FDA Halts Sale of Four R.J. Reynolds Products

The U.S. Food and Drug Administration on Sept. 15 issued orders to stop the sale and distribution of four R.J. Reynolds cigarette products because they did not meet requirements set forth in the federal Food, Drug and Cosmetic Act.
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The U.S. Food and Drug Administration on Sept. 15 issued orders to stop the sale and distribution of four R.J. Reynolds cigarette products because they did not meet requirements set forth in the federal Food, Drug and Cosmetic Act.

Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes can no longer be sold, distributed, imported or marketed in interstate commerce, the FDA said. 

FDA said it would refrain from taking enforcement action on previously purchased merchandise for 30 days. Retailers may continue to sell existing inventory throughOct. 15 provided it was purchased by the retailer before the ruling was issued on Sept. 15.

Any inventory purchased after Sept. 15 should be pulled from store shelves immediately. Retailers who continue to sell merchandise purchased after Sept. 15 face FDA violations. NATSO is encouraging retailers to contact their supplier or manufacturer to discuss options for disposing of existing inventory.

The FDA ruled that the four R.J. Reynolds’ brands were “not substantially equivalent” to their respective predicate products as identified by the manufacturer. Predicate products are products that were commercially marketed as of Feb. 15, 2007. The FDA concluded that these products have different characteristics and said the manufacturer failed to show that the new products do not raise different public health questions than their previous counterparts. 

 

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