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)
July 2, 2024 – The Supreme Court has granted the FDA’s petition and agreed to hear the agency’s appeal of the Fifth Circuit’s ruling in favor of Triton Distribution. The case will be heard next term.
June 28, 2024 – The Supreme Court has scheduled a second conference for July 1 to discuss the four pending petitions for review (Triton, Magellan, Lotus and Logic) of lower court decisions regarding FDA marketing denials.
June 28, 2024 – The Supreme Court has overturned a decades-old precedent, ruling that courts no longer need to defer to federal agencies’ judgment when interpreting ambiguous laws. The ending of “Chevron deference” could have a major impact on future challenges to FDA vaping regulations.
June 6, 2024 – The FDA rescinded its MDO of all Juul Labs products and placed Juul’s PMTA back into scientific review.
June 4, 2024 – The Supreme Court has scheduled a conference for June 20 to discuss the four pending petitions for review (Triton, Magellan, Lotus and Logic) of lower court decisions regarding FDA marketing denials.
May 2024 – The FDA petitioned the Supreme Court to review the Fifth Circuit’s rulings that the Fifth Circuit is an appropriate venue for R.J. Reynolds’ appeals of Vuse menthol products.
April 15, 2024
– Logic Technology Development petitioned the Supreme Court to review the Third Circuit Court decision upholding the FDA’s MDO for Logic menthol refills.
– Bidi Vapor filed the first brief in its Eleventh Circuit challenge of the MDO issued in January for the Bidi Stick Classic.
March 19, 2024 – The FDA petitioned the Supreme Court to review the Fifth Circuit decision that nullified Triton Distribution’ MDOs and ordered the FDA to conduct a new PMTA review.
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.
– The Fifth Circuit consolidated R.J. Reynolds’ appeals of its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO, according to attorney Gregory Troutman. (The Vuse Solo menthol refill MDO appeal was previously consolidated with the Vibe appeal.)
Oct. 16, 2023 – The Fifth Circuit issued a temporary stay of the MDO issued to R.J. Reynolds for its Vuse Alto menthol pods on Oct. 13.
Oct. 10, 2023 – The Supreme Court refused to hear AVAIL Vapor’s appeal of its loss in the Fourth Circuit. The case was rejected without comment. According to legal expert Jonathan Adler, the Court may be waiting for a broader split of opinions among the circuit courts and a stronger case to hear.
Sept. 14, 2023 – Lotus Vaping Technologies’ motion for an en banc rehearing of its petition for review was denied by the Ninth Circuit.
Aug. 29, 2023 – A three-judge panel of the D.C. Circuit issued a divided decision in the Fontem US myblu appeal, granting Fontem’s petition for review of the MDOs for the myblu device and tobacco-flavored pods, and denying the company’s appeal of MDOs for most pods in flavors other than tobacco.
Aug. 21, 2023 – Lotus Vaping Technologies filed a motion in the Ninth Circuit for an en banc rehearing of its petition for review.
July 7, 2023 – A three-judge panel of the Ninth Circuit ruled unanimously to deny the consolidated Lotus Vaping Technologies/Nude Nicotine petition for review. The companies could now ask for an en banc rehearing with all active Ninth Circuit judges, or request a hearing by the Supreme Court.
June 27, 2023 – The Fifth Circuit denied a motion (filed earlier in June) by the FDA to transfer R.J. Reynolds’ Vuse menthol MDO appeal to the District of Columbia Circuit Court.
June 16, 2023 – A Second Circuit three-judge panel unanimously denied Magellan’s petition for review of its MDO for flavored Juno refill pods.
June 15, 2023 – The Fifth Circuit granted R.J. Reynolds’ motion (filed yesterday) to stay the merits briefing in its appeal of the MDO for menthol Vuse products until after the court decision in the Triton Distribution rehearing. (Reported by attorney Greg Troutman.)
June 14, 2023 – R.J. Reynolds filed a motion asking the Fifth Circuit to stay the merits briefing in its appeal of the MDO for menthol Vuse products until after the court decision in the Triton Distribution rehearing. (The Triton case covers many of the same issues.)
June 14, 2023 – An amicus brief was filed today by a group of experts including David Abrams, Clive Bates and David Sweanor in support of AVAIL Vapor’s Supreme Court appeal of the company’s loss in the Fourth Circuit. A separate amicus brief was filed today by the Vapor Technology Association (VTA).
May 31, 2023 – An amicus brief was filed today by the Washington Legal Foundation, supporting AVAIL Vapor’s Supreme Court appeal of its loss in the Fourth Circuit.
May 16, 2023 – Triton Distribution/Vapetasia and the FDA engaged in oral arguments before the full Fifth Circuit. Triton argued in favor of its petition for review, and the FDA defended its MDOs.
May 11, 2023 – AVAIL Vapor appealed the Fourth Circuit’s denial of its petition for review to the Supreme Court, asking for a writ of certiorari that would allow a fresh look at the deficiencies of the PMTA process by the high court.
May 9, 2023 – The Third Circuit heard oral arguments from Logic and the FDA supporting and opposing Logic’s petition for review of the MDOs for Logic’s menthol refills.
April 7, 2023 – The FDA petitioned the Fifth Circuit to rehear its decision granting R.J. Reynolds a stay pending review of the FDA’s MDO of Vuse Vibe menthol refills. The FDA requests an en banc (full-court) review, to be heard in conjunction with the court’s en banc review of Triton Distribution’s MDO appeal (scheduled for oral arguments May 16). In addition to other grounds for granting a rehearing, the FDA petition challenges Reynolds’ right under the Tobacco Control Act to appeal the Vuse MDO in the Fifth Circuit, which is not, says the FDA, the circuit appeals court closest to Reynolds’ “principal place of business.”
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