The US Food and Drug Administration (FDA) ordered cigarette manufacturer RJ Reynolds to cease the sale and distribution of 4 currently marketed products — Camel Crush Bold, Vantage Tech 13, Pall Mall Deep Set Recessed Filter, and Pall Mall Deep Set Recessed Filter Menthol cigarettes — because they did not meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to a press release.
The FDA concluded that the 4 products did not resemble those that were originally released in 2007, and ruled them “not substantially equivalent” (NSE) to their predicate products. The newer products have different characteristics than previous versions, and the manufacturer failed to prove that the newer products do not have harmful effects on public health.
The FDA ruled that the 4 products can no longer be sold, distributed, imported, or marketed in interstate commerce. They were allowed to remain on the market on a provisional period required by the Family Smoking Prevention and Tobacco Control Act of 2009. RJ Reynolds Tobacco Company had to submit a substantial equivalence application in order for the products to progress through the provisional period. But the FDA found that the evidence submitted showed that the products in question were not the same as their predecessors.
The FDA requires that tobacco products with increased amounts of potentially harmful constituents, higher levels of menthol, or new ingredients must demonstrate that the new additions do not harm public health. Camel Crush Bold in particular had an added menthol capsule in the filter that the FDA claimed could affect consumer perception.
“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.”
Tobacco products in retail locations become misbranded after an NSE order, which means it is illegal to sell the product in interstate commerce, or sell the product once it is received from interstate commerce. However, the FDA does not enforce the rule on previously purchased tobacco products that retailers may still have in inventory for 30 days, and it only applies the rule to purchases made before the date of the FDA ruling.
The FDA encourages consumers and other parties to report the sale or distribution of the 4 tobacco products or other potential tobacco-related violations of the FD&C Act with the FDA’s Potential Tobacco Product Violation Reporting Form.