FDA issues order to stop sales on 4 cigarette products

Information derived from The Daily Intake, 
a legal and regulatory service blog by Keller and Heckman LLP


On September 15, 2015, FDA issued orders to stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products.  FDA evaluated the company’s SE applications and found that the following cigarettes have “different characteristics than the predicate products and that the manufacturer failed to show that the new products do not raise different questions of public health when compared to them.”

  • Camel Crush Bold,
  • Pall Mall Deep Set Recessed Filter,
  • Pall Mall Deep Set Recessed Filter Menthol, and
  • Vantage Tech 13 cigarettes

All were NSE to their respective predicate products.

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When FDA issues an NSE order, the tobacco product subject to the order becomes adulterated and misbranded; thus, further marketing or distribution is prohibited.  FDA has stated that it will not take enforcement action against retailers for 30 days to give them sufficient time to dispose of current inventory.  FDA’s NSE orders mark the first time that the Agency has ordered a company to pull a major brand off the market and serves as a reminder to the tobacco industry of FDA’s significant authorities under the Tobacco Control Act.