FDA bans U.S. sale of 4 RJ Reynolds cigarette brands; company 'strongly disagrees'

By Doug G. Ware

SILVER SPRING, Md., Sept. 15 (UPI) -- The U.S. Food and Drug Administration on Tuesday announced it was ordering the stop of sales of four brands of cigarettes made by Reynolds American, also known as RJ Reynolds.

The FDA said the order affects Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 brands. Officials ordered the halt of sales of these brands because they differed than their "predicate" versions.


In other words, the banned brands were found by the FDA to be not substantially equivalent to earlier versions of the brands previously approved by the administration and sold by the company.

"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," the FDA said in a statement Tuesday. "Consequently, at this time, these products can no longer be sold, distributed, imported or marketed in interstate commerce."

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"These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law."


RJ Reynolds strenuously disagreed with the agency's decision.

"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," Jeffery S. Gentry, the chief scientific officer for RJ Reynolds, said. "Our product stewardship process is rigorous and ensures that we are producing the highest quality products that meet regulatory requirements."

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The FDA said the addition of menthol or other ingredients, when compared to the predicate materials, led them to determine the products need additional review. The menthol capsule in the Camel Crush Bold brand, it also noted, may have altered consumer perception and use of that product.

Effectively, the NSE orders deem the four cigarette brands to be adulterated and misbranded, and thus illegal.

Reynolds American said it is working to determine its plan of action in light of the FDA's declaration.

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"We're examining all of our options at this time," Gentry said.

Retailers have 30 days to remove the affected brands from their inventories, the agency said. The company said the affected brands account for a very small portion -- 0.4 percent -- of its overall market presence.

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