FDA Denies Marketing of 2 Vuse Menthol Products
Unsurprisingly, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company.
In a release today, the regulatory agency said that the products include the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now banned from marketing or distributing these products in the U.S. or they risk FDA enforcement action.
The company may resubmit applications or submit new applications to address the deficiencies of the products that are subject to these MDOs. The company may also file a lawsuit against the agency’s denial.
“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, director of the FDA’s Center for Tobacco Products, wrote. “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
The FDA isn’t expected to approve any flavored vaping products in the near future.
Memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that the U.S. Food and CTP King, reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. The new documents were made available to Logic after it had filed its motion for a stay of its marketing denial order (MDO) for its menthol vaping products.
The Vuse products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory.
“Today’s decision pertains to the specific application submitted for review by FDA,” said King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”