FDA order requires retailers to stop sales of four cigarette products.
The U.S. Food and Drug Administration’s Center for Tobacco Products has announced the issuance of Not Substantially Equivalent orders that will stop the further distribution and sale of four R.J. Reynolds Tobacco Co. cigarette products.
R.J. Reynolds Tobacco Co. has released a statement in response that it strongly disagrees with the U.S. Food and Drug Administration (FDA)’s ruling that four of the company’s Brands—Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13—are not substantially equivalent (NSE) to—or did not have the same characteristics as—their respective “predicate” products.
“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 Gentry, Ph.D., executive vice president of operations and chief scientific officer for R.J. Reynolds. “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.
R.J. Reynolds Tobacco Co., an indirect subsidiary of Reynolds American Inc., is the second-largest tobacco company in the U.S.
The National Associate of Tobacco Outlets (NATO) outlines that the NSE order means that effective immediately upon the issuance of the order, it is illegal to sell or distribute these tobacco product in the U.S., to import the tobacco product into the U.S., or to receive, offer to sell, or sell the tobacco product. In addition, the FDA can seize a tobacco product that is the subject of an NSE order at any time.
So what does this mean for retailers? FDA has acknowledged that retailers may be unable to easily dispose of the NSE cigarette products currently on store shelves. For this reason, the FDA has stated that it does not intend to take enforcement action for 30 days on these four cigarette products that were previously purchased and held in a retailer’s inventory as of today. It is important to understand that this 30-day deferral of enforcement action only applies to the four R.J. Reynolds cigarette products in a retailer’s inventory today and does not extend to inventory of these four cigarette products purchased by retailers after today, NATO explained. In other words, retailers can continue to sell any inventory on hand today of the four R.J. Reynolds cigarette products through Oct. 15, 2015. The FDA recommended that retailers also contact their distributor or R.J. Reynolds Tobacco Co. to discuss possible options for existing inventory of these four cigarette products at retail stores.