The US FDA has issued orders that will stop the further sale and distribution of four currently marketed RJ Reynolds Tobacco Company cigarette products. The company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to an agency news announcement.
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 (ie, 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.
“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, JD, 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.”