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November 1, 2022

Appeals Court Grants Logic Temporary Stay of Menthol MDOs

May 9, 2023 update
Logic and the FDA took part in oral arguments today in the Third Circuit Court of Appeals, debating the FDA's MDOs for menthol Logic vape products.

Nov. 1 update
On Oct. 28, the Third Circuit Court of Appeals temporarily stayed the marketing denial orders (MDOs) issued to Logic LLC for its menthol-flavored refills for Logic Pro and Logic Power devices. The court order allows Logic to continue selling its menthol refills until the court decides on a motion for a full stay pending review of the MDO.

Logic filed its petition for review of the MDO on Oct. 27, along with an emergency motion for a temporary stay. The company was given seven days from Oct. 28 by the court to file a motion for a full stay pending review. The FDA will then have 10 days to file a response.

On Oct. 27---the same day Logic filed its petition and motion for a temporary stay---a three-judge panel of the same court voted unanimously to deny Liquid Labs’ petition for review of its MDOs for flavored e-liquids. The Third Circuit has issued no other rulings on vape company challenges to the FDA.

Oct. 26, 2022
The FDA today issued its first marketing denial orders (MDOs) for menthol vaping products. The move suggests that the agency could bow to prohibitionist anti-vaping groups’ demands to eliminate all non-tobacco flavored vape products.

The FDA has already issued MDOs for nearly all vape products in flavors other than tobacco and menthol. There has been considerable speculation that menthol vapes would be spared in order to provide alternatives for people who smoke menthol cigarettes, which the agency intends to remove from the market. The FDA began the process of banning menthol cigarettes and flavored cigars in March with a draft rule and public comment period.

To date, the FDA has not authorized a single product in any flavor other than tobacco, and has not authorized any bottled e-liquid or refillable products in any flavor, including tobacco.

Logic receives the first menthol vape product MDOs

The products named by the FDA that received MDOs are the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package—both refill cartridges for the Logic Pro and Logic Power devices. The same devices were authorized for sale by the FDA in March, along with tobacco-flavored refills.

The Logic Pro is a vape pen with drop-in sealed capsules that hold 1.5 mL of e-liquid. The Logic Power is a rechargeable cigalike-style device with traditional screw-in cartomizer refills.

The FDA press release seems to indicate that additional Logic products received denials today. It says that MDOs were issued for “several e-cigarette products currently marketed by Logic,” and went on to confusingly note that “the FDA publicly names only products that the applicant is marketing.”

How an unnamed product can be “currently marketed,” and at the same time not named because it is not currently marketed was not explained by the agency. When the FDA authorized tobacco-flavored Logic refills in March, it stated that it had “issued marketing denial orders to Logic for multiple other ENDS products,” but that the company’s menthol refills remained under review.

Logic is owned by Japan Tobacco International (JTI), one of the largest tobacco companies in the world. Presumably Logic’s premarket tobacco applications (PMTAs) were detailed and thorough.

Logic’s options now are to comply with the FDA order and remove its menthol products from the market, or to challenge the agency in court or through an internal FDA appeal. Dozens of vaping companies have chosen to fight MDOs in federal court.

FDA logic: menthol vapes denied, menthol cigarettes authorized

The FDA says Logic did not provide enough evidence in its PMTAs to prove “that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.”

When announcing its first denials of flavored vape products in August 2021, the FDA took pains to separate menthol from other flavors. “The scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises unique considerations,” said the FDA’s Aug. 26, 2021 statement.

Today the agency seems to have decided that the “unique considerations” have been settled, and that menthol poses the same “risks to youth” that other flavors do. The regulator cites 2022 National Youth Tobacco Survey data as evidence.

“For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use,” says today’s FDA press release. “Recent data from the 2022 National Youth Tobacco Survey found most (84.9%) youth who used e-cigarettes in the past 30 days used non-tobacco-flavored e-cigarettes, and of them, 26.6% used menthol-flavored e-cigarettes. Additionally, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk of youth uptake.”

The FDA ignores the fact that a majority of youth vapers use unauthorized, gray market disposable vapes, available in all kinds of flavors, many of them mentholated. They will continue using those products too, while the FDA pursues its goal of eliminating legal vaping, locked into the belief that its “authority” has some effect on the market. The illegal market will grow even more quickly if FDA cuts off a legal path for menthol vaping products.

It’s worth remembering that one menthol product has been authorized by the FDA. 22nd Century Group’s VLN Menthol King cigarettes are currently being sold with FDA’s okay under both PMTA and modified risk (MRTP) pathways.

The FDA clearly believes Logic’s menthol vaping products—and perhaps all menthol vaping products—pose more risk than 22nd Century’s combustible cigarettes. Despite emitting no smoke, tar or carbon monoxide, the agency has decided that at least some menthol vapes are a greater danger to public health than menthol cigarettes. It’s logic only a prohibitionist could understand.

Note (Oct. 28)
Some readers have noted that Juul Labs' MDO included that company's menthol JUUL pods. That is true---which means the Logic menthol pods aren't technically the first menthol products to receive denials. However, the Juul products were denied based on a purported toxicological issue, not on the basis that their menthol flavor posed a special threat to youth. Further, FDA soon backed down and agreed to re-review Juul's PMTA.

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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