FDA Orders R.J. Reynolds Tobacco To Stop Selling Four Cigarette Products

(RTTNews) - The U.S. Food and Drug Administration issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products - including its Camel Crush Bold brand - because the company's submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic 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 or NSE to their respective "predicate" products (i.e., products that were commercially marketed as of Feb. 15, 2007) as identified by the manufacturer.

More specifically, 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.

Responding to the FDA decision, R.J. Reynolds Tobacco Company, an indirect subsidiary of Reynolds American Inc. (RAI), said that it strongly disagrees with the U.S. Food and Drug Administration's ruling that four of the company's brands - Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 - are not substantially equivalent to their respective "predicate" products.

"We believe that our substantial equivalent applications fully satisfied the guidance the agency provided, and we respectfully disagree with their evaluations of the products in question," said Jeffery S. Gentry, Ph.D., executive vice president of operations and chief scientific officer for R.J. Reynolds. "We supplied the agency with extensive information on each of the products, and responded to all of the agency's questions. Our product stewardship process is rigorous and ensures that we are producing the highest quality products that meet regulatory requirements."