FDA Orders the Suspension of 13 Tobacco Products From the Market

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The U.S. Food and Drug Administration (FDA) has ordered retailers to stop selling 13 different tobacco products after issuing non-substantial equivalent orders.

The FDA urges not to sell, distribute, import, sell, or promote the following products in the United States because these products are misbranded and adulterated:

  • Camel Sticks Mint, Viceroy Flex, Camel Strips Mint, and Camel Orbs Mint by R.J. Reynolds Tobacco Co.
  • Skoal Smooth Mint Tobacco Stick, Skoal Rich Tobacco Stick, Skoal Mint Tobacco Stick, and Skoal Original Tobacco Stick by U.S. Smokeless Tobacco Co.
  • Union Full Flavor 100s Box, Union Gold 100’s Box, Union Platinum 100’s Box, Union Menthol 100’s Box, and Union Menthol Gold 100’s Box by Heritage Tobacco, LLC.

These products were all released after February 15, 2007. Since the submitted substantial equivalent report submitted to the FDA on or before March 22, 2001, they were allowed to continue to place on the market. The FDA reviewed products from R.J. Reynolds Tobacco Co. and U.S. Smokeless Tobacco Co. and found that due to the different characteristics of the new and old products, these products are not substantially equivalent to predicate tobacco products. In reviewing the substantial equivalence report of Heritage Tobacco, LLC, the FDA determined that the company failed to prove that the tobacco product commercially sold in the United States before the 2007 predicate date. The FDA recommends that retailers using any of these products work with manufacturers to study how to dispose of these new illegal products properly. If the FDA finds that these products will continue to place on the market, it will take further action without notice.

Reynolds told Winston-Salem Journal that the order would not impact its business because related products have never sold in the United States since the end of 2013.

 

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