FDA Orders RJR to Stop Selling Four Cigarette Brands
WASHINGTON — Today the U.S. Food & Drug Administration (FDA) issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Co. cigarette products because the company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug & Cosmetic Act (FD&C Act).
The FDA’s evaluation found that Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes were not substantially equivalent (NSE) to their respective “predicate” products (products that were commercially marketed as of Feb. 15, 2007) as identified by the manufacturer.
The agency concluded the products 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.
Consequently, at this time, these products can no longer be sold, distributed, imported or marketed in interstate commerce, the FDA said.
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