This article attempts to identify all of the companies who have challenged the FDA's Marketing Denial Orders (MDOs) in court, as well as to follow up on any additional proceedings, such as motions, stays, and decisions. We will also post administrative stays (or denials) issued by the FDA as a result of the agency's MDO reviews.
More than 30 corporations have filed legal action to challenge FDA denials.
We've updated this article to make it easier to navigate. Legal and administrative actions can now be viewed by date (with the most recent occurrences listed first) or by company name (sorted alphabetically).
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' petition 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 Triton setback to the Supreme Court.
Feb. 14, 2024
An Eighth Circuit Court panel heard oral arguments from SWT Global Supply and the FDA on SWT's appeal of MDOs for menthol e-liquids. (SWT is also pursuing an appeal for non-menthol-flavored goods in the Fifth Circuit.)
Lotus Vaping Technologies has petitioned the Supreme Court to appeal the Ninth Circuit's 2023 denial of its petition to review MDOs for over 200 flavored e-liquids.
Feb. 6, 2024
The Fifth Circuit Court dismissed the FDA's move for an en banc rehearing of R.J. Reynolds' applications for stays of the Vuse menthol MDOs (Vuse Vibe, Solo, and Alto) pending review, which the court had granted. The stay awaiting evaluation of the now-consolidated applications remains in effect.
Feb. 2, 2024
The Fifth Circuit Court issued two rulings in R.J. Reynolds' now-consolidated challenges against MDOs for menthol Vuse Vibe, Solo, and Alto refills. The first order dismissed the FDA's move to dismiss or transfer the Alto appeal to a different circuit. The second ruling approved Reynolds' application for a stay pending review for the Vuse Alto menthol refills while denying the FDA's motion to lift earlier stays granted to Reynolds for the Vibe and Solo refills.
- Bidi Vapor filed a move with the Eleventh Circuit Court to delay the MDO for their tobacco-flavored disposable Bidi Stick-Classic pending review. On January 26, the business filed a petition to review the MDO.
Feb. 1, 2024
R.J. Reynolds moved 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 earlier determined (on June 15, 2023), that the Vuse appeals should be kept in abeyance (put on hold) until the conclusion of the Triton appeal, because the two cases relied on similar reasons. On January 3, the Fifth Circuit ruled in favor of Triton and against the FDA. That judgment left the FDA with just one option for reversing the Triton decision: file a petition with the Supreme Court.
Jan 22, 2024
Magellan filed a petition with the Supreme Court to reconsider the Second Circuit's decision to deny their appeal of MDOs for Juno refill pods.
On January 18, 2024, SMOK and a Texas-based distributor filed a petition in the Fifth Circuit to challenge the FDA's Jan. 16 MDO for 22 standalone SMOK hardware devices.
On January 3, 2024, the Fifth Circuit decided 10-6 in favor of Triton and Vapetasia, approving their combined appeal and returning their PMTAs to FDA for assessment.
Nov. 14, 2023
A Tenth Circuit Court panel heard oral arguments from Electric Clouds, Cloud Nine Vapor Products, and the FDA in their appeals of FDA MDOs. Cases were previously aggregated (date unknown).
Oct. 19, 2023
A 2-1 decision by a Third Circuit Court panel denied Logic's appeal of a year-old MDO for Logic Power and Logic Pro menthol refills. Judge David Porter dissented, saying he thought the FDA's unexpected decision to classify menthol vapes like other flavors was political rather than scientific. Logic might now pursue an en banc rehearing with all Third Circuit judges, or a hearing before the Supreme Court.
- According to attorney Gregory Troutman, the Fifth Circuit combined R.J. Reynolds' challenges over its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO. (The Vuse Solo menthol refill MDO appeal was formerly combined with the Vibe appeal.)
Oct. 16, 2023
On October 13, the Fifth Circuit ordered a temporary stay of R.J. Reynolds' MDO for Vuse Alto menthol pods.
Oct. 10, 2023
The Supreme Court denied AVAIL Vapor's appeal of its Fourth Circuit defeat. The lawsuit was dismissed without comment. According to legal analyst Jonathan Adler, the Court may be waiting for a more pronounced division among the circuit courts and a better case to hear.
On September 14, 2023, the Ninth Circuit dismissed Lotus Vaping Technologies' demand for an en banc rehearing of its petition for review.
Aug. 29, 2023
A three-judge panel of the D.C. Circuit delivered a mixed ruling in the Fontem US myblu appeal, approving Fontem's petition for review of the MDOs for the myblu device and tobacco-flavored pods while rejecting the company's appeal of MDOs for most pods in flavors other than tobacco.
Aug. 21, 2023
Lotus Vaping Technologies moved the Ninth Circuit for an en banc rehearing of their petition for review.
July 7, 2023
A three-judge panel of the Ninth Circuit unanimously denied Lotus Vaping Technologies/Nude Nicotine's combined petition for review. The firms can now request an en banc rehearing with all active Ninth Circuit judges, as well as a hearing before the Supreme Court.
June 27, 2023
The Fifth Circuit refused the FDA's move (filed earlier in June) to transfer R.J. Reynolds' Vuse menthol MDO appeal to the District of Columbia Circuit Court.
June 16, 2023
A three-judge panel of the Second Circuit unanimously dismissed Magellan's petition for reconsideration of its MDO for flavored Juno refill pods.
June 15, 2023
The Fifth Circuit allowed R.J. Reynolds' petition (filed yesterday) to halt the merits briefing in its appeal of the MDO for menthol Vuse products until after the court's ruling in the Triton Distribution rehearing. (Reported by attorney Greg Troutman.)
On June 14, 2023
R.J. Reynolds requested that the Fifth Circuit delay the merits briefing in their appeal of the MDO for menthol Vuse products until after the Triton Distribution rehearing ruling. (The Triton case addresses many of the same problems.)
June 14, 2023
A group of specialists, including David Abrams, Clive Bates, and David Sweanor, filed an amicus brief today supporting AVAIL Vapor's Supreme Court appeal of its Fourth Circuit defeat. The Vapor Technology Association submitted a separate amicus brief today.
May 31, 2023
The Washington Legal Foundation submitted an amicus brief today in support of AVAIL Vapor's Supreme Court appeal following its Fourth Circuit setback.
May 16, 2023
Triton Distribution/Vapetasia and the FDA presented oral arguments before the Fifth Circuit. Triton argued in support of its petition for reconsideration, while the FDA defended its MDOs.
May 11, 2023
AVAIL Vapor filed an appeal with the Supreme Court, seeking a writ of certiorari to address inadequacies in the PMTA procedure.
May 9, 2023
The Third Circuit heard oral arguments from Logic and the FDA in favor and opposition to Logic's petition for reconsideration of the MDOs for its menthol refills.
April 7, 2023.
The FDA asked the Fifth Circuit to reconsider its ruling giving R.J. Reynolds a stay pending reconsideration of the FDA's MDO for Vuse Vibe menthol refills. The FDA wants an en banc (full-court) review, to be heard concurrently with the court's en banc review of Triton Distribution's MDO appeal (oral arguments set for May 16). In addition to other reasons for requesting a rehearing, the FDA petition questions Reynolds' jurisdiction under the Tobacco Control Act to appeal the Vuse MDO in the Fifth Circuit, which, according to the FDA, is not the circuit appeals court nearest to Reynolds' "principal place of business."
March 23, 2023.
The Fifth Circuit issued a stay pending review of the MDO for the Vuse Vibe menthol refill. (Reynolds discontinued their request for Vuse Ciro refills since it no longer distributes the product).
March 20, 2023.
The Fifth Circuit granted R.J. Reynolds a temporary stay of the Vuse Solo menthol refill MDO dated March 17. The interim stay will remain in force awaiting an application for a stay pending appeal.
Feb. 6, 2023
The Second Circuit heard oral arguments in Magellan's appeal against the MDO for its Juno-brand refill pods.
Jan. 25, 2023
The Fifth Circuit granted R.J. Reynolds a temporary stay on the MDO issued yesterday for Vuse Vibe and Ciro menthol refills. The interim stay will remain in force awaiting an application for a stay pending appeal. The D.C. Circuit Court heard oral arguments from Fontem US and the FDA on MDOs for the myblu device and several flavored refill pods.
Jan. 19, 2023
The Fifth Circuit Court granted Triton Distribution and Vapetasia a rare en banc rehearing of their MDO petition, which had been dismissed by a three-judge panel last year. In the en banc rehearing, all current Fifth Circuit judges will hear the case.
Dec. 12, 2022
A three-judge panel of the Fourth Circuit unanimously denied AVAIL Vapor's petition for reconsideration of its Master Data Order. The corporation can now request an en banc rehearing with all Fourth Circuit judges, or a hearing before the Supreme Court.
Oct. 28, 2022
The Third Circuit granted Logic LLC a temporary stay of two MDOs issued on October 26. The court set a seven-day deadline for applying to halt the rejections pending an appeal.
Oct. 27, 2022
A three-judge panel of the Third Circuit unanimously denied Liquid Labs' petition for reconsideration of its MDO. The corporation can now request an en banc rehearing with all Third Circuit judges, or a hearing before the Supreme Court.
Logic LLC filed a petition for review in the Third Circuit of the MDO on October 26th for its menthol-flavored refills. The business also filed an emergency request seeking a temporary stay of the MDO.
Oct. 11, 2022
Triton Distribution/Vapetasia submitted a reply brief on September 30 in response to the FDA's answer to Triton's en banc review petition in the Fifth Circuit.
Sept. 30, 2022
The FDA responded to Triton Distribution/Vapetasia's en banc review motion filed on September 1 in the Fifth Circuit.
Sept 20, 2022
Juul Labs filed a lawsuit against the FDA in the United States District Court for the District of Columbia, alleging that the agency wrongfully suppressed records sought under the Freedom of Information Act (FOIA). The materials are relevant to Juul's MDO released on June 23.
Sept 01, 2022
Triton Distribution and Vapetasia requested panel and en banc rehearings of their case with the Fifth Circuit Court. Panel rehearing refers to a rehearing by the original three-judge panel that ruled in favor of the FDA, while en banc refers to a complete rehearing by the whole court. The petitions are based in part on the FDA's failure to include its "bracketing and bundling" letter in the administrative record (hiding it from the vape company petitioners), as well as the panel judges' misunderstanding of the FDA's rules for manufacturers submitting PMTAs.
Aug. 29, 2022
The Seventh Circuit Court of Appeals dismissed Gripum LLC's petition for review. The corporation can now request an en banc rehearing with all Seventh Circuit judges, or a hearing before the Supreme Court.
Aug. 23, 2022
The Eleventh Circuit Court ruled in favor of six manufacturers: Bidi Vapor, Diamond Vapor, Johnny Copper, Pop Vapor Co., Union Street Brands, and Vapor Unlimited. The verdict nullifies their MDOs and requires the FDA to perform new evaluations of the firms' PMTAs.
Aug. 4, 2022
The Ninth Circuit Court combined Lotus Vaping Technologies and Nude Nicotine's appeals (date of action unclear). Oral arguments are set for August 11, according to attorney Lance Churchill. They can be heard around 9:30 a.m.
July 26, 2022
The D.C. Circuit Court of Appeals dismissed petitions for review filed by four manufacturers: Prohibition Juice Co., Cool Breeze Vapor, Ecig Charleston, and Jay Shore Liquids. The court has combined the cases. The firms can now request an en banc rehearing with all D.C. Circuit judges, as well as a hearing before the Supreme Court.
July 25, 2022
The D.C. Circuit Court refused Fontem US's emergency application for a stay, keeping the myblu MDO in force. The court established a filing timeline for the appeal, with Fontem's first brief due by August 10.
July 19, 2022
In a Ninth Circuit Court filing, the FDA indicated it may not decide on MVO's administrative appeal.
July 18, 2022
The Fifth Circuit decided against Triton Distribution and Vapetasia in their appeal of last year's MDOs. The vote was 2-1, with Judge Edith Jones writing a scorching dissent. The firms said they will want an en banc rehearing of their petitions, with all active Fifth Circuit judges present.
July 12, 2022
Fontem US filed an emergency action in the D.C. Circuit Court seeking a stay on its MDO for the myblu device and refill pods.
On July 6, 2022
Juul Labs and the FDA requested that the D.C. Circuit Court put Juul's legal challenge on hold until the FDA's administrative review is complete. Juul also withdraws its emergency application for a stay awaiting review (which can be resubmitted if the FDA rejects Juul's appeal).
July 5, 2022
The FDA granted Juul an administrative stay of its MDO, agreeing not to pursue enforcement action while the FDA's "supervisory review" is ongoing.
June 27, 2022
Juul filed an emergency request in the D.C. Circuit seeking a stay pending review. The FDA's answer is expected July 7.
June 24, 2022
Juul Labs petitioned the D.C. Circuit for review of their MDO. They requested a temporary stay until they may submit a complete stay motion for review. The interim stay was granted later that day.
May 17, 2022
The Eleventh Circuit Court heard oral arguments from attorneys for the FDA, Bidi Vapor, Pop Vapor, and a combined action involving Diamond Vapor, Johnny Copper, Union Street Brands, Vapornine, and Vapor Unlimited. (The links go to downloading MP3s. You may also listen via the court's website.
April 22, 2022.
On April 22, Vapor Voice stated that Simple Vapor had voluntarily withdrawn its petition for review in the Sixth Circuit. The date of action is unclear.
April 20, 2022.
The Seventh Circuit heard oral arguments from lawyers for Gripum and the FDA.
March 14, 2022.
According to Vapor Voice, the Eleventh Circuit Court has suspended the implementation of Pop Vapor's MDO pending review.
March 1, 2022.
The FDA canceled Al Khalifa Group's MDO following an administrative review. Date: unknown. According to Vapor Voice, Al Khalifa has voluntarily withdrawn its suit to the Ninth Circuit Court.
Feb. 23, 2022
AVAIL Vapor has lost its FDA appeal. (The business is also appealing its MDO to the Fourth Circuit.)
Feb. 10, 2022
According to Vapor Voice, Breeze Smoke voluntarily dropped their MDO appeal to the Sixth Circuit, which was slated for oral arguments on February 22.
Feb. 9, 2022
The D.C. Circuit has set oral arguments in a combined case on April 21. The four petitioners, Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co., are all represented by the Texas-based Najvar Law.
Feb. 2, 2022
Following the FDA's withdrawal of its MDO in October, Fumizer's lawsuit against the FDA was rejected by the Ninth Circuit for "failure to prosecute," according to Vapor Voice.
Feb 1, 2022
The Eleventh Circuit delayed the MDOs for Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited pending review. The court ordered that these four cases, together with three others that did not receive stays—Pop Vapor Co., Union Street Brands, and Vapornine (New Leaf Vapor Co.), appear together for oral arguments on a later date.
Jan. 31, 2022
The Fifth Circuit heard oral arguments from attorneys for Triton Distribution and the FDA.
Jan. 28, 2022
The Fifth Circuit granted a stay of proceedings for American Vapor, Inc.'s petition awaiting Triton Distribution's review (as noted in the FDA's official MDO list, updated Feb. 3). Vapor Voice stated later (April 22) that American Vapor has voluntarily withdrew their petition for review.
Dec. 30, 2021
David Abrams, Clive Bates, and David Sweanor filed an amicus brief before the Seventh Circuit to support Gripum's petition.
Dec. 10, 2021
The Supreme Court dismissed Breeze Smoke's emergency motion for a stay on its MDO. The Sixth Circuit Court will now hear Breeze Smoke's petition for review, but the firm will face FDA punishment if it continues to sell the rejected goods throughout the appeal.
Dec. 7, 2021
Breeze Smoke has reacted to the FDA's brief filed yesterday opposing Breeze Smoke's motion to the Supreme Court for a stay on its MDO.
Dec. 6, 2021
The FDA submitted a memorandum opposing Breeze Smoke's appeal for a stay of its MDO with the Supreme Court. In the brief, the agency argued that Breeze Smoke's products were launched after August 8, 2016, the deadline for items allowed to remain on the market (until September 9, 2020) without FDA approval.
Nov. 29, 2021
Supreme Court Justice Brett Kavanaugh requested that the FDA answer to Breeze Smoke's plea for a stay by Monday, December 6.
The Fifth Circuit granted stays pending review to Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized and merged the cases. The FDA did not challenge the stay motions.
Nov. 24, 2021
David Abrams, Clive Bates, and David Sweanor filed an amicus brief in the Eleventh Circuit to support Bidi Vapor's petition for review.
David Abrams, Clive Bates, and David Sweanor filed an amicus brief in the Ninth Circuit supporting My Vape Order's petition for review.
Nov. 23, 2021
Breeze Smoke petitioned the Supreme Court for an emergency stay pending circuit court review of the MDO. The FDA partly canceled Pop Vapor Co.'s MDO. On November 19, 2021, Bidi Vapor filed an opening brief in the Eleventh Circuit, requesting oral arguments.
Nov. 17, 2021
David Abrams, Clive Bates, and David Sweanor filed an amicus brief in the Fifth Circuit to support Triton Distribution's petition for review.
Nov. 12, 2021
The Sixth Circuit dismissed Breeze Smoke's plea for a stay. On November 4, 2021, the Seventh Circuit Court halted Gripum's MDO pending review.
On November 3, 2021, the FDA halted Al Khalifa Group's MDO pending administrative review (as per the FDA's official MDO list updated on February 17).
Nov. 2, 2021
The FDA withdrew Humble Juice's MDO (according to the FDA's official MDO list, which was last updated on November 3), and the products were returned for scientific evaluation. According to Tobacco Reporter, Humble Juice abandoned its Ninth Circuit petition for review when the FDA rescinded its MDO.
Nov. 1, 2021
The FDA halted AVAIL Vapor's MDO pending an administrative review.
Oct. 26, 2021
The FDA partially withdrew ECS Global's MDO (according to the FDA's official MDO list, which was revised on November 3), and the items were returned for scientific evaluation.
The Fifth Circuit merged the Triton Distribution and Vapetasia cases and halted both MDOs awaiting review.
October 25, 2021
Bidi Vapor requested a stay in the Eleventh Circuit to allow for a review of its MDO.
Oct. 22, 2021
The FDA issued a hold on Bidi Vapor's MDO pending administrative review.
- The FDA withdrew Fumizer's MDO, and the goods were returned to scientific evaluation.
Oct. 19, 2021
The Seventh Circuit temporarily delayed Gripum's MDO while it considered the company's application for a stay.
Oct. 18, 2021
The FDA suspended my Vape Order's MDO pending administrative review.
Oct 17, 2021
Grippom filed an emergency application for a stay in the Seventh Circuit, pending judicial review of the company's MDO.
Oct 14, 2021
Triton Distribution filed a response to the FDA in court.
Oct 13, 2021
Breeze Smoke requested an emergency stay in the Sixth Circuit to allow for a court review of its MDO.
Oct. 12, 2021
The FDA addressed Triton Distribution's emergency application for a stay.
Oct 8, 2021
Turning Point Brands withdrew their petition for review when the FDA revoked its MDO.
Oct. 7, 2021
The FDA withdrew Turning Point Brands' MDO, stating that the agency overlooked evidence presented in the company's PMTA. Turning Point's goods were returned to scientific assessment.
Oct 6, 2021
Triton Distribution filed an emergency application for a stay in the Fifth Circuit, requesting expedited review of the MDO.
Sept 30, 2021
Turning Point Brands filed an emergency move for a stay pending judicial review of its MDO. They requested expedited consideration.
Legal proceedings by firm (alphabetical)
7 Daze LLC - Petition for review filed October 7, 2021 - Ninth Circuit Court of Appeals.
Al Khalifa Group LLC - Petition for Review filed in 2021 (precise date unclear). On November 3, 2021, the FDA halted the Al Khalifa Group MDO awaiting administrative review, as reported by the Ninth Circuit Court of Appeals.
- On March 1, 2022, the FDA withdrew Al Khalifa Group's MDO following an administrative review.
- (date unknown): Al Khalifa voluntarily withdraws its plea for review, according to Vapor Voice.
American Vapor, Inc. submitted a petition for review in 2021 (the precise date is unclear).- Fifth Circuit Court of Appeals: January 28, 2022. According to the FDA's official MDO list, the court "issued a stay of proceedings for American Vapor, Inc. 's petition pending a decision in [Triton Distribution's petition]" (updated Feb. 3).
AVAIL Vapor, LLC - Petition for Review filed on September 30, 2021 - Fourth Circuit Court of Appeals
- On November 1, 2021, the FDA halted AVAIL MDO pending an administrative review.
- February 23, 2022: The FDA refused AVAIL's appeal.
- On December 12, a three-judge Fourth Circuit panel unanimously denied AVAIL's petition for review of its MDO. The corporation can now request an en banc rehearing with all active Fourth Circuit judges, as well as a hearing before the Supreme Court.
- On May 11, 2023, AVAIL appealed the Fourth Circuit's denial of its petition for review to the Supreme Court, requesting a writ of certiorari that would allow the top court to take a second look at the flaws of the PMTA process.
- May 31: The Washington Legal Foundation submitted an amicus brief today to support AVAIL's Supreme Court appeal.
- On June 14, several specialists, including David Abrams, Clive Bates, and David Sweanor, filed an amicus brief supporting AVAIL's Supreme Court appeal. The Vapor Technology Association submitted a separate brief today.
- On October 10, the Supreme Court refused to hear AVAIL's appeal from its Fourth Circuit setback. The lawsuit was dismissed without comment. According to legal analyst Jonathan Adler, the Court may be waiting for a more pronounced division among the circuit courts and a better case to hear.
Bad Modder Fogger (BMF Labs) - Petition for Review filed on October 4, 2021 - Fourth Circuit Court of Appeals
Bidi Vapor LLC (PMTAs for flavored Bidi Stick disposables) - Petition for review and petition for expedited review filed on September 29, 2021 - Eleventh Circuit Court of Appeals
- On October 22, 2021, the FDA halted Bidi Vapor's MDO pending an administrative review.
- On October 25, Bidi filed a petition for a stay pending judicial review of its MDO.
- On November 19, Bidi filed its opening brief and requested that the court allow oral argument.
- On November 24, David Abrams, Clive Bates, and David Sweanor filed an amicus brief supporting Bidi Vapor's petition.
- On February 1, 2022, the court halted Bidi's MDO awaiting review.
- On May 17, the court heard oral arguments from Bidi Vapor and the FDA.
- On August 23, the court found in favor of Bidi Vapor and five other petitioners, nullifying their MDOs and returning their PMTAs to the FDA for scientific evaluation.
Bidi Vapor LLC (PMTA for tobacco-flavored Bidi Stick-Classic disposable) filed a petition for review with the Eleventh Circuit Court of Appeals on January 26, 2024. On February 2, 2024, Bidi Vapor filed a motion to stay the MDO for its tobacco-flavored disposable Bidi Stick-Classic pending review.
Breeze Smoke, LLC filed a petition for review with the Sixth Circuit judicial of Appeals on October 4, 2021. On October 13, 2021, they filed an emergency application for a stay pending judicial review of their MDO.
- On November 12, the court refused Breeze Smoke's plea for a stay.
- On November 23, Breeze Smoke appealed to the Supreme Court for a stay pending the circuit court's reconsideration of its MDO.
- November 29: Supreme Court Justice Brett Kavanaugh requests that the FDA answer to Breeze Smoke's plea for a stay by Monday, December 6.
- On December 6, the FDA filed a memorandum in opposition to Breeze Smoke's appeal for a stay of its MDO by the Supreme Court.
- December 7: Breeze Smoke responded to the FDA brief filed yesterday opposing the company's request to the Supreme Court for a stay of its MDO. Breeze Smoke also filed a supplemental declaration from employee Steven Haddad, who claimed that Breeze Smoke "developed the ENDS products that are the subject of its September 3, 2020 PMTAs by building on the specifications of the Arctic Smoke product, which had been on the market well before the FDA 'deemed' e-cigarette products effective August 8, 2016."
- On December 10, the Supreme Court refused Breeze Smoke's emergency appeal for a stay of the MDO. The complete evaluation of Breeze Smoke's MDO will now proceed in the Sixth Circuit; nonetheless, the firm will be vulnerable to FDA enforcement.
Breeze Smoke voluntarily dropped their appeal to the Sixth Circuit (which was slated for oral arguments on February 22), according to Vapor Voice.
Cloud House LLC filed a petition for review with the Fifth Circuit Court of Appeals on October 8, 2021. The case was heard on November 29, 2021.The Fifth Circuit stays Cloud House's MDO pending appeal (the request was uncontested by the FDA) and consolidates five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.
Cloud Nine Vapor Products - Petition for review filed on October 8, 2021 - Tenth Circuit Court of Appeals
The date of the combined appeal with Electric Clouds is unclear. The Tenth Circuit will hear oral arguments on November 14, 2023.
- On February 27, 2024, a three-judge panel from the Tenth Circuit Court decided unanimously against Cloud Nine and Electric Clouds in their unified MDO appeal. The firms can now request an en banc rehearing with all active Tenth Circuit judges, or a hearing before the Supreme Court.
Cool Breeze Vapor LLC submitted a petition for review in 2021 (the precise date is unclear). District of Columbia Circuit Court of Appeals (2021/22 - unknown date): The D.C. Circuit combined the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
- On February 4, 2022, the FDA filed a brief supporting its MDOs.
- February 9: The D.C. Circuit set oral arguments in the combined case for April 21.
- On July 26, the D.C. Circuit dismissed petitions for review filed by Cool Breeze Vapor and three other manufacturers in a unified appeal. The petitioners can now request an en banc rehearing with all active D.C. Circuit judges, as well as a hearing before the Supreme Court.
Diamond Vapor LLC - Petition for review filed on October 1, 2021 - Eleventh Circuit Court of Appeals (February 1, 2022): The Eleventh Circuit halted Diamond Vapor's MDO, pending review.
- On May 17, the court heard oral arguments from the FDA and Diamond Vapor (and co-petitioners).
- On August 23, the court found in favor of Diamond Vapor and five other petitioners, nullifying their MDOs and returning their PMTAs to the FDA for scientific evaluation.
E-Liquid Brands, LLC - Petition for review filed on October 7, 2021 - Fourth Circuit Court of Appeals
ECig Charleston LLC - Petition for review filed in 2021 (precise date unknown) before the District of Columbia Circuit Court of Appeals
- (2021/22 - unknown date): The D.C. Circuit combined the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
- On February 4, 2022, the FDA filed a brief supporting its MDOs.
- On February 9, the D.C. Circuit scheduled oral arguments in the combined case on April 21.
- On July 26, the D.C. Circuit dismissed petitions for review filed by ECig Charleston and three other manufacturers in a joint appeal. The petitioners can now request an en banc rehearing with all active D.C. Circuit judges, as well as a hearing before the Supreme Court.
ECS Global LLC filed a petition for review on October 12, 2021, with the District of Columbia Circuit Court of Appeals. (ECS Global acquired MDOs for Phix pod-vape devices and prefilled Phix pods.)
- On October 26, the FDA partly withdrew ECS Global's MDO (according to the FDA's official MDO list, which was last updated on November 3), and items were returned to scientific evaluation.
Electric Clouds - Petition for review filed Oct. 8, 2021 - Tenth Circuit Court of Appeals - Date unknown: merged with Cloud Nine Vapor Products appeal - Oral arguments heard Nov. 14, 2023
- On February 27, 2024, a three-judge panel of the Tenth Circuit Court unanimously decided against Electric Clouds and Cloud Nine Vapor Products in their consolidated MDO appeal.
Fontem US, LLC - Petition for review filed on May 6, 2022 - District of Columbia Circuit Court of Appeals. Fontem, a subsidiary of Imperial Brands, got MDOs for the myblu device and refill pods. On July 12, 2022, Fontem filed an emergency application to stay the MDO.
- July 25: The court refused Fontem's emergency application for a stay, keeping the myblu MDO in force. The court established a filing schedule for the appeal, with Fontem's first brief due on August 10.
- On January 25, 2023, the court heard oral arguments from Fontem and the FDA.
- On August 29, a three-judge panel of the D.C. Circuit issued a split opinion on the myblu appeal, allowing Fontem's motion for review of the MDOs for Most pods come in tastes other than tobacco.
Fumizer, LLC filed a petition for review with the Ninth Circuit Court of Appeals on October 6, 2021.
- On October 22, 2021, the FDA withdrew Fumizer's MDO and returned the items to scientific assessment.
- On February 2, 2022, the Ninth Circuit denied Fumizer's appeal for "failure to prosecute," according to Vapor Voice.
Gripum LLC - Petition for review filed on October 8, 2021 - Seventh Circuit Court of Appeals.
- On October 17, Gripum filed an emergency application for a stay pending judicial review of its MDO.
- On October 19, the court temporarily halted Gripum's MDO while the application was examined.
- October 27: Gripum responded
- On November 4, the court halted Gripum's MDO for review.
- On December 27, Gripum submitted a brief before oral arguments.
- On December 30, David Abrams, Clive Bates, and David Sweanor filed an amicus brief supporting Gripum's petition.
- On April 20, 2022, the court heard oral arguments from Gripum and the FDA.
- On August 29, the court refused Gripum's plea for review. The corporation can now request an en banc rehearing with all active Seventh Circuit judges, as well as a hearing before the Supreme Court.
Humble Juice Co., LLC - Petition for review filed in October 2021 (precise date unclear), Ninth Circuit Court of Appeals
- On November 2, 2021, the FDA withdrew Humble Juice's MDO (according to the FDA's official MDO list, which was revised on November 3), and the products were returned to scientific evaluation. According to the Tobacco Reporter, Humble Juice abandoned its plea for review.
Jay Shore Liquids LLC filed a petition for review in 2021 (precise date unknown) to the District of Columbia Circuit Court of Appeals. The D.C. Circuit combined appeals from Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co. On February 4, 2022, the FDA filed a brief defending its MDOs.
- On February 9, the D.C. Circuit scheduled oral arguments in the combined case on April 21.
- On July 26, the D.C. Circuit dismissed petitions for review filed by Jay Shore Liquids and three other manufacturers in a combined appeal. The petitioners can now request an en banc rehearing with all active D.C. Circuit judges, as well as a hearing before the Supreme Court.
Johnny Copper LLC filed a petition for review with the Eleventh Circuit Court of Appeals on October 7, 2021. On February 1, 2022, the court delayed Johnny Copper's MDO pending review.
- On May 17, the FDA and Johnny Copper (together with four other petitioners) presented oral arguments to the court.
- On August 23, the court found in favor of Johnny Copper and five other petitioners, nullifying their MDOs and returning their PMTAs to the FDA for scientific assessment.
On June 24, 2022, Juul Labs filed a petition for review of their MDO in the District of Columbia Circuit Court of Appeals. They requested a temporary stay until they could file a move for a complete stay awaiting review. The interim stay is granted later that same day.
- On June 27, Juul filed an emergency application for a stay pending review. The FDA's answer is expected July 7.
- July 5: The FDA granted Juul an administrative stay of its MDO, agreeing not to pursue enforcement action while the FDA's "supervisory review" is ongoing.
- On July 6, Juul Labs and the FDA filed a combined motion requesting the court to put Juul's legal challenge on hold (stop the process) until the FDA completes its administrative review. Juul also withdraws its current emergency application for a stay awaiting review by the D.C. Circuit (which can be refiled if the FDA rejects Juul's appeal).
- On September 20, Juul Labs filed a complaint against the FDA in the United States District Court for the District of Columbia, saying that the agency wrongfully suppressed records requested by Juul under the Freedom of Information Act (FOIA). The papers refer to the MDO given to Juul.
Liquid Labs LLC filed a petition for review with the Third Circuit Court of Appeals on October 12, 2021. The case was heard on October 27, 2022. A unanimous Third Circuit panel dismissed Liquid Labs' petition to reconsider MDO. The corporation can now request an en banc rehearing with all Third Circuit judges, or a hearing before the Supreme Court.
Logic Technology Development (Logic LLC) filed a petition for review with the Third Circuit Court of Appeals on October 27, 2022. The petition was received on October 26, 2022. Logic got MDOs for two menthol-flavored refills.
- On October 27, Logic LLC filed a petition to challenge the MDO issued on October 26 for its menthol-flavored refills. The business also filed an emergency request seeking a temporary stay of the MDO.
- On October 28, the Third Circuit granted Logic a temporary stay of its MDO, setting a seven-day deadline for a move to stay the rejections pending appeal.
- On May 9, 2023, the Third Circuit heard oral arguments from both Logic and the FDA in favor and opposition to Logic's petition for reconsideration of the FDA's MDOs for Logic's menthol refills.
- On October 19, 2023, a Third Circuit Court panel ruled 2-1 to refuse Logic's appeal of MDOs for Logic Power and Logic Pro menthol refills issued a year ago. Judge David Porter dissented, saying he thought the FDA's unexpected decision to classify menthol vapes like other flavors was political rather than scientific. Logic might now request an en banc rehearing before all Third Circuit judges.
Magellan Technology, Inc. - Petition for review filed on September 24, 2021 - Second Circuit Court of Appeals
- On February 6, 2023, the Second Circuit heard oral arguments in Magellan's appeal of the MDO for Juno-brand refill pods.
- On June 16, a Second Circuit panel unanimously denied Magellan's petition to reconsider the MDO for its flavored Juno refill pods. The corporation can now request an en banc rehearing with all active Second Circuit judges, or a hearing before the Supreme Court.
- On January 22, 2024, Magellan petitioned the Supreme Court to examine the Second Circuit's dismissal of the company's appeal of MDOs for Juno refill pods.
My Vape Order, Inc. - Petition for review filed on September 30, 2021 - Ninth Circuit Court of Appeals
- On October 18, 2021, the FDA halted My Vape Order's MDO pending administrative review.
- On November 24, David Abrams, Clive Bates, and David Sweanor filed an amicus brief supporting My Vape Order's petition.
- On January 5, 2022, the court decided to put MVO's appeal on hold awaiting the conclusion of the FDA's administrative appeals procedure.
- On January 19, the FDA "partially rescinded" MVO's MDO "with respect to certain products."
- July 19: In a court filing, the FDA confessed it may not rule on MVO's appeal until January 2024.
Petition for review filed on October 11, 2021 by New World Wholesale, Inc. and Shenzhen Goldreams Technology Co., Ltd. in the Fifth Circuit Court of Appeals.
Nude Nicotine, Inc. filed a petition for review with the Ninth Circuit Court of Appeals on October 6, with an update on August 4, 2022. The Ninth Circuit combined Nude Nicotine's appeal with Lotus Vaping Technologies' (date unknown). Attorney Lance Churchill has scheduled oral arguments for August 11 and July 7, 2023. A three-judge panel of the Ninth Circuit unanimously denied the combined Lotus/Nude Nicotine petition for review. The firms can now request an en banc rehearing with all active Ninth Circuit judges, as well as a hearing before the Supreme Court.
Paradigm Distribution filed a petition for review with the Fifth Circuit Court of Appeals on October 11, 2021. The case was heard on November 29, 2021.The Fifth Circuit stayed Paradigm's MDO pending appeal (the request was uncontested by the FDA) and merged five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.
Pop Vapor Co. LLC filed a petition for review in 2021 (precise date unknown).On November 23, 2021, Pop Vapor Co.'s MDO was partially withdrawn by the Eleventh Circuit Court of Appeals, as per the FDA's official MDO list revised on February 17.
- Vapor Voice reports that on March 14, 2022, the Eleventh Circuit halted FDA enforcement of Pop Vapor's MDO pending review.
- On May 17, the court heard oral arguments from both Pop Vapor and the FDA.
- On August 23, the court found in favor of Pop Vapor Co. and five other petitioners, nullifying their MDOs and returning their PMTAs to the FDA for reconsideration.
Prohibition Juice Co. - Petition for review filed on October 13, 2021 - District of Columbia Circuit Court of Appeals
- (2021/22 - unknown date): The D.C. Circuit combined the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
- On February 4, 2022, the FDA filed a brief supporting its MDOs.
- On February 9, the D.C. Circuit scheduled oral arguments in the combined case on April 21.
- On July 26, the D.C. Circuit dismissed the petitions for review filed by Prohibition Juice Co. and three other manufacturers in a combined appeal.
The petitioners can now request an en banc rehearing with all active D.C. Circuit judges, as well as a hearing before the Supreme Court.
R.J. Reynolds Vapor Co. (Vuse Alto menthol refills MDO) filed a review petition with the Fifth Circuit Court of Appeals on October 13, 2023. The case was heard on October 16, 2023. On October 13, the Fifth Circuit temporarily stayed R.J. Reynolds' MDO for Vuse Alto menthol pods. - October 19, 2023: According to attorney Gregory Troutman, the Fifth Circuit has merged R.J. Reynolds' appeals of its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO. (The Vuse Solo menthol refill MDO appeal may have previously been combined with the Vibe appeal.)
- On February 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 (for Vuse Vibe, Solo, and Alto), "pending resolution of any further proceedings" in the Triton Distribution vs. FDA appeal, "including before the Supreme Court of the United States."
- On February 2, 2024, the Fifth Circuit Court issued two orders in R.J. Reynolds' combined appeals of MDOs for menthol Vuse Vibe, Solo, and Alto refills. The first order dismissed the FDA's move to dismiss or transfer the Alto appeal to a different circuit.
The second ruling approved Reynolds' application for a stay pending review for the Vuse Alto menthol refills while denying the FDA's motion to lift earlier stays granted to Reynolds for the Vibe and Solo refills.
- On February 6, 2024, the Fifth Circuit Court refused the FDA's move for an en banc rehearing of R.J. Reynolds' applications for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo, and Alto) pending review, which the court had granted. The stay awaiting evaluation of the now-consolidated applications remains in effect.
- On February 15, 2024, the Fifth Circuit granted R.J. Reynolds' petition 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 Triton setback to the Supreme Court.
R.J. Reynolds Vapor Co. (Vuse Ciro and Vibe menthol refills MDO) - Petition for review submitted in January 2023 (precise date unclear). Reynolds was granted a temporary stay by the Fifth Circuit Court of Appeals on January 25, 2023, pending his appeal move.
- On March 23, the Fifth Circuit issued a stay pending review of the MDO for the Vuse Vibe menthol refill.
- April 7: The FDA asked the Fifth Circuit to reconsider its ruling giving R.J. Reynolds a stay pending reconsideration of the FDA's MDO for Vuse Vibe menthol refills. The FDA requested an en banc (full-court) review, which would be heard concurrently with the court's en banc review of Triton Distribution's MDO appeal (oral arguments set for May 16). In addition to other reasons for requesting a rehearing, the FDA petition questions Reynolds' jurisdiction under the Tobacco Control Act to appeal the Vuse MDO in the Fifth Circuit, which, according to the FDA, is not the circuit appeals court nearest to Reynolds' "principal place of business."
- On June 14, R.J. Reynolds filed a petition requesting that the Fifth Circuit suspend the merits briefing in its appeal to the FDA denial order for menthol Vuse products until after the court's judgment in the Triton rehearing. (The Triton case addresses many of the same problems.)
- June 15: The Fifth Circuit granted R.J. Reynolds' (filed yesterday) move to postpone the merits briefing in its appeal to the FDA denial order for menthol Vuse products until after the court's judgment in the Triton rehearing.
- On June 27, the Fifth Circuit dismissed the FDA's move (filed earlier in June) to transfer R.J. Reynolds' Vuse menthol MDO appeal to the D.C. Circuit Court.
- On October 19, 2023, the Fifth Circuit combined R.J. Reynolds' challenges over its Vuse Alto menthol pod MDO and Vuse Vibe menthol refill MDO, according to attorney Gregory Troutman. (The Vuse Solo menthol refill MDO appeal may have previously been combined with the Vibe appeal.)
- On February 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 (for Vuse Vibe, Solo, and Alto), "pending resolution of any further proceedings" in the Triton Distribution vs. FDA appeal, "including before the Supreme Court of the United States."
- On February 2, 2024, the Fifth Circuit Court issued two orders in R.J. Reynolds' combined appeals of MDOs for menthol Vuse Vibe, Solo, and Alto refills. The first order dismissed the FDA's move to dismiss or transfer the Alto appeal to a different circuit. The second ruling approved Reynolds' application for a stay pending review for the Vuse Alto menthol refills while denying the FDA's motion to lift earlier stays granted to Reynolds for the Vibe and Solo refills.
- On February 6, 2024, the Fifth Circuit Court refused the FDA's move for an en banc rehearing of R.J. Reynolds' applications for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo, and Alto) pending review, which the court had granted.
- On February 15, 2024, the Fifth Circuit granted R.J. Reynolds' petition 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 Triton setback to the Supreme Court.
R.J. Reynolds Vapor Co. (Vuse Solo menthol refills MDO) - Petition for review submitted in 2023 (precise date unclear).On March 20, 2023, the Fifth Circuit Court of Appeals granted Reynolds a temporary stay pending an appeal request.
- On October 19, 2023, the Fifth Circuit combined R.J. Reynolds' challenges over 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 formerly combined with the Vibe appeal.)
- On February 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 (for Vuse Vibe, Solo, and Alto), "pending resolution of any further proceedings" in the Triton Distribution vs. FDA appeal, "including before the Supreme Court of the United States."
- On February 2, 2024, the Fifth Circuit Court issued two orders in R.J. Reynolds' combined appeals of MDOs for menthol Vuse Vibe, Solo, and Alto refills. The first order dismissed the FDA's move to dismiss or transfer the Alto appeal to a different circuit. The second ruling approved Reynolds' application for a stay pending review for the Vuse Alto menthol refills while denying the FDA's motion to lift earlier stays granted to Reynolds for the Vibe and Solo refills.
- On February 6, 2024, the Fifth Circuit Court refused the FDA's move for an en banc rehearing of R.J. Reynolds' applications for stays of the Vuse menthol MDOs (for Vuse Vibe, Solo, and Alto) pending review, which the court had granted.
- On February 15, 2024, the Fifth Circuit granted R.J. Reynolds' petition 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 Triton setback to the Supreme Court.
Simple Vapor Company filed a petition for review with the Sixth Circuit Court of Appeals on October 12, 2021 (unknown date). On April 22, 2022, Vapor Voice stated that Simple Vapor has voluntarily withdrew their plea before the court.
SMOK (Shenzhen IVPS Technology Co., Ltd.) - Petition for review filed on January 18, 2024 - Fifth Circuit Court of Appeals
- On January 18, 2024, SMOK and a Texas-based distributor petitioned the Fifth Circuit to examine the FDA's Jan. 16 MDO for 22 standalone SMOK hardware items.
SWT Global Supply, Inc. (spelled "STW" mistakenly in some court papers) filed a petition for review with the Fifth Circuit Court of Appeals on October 1, 2021. The case was heard on November 29, 2021. The Fifth Circuit stayed SWT's MDO pending appeal (the request was uncontested by the FDA) and merged five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.
SWT Global Supply, Inc. (incorrectly written "STW" in some legal documents) - Petition for review filed June 12, 2023 at the Eighth Circuit Court of Appeals
- On February 14, 2024, an Eighth Circuit Court panel heard oral arguments from SWT Global Supply and the FDA on SWT's appeal of MDOs for menthol e-liquids. (SWT is also pursuing an appeal for non-menthol-flavored goods in the Fifth Circuit.)
SV Packaging, LLC (SAVEURVAPE) filed a petition for review with the Fifth Circuit Court of Appeals on November 29, 2021. The precise date is uncertain.The Fifth Circuit granted a stay of SV Packaging's MDO pending appeal (the request was not contested by the FDA), and aggregated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.
Triton Distribution (also known as Wages and White Lion Investments, LLC) - Petition for Review filed on October 6, 2021 - Fifth Circuit Court of Appeals
- On October 6, 2021, Triton Distribution filed an emergency move for a stay pending a judicial review of its MDO, requesting expedited action.
- On October 12, the FDA reacted to Triton's emergency motion with a court filing.
- On October 14, Triton Distribution reacted to the FDA's opposition to a stay.
- On October 26, the Fifth Circuit merged the Triton Distribution and Vapetasia cases and halted both MDOs for review.
- On November 17, David Abrams, Clive Bates, and David Sweanor filed an amicus brief supporting Triton Distribution's case.
- July 18: The Fifth Circuit denied Triton Distribution and Vapetasia's appeals of MDOs granted last year. The vote was 2-1, with Judge Edith Jones writing a scorching dissent. The firms said that they will seek an en banc rehearing of their requests for review, with all active Fifth Circuit judges participating.
- On September 1, Triton Distribution and Vapetasia petitioned the court for both panel and en banc rehearings of their case. The petitions were based partially on the FDA's failure to include its "bracketing and bundling" document in the official record.
- On September 30, the FDA issued its answer to the Triton/Vapetasia application for en banc review.
- On October 11, Triton/Vapetasia submitted a reply brief to the FDA's answer on September 30.
- On January 19, 2023, the Fifth Circuit Court granted Triton Distribution and Vapetasia a rare en banc rehearing of their MDO appeal, which a three-judge panel from the same court refused last year. In the en banc rehearing, all current Fifth Circuit judges will hear the case. The decision to rehear the matter invalidates the earlier ruling.
- On May 16, lawyers for Triton/Vapetasia and the FDA presented oral arguments before the full Fifth Circuit. Triton argued in support of its petition for reconsideration of the FDA's MDOs, while the FDA supported its own.
- On January 3, 2024, the Fifth Circuit decided 10-6 for Triton and Vapetasia, approving their combined appeal and returning their PMTAs to the FDA for review.
- On February 15, 2024, the Fifth Circuit granted R.J. Reynolds' petition 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 Triton setback to the Supreme Court.
Turning Point Brands, Inc. filed a petition for review with the Sixth Circuit Court of Appeals on September 23, 2021. On September 30, 2021, the company requested an emergency stay for its MDO review and expedited consideration.
- On October 7, the FDA revoked Turning Point Brands' MDO, saying the agency overlooked evidence submitted in the company's PMTA. TPB's goods have been resubmitted for scientific assessment.
- On Oct. 8, Turning Point Brands withdrew its petition for review after the FDA revoked the company's MDO.
Union Street Brands - Petition for review likely filed in 2021 (precise date uncertain).On May 17, 2022, the Eleventh Circuit Court of Appeals heard oral arguments from the FDA, Union Street Brands, and other petitioners.
- On August 23, the court decided in favor of Union Street Brands and five other petitioners, nullifying their MDOs and returning their PMTAs to the FDA for reconsideration.
Vapetasia LLC filed a petition for review in 2021 (the precise date is unclear). - Fifth Circuit Court of Appeals: October 26, 2021. The court merged the Triton Distribution and Vapetasia cases and halted both MDOs awaiting review. For further information, see the Triton Distribution entry.
Vapor Unlimited LLC - Petition for review filed on October 8, 2021 The Eleventh Circuit Court of Appeals suspended Vapor Unlimited's MDO on February 1, 2022, pending review.
- On May 17, the court heard oral arguments from the FDA and Vapor Unlimited (and co-petitioners).
- On August 23, the Eleventh Circuit ruled in favor of Vapor Unlimited and five other petitioners, nullifying their MDOs and returning their PMTAs to the FDA for reconsideration.
Vaporized, Inc. filed a petition for review with the Fifth Circuit Court of Appeals on October 11, 2021, which was heard on November 29, 2021.The Fifth Circuit stayed Vaporized's MDO pending appeal (the request was uncontested by the FDA) and aggregated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.
Vapornine LLC (New Leaf Vapor Co.) - Petition for review was likely submitted in 2021 (precise date unclear).- Eleventh Circuit Court of Appeals: May 17, 2022. The FDA and Vapornine (together with four other petitioners) presented oral arguments before the court.
- August 23: Despite being combined for oral arguments with four of the firms whose MDOs were later annulled in a favorable court decision, Vapornine was not included in that result. The fate of Vapornine's MDO appeal is uncertain.
