FDA orders retailers to stop selling 13 tobacco products

FDA released Not Substantially Equivalent (NSE) orders for 13 tobacco products that had been provisionally permitted to be sold on the market since 2011. The agency said these tobacco products are now adulterated and misbranded, and therefore can no longer be distributed, imported, sold, marketed, or promoted in the United States. The products include mint and menthol cigarette and smokeless tobacco products. FDA says retailers with remaining inventory of the combustible cigarette and smokeless tobacco products listed should consult with the product manufacturer or supplier to discuss options for disposing of these products. Noncompliance with the Federal Food, Drug and Cosmetic (FD&C) Act may result in FDA taking such regulatory actions as civil money penalties, seizure, and/or injunction. According to a scientific review of the Substantial Equivalence (SE) Reports submitted by R.J. Reynolds Tobacco Company and U.S. Smokeless Tobacco Company for their smokeless tobacco products, the new tobacco products were not substantially equivalent to the predicate tobacco products. Regarding Heritage Tobacco LLC’s cigarette products, FDA said the information the company submitted failed to sufficiently demonstrate that the predicate tobacco products listed in the SE Reports were commercially marketed in the United States as of February 15, 2007. As a result, they were not eligible predicate tobacco products.