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March 17, 2023

FDA Denies Vuse Solo Menthol Refills, Cites Youth Appeal

March 20 update
The Fifth Circuit Court of Appeals has granted R.J. Reynolds a temporary stay of the FDA denial of the company's Vuse Solo menthol refills. The stay allows the company to sell the products at least until the court hears arguments over Reynolds' motion for a stay pending appeal.

The FDA has rejected another menthol vaping product—this time two menthol refills for the Vuse Solo. In 2021, the Solo device and its tobacco-flavored refills became the first vaping products to receive FDA marketing authorization. The Solo is a primitive cigalike-style vape, powered by a cigarette-shaped battery and using screw-on prefilled cartomizer refills.

In a press release, the FDA explained the Vuse Solo menthol refills didn’t meet the agency’s “appropriate for the protection of public health” standard because menthol e-cigarettes “have a known and substantial risk with regard to youth appeal, uptake and use.”

Since it began rejecting premarket tobacco applications (PMTAs) in August 2021, the FDA has issued marketing denial orders (MDOs) for millions of flavored e-liquids and pre-filled devices, but left most menthol products under review until after Brian King was appointed director the FDA’s Center for Tobacco Products last summer.

There had been speculation that the FDA would authorize some menthol products as low-risk alternatives for people who smoke menthol cigarettes, which the agency intends to ban. Since King’s arrival, however, the FDA has denied applications for menthol refills for multiple previously authorized mass-market vaping devices, beginning with refills for the Logic Pro and Logic Power.

Logic immediately challenged the FDA decision in court, and was granted a temporary stay of the denial order by the Third Circuit Court of Appeals. CTP documents unearthed in Logic’s lawsuit showed that the CTP director’s office (both before and after King took over) pressured the CTP Office of Science to reject Logic’s menthol refills after the science office initially recommended authorization.

In January, the agency issued MDOs for menthol refills for two previously authorized Vuse devices, the Vuse Ciro and Vuse Vibe. A day after the marketing denial order (MDO) was issued, the Fifth Circuit Court of Appeals granted Vuse manufacturer R.J. Reynolds a temporary stay of the order.

Reynolds will probably contest the Vuse Solo menthol MDO in court, as it is the Ciro and Vibe menthol denials. None of the three authorized Vuse products are popular, but Reynolds probably fears a denial order down the road for the Vuse Alto and its menthol refills. Unlike the three other Vuse products, the Alto is a leader in the convenience store/gas station segment of the vaping products market. The Alto PMTA remains under FDA review.

In its press release, the FDA disingenuously mentions that National Youth Tobacco Survey data show that Vuse is the “second most common brand youth e-cigarette users reported ‘usually’ using.” All three FDA-authorized Vuse products (and their menthol refills) are unpopular with users of all ages, and the agency knows that. The NYTS data refers largely to the very popular Vuse Alto.

R.J. Reynolds recently asked the FDA to crack down on popular disposable vapes that currently dominate the c-store/gas station vape marketplace.

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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John Hastings
John Hastings
6 months ago

More evidence that the FDA does not intend to approve flavors of any kind any time soon.