The Food and Drug Administration issued orders on Tuesday calling for the end of sales and distribution of four R. J. Reynolds Tobacco Company cigarette products. The products were deemed to be in violation of the Federal Food, Drug, and Cosmetic Act.
The four brands include Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall mall Deep Set Recessed Filter Menthol, and Vantage Tech 13.
The agency concluded that the products have “different characteristics than the predicate products,” or that the four products have changed in composition from their previous versions, the FDA said in a press release. R. J. Reynolds failed to show how the new formulations did not raise different public health questions, thereby conflicting with the FD&C Act. In the example of Camel Crush Bold, the company was unable to show how the addition of a menthol capsule did not change consumer perception and use of the product.
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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,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said. “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.”
The FDA is giving retailers 30 days to stop selling these four products, after which the products will be considered “adulterated and misbranded,” thereby making it illegal to sell them in the United States and subjecting retailers to prosecution and/or fines.
