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February 15, 2024

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.

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. 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.”

March 23, 2023
The Fifth Circuit granted a stay pending review of the MDO for the Vuse Vibe menthol refill. (Reynolds dropped its appeal of the Vuse Ciro refills because it no longer sells that product).

March 20, 2023
The Fifth Circuit granted R.J. Reynolds a temporary stay of the March 17 Vuse Solo menthol refill MDO. The temporary stay will be in effect pending a motion for a stay pending appeal.

Feb. 6, 2023
The Second Circuit heard oral arguments in Magellan’s appeal of the MDO for its Juno-brand refill pods.

Jan. 25, 2023
– The Fifth Circuit granted R.J. Reynolds a temporary stay of the MDO issued yesterday for Vuse Vibe and Ciro menthol refills. The temporary stay will be in effect pending a motion for a stay pending appeal.

– The D.C. Circuit Court heard oral arguments from Fontem US and the FDA regarding MDOs issued for the myblu device and multiple flavored refill pods.

Jan. 19, 2023
The Fifth Circuit Court granted Triton Distribution and Vapetasia a rare en banc rehearing of their MDO appeal, which a three-judge Fifth Circuit panel denied last year. In the en banc rehearing, all active judges on the Fifth Circuit will rehear the case.

Dec. 12, 2022
A three-judge panel of the Fourth Circuit ruled unanimously to deny AVAIL Vapor’s petition for review of its MDO. The company could now ask for an en banc rehearing with all Fourth Circuit judges, or request a hearing by the Supreme Court.

Oct. 28, 2022
The Third Circuit granted Logic LLC a temporary stay of two MDOs issued Oct. 26. The court set a seven-day deadline for a motion to stay the denials pending appeal.

Oct. 27, 2022
– A three-judge panel of the Third Circuit ruled unanimously to deny Liquid Labs’ petition for review of its MDO. The company could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

– Logic LLC filed a petition for review in the Third Circuit of the MDO issued Oct. 26 for its menthol-flavored refills. The company also filed an emergency motion for a temporary stay of the MDO.

Oct. 11, 2022
Triton Distribution/Vapetasia filed a reply brief addressing the FDA’s Sept. 30 response to the Triton petition for en banc review in the Fifth Circuit.

Sept. 30, 2022
The FDA filed its response to the Sept. 1 Triton Distribution/Vapetasia motion for en banc review in the Fifth Circuit.

Sept. 20, 2022
Juul Labs sued the FDA in the U.S. District Court for D.C., charging the agency improperly withheld documents requested by Juul under the Freedom of Information Act (FOIA). The documents are related to the June 23 MDO issued to Juul.

Sept. 1, 2022
Triton Distribution and Vapetasia petitioned the Fifth Circuit Court for both panel and en banc rehearings of their case (panel rehearing means a rehearing by the original three-judge panel that voted in the FDA’s favor; en banc is a full rehearing by the whole court). The petitions are based partly on the FDA not including its “bracketing and bundling” memo in the administrative record (thus hiding it from the vape company petitioners); and on the panel judges’ misunderstanding of the requirements the FDA imposed on manufacturers submitting PMTAs.

Aug. 29, 2022
The Seventh Circuit Court of Appeals denied the petition for review filed by Gripum LLC. The company could now ask for an en banc rehearing with all Seventh Circuit judges, or request a hearing by the Supreme Court.

Aug. 23, 2022
The Eleventh Circuit Court found in favor of six manufacturers—Bidi Vapor, Diamond Vapor, Johnny Copper, Pop Vapor Co., Union Street Brands, and Vapor Unlimited. The ruling vacates their MDOs and forces the FDA to conduct new reviews of the companies’ PMTAs.

Aug. 4, 2022
The Ninth Circuit Court has consolidated appeals by Lotus Vaping Technologies and Nude Nicotine (date of action unknown). Oral arguments are scheduled for Aug. 11, according to attorney Lance Churchill. They can be heard at 9:30 a.m. PDT at this site.

July 26, 2022
The D.C. Circuit Court of Appeals denied petitions for review filed by four manufacturers—Prohibition Juice Co., Cool Breeze Vapor, Ecig Charleston, and Jay Shore Liquids. The cases had been consolidated by the court. The companies could now ask for an en banc rehearing with all D.C. Circuit judges, or request a hearing by the Supreme Court.

July 25, 2022
The D.C. Circuit Court denied Fontem US’s emergency motion for a stay, leaving the myblu MDO in effect. The court set a schedule for briefs to be filed in the appeal, with the first brief from Fontem due by Aug. 10.

July 19, 2022
In a Ninth Circuit Court filing, the FDA admitted it may not make a decision on MVO’s administrative appeal until January 2024.

July 18, 2022
The Fifth Circuit ruled against Triton Distribution and Vapetasia in their appeal of MDOs issued last year. The vote was 2-1, with Judge Edith Jones issuing a blistering dissent. The companies say they will ask the court to grant an en banc rehearing of their petitions, with all active Fifth Circuit judges participating.

July 12, 2022
In the D.C. Circuit Court, Fontem US filed an emergency motion for a stay of its MDO for the myblu device and refill pods.

July 6, 2022
Juul Labs and the FDA filed a joint motion asking the D.C. Circuit Court to hold Juul’s legal challenge in abeyance (pausing the process) until the FDA has completed its administrative review. Juul also withdrew its emergency motion for a stay pending review (which can be refiled if the FDA denies Juul’s appeal).

July 5, 2022
The FDA granted Juul an administrative stay of its MDO, agreeing not to take enforcement action while the FDA “supervisory review” is in progress.

June 27, 2022
Juul filed an emergency motion in the D.C. Circuit for a stay pending review. FDA’s response is due July 7.

June 24, 2022
Juul Labs filed a petition in the D.C. Circuit for review of its MDO, and asked the court to temporarily stay the MDO until Juul is able to file a motion for a full stay pending review. The temporary stay was granted later the same day.

May 17, 2022
The Eleventh Circuit Court heard oral arguments from lawyers for the FDA and Bidi Vapor, Pop Vapor, and a consolidated case including Diamond Vapor, Johnny Copper, Union Street Brands, Vapornine and Vapor Unlimited. (The links are downloadable MP3s. You can also listen on the court’s website.)

April 22, 2022
Vapor Voice reported on April 22 that Simple Vapor had voluntarily withdrawn its petition for review in the Sixth Circuit. Date of action unknown.

April 20, 2022
The Seventh Circuit heard oral arguments from lawyers for Gripum and the FDA.

March 14, 2022
The Eleventh Circuit Court stayed enforcement of Pop Vapor’s MDO pending review, according to Vapor Voice.

March 1, 2022
The FDA rescinded Al Khalifa Group’s MDO after an administrative review (according to the FDA’s official MDO list updated April 25). Date unknown: Al Khalifa voluntarily withdrew its petition to the Ninth Circuit Court, according to Vapor Voice.

Feb. 23, 2022
AVAIL Vapor lost its FDA appeal. (The company is also appealing its MDO in the Fourth Circuit.)

Feb. 10, 2022
Breeze Smoke voluntarily withdrew its MDO appeal to the Sixth Circuit (which had been scheduled for oral arguments Feb. 22), according to Vapor Voice.

Feb. 9, 2022
The D.C. Circuit scheduled oral arguments in a consolidated case for 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 Firm.

Feb. 2, 2022
After FDA withdrew its MDO in October, Fumizer’s action against the FDA was dismissed by the Ninth Circuit for “failure to prosecute,” according to Vapor Voice.

Feb. 1, 2022
MDOs for Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited MDOs were all stayed by the Eleventh Circuit pending review. The court ordered these four cases, and three others that did not receive stays—Pop Vapor Co., Union Street Brands, and Vapornine (New Leaf Vapor Co.)—to appear together for oral arguments on a date to be set later.

Jan. 31, 2022
The Fifth Circuit heard oral arguments from attorneys for Triton Distribution and the FDA.

Jan. 28, 2022
The Fifth Circuit issued a “stay of proceedings…for American Vapor, Inc.s petition pending a decision in [Triton Distribution’s review]” (reported in the FDA’s official MDO list updated Feb. 3). Vapor Voice reported later (April 22) that American Vapor had voluntarily withdrawn its petition for review.

Dec. 30, 2021
An amicus brief in support of Gripum’s petition was filed in the Seventh Circuit by David Abrams, Clive Bates, and David Sweanor.

Dec. 10, 2021
The Supreme Court denied Breeze Smoke’s emergency application for a stay of its MDO. The Sixth Circuit Court will now consider Breeze Smoke’s petition for review, but the company will be subject to FDA enforcement if it continues selling the denied products during the appeal.

Dec. 7, 2021
Breeze Smoke responded to the FDA’s brief filed yesterday opposing Breeze Smoke’s application to the Supreme Court for a stay of its MDO.

Dec. 6, 2021
The FDA filed a memorandum in opposition to Breeze Smoke’s application for a stay of its MDO with the Supreme Court. In the brief, the agency claimed that Breeze Smoke’s products were introduced after Aug. 8, 2016—the cutoff date for products allowed to remain on the market (until Sept. 9, 2020) without first being authorized by the FDA.

Nov. 29, 2021
– Supreme Court Justice Brett Kavanaugh asked the FDA to respond to Breeze Smoke’s application for a stay by Monday, Dec. 6.

– The Fifth Circuit granted stays pending review to Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized, and consolidated the cases. The stay motions were unopposed by the FDA.

Nov. 24, 2021
– An amicus brief in support of Bidi Vapor’s petition for review was filed in the Eleventh Circuit by David Abrams, Clive Bates, and David Sweanor.

– An amicus brief in support of My Vape Order’s petition for review was filed in the Ninth Circuit by David Abrams, Clive Bates, and David Sweanor.

Nov. 23, 2021
– Breeze Smoke applied to the Supreme Court for an emergency stay pending circuit court review of its MDO.

– Pop Vapor Co.’s MDO was partially rescinded by the FDA (according to the FDA’s official MDO list updated Feb. 17).

Nov. 19, 2021
Bidi Vapor filed its opening brief in the Eleventh Circuit, and requested the court allow oral argument.

Nov. 17, 2021
An amicus brief in support of Triton Distribution’s petition for review was filed in the Fifth Circuit by David Abrams, Clive Bates, and David Sweanor.

Nov. 12, 2021
Breeze Smoke’s motion for a stay was denied by the Sixth Circuit.

Nov. 4, 2021
Gripum’s MDO was stayed by the Seventh Circuit Court pending review.

Nov. 3, 2021
Al Khalifa Group’s MDO was stayed by the FDA pending administrative review (according to the FDA’s official MDO list updated Feb. 17).

Nov. 2, 2021
Humble Juice’s MDO was rescinded by the FDA (according to the FDA’s official MDO list updated Nov. 3), and the products were moved back into scientific review. Tobacco Reporter reported that Humble Juice withdrew its petition for review in the Ninth Circuit after the FDA recission of its MDO.

Nov. 1, 2021
AVAIL Vapor’s MDO was stayed by the FDA pending administrative review.

Oct. 26, 2021
– ECS Global’s MDO was partially rescinded by the FDA (according to the FDA’s official MDO list updated Nov. 3) and the products were moved back into scientific review.

– The Triton Distribution and Vapetasia cases were consolidated by the Fifth Circuit, and both MDOs were stayed by the court pending review.

Oct. 25, 2021
Bidi Vapor filed a motion for a stay in the Eleventh Circuit pending court review of its MDO.

Oct. 22, 2021
– Bidi Vapor’s MDO was stayed by the FDA pending administrative review.

– Fumizer’s MDO was rescinded by the FDA and the products moved back into scientific review.

– Gripum replied in a court filing to the FDA’s filing opposing a stay.

Oct. 19, 2021
Gripum’s MDO was temporarily stayed by the Seventh Circuit while the company’s motion for a stay is considered.

Oct. 18, 2021
My Vape Order’s MDO was stayed by the FDA pending administrative review.

Oct. 17, 2021
Gripum filed an emergency motion for a stay in the Seventh Circuit pending court review of the company’s MDO.

Oct. 14, 2021
Triton Distribution responded to the FDA in a court filing.

Oct. 13, 2021
Breeze Smoke filed an emergency motion for a stay in the Sixth Circuit pending court review of its MDO.

Oct. 12, 2021
The FDA responded to Triton Distribution’s emergency motion for a stay.

Oct. 8, 2021
Turning Point Brands withdrew its petition for review after the FDA’s rescission of Turning Point’s MDO.

Oct. 7, 2021
The FDA rescinded Turning Point Brands’ MDO, claiming the agency missed evidence included in the company’s PMTA. Turning Point’s products were moved back into scientific review.

Oct. 6, 2021
Triton Distribution filed an emergency motion for a stay in the Fifth Circuit pending court review of its MDO, and requested expedited consideration of the motion.

Sept. 30, 2021
Turning Point Brands filed an emergency motion for a stay pending court review of its MDO, and requested expedited consideration of the motion.

7 Daze LLC – Petition for review filed Oct. 7, 2021 – Ninth Circuit Court of Appeals

Al Khalifa Group LLC – Petition for review filed in 2021 (exact date unknown) – Ninth Circuit Court of Appeals
– Nov.3, 2021: Al Khalifa Group MDO stayed by FDA pending administrative review.
– March 1, 2022: FDA rescinded Al Khalifa Group’s MDO after administrative review.
– (date unknown): Al Khalifa voluntarily withdrew its petition for review, according to Vapor Voice.

American Vapor, Inc. – Petition for review filed in 2021 (exact date unknown)– Fifth Circuit Court of Appeals
– Jan. 28, 2022: Court “issued a stay of proceedings for American Vapor, Inc.s petition pending a decision in [Triton Distribution’s petition]” (according to FDA’s official MDO list updated Feb. 3).
– (2022 – date unknown): Vapor Voice reported April 22 that American Vapor withdrew its petition to the court.

AVAIL Vapor, LLC – Petition for review filed Sept. 30, 2021 – Fourth Circuit Court of Appeals
– Nov. 1, 2021: AVAIL MDO stayed by FDA pending administrative review.
– Feb. 23, 2022: FDA denied AVAIL’s appeal.
– Dec. 12: A three-judge Fourth Circuit panel decided unanimously to deny AVAIL’s petition for review of its MDO. The company could now ask for an en banc rehearing with all active Fourth Circuit judges, or request a hearing by the Supreme Court.
– May 11, 2023: AVAIL 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 31: An amicus brief was filed today by the Washington Legal Foundation, supporting AVAIL’s Supreme Court appeal.
– June 14: An amicus brief was filed today by a group of experts including David Abrams, Clive Bates and David Sweanor supporting AVAIL’s Supreme Court appeal. A separate brief was filed today by the Vapor Technology Association (VTA).
– Oct. 10: The Supreme Court refused to hear AVAIL’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.

Bad Modder Fogger (BMF Labs)Petition for review filed Oct. 4, 2021 – Fourth Circuit Court of Appeals

Bidi Vapor LLC (PMTAs for flavored Bidi Stick disposables) – Petition for review and motion for expedited review filed Sept. 29, 2021 – Eleventh Circuit Court of Appeals
– Oct. 22, 2021: Bidi Vapor’s MDO was stayed by FDA pending administrative review.
– Oct. 25: Bidi filed a motion for a stay pending court review of its MDO.
– Nov. 19: Bidi filed its opening brief and requested the court allow oral argument.
– Nov. 24: An amicus brief in support of Bidi Vapor’s petition was filed by David Abrams, Clive Bates and David Sweanor.
– Feb. 1, 2022: Bidi’s MDO was stayed by the court pending review.
– May 17: The court heard oral argument from Bidi Vapor and the FDA.
– Aug. 23: The court ruled in favor of Bidi Vapor and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA scientific review.

Bidi Vapor LLC (PMTA for tobacco-flavored Bidi Stick-Classic disposable) – Petition for review filed Jan. 26, 2024 – Eleventh Circuit Court of Appeals
– Feb. 2, 2024: Bidi Vapor filed a motion asking the Eleventh Circuit Court to stay the MDO for its tobacco-flavored disposable Bidi Stick-Classic pending review.

Breeze Smoke, LLC – Petition for review filed Oct. 4, 2021 – Sixth Circuit Court of Appeals
– Oct. 13, 2021: Breeze Smoke files an emergency motion for a stay pending court review of its MDO.
– Nov. 12: Breeze Smoke’s motion for a stay was denied by the court.
– Nov. 23: Breeze Smoke applied to the Supreme Court for a stay pending review by the circuit court of its MDO.
– Nov. 29: Supreme Court Justice Brett Kavanaugh asks the FDA to respond to Breeze Smoke’s application for a stay by Monday, Dec. 6.
– Dec. 6: FDA files its memorandum in opposition to Breeze Smoke’s application for a stay of its MDO by the Supreme Court.
– Dec. 7: Breeze Smoke responded to the FDA brief filed yesterday opposing Breeze Smoke’s application to the Supreme Court for a stay of its MDO. Breeze Smoke also filed a supplemental declaration from employee Steven Haddad in which Haddad claims 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 FDA ‘deemed’ e-cigarette products effective August 8, 2016.”
– Dec. 10: The Supreme Court denied Breeze Smoke’s emergency application for a stay of its MDO. The full review of Breeze Smoke’s MDO will now proceed in the Sixth Circuit, but the company will be subject to FDA enforcement if it continues selling the denied products during the court review.
– Feb. 10, 2022: Breeze Smoke voluntarily withdrew its petition to the Sixth Circuit (which had been scheduled for oral arguments Feb. 22), according to Vapor Voice.

Cloud House LLC – Petition for review filed Oct. 8, 2021 – Fifth Circuit Court of Appeals
– Nov. 29, 2021:The Fifth Circuit grants a stay of Cloud House’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

Cloud Nine Vapor Products – Petition for review filed Oct. 8, 2021 – Tenth Circuit Court of Appeals
– Date unknown: consolidated with Electric Clouds appeal
– Nov. 14, 2023: Tenth Circuit hears oral arguments

Cool Breeze Vapor LLC – Petition for review filed in 2021 (exact date unknown) – District of Columbia Circuit Court of Appeals
– (2021/22 – date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: The FDA filed a brief supporting its MDOs.
– Feb. 9: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.
– July 26: The D.C. Circuit denied petitions for review filed by Cool Breeze Vapor and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

Diamond Vapor LLC – Petition for review filed Oct. 1, 2021 – Eleventh Circuit Court of Appeals
– Feb. 1, 2022: Diamond Vapor’s MDO was stayed by the Eleventh Circuit pending review.
– May 17: The court heard oral arguments from the FDA and Diamond Vapor (and co-petitioners).
– Aug. 23: The court ruled in favor of Diamond Vapor and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA scientific review.

E-Liquid Brands, LLC – Petition for review filed Oct. 7, 2021 – Fourth Circuit Court of Appeals

ECig Charleston LLC – Petition for review filed in 2021 (exact date unknown) – District of Columbia Circuit Court of Appeals
– (2021/22 – date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: The FDA filed a brief supporting its MDOs.
– Feb. 9: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.
– July 26: The D.C. Circuit denied petitions for review filed by ECig Charleston and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

ECS Global LLC Petition for review filed Oct. 12, 2021 – District of Columbia Circuit Court of Appeals. (ECS Global received MDOs for Phix pod-vape devices and prefilled Phix pods.)
– Oct. 26: ECS Global’s MDO was partially rescinded by the FDA (according to the FDA’s official MDO list updated Nov. 3) and products were moved back into scientific review.

Electric Clouds – Petition for review filed Oct. 8, 2021 – Tenth Circuit Court of Appeals
– Date unknown: consolidated with Cloud Nine Vapor Products appeal
– Nov. 14, 2023: Tenth Circuit hears oral arguments

Fontem US, LLCPetition for review filed May 6, 2022 – District of Columbia Circuit Court of Appeals. (Fontem, a subsidiary of Imperial Brands, received MDOs for the myblu device and refill pods)
– July 12, 2022: Fontem filed an emergency motion for a stay of its MDO.
– July 25: The court denied Fontem’s emergency motion for a stay, leaving the myblu MDO in effect. The court set a schedule for briefs to be filed in the appeal, with the first brief from Fontem due Aug. 10.
– Jan. 25, 2023: The court heard oral arguments from Fontem and the FDA.
– Aug. 29: A three-judge panel of the D.C. Circuit issued a divided decision on the 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.

Fumizer, LLC – Petition for review filed Oct. 6, 2021 – Ninth Circuit Court of Appeals.
– Oct. 22, 2021: Fumizer’s MDO was rescinded by the FDA and the products were moved back into scientific review.
– Feb 2, 2022: The Ninth Circuit dismissed Fumizer’s appeal for “failure to prosecute,” according to Vapor Voice (which does not affect the FDA review already granted).

Gripum LLC – Petition for review filed Oct. 8, 2021 – Seventh Circuit Court of Appeals
– Oct. 17: Gripum filed an emergency motion for a stay pending court review of its MDO.
– Oct. 19: Gripum’s MDO was temporarily stayed by court while the motion is considered.
– Oct. 27: Gripum replied in a court filing to the FDA filing opposing a stay.
– Nov. 4: Gripum’s MDO was stayed by court pending review.
– Dec. 27: Gripum filed a brief preceding oral arguments.
– Dec. 30: An amicus brief in support of Gripum’s petition was filed by David Abrams, Clive Bates, and David Sweanor.
– April 20, 2022: The court heard oral arguments from Gripum and the FDA.
– Aug. 29: The court denied Gripum’s petition for review. The company could now ask for an en banc rehearing with all active Seventh Circuit judges, or request a hearing by the Supreme Court.

Humble Juice Co., LLC – Petition for review filed in October 2021 (exact date unknown) – Ninth Circuit Court of Appeals
– Nov. 2, 2021: Humble Juice’s MDO was rescinded by the FDA (according to FDA’s official MDO list updated Nov. 3) and the products were moved back into scientific review. Tobacco Reporter reports that Humble Juice then withdrew its petition for review.

Jay Shore Liquids LLC – Petition for review filed in 2021 (exact date unknown) – District of Columbia Circuit Court of Appeals
– (2021/22 – date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: The FDA filed a brief supporting its MDOs.
– Feb. 9: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.
– July 26: The D.C. Circuit denied petitions for review filed by Jay Shore Liquids and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

Johnny Copper LLC – Petition for review filed Oct. 7, 2021 – Eleventh Circuit Court of Appeals
– Feb. 1, 2022: Johnny Copper’s MDO was stayed by the court pending review.
– May 17: The court heard oral arguments from the FDA and Johnny Copper (and four co-petitioners).
– Aug. 23: The court ruled in favor of Johnny Copper and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA scientific review.

Juul Labs, Inc.Petition for review filed June 24, 2022 – District of Columbia Circuit Court of Appeals
– June 24, 2022: Juul Labs filed a petition for review of its MDO, and asked the court to temporarily stay the MDO until Juul is able to file a motion for a full stay pending review. The temporary stay is granted later the same day.
– June 27: Juul filed an emergency motion for a stay pending review. The FDA’s response is due July 7.
– July 5: The FDA granted Juul an administrative stay of its MDO, agreeing not to take enforcement action while the FDA “supervisory review” is in progress.
– July 6: Juul Labs and the FDA filed a joint motion asking the court to hold Juul’s legal challenge in abeyance (pause the process) until the FDA has completed its administrative review. Juul also withdrew its pending emergency motion for a stay pending review in the D.C. Circuit (which can be refiled if FDA denies Juul’s appeal).
– Sept. 20: Juul Labs filed a lawsuit against the FDA in the U.S. District Court for D.C., charging the agency improperly withheld documents requested by Juul under the Freedom of Information Act (FOIA). The documents are related to the MDO issued to Juul on June 23.

Liquid Labs LLC – Petition for review filed Oct. 12, 2021 – Third Circuit Court of Appeals
– Oct. 27, 2022: A Third Circuit panel unanimously denied Liquid Labs’ petition for review of MDO. The company could now ask for an en banc rehearing with all Third Circuit judges, or request a hearing by the Supreme Court.

Logic Technology Development (Logic LLC) – Petition for review filed Oct. 27, 2022 – Third Circuit Court of Appeals
– Oct. 26, 2022: Logic received MDOs for two menthol-flavored refills.
– Oct. 27: Logic LLC filed a petition for review of the MDO issued Oct. 26 for its menthol-flavored refills. The company also filed an emergency motion for a temporary stay of the MDO.
– Oct. 28: The Third Circuit granted Logic a temporary stay of its MDO, and set a seven-day deadline for a motion to stay the denials pending appeal.
– May 9, 2023: The Third Circuit heard oral arguments from Logic and the FDA supporting and opposing Logic’s petition for review of the FDA’s MDOs for Logic’s menthol refills.
– 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.

Lotus Vaping Technologies, LLCPetition for review filed Oct. 14, 2021 – Ninth Circuit Court of Appeals
– Aug. 4, 2022 update: The Ninth Circuit consolidated Lotus’s petition with Nude Nicotine’s (date unknown). According to attorney Lance Churchill, oral arguments are scheduled for Aug. 11.
– July 7, 2023: A three-judge panel of the Ninth Circuit ruled unanimously to deny the consolidated Lotus/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.
– Aug. 21: Lotus filed a motion with the Ninth Circuit, asking for an en banc rehearing.
– Sept. 14: Lotus’ motion for an en banc rehearing of its petition for review was denied by the Ninth Circuit.
– Feb. 9, 2024: Lotus 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.

Magellan Technology, Inc.Petition for review filed Sept. 24, 2021 – Second Circuit Court of Appeals
– Feb. 6, 2023: The Second Circuit heard oral arguments in Magellan’s appeal of the MDO for Juno-brand refill pods.
– June 16: A Second Circuit panel ruled unanimously to deny Magellan’s petition for review of the MDO for its flavored Juno refill pods. The company could now ask for an en banc rehearing with all active Second Circuit judges, or request a hearing by the Supreme Court.
– 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.

My Vape Order, Inc. – Petition for review filed Sept. 30, 2021 – Ninth Circuit Court of Appeals
– Oct. 18, 2021: My Vape Order’s MDO was stayed by the FDA pending administrative review.
– Nov. 24: An amicus brief in support of My Vape Order’s petition was filed by David Abrams, Clive Bates and David Sweanor.
– Jan. 5, 2022: The court agreed to hold MVO’s appeal in abeyance (put it on hold) pending the outcome of the FDA’s administrative appeals process.
– Jan. 19: The FDA “partially rescinded” MVO’s MDO “with respect to certain products.”
– July 19: In a court filing, the FDA admitted it may not make a decision on MVO’s appeal until January 2024.

New World Wholesale, Inc. & Shenzhen Goldreams Technology Co., Ltd.Petition for review filed Oct. 11, 2021 – Fifth Circuit Court of Appeals

Nude Nicotine, Inc. – Petition for review filed Oct. 6 – Ninth Circuit Court of Appeals
– Aug. 4, 2022 update: The Ninth Circuit consolidated Nude Nicotine’s appeal with Lotus Vaping Technologies’ (date unknown). According to attorney Lance Churchill, oral arguments are scheduled for Aug. 11.
– July 7, 2023: A three-judge panel of the Ninth Circuit ruled unanimously to deny the consolidated Lotus/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.

Paradigm Distribution Petition for review filed Oct. 11, 2021 – Fifth Circuit Court of Appeals
– Nov. 29, 2021:The Fifth Circuit granted a stay of Paradigm’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

Pop Vapor Co. LLC – Petition for review filed in 2021 (exact date unknown)– Eleventh Circuit Court of Appeals
– Nov. 23, 2021: Pop Vapor Co.’s MDO was partially rescinded (according to FDA’s official MDO list updated Feb. 17).
– March 14, 2022: The Eleventh Circuit stayed FDA enforcement of Pop Vapor’s MDO pending review, according to Vapor Voice.
– May 17: The court heard oral argument from Pop Vapor and FDA.
– Aug. 23: The court ruled in favor of Pop Vapor Co. and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review.

Prohibition Juice Co.Petition for review filed Oct. 13, 2021 – District of Columbia Circuit Court of Appeals

– (2021/22 – date unknown): The D.C. Circuit consolidated the appeals of Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: The FDA filed a brief supporting its MDOs.
– Feb. 9: The D.C. Circuit scheduled oral arguments in the consolidated case for April 21.
– July 26: The D.C. Circuit denied petitions for review filed by Prohibition Juice Co. and three other manufacturers in a consolidated appeal. The petitioners could now ask for an en banc rehearing with all active D.C. Circuit judges, or request a hearing by the Supreme Court.

R.J. Reynolds Vapor Co. (Vuse Alto menthol refills MDO) – Petition for review filed Oct. 13, 2023 – Fifth Circuit Court of Appeals
– 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. 19,2023: 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 may have been previously consolidated with the Vibe appeal.)
– 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 (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.”
– 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.
– 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. 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.

R.J. Reynolds Vapor Co. (Vuse Ciro and Vibe menthol refills MDO) – Petition for review filed in January 2023 (exact date unknown) – Fifth Circuit Court of Appeals
– Jan. 25, 2023: The Fifth Circuit granted Reynolds a temporary stay pending a motion for a stay pending appeal.
– March 23: The Fifth Circuit granted a stay pending review of the MDO for the Vuse Vibe menthol refill. (Reynolds dropped its appeal of Vuse Ciro refills because it no longer sells that product).
– April 7: 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 requested 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.”
– June 14: R.J. Reynolds filed a motion asking the Fifth Circuit to stay the merits briefing in its challenge to the FDA denial order for menthol Vuse products until after the court decision in the Triton rehearing. (The Triton case covers many of the same issues.)
– June 15: The Fifth Circuit granted R.J. Reynolds’ motion (filed yesterday) to stay the merits briefing in its challenge to the FDA denial order for menthol Vuse products until after the court decision in the Triton rehearing.
– June 27: The Fifth Circuit denied a motion (filed earlier in June) by the FDA to transfer R.J. Reynolds’ Vuse menthol MDO appeal to the D.C. Circuit Court.
– Oct. 19,2023: 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 may have been previously consolidated with the Vibe appeal.)
– 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 (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.”
– 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.
– 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. 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.

R.J. Reynolds Vapor Co. (Vuse Solo menthol refills MDO) – Petition for review filed in 2023 (exact date unknown)– Fifth Circuit Court of Appeals
– March 20, 2023: The Fifth Circuit granted Reynolds a temporary stay pending a motion for a stay pending appeal.
– Oct. 19, 2023: 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.)
– 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 (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.”
– 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.
– 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. 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.

Simple Vapor Company – Petition for review filed Oct. 12, 2021 – Sixth Circuit Court of Appeals
– (date unknown): Vapor Voice reported on April 22, 2022 that Simple Vapor had voluntarily withdrawn its petition to the court.

SMOK (Shenzhen IVPS Technology Co., Ltd.) – Petition for review filed Jan. 18, 2024 – Fifth Circuit Court of Appeals
– 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.

SWT Global Supply, Inc. (incorrectly spelled “STW” on some legal documents) – Petition for review filed Oct. 1, 2021 – Fifth Circuit Court of Appeals
– Nov. 29, 2021: The Fifth Circuit granted a stay of SWT’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

SV Packaging, LLC (SAVEURVAPE) – Petition for review filed in 2021 (exact date unknown) – Fifth Circuit Court of Appeals
– Nov. 29, 2021:The Fifth Circuit granted a stay of SV Packaging’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated 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 Oct. 6, 2021 – Fifth Circuit Court of Appeals
– Oct. 6, 2021: Triton Distribution filed an emergency motion for a stay pending court review of its MDO and asked for expedited consideration of the motion.
– Oct. 12: The FDA responded to Triton’s emergency motion in a court filing.
– Oct. 14: Triton Distribution responded to the FDA’s opposition to a stay.
– Oct. 26: The Triton Distribution and Vapetasia cases were consolidated by the Fifth Circuit, and both MDOs were stayed pending review.
– Nov. 17: An amicus brief in support of Triton Distribution’s petition was filed by David Abrams, Clive Bates and David Sweanor.
– Jan. 31, 2022: The Fifth Circuit heard oral arguments from attorneys for Triton Distribution/Vapetasia and the FDA.
– July 18: The Fifth Circuit ruled against Triton Distribution and Vapetasia, denying their appeals of MDOs issued last year. The vote was 2-1, with Judge Edith Jones issuing a blistering dissent. The companies announced they will ask the court to grant an en banc rehearing of their petitions for review with all active Fifth Circuit judges participating.
– Sept. 1: Triton Distribution and Vapetasia petitioned the court for both panel and en banc rehearings of their case (a panel rehearing is a rehearing by the original three-judge panel that voted in the FDA’s favor; an en banc review is a full rehearing by the entire court). The petitions were based partly on the FDA not including its “bracketing and bundling” memo in the administrative record (thus hiding it from the vape company petitioners); and also on the panel judges’ misunderstanding of the requirements FDA imposed on manufacturers submitting PMTAs.
– Sept. 30: The FDA filed its response to the Triton/Vapetasia motion for en banc review.
– Oct. 11: Triton/Vapetasia filed a reply brief addressing the FDA’s Sept. 30 response.
– Jan. 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 denied last year. In the en banc rehearing, all active judges on the Fifth Circuit will rehear the case. The decision to rehear the case nullifies the previous decision.
– May 16: Lawyers for Triton/Vapetasia and the FDA engaged in oral arguments before the full Fifth Circuit. Triton argued in favor of its petition for review of the agency’s MDOs, and the FDA defended its MDOs.
– 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.
– 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.

Turning Point Brands, Inc.Petition for review filed Sept. 23, 2021 – Sixth Circuit Court of Appeals
– Sept. 30, 2021: Turning Point Brands filed an emergency motion for a stay pending court review of its MDO, and asked for expedited consideration of the motion.
– Oct. 7: The FDA rescinded Turning Point Brands’ MDO, claiming the agency missed evidence included in the company’s PMTA. TPB’s products are moved back into scientific review.
– Oct. 8: Turning Point Brands withdrew its petition for review after the FDA rescinded the company’s MDO.

Union Street Brands – Petition for review probably filed in 2021 (exact date unknown)– Eleventh Circuit Court of Appeals
– May 17, 2022: The court heard oral arguments from the FDA and Union Street Brands (and co-petitioners).
– Aug. 23: The court ruled in favor of Union Street Brands and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review.

Vapetasia LLC – Petition for review filed in 2021 (exact date unknown) – Fifth Circuit Court of Appeals
– Oct. 26, 2021: The Triton Distribution and Vapetasia cases were consolidated by the court, and both MDOs were stayed pending review. See the Triton Distribution entry for further developments.

Vapor Unlimited LLC – Petition for review filed Oct. 8, 2021 – Eleventh Circuit Court of Appeals
– Feb. 1, 2022: Vapor Unlimited’s MDO was stayed by the Eleventh Circuit pending review.
– May 17: The court heard oral arguments from the FDA and Vapor Unlimited (and co-petitioners).
– Aug. 23: The Eleventh Circuit ruled in favor of Vapor Unlimited and five other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review.

Vaporized, Inc.Petition for review filed Oct. 11, 2021 – Fifth Circuit Court of Appeals
– Nov. 29, 2021:The Fifth Circuit granted a stay of Vaporized’s MDO pending appeal (the motion was unopposed by the FDA), and consolidated five petitions: Cloud House, Paradigm, SWT Global Supply, SV Packaging, and Vaporized.

Vapornine LLC (New Leaf Vapor Co.) – Petition for review probably filed in 2021 (exact date unknown)– Eleventh Circuit Court of Appeals
– May 17, 2022: The court heard oral arguments from the FDA and Vapornine (and four co-petitioners).
– Aug. 23: Despite being consolidated for oral arguments with four of the companies that today had MDOs vacated in a favorable court decision, Vapornine was not included in that ruling. The status of Vapornine’s MDO appeal is unclear.

Wages and White Lion Investments, LLC – see Triton Distribution

Vaping360 coverage of FDA Marketing Denial Orders (MDOs)

2021

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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Greg
Greg
1 year ago

Curious if there is any class action for smaller companies to join forces whom can’t afford the appeal by themselves… Also, is there a deadline for small companies to appeal?

Jcole
Jcole
2 years ago

Any updates coming soon?

Ben
Ben
7 months ago

Do any of these challenge the FDA’s authority to regulate the entire class of products as tobacco products referencing the new “major questions doctrine”? The deeming rule sounds a lot like, e.g., the ATF frames and receivers rule that was just struck down in Texas.

No Cigs
No Cigs
2 years ago

Really glad to hear this news!