Reynolds Disagrees With FDA's Stop-Sale Orders

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Reynolds Disagrees With FDA's Stop-Sale Orders


WINSTON-SALEM, N.C. — R.J. Reynolds Tobacco Co. is exploring its options after the Food and Drug Administration (FDA) ordered the company to stop selling four of its cigarette brands.

In a statement on Wednesday afternoon, the tobacco company said it "strongly disagrees" with the FDA's ruling that 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, 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." 

All of the brands included in the order represent a very small portion of R.J. Reynolds' business, less than 0.4 share of the market. 

"Our submissions to the agency on these brands were comprehensive and we believe we effectively demonstrated substantial equivalence. We're examining all of our options at this time," Gentry said. 

Based in Winston-Salem, R.J. Reynolds is an indirect subsidiary of Reynolds American Inc. Its brands include Newport, Camel, Pall Mall, Doral, Misty and Capri.