Says products didn’t meet requirement that they be substantially the same as existing cigarettes
WEDNESDAY, Sept. 16, 2015 (HealthDay News) — The U.S. Food and Drug Administration has ordered the R.J. Reynolds Tobacco Co. to stop selling four new cigarette brands because submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act, according to an announcement issued Sept. 15 by the agency.
The FDA determined that the cigarettes are substantially different from existing Reynolds tobacco products on the market and need a full agency review before they can be marketed. The cigarettes are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.
These new cigarettes contain higher levels of some ingredients and ingredients that were not in the comparison products, the agency said Tuesday. Camel Crush Bold, for example, contains a menthol capsule in its filter that the agency believes would make it more attractive to younger smokers.
“These products had been provisionally marketed while our scientific review has taken place,” Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, explained during a morning news conference. But going forward, these products can no longer “be sold, distributed, imported or marketed in interstate commerce,” Zeller said. Selling or distributing these brands could result in FDA enforcement action, including seizure, the agency said. Retail stores, however, have 30 days to dispose of any inventory on hand.
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