FDA Clears First Tobacco Product for Marketing
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 [...]