FDA Denies Substantial Equivalence Applications for 13 Tobacco Products

FDA Denies Substantial Equivalence Applications for 13 Tobacco Products

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

The FDA is calling for the following products to not be sold, distributed, importer, marketed or promoted int he U.S. and considers them to be 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.

Each of these products were released after Feb. 15, 2007 and were allowed to remain on the market because of a submitted substantial equivalence report that was submitted to the FDA on or before March 22, 2001. The FDA reviewed the submitted substantial equivalence reports from R.J. Reynolds Tobacco Co. and U.S. Smokeless Tobacco Co. and determined that these products were not substantially equivalent to predicate tobacco products due to different characteristics between the new and old products. When reviewing the substantial equivalence reports from Heritage Tobacco, LLC, the FDA determined that the company failed to demonstrate that the tobacco products in question were commercially marketed in the U.S. before the 2007 predicate date. The FDA is advising retailers with any of these products to work with the manufacturers to figure out how to properly dispose of these new illegal products. The FDA will take further action without notice should they find these products still on the market going forward.

In a report from the Winston-Salem Journal, Reynolds responded to this news that the order would have no impact on its business because the products in question had not been sold in the U.S. since the end of 2013.

All covered tobacco products–including cigars, pipe tobacco, and vapor products–are subject to the substantial equivalence process. For those manufacturers in the vapor and premium cigar categories, they must submit the required substantial equivalence reports for any product sold and marketed in the U.S. after Feb. 15, 2007 to the FDA by Sept. 9, 2020 [read more here].

You can view the FDA’s letter to R.J. Reynolds Tobacco Company notifying it of the non-substantial equivalence status by clicking here.