FDA Issues MDOs for 2 Menthol Vuse Products

R.J. Reynolds plans to seek a stay of enforcement to challenge the agency’s decision.

January 25, 2023

WASHINGTON—The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for two menthol e-cigarette products marketed by R.J. Reynolds Vapor Company. The products are the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. These products must not be marketed or distributed in the U.S., according to the agency.

“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,” said Brian King, director of the FDA’s Center for Tobacco Products.

The FDA said R.J. Reynolds may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.

A spokesperson for R.J. Reynolds told NACS Daily that the company was disappointed in the FDA’s decision and intends to immediately seek a stay of enforcement, as well as pursue other appropriate avenues that would allow Vuse to be available to adult nicotine consumers.

“We believe that menthol vapor products are critical to helping adult smokers migrate away from combustible cigarettes. FDA’s decision, if allowed to go into effect, will harm, not benefit, public health. Reynolds will challenge the denials,” said the spokesperson. “We remain confident in the quality of all of Reynolds’ applications, and we believe that there is ample evidence for FDA to determine that the marketing of these products is appropriate for the protection of public health.”

The FDA said R.J. Reynolds’ premarket tobacco product applications (PMTAs) lacked sufficient evidence to demonstrate that permitting the marketing of the products would be “appropriate for the protection of the public health,” which is the standard required by the 2009 Family Smoking Prevention and Tobacco Control Act.

“This decision is especially troubling given FDA’s ongoing efforts to ban menthol cigarettes. Taken together, these decisions and actions threaten to deprive menthol smokers of innovative and potentially less harmful alternatives that appeal to their preferences,” said the R.J. Reynolds spokesperson. “We will challenge the denials.”

Last April, the FDA released two proposed tobacco product standards that would prohibit menthol as a characterizing flavor in cigarettes and prohibit all flavors other than tobacco in cigars. In August, the agency closed its comment period for the standards after receiving about 175,000 comments for the menthol cigarettes proposed rule and about 71,000 for the flavored cigars proposed rule.

“NACS believes that adopting these regulations that ban two of the most popular tobacco products in the U.S. will push a portion of current smokers to the illicit market and severely injure the convenience store industry,” wrote NACS in its comments to the FDA on the ban. “These bans seek to prohibit the use of two of the most popular tobacco products among adult users, and it is unrealistic to assume that demand for these products will just disappear. Instead, an illicit market for these products will emerge, creating a larger problem within tobacco regulation than the FDA hopes to solve by instituting these bans.”

In November, California voted to allow a law that bans the sale of flavored tobacco products, including menthol products. The law also bans the sale of pods for vape pens, tank-based systems and chewing tobacco. The law exempts hookah, expensive cigars and pipe tobacco.