FDA Rejects Menthol Refills for Vuse Vibe and Ciro

The FDA Center for Tobacco Products today denied marketing applications from R.J. Reynolds for menthol refills used in its Vuse Vibe and Vuse Ciro vape devices. The CTP action marks the second time the agency has issued a marketing denial order (MDO) for menthol vaping products based solely on the flavor itself.

“Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk,” the FDA said in a press release.

“Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol flavored e-cigarette products are likely to promote a complete switch or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes products.”

Both the Vibe and Ciro devices, and tobacco-flavored refills for both, were authorized by the CTP last May to be sold. At that time, the agency said the menthol refills were still under review. Neither Vuse device has a significant share of the convenience store/gas station vaping market segment. (The FDA has taken no action on Reynolds’ very popular Vuse Alto device or its refills.)

The FDA has not yet authorized any vaping products in flavors other than tobacco, and has not authorized any bottled e-liquid or open-system (refillable) products in any flavor, including tobacco. Manufacturers submitted millions of products for review through the FDA’s premarket tobacco application (PMTA) pathway.

Reynolds will challenge menthol MDO in court

Like Reynolds, vape manufacturer Logic received FDA authorization last spring for its Pro and Power devices, along with tobacco-flavored refills. However, last October, the FDA issued denial orders for menthol refills sold by Logic for those devices. The company quickly appealed the MDO, and received a temporary stay of the order from a federal appeals court.

R.J. Reynolds will likewise seek relief in the courts. The company announced today that it “intends to seek a stay of enforcement immediately and will pursue other appropriate avenues to allow Vuse to continue offering its innovative products.”

Dozens of smaller vaping manufacturers have appealed FDA denial orders in federal courts across the country, with mixed results. Last week, Triton Distribution was granted a rehearing of a failed appeal in the Fifth Circuit Court of Appeals.

CTP documents exposed in Logic’s lawsuit showed that the office of CTP Director Brian King pressured the center’s Office of Science (OS) to change its position on Logic’s menthol refills after the OS originally recommended authorizing them. The story was first reported last December by Filter’s Alex Norcia.

One of the internal FDA memos described by Norcia noted that the OS originally “concluded that the existing literature supports that menthol-flavored cigarette smokers show a preference for menthol-flavored ENDS relative to tobacco-flavored ENDS.” Discussions over the menthol issue between the OS and director’s office had gone on for months. But shortly after King took over as CTP director in July, the OS saw the light and flipped its position on Logic’s menthol product application.

Menthol is the new cotton candy

The FDA issued MDOs for nearly all vaping products in flavors other than tobacco and menthol in 2021, leaving most tobacco and menthol PMTAs under review, and authorizing a small handful of unpopular tobacco-flavored products. There had been speculation that the agency would authorize some menthol products as alternatives for people who smoke menthol cigarettes, which the FDA intends to ban.

When it announced the first MDOs for vape products in flavors other than tobacco and menthol, the CTP clearly distinguished menthol from other non-tobacco flavors. “The scientific review of menthol ENDS as compared to other non-tobacco-flavored ENDS products, raises unique considerations,” said the FDA.

But, as the FDA memos revealed in Logic’s legal filings show, the agency has now taken a different stance on menthol. New CTP director Brian King, a longtime foe of vaping, has brought with him the position of his comrades at anti-vaping tobacco control groups like the Campaign for Tobacco-Free Kids and Truth Initiative—that flavors are merely a trick to hook children on nicotine. To them, whether it’s the cotton candy and gummy bear flavors they love to demonize, or plain old menthol, the only good flavor is a dead flavor.

On the verge of killing the independent vaping industry, removing most nicotine from cigarettes, and banning menthol smokes, King and the prohibitionist wing of tobacco control are greedily trying to scratch all the items off their wish list at once. With a presidential administration amenable to such policies, the future of menthol—and all nicotine use—may come down to the courts.