This page aims to provide a comprehensive list of all the businesses contesting FDA Marketing Denial Orders (MDOs)in court, as well as to track further developments, such as rulings, stays, and motions. We will also provide a list of administrative stays (or rejections) that the FDA has issued as a result of the agency's MDO reviews.
Over thirty businesses have filed lawsuits to contest FDA rejections.
This article has been completely rewritten to make it simpler to read. Legal and administrative actions may now be viewed by date (the most recent events are shown first) or by the participating businesses (listed alphabetically). The fast links at the top of the page allow you to quickly access any area or our collection of Vaping360 articles on MDO events.
Although the original story was published on October 18, several of the events had taken place earlier. It's probable that there are still businesses out there that have brought legal challenges against MDOs that we're not aware of. Please let me know or leave a comment if you know of any. Similarly, do inform us of any businesses you know of that have had their petitions for administrative review denied.
2024 Legal Actions
April 15, 2024
A petition was filed with the Supreme Court by Logic Technology Development to challenge the ruling of the Third Circuit Court that upheld the FDA's MDO for Logic menthol refills.
In its Eleventh Circuit appeal to the MDO granted in January regarding the Bidi Stick Classic, Bidi Vapor submitted the opening brief.
March 19, 2024
The FDA filed a petition with the Supreme Court on March 19, 2024, requesting a review of the Fifth Circuit ruling that invalidated Triton Distribution's MDOs and mandated a fresh PMTA examination.
February 27, 2024
In their combined MDO appeal, a three-judge panel of the Tenth Circuit Court found unanimously against Cloud Nine Vapor Products and Electric Clouds. The firms now have the option to seek a Supreme Court hearing or an en banc rehearing with every judge currently serving on the Tenth Circuit.
February 15, 2024
In Wages and White Lion v. FDA (Triton Distribution), R.J. Reynolds moved to halt the combined appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo, and Alto). The Fifth Circuit approved his plea to halt the proceedings. The Supreme Court may hear an appeal by the FDA from its Triton defeat.
February 14, 2024
Oral arguments were presented by the FDA and SWT Global Supply before an Eighth Circuit Court panel concerning SWT's appeal of MDOs for menthol e-liquids. (SWT also has an appeal in the Fifth Circuit pending for non-menthol-flavored goods.)
February 9, 2024
In 2023, the Ninth Circuit denied Lotus Vaping Technologies' request for a review of MDOs granted for more than 200 flavored e-liquids. The firm has now filed a petition with the Supreme Court to have this decision reviewed.
February 6, 2024
The FDA moved for an en banc rehearing of R.J. Reynolds's requests to halt the Vuse menthol MDOs (for Vuse Vibe, Solo, and Alto) while the court reviewed them; the motion was refused by the Fifth Circuit Court. The stay is still in effect while the now-consolidated applications are reviewed.
February 2, 2024
- In R.J. Reynolds's now-consolidated appeals of MDOs for menthol Vuse Vibe, Solo, and Alto refills, the Fifth Circuit Court issued two orders. The FDA's request to have the Alto appeal dismissed or transferred to a different circuit was refused in the first ruling. The FDA's move to rescind the stays that had previously been granted to Reynolds for the Vibe and Solo refills was refused in the second ruling, which approved Reynolds' request for a stay pending review for the Vuse Alto menthol refills.
- Bidi Vapor filed a move requesting that the MDO for its disposable, tobacco-flavored Bidi Stick-Classic be stayed while it is reviewed by the Eleventh Circuit Court. On January 26, the business submitted a petition for the MDO to be reviewed.
February 1, 2024
In Wages and White Lion v. FDA (Triton Distribution), R.J. Reynolds filed a motion requesting that the Fifth Circuit halt the consolidated appeal of MDOs for Vuse menthol refills (Vuse Vibe, Solo, and Alto) "pending resolution of any further proceedings," including before the Supreme Court of the United States.
Due to the same grounds in both petitions, the court had already decided (on June 15, 2023) that the Vuse appeals should be kept in abeyance (put on hold) until the Triton appeal was resolved. The Fifth Circuit ruled against the FDA and in favor of Triton on January 3. The FDA's sole option to overturn the Triton ruling after that ruling was to file a petition with the Supreme Court.
January 22, 2024
In an effort to have the Second Circuit's dismissal of the company's appeal of MDOs for Juno refill pods reviewed, Magellan has filed a petition with the Supreme Court.
January 18, 2024
In the Fifth Circuit, SMOK and a distributor headquartered in Texas submitted a petition for reconsideration of the FDA's Jan. 16 MDO pertaining to 22 independent SMOK hardware devices.
January 3, 2024
Triton and Vapetasia won their combined appeal and had their PMTAs returned to the FDA for examination when the Fifth Circuit decided 10–6 in their favor.
