Retailers have 30 days to dispose of inventory for Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 NACS Online
Recently, the U.S. Food and Drug Administration issued orders that will stop the further sale and distribution of four currently marketed R.J. Reynolds Tobacco Company cigarette products—including its Camel Crush Bold brand—because the company’s submissions for these products did not meet requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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 (i.e., products that were commercially marketed as of Feb. 15, 2007) as identified by the manufacturer. The FDA says that at this time, these products can no longer be sold, distributed, imported or marketed in interstate commerce.
“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, Ph.D., executive vice president of operations and chief scientific officer for R.J. Reynolds, in a statement. “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 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.
When the FDA issues an NSE order, the tobacco product in inventory, including at a retail location, becomes adulterated and misbranded. As a result, it is illegal to sell or distribute the product in interstate commerce, or sell or distribute the product received from interstate commerce. Doing so may result in the FDA initiating enforcement action, including seizure, without further notice.
Recognizing that retailers may have limited options for disposing of products in their current inventories, the FDA does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory. Importantly, the policy does not apply to inventory purchased by retailers after the date of the order. Retailers are encouraged to contact their supplier or manufacturer to discuss possible options for existing inventories at specific retailer locations.