Vape Companies vs FDA: Appeals and Legal Actions

Nov. 16, 2021
This article is an attempt to list all of the companies challenging the FDA’s Marketing Denial Orders (MDOs) in court, and to follow up on additional actions, including motions, stays, and decisions. We will also list administrative stays (or denials) issued by the FDA, based on MDO reviews conducted by the agency.

More than 30 companies have taken legal action to dispute FDA denials.

We’ve overhauled this article, making it easier to navigate. You can now view legal and administrative actions by date (with the newest events listed first) or by the companies involved (listed alphabetically). You can navigate to either section, or to our list of Vaping360 articles about MDO events, using the quick links at the top of the page.

The original article was posted Oct. 18, but many of the events predated the article. It is possible there are still companies that have filed legal challenges to MDOs we aren’t aware of. If you know of any, please comment or contact me. Likewise, if you’re aware of companies receiving denials of administrative review applications, please let us know.

Legal actions listed by date (newest first)

Feb. 27, 2024
A Tenth Circuit Court three-judge panel ruled unanimously against Cloud Nine Vapor Products and Electric Clouds in their consolidated MDO appeal. The companies could now ask for an en banc rehearing with all active Tenth Circuit judges, or request a hearing by the Supreme Court.

Feb. 15, 2024
The Fifth Circuit granted R.J. Reynolds’ motion to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution). The FDA may appeal its loss in Triton to the Supreme Court.

Feb. 14, 2024
An Eighth Circuit Court panel heard oral arguments from SWT Global Supply and the FDA regarding SWT’s appeal of MDOs for menthol e-liquids. (SWT also has a pending appeal for non-menthol-flavored products in the Fifth Circuit.)

Feb. 9, 2024
Lotus Vaping Technologies has petitioned the Supreme Court for review of the Ninth Circuit’s 2023 denial of the company’s petition for review of MDOs issued for over 200 flavored e-liquids.

Feb. 6, 2024
The Fifth Circuit Court denied the FDA’s motion for an en banc rehearing of R.J. Reynolds’ motions for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo and Alto) pending review, which were granted by the court. The stay pending review for the now-consolidated petitions remains in place.

Feb. 2, 2024
– The Fifth Circuit Court issued two orders in R.J. Reynolds’ now-consolidated appeals of MDOs for menthol Vuse Vibe, Solo and Alto refills. The first order denied the FDA’s motion to dismiss the Alto appeal or transfer it to a different circuit. The second order granted Reynolds’ motion for a stay pending review for the Vuse Alto menthol refills, and denied the FDA’s motion to lift previous stays granted to Reynolds for the Vibe and Solo refills.

– Bidi Vapor filed a motion asking the Eleventh Circuit Court to stay the MDO for its tobacco-flavored disposable Bidi Stick-Classic pending review. The company had filed a petition for review of the MDO on Jan. 26.

Feb. 1, 2024
R.J. Reynolds filed a motion asking the Fifth Circuit to stay proceedings in the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo and Alto), “pending resolution of any further proceedings” in Wages and White Lion v. FDA (Triton Distribution), “including before the Supreme Court of the United States.”

The court had previously ruled (on June 15, 2023) that the Vuse appeals should be held in abeyance (put on hold) pending the outcome of the Triton appeal, since both cases hinged on similar arguments. On Jan. 3, the Fifth Circuit decided in favor of Triton and against the FDA. That decision left a petition to the Supreme Court as the FDA’s only possibility for reversal of the Triton decision.

Jan. 22, 2024
Magellan has petitioned the Supreme Court to review the Second Circuit’s denial of the company’s appeal of MDOs for Juno refill pods.

Jan. 18, 2024
SMOK and a Texas-based distributor filed a petition for review in the Fifth Circuit of the FDA’s Jan. 16 MDO for 22 standalone SMOK hardware products.

Jan. 3, 2024
The Fifth Circuit ruled 10-6 for Triton and Vapetasia, granting their consolidated appeal, and sending their PMTAs back to the FDA for review.

Nov. 14, 2023
A Tenth Circuit Court panel heard oral arguments from Electric Clouds and Cloud Nine Vapor Products, and the FDA, in the companies’ appeal of FDA MDOs. The cases were previously consolidated (date unknown).

Oct. 19, 2023
– A Third Circuit Court panel decided 2-1 to deny Logic’s appeal of MDOs for Logic Power and Logic Pro menthol refills, issued a year ago. Judge David Porter dissented, noting that he believed the FDA’s sudden decision to treat menthol vapes like other flavors was a political rather than a scientific decision. Logic could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.