower risk.
Swedish Match isn’t a big player in the U.S., where Reynolds American Inc.’s Camel snus holds more than 80 percent of the market, Vivien Azer, an analyst with Cowen & Co. wrote in a note to clients last week. Still, the FDA’s final decision could set the tone for others, the analyst wrote.
The FDA regulates tobacco products including cigarettes and smokeless tobacco, as well as snuff. The agency is finalizing its oversight of electronic cigarettes and cigars. Any tobacco product regulated by the FDA that is able to prove it is lower risk could potentially seek clearance for modified labels.
In a vote Friday, an FDA advisory panel tied 4-4 on whether the evidence showed that exclusive use of Swedish Match’s 10 snus products offered a substantially lower risk to health than smoking. Advisers mainly took issue with the word “substantially.”
The panel voted unanimously that Swedish Match’s proposed warning label inadequately communicates snus’ health risks. The label would omit required warnings that the products can cause mouth cancer, gum disease and tooth loss.
Proposed Label
The label also would include the statement: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” The snus label would maintain the addiction warning required on tobacco products.
FDA advisers also voted that if the FDA does allow some kind of modified risk statement on snus packaging, it should be made separate from the warnings.
The panel was tied 3-3, with two abstentions, over whether the evidence supported the claim that snus don’t cause oral cancer.
The FDA will consider the panel’s votes, though it doesn’t have to follow their recommendations when making a final decision.
News by Bloomberg, edited by ESM
