The FDA has issued Marketing Denial Orders (MDOs) for two menthol e-cigarette products currently marketed by RJ Reynolds Vapor.
In today's press release, the regulator said the products included Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%. Reynolds is now prohibited from marketing or distributing these products in the U.S., or they risk an FDA enforcement action.
Companies may resubmit applications or submit new applications to address deficiencies in products subject to these MDOs. The company could also sue over the agency's refusal.
"Consistent with the authority delegated by Congress, FDA remains committed to evaluating the use of new tobacco products against public health criteria that consider the risks and benefits of tobacco products for the entire population," said FDA Director Brian King.
The FDA's Center for Tobacco Products wrote: "The applications for these products do not provide sufficient scientific evidence to show that the potential benefits to adult smokers outweigh the risks of youth initiation and use."
The FDA is not expected to approve any flavored vaping products in the near future.
According to Logic's lawyers, a recent memorandum filed with the U.S. Court of Appeals for the Third Circuit shows that Foods of America and CTP King ignored the advice of FDA scientists and revoked the recommended marketing approval for Logic Technology's menthol vaping product. Logic obtained the new documents after Logic filed a motion to stay a Marketing Denial Order (MDO) for its menthol vaping products.
Vuse products cannot be legally introduced into interstate commerce in the United States without risking FDA enforcement. In addition to ensuring that manufacturers comply with this order, as with unauthorized products in general, FDA also intends to ensure compliance by distributors and retailers. Retailers should contact RJ Reynolds Vapor Company with any questions regarding product in stock.
"Today's decision relates to the specific application submitted for FDA review," Kim said. "The onus is on the applicant to provide sufficiently robust scientific evidence that the necessary public health standard has been met. In this case, the evidence provided did not meet that standard."