WASHINGTON (Reuters) - In a decision that could reshape U.S. tobacco regulation, a health advisory panel will vote next week on whether Swedish Match AB, a Stockholm-based maker of smokeless tobacco products known as snus, can claim they are less harmful than cigarettes.
The closely watched vote could pave the way for the first Food and Drug Administration approval of a modified risk tobacco product and set a precedent for companies seeking to make similar claims. The two-day discussion will culminate in a vote on April 10th.
Snus is a moist smokeless tobacco product that users place underneath the upper lip. It can be bought loose, or in small teabag-like pouches. It does not involve chewing or spitting.
Swedish Match is asking permission to remove required warnings about mouth cancer, gum disease and tooth loss from its product packaging, saying there is no evidence to support a link between mouth disease and Swedish snus. It proposes retaining the risk of nicotine addiction.
The company also wants to replace a warning that smokeless tobacco is not a safe alternative to cigarettes with one that acknowledges no tobacco product is safe, but states its own products are substantially less risky than cigarettes.
The hurdles for winning approval are high.
In crafting the 2009 law giving the FDA authority to regulate tobacco, Congress, leery of the industry’s misleading marketing of implicitly safer “light” and “low tar” cigarettes, set rigorous standards for approving modified risk products.
Companies must show a product significantly reduces the risk of disease for individual tobacco users. It must also show a health benefit to the population as a whole, taking into account tobacco and non-tobacco users.
Products such as snus and e-cigarettes are generally considered safer than combustible cigarettes and may benefit a smoker who switches. But if smokers use both products instead of switching, or if the less risky products are taken up by people who otherwise would not have used any tobacco product, the calculus might be different.
Swedish Match believes it has a strong case.
Snus use in Sweden, particularly among men, has risen over the past 30 years. It is now the country’s most popular tobacco product. At the same time, smoking rates have plunged to the lowest in Europe. Smoking related diseases, including lung cancer and heart disease, have also fallen.
Azim Chowdhury, a partner at the law firm Keller and Heckman LLP, said regulators should not ignore such statistics. If FDA were to deny Swedish Match’s application, Chowdhury said, “they would basically be saying no-one will ever be approved.”
Scott Ballin, a health policy consultant based in Washington, D.C., agrees. He sees a 60 percent chance the advisory panel will vote in favor of Swedish Match but concedes opposition from public health groups is strong.
“If the committee responds to pressure from tobacco control advocates who believe that all tobacco is equally harmful then I think we will see it punting and suggesting more research needs to be done,” he said.
Opponents of approval argue FDA does not have legal authority to permit changes to government-mandated warning labels. Moreover, they say, the proposed label changes do not appropriately capture potential risks associated with snus.
“We don’t know yet whether or not we are going to see people use both products, or whether kids take up snus who would not otherwise have smoked,” said Erika Sward, an advocate with the American Lung Association.
Critics also say it is unclear whether the population-level benefits seen in Sweden would translate to the United States. Other factors, including more restrictive bans on advertising, could be at play.
“The real question isn’t whether a well done application for Swedish snus could qualify for a modified risk claim, it is whether this specific request should qualify,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.
Sandy Fowler-Jones, a Swedish Match spokeswoman, said the FDA “fully vetted” the legal issue before the company filed its application. The agency can permit changes to an individual product’s warning label, she said.
Adult smokeless tobacco use was 3.6 percent in 2012, according to the Centers for Disease Control and Prevention, with the highest rates among 18 to 25-year-old males.
The overall rate of snus use was 2.5 percent during the same period. Among high school boys it was 3.9 percent.
U.S. smokeless tobacco products include Altria Group’s Copenhagen, Skoal and Red Seal brands.
Altria also sells Marlboro snus and Reynolds American Inc sells Camel snus. These products would not be covered by any FDA decision on the Swedish Match product, but some anti-tobacco groups fear that consumers would not differentiate.
Swedish Match’s products follow standards for reducing heavy metals and other toxic substances that U.S. products are not bound by. In an odd twist, Swedish snus is banned in Europe outside Sweden for health reasons.
Cigarettes remain on the market.
Reporting by Toni Clarke in Washington; Editing by David Gregorio