For the first time since it was given the power to regulate tobacco, the US Food and Drug Administration (FDA) has authorized marketing of a new product.

The agency said that eight new smokeless snus products, to be sold in the United States under the “General” brand name by Stockholm-based Swedish Match AB, are now authorized under the premarket tobacco application pathway, which was established by the 2009 Family Smoking Prevention and Tobacco Control Act. Snus cannot be marketed as “FDA-approved,” however.

“Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed, as long as the public health can be protected,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a statement.

This is the first time any tobacco maker has completed the rigorous premarket tobacco application review process at the agency; others have had products approved by proving they are substantially equivalent to what is already on the market.

The agency said that Swedish Match provided evidence that “these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively.” The agency also agreed with the company that snus’ availability would not result in substantial new use, delay quit attempts, or attract ex-smokers.

Swedish Match had been seeking separately to remove warnings that snus is harmful, but the agency has not yet ruled on that request.

In that separate application, Swedish Match was seeking to have the 10 types of snus it already sells in the United States designated as modified-risk tobacco products. The agency accepted the company’s application in August 2014 and held a meeting of its advisory panel to review the evidence in April 2015.

The company wanted to remove warnings that snus could cause gum disease and tooth loss or mouth cancer. It also sought to label its products with the statement that reads, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” The advisory committee could not reach consensus on whether snus was a safer alternative to smoking, and also was not convinced that the product would not attract new users. At that meeting, Dennis Henigan, director of legal and policy analysis for the Campaign for Tobacco-Free Kids, said Swedish Match had failed to show that users would not use both cigarettes and snus, or that young people would not initiate use.

Snus, which is ground tobacco, salt, and water, comes in a pouch that users place under their upper lip. It can be used for up to 30 minutes, according to the company. It is popular in Sweden, but less so in the United States. Swedish Match says its General brand accounts for 11% of American convenience store snus sales. The 60 million cans it sells annually in the United States are dwarfed by the billion cans of smokeless tobacco sold.

The Centers for Disease Control and Prevention estimates that less than 4% of adults use smokeless tobacco, with rates highest among men aged 18 to 25 years (10%). A 2014 Centers for Disease Control and Prevention survey of high school students found that 5.5% of overall used smokeless tobacco, and an additional 1.9% reported current use of snus.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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