WASHINGTON—The U.S. Food and Drug Administration (FDA) has issued Not Substantially Equivalent (NSE) orders for 13 tobacco products that had been provisionally permitted to be sold on the market since 2011. These tobacco products are now misbranded and adulterated and can no longer be distributed, imported, sold, marketed or promoted in the United States, the agency said.
The following products may no longer be sold:
R.J. Reynolds Tobacco Company
U.S. Smokeless Tobacco Company [PDF – 583KB]
Heritage Tobacco LLC [PDF – 613KB]
- Skoal Smooth Mint Tobacco Stick
- Skoal Rich Tobacco Stick
- Skoal Mint Tobacco Stick
- Skoal Original Tobacco Stick
- Union Full Flavor 100’s Box
- Union Gold 100’s Box
- Union Platinum 100’s Box
- Union Menthol 100’s Box
- Union Menthol Gold 100’s Box
Retailers with remaining inventory of the combustible cigarette and smokeless tobacco products listed above should work with the product manufacturer or supplier to discuss options for disposing of these products, the agency said. Failure to comply with the Federal Food, Drug and Cosmetic (FD&C) Act may result in FDA taking regulatory action without further notice. These actions may include but are not limited to civil money penalties, seizure, and/or injunction.
Upon 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, FDA said it determined that the new tobacco products were not substantially equivalent to the predicate tobacco products.
Regarding the Heritage Tobacco LLC cigarette products, the FDA determined the information submitted failed to sufficiently demonstrate that the predicate tobacco products listed in the SE Reports were commercially marketed in the United States as of Feb. 15, 2007; therefore, they were not eligible predicate tobacco products.
Before the issuance of the NSE orders, these provisional SE tobacco products were allowed to be marketed because new tobacco products first commercially marketed after Feb. 15, 2007, but before March 22, 2011—with an SE Report submitted to the FDA by March 22, 2011—could remain on the market unless the FDA issued an order that the new products were not substantially equivalent.