SILVER SPRING, Md. — The U.S. Food and Drug Administration is ordering retailers to stop selling 13 tobacco products.
The products—from R.J. Reynolds Tobacco Co., U.S. Smokeless Tobacco Co. and Heritage Tobacco LLC—can no longer be distributed, imported, sold, marketed or promoted in the United States, according to an announcement from the FDA, Silver Springs, Md.
The FDA issued in May non-substantially equivalent orders for the products, which were provisionally permitted to be sold on the market since 2011. The tobacco products are now misbranded and adulterated, according to the FDA.
Those products include:
- R.J. Reynolds Tobacco Co., Winston-Salem, N.C.: Camel Sticks Mint, Viceroy Flex, Camel Strips Mint and Camel Orbs Mint.
- U.S. Smokeless Tobacco Co., Greenwich, Conn.: Skoal Smooth Mint Tobacco Stick, Skoal Rich Tobacco Stick, Skoal Mint Tobacco Stick and Skoal Original Tobacco Stick
- Heritage Tobacco LLC, Miami: Union Full Flavor 100’s Box, Union Gold 100’s Box, Union Platinum 100’s Box, Union Menthol 100’s Box and Union Menthol Gold 100’s Box.
Retailers with remaining inventory should work with the product manufacturer or supplier to discuss options for disposing of the products, the FDA said. Failure to comply may result in the FDA taking regulatory action without further notice, the administration said.
These products were formally allowed to be marketed because new tobacco products first commercially marketed after Feb. 15, 2007 but before March 22, 2011 with a substantial equivalence report submitted to the FDA by March 22, 2001 could remain on the market, unless the FDA issued an order that the new product is not substantially equivalent, the FDA said.
The FDA determined upon review of substantial equivalence reports submitted by R.J. Reynolds Tobacco Co. and U.S. Smokeless Tobacco Co. that the new tobacco products were not substantially equivalent to the predicate tobacco products. The FDA found in both applications, there were differences in characteristics between the new and corresponding tobacco products, some of which raised questions of public health.
The FDA determined information submitted by the Heritage Tobacco LLC cigarette products failed to demonstrate the tobacco products listed in the substantial equivalence reports were commercially marketed in the U.S. as of Feb. 15, 2007; and therefore were not eligible predicate tobacco products.
An eligible predicate tobacco product is a tobacco product commercially marketed in the United States as of Feb. 15, 2007, or a tobacco product that the FDA previously determined to be substantially equivalent and in compliance with the requirements of the Federal Food, Drug and Cosmetic Act.
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