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 legal actions like motions, stays, and other filings. 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.

Aug. 29, 2023
A three-judge panel of the D.C. Circuit issues a split decision to Fontem US for its myblu products, 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 files a motion with the Ninth Circuit for an en banc rehearing of its petition for review

July 7, 2023
A three-judge panel of the Ninth Circuit Court today rules 3-0 to deny Lotus Vaping Technologies’ petition for review of its MDO. The company could now ask for an en banc rehearing with all Ninth Circuit judges

June 27, 2023
The Fifth Circuit denies 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 the MDO for its flavored Juno refill pods

June 15, 2023
The Fifth Circuit grants 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. This news according to attorney Greg Troutman

June 14,2023
R.J. Reynolds files 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 14, 2023
Amicus brief filed today from a group of experts including David Abrams, Clive Bates and David Sweanor supporting AVAIL Vapor’s Supreme Court challenge of the Fourth Circuit Court’s denial of AVAIL’s petition for review. A separate brief also 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 challenge of the Fourth Circuit Court’s denial of AVAIL’s petition for review

May 16, 2023
Triton (and Vapetasia) and the FDA engage in oral arguments before the full Fifth Circuit. Triton argues in favor of its petition for review of the agency’s MDOs, and the FDA defends the MDOs

May 11, 2023
AVAIL appeals the Fourth Circuit’s denial of its petition for review of its MDOs 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 hears 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

April 7, 2023
The FDA petitions 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 grants 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 grants R.J. Reynolds a temporary stay of the MDO issued March 17 for Vuse Solo menthol refills. The temporary stay is in effect pending a motion for a stay pending appeal

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

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

The D.C. Circuit Court hears 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 grants 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 Court rules 3-0 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

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

Oct. 27, 2022
A three-judge panel of the Third Circuit Court rules 3-0 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

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

Oct. 11, 2022
Triton/Vapetasia files 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 files its response to the Sept. 1 Triton/Vapetasia motion for en banc review in the Fifth Circuit

Sept. 20, 2022
Juul Labs sues 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

Sept. 1, 2022
Triton Distribution and Vapetasia petition the Fifth Circuit Court for both panel and en banc rehearings of their case (panel rehearing means a redo 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 FDA imposed on manufacturers submitting PMTAs

Aug. 29, 2022
The Seventh Circuit Court of Appeals denies petition for review filed by Gripum LLC. The company could now ask for an en banc rehearing with all Seventh Circuit judges

Aug. 23, 2022
The Eleventh Circuit Court finds 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 advocate Lance Churchill. They can heard at 9:30 a.m. PDT at this site

July 26, 2022
The D.C. Circuit Court of Appeals denies 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

July 25, 2022
The D.C. Circuit Court of Appeals denies 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 Aug. 10

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

July 18, 2022
The Fifth Circuit Court of Appeals rules 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 for review with all 17 Fifth Circuit judges participating

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

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

July 5, 2022
The FDA grants 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 files an emergency motion for a stay pending review. FDA’s response is due July 7

June 24, 2022
Juul Labs files a petition for review of its MDO, and asks 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

May 17, 2022
The Eleventh Circuit Court hears oral arguments from lawyers for 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 to the Sixth Circuit Court. Date of action unknown

April 20, 2022
The Seventh Circuit Court hears 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
FDA rescinds Al Khalifa Group MDO after administrative review (according to FDA’s official MDO list updated April 25). Date unknown: Al Khalifa voluntarily withdraws petition to Ninth Circuit Court, according to Vapor Voice

Feb. 23, 2022
AVAIL VAPOR loses its FDA appeal. (The company is also challenging its MDO in the Fourth Circuit Court)
**NOTE: As of Oct. 31, 2022, the FDA’s official MDO list continues to show the stay granted while this appeal was in progress as active. This is apparently an agency mistake

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

Feb. 9, 2022
The D.C. Circuit Court schedules oral arguments in four consolidated cases 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 Court for “failure to prosecute,” according to Vapor Voice

Feb. 1, 2022
MDOs for Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited MDOs all stayed by the Eleventh Circuit Court pending review. The court orders 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 Court hears oral arguments from attorneys for Triton Distribution and the FDA

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

Dec. 30
Amicus brief in support of Gripum’s petition filed in Seventh Circuit by David Abrams, Clive Bates, and David Sweanor

Dec. 10
The Supreme Court denies 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 court process

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

Breeze Smoke also files 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. 6
FDA files its memorandum in opposition to Breeze Smoke’s application for a stay of its MDO with the Supreme Court. In the brief, the agency notes that Breeze Smoke’s products were introduced after Aug. 8, 2016—the deadline for products to remain on the market (until Sept. 9, 2020) without first being authorized by FDA with a successful PMTA

Nov. 29
Supreme Court Justice Brett Kavanaugh asks FDA to respond to Breeze Smoke’s application for a stay by Monday, Dec. 6 at 2:00 p.m.

The Fifth Circuit Court grants stays pending review to Cloud House, Paradigm, STW Global Supply, SV Packaging, and Vaporized. Motions for stay were unopposed by FDA. Court consolidated these five cases

Nov. 24
Amicus brief in support of Bidi Vapor’s petition filed in Eleventh Circuit Court by David Abrams, Clive Bates, and David Sweanor

Amicus brief in support of My Vape Order’s petition filed in Ninth Circuit Court by David Abrams, Clive Bates, and David Sweanor

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

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

Nov. 19
Bidi Vapor files opening brief and requests the court allow oral argument

Nov. 17
Amicus brief in support of Triton Distribution’s petition filed in Fifth Circuit Court by David Abrams, Clive Bates, and David Sweanor

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

Nov. 4
Gripum MDO stayed by the Seventh Circuit Court pending review

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

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

Nov. 1
AVAIL Vapor MDO stayed by FDA pending administrative review

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

Triton Distribution and Vapetasia cases are consolidated, and both MDOs are stayed by the court pending review

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

Oct. 22
Bidi Vapor MDO stayed by FDA pending administrative review

Fumizer MDO rescinded by FDA and products moved back into scientific review

Gripum replies in court filing to FDA filing opposing stay

Oct. 19
Gripum MDO temporarily stayed by court while motion for a full stay is considered

Oct. 18
My Vape Order MDO stayed by FDA pending administrative review

Oct. 17
Gripum files emergency motion for a stay in the Seventh Circuit pending court review of its MDO

Oct. 14
Triton Distribution responds to FDA in a court filing

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

Oct. 12
FDA responds to Triton Distribution’s emergency motion for a stay

Oct. 8
Turning Point Brands withdrew its petition for review after FDA rescission of its MDO

Oct. 7
FDA rescinds Turning Point Brands MDO, claiming it missed evidence included in the company’s PMTA. Its products are moved back into scientific review

Oct. 6
Triton Distribution files emergency motion for a stay pending court review of its MDO and requests expedited consideration

Sept. 30
Turning Point Brands files emergency motion for a stay pending court review of its MDO and requests expedited consideration

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

Al Khalifa Group LLC – Petition for review filing date unknown – Ninth Circuit Court of Appeals
– Nov.3: Al Khalifa Group MDO stayed by FDA pending administrative review (according to FDA’s official MDO list updated Feb. 17)
– March 1, 2022: FDA rescinds Al Khalifa Group MDO after administrative review (according to FDA’s official MDO list updated April 25)
– (date unknown): Al Khalifa voluntarily withdraws petition for review, according to Vapor Voice

American Vapor, Inc. – Petition for review filing 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)
– (date unknown): Vapor Voice reported April 22 that American Vapor had voluntarily withdrawn its petition to the court

AVAIL Vapor, LLC – Petition for review filed Sept. 30 – Fourth Circuit Court of Appeals
– Nov. 1: AVAIL Vapor MDO stayed by FDA pending administrative review
– Feb. 23, 2022: FDA denies AVAIL’s appeal. (Apparently by mistake, the FDA’s official MDO list continues to list the stay that ended when the appeal was lost; it is still shown on the Oct. 31 version of the file)
– Dec. 12: A three-judge 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 Fourth Circuit judges
– May 11, 2023: AVAIL appeals the Fourth Circuit’s denial of its petition for review of its MDOs 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 challenge of the Fourth Circuit Court’s denial of AVAIL’s petition for review
– June 14: Amicus brief filed today from a group of experts including David Abrams, Clive Bates and David Sweanor supporting AVAIL Vapor’s Supreme Court challenge of the Fourth Circuit Court’s denial of AVAIL’s petition for review. A separate brief also filed today by the Vapor Technology Association (VTA)

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

Bidi Vapor LLC – Petition for review and motion for expedited review filed Sept. 29 – Eleventh Circuit Court of Appeals
– Oct. 22: Bidi Vapor MDO stayed by FDA pending administrative review
– Oct. 25: Bidi Vapor files motion for a stay pending court review of its MDO
– Nov. 19: Bidi Vapor files opening brief and requests the court allow oral argument
– Nov. 24: Amicus brief in support of Bidi Vapor’s petition filed by David Abrams, Clive Bates and David Sweanor
– Feb. 1, 2022: MDO stayed by the court pending review
– May 17: The court hears oral argument from Bidi Vapor and the FDA
– Aug. 23: The court rules in favor of Bidi Vapor and six other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review

Breeze Smoke, LLC – Petition for review filed Oct. 4 – Sixth Circuit Court of Appeals
– Oct. 13: Breeze Smoke files an emergency motion for a stay pending court review of its MDO
– Nov. 12: Breeze Smoke’s motion for a stay denied by the court
– Nov. 23: Breeze Smoke applies to the Supreme Court for a stay pending review by the circuit court of its MDO
– Nov. 29: Supreme Court Justice Brett Kavanaugh asks FDA to respond to Breeze Smoke’s application for a stay by Monday, Dec. 6 at 2:00 p.m.
– Dec. 6: FDA files its memorandum in opposition to Breeze Smoke’s application for a stay of its MDO with the Supreme Court
– Dec. 7: Breeze Smoke responds to the FDA brief filed yesterday opposing Breeze Smoke’s application to the Supreme Court for a stay of its MDO. Breeze Smoke also files 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 denies Breeze Smoke’s emergency application for a stay of its MDO. The full review of Breeze Smoke’s MDO will now proceed in the circuit court, 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 Court (which had been scheduled for oral arguments Feb. 22), according to Vapor Voice

Cloud House LLC – Petition for review filed Oct. 8 – Fifth Circuit Court of Appeals
– Nov. 29: Court grants stay of MDO pending appeal (unopposed by FDA), and consolidates five petitions: Cloud House, Paradigm, STW Global Supply, SV Packaging, and Vaporized

Cloud Nine Vapor Products – Petition for review filed Oct. 8 – Tenth Circuit Court of Appeals

Cool Breeze Vapor LLC – Petition for review filing date unknown – District of Columbia Circuit Court of Appeals
– date unknown): Appeal consolidated with ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– Feb. 9: Court schedules oral arguments in consolidated cases for April 21
– July 26: The D.C. Circuit Court of Appeals denies petitions for review filed by Cool Breeze Vapor and three other manufacturers in a consolidated appeal

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

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

ECig Charleston LLC – Petition for review filing date unknown – District of Columbia Circuit Court of Appeals
– (date unknown): Appeal consolidated with Cool Breeze Vapor, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– Feb. 9: Court schedules oral arguments in consolidated cases for April 21
– July 26: The D.C. Circuit Court of Appeals denies petitions for review filed by Ecig Charleston and three other manufacturers in a consolidated appeal

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

Electric Clouds – Petition for review filed Oct. 8 – Tenth Circuit Court of Appeals

Fontem US, LLC – Petition 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 files an emergency motion for a stay of its MDO
– July 25: The court denies Fontem’s emergency motion for a stay, leaving the company’s 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 hears oral arguments from Fontem and the FDA
– Aug. 29: A three-judge panel of the D.C. Circuit issues a split decision on myblu products, 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 – Ninth Circuit Court of Appeals.
– Oct. 22: Fumizer MDO rescinded by FDA and products moved back into scientific review
– Feb 2, 2022: Court dismisses case for “failure to prosecute,” according to Vapor Voice

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

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

Jay Shore Liquids LLC – Petition for review filing date unknown – District of Columbia Circuit Court of Appeals
– (date unknown): Appeal consolidated with Cool Breeze Vapor, ECig Charleston, and Prohibition Juice Co.
– Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– Feb. 9: Court schedules oral arguments in consolidated cases for April 21
– July 26: The D.C. Circuit Court of Appeals denies petitions for review filed by Jay Shore Liquids and three other manufacturers in a consolidated appeal

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

Juul Labs, Inc. – Petition for review filed June 24, 2022 – District of Columbia Circuit Court of Appeals
– June 24, 2022: Juul Labs files a petition for review of its MDO, and asks 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 files an emergency motion for a stay pending review. FDA’s response is due July 7
– July 5: The FDA grants 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 file a joint motion asking the court to hold Juul’s legal challenge in abeyance (pausing the process) until the FDA has completed its administrative review. Juul also withdraws its pending emergency motion for a stay pending review (which can be refiled if FDA denies Juul’s appeal)
– Sept. 20: Juul Labs sues 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 – Third Circuit Court of Appeals
– Oct. 27, 2022: Court panel denies petition for review of MDO in a 3-0 vote

Logic Technology Development (Logic LLC) – Petition for review date unknown – Third Circuit Court of Appeals
– Oct. 26, 2022: Logic receives MDOs for two menthol-flavored refills
– Oct. 27: Logic LLC files a petition for review of the MDO issued Oct. 26 for its menthol-flavored refills. The company also files an emergency motion for a temporary stay of the MDO
– Oct. 28: Court grants Logic a temporary stay of its MDO, and sets a seven-day deadline for a motion to stay the denials pending appeal
– May 9, 2023: The Third Circuit hears 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

Lotus Vaping Technologies, LLC – Petition for review filed Oct. 14 – Ninth Circuit Court of Appeals
– Aug. 4, 2022 update: Court consolidated case with Nude Nicotine (date unknown). According to Lance Churchill, oral arguments are scheduled for Aug. 11
– July 7, 2023: A three-judge panel of the Ninth Circuit rules 3-0 to deny Lotus’ petition for review of its MDO. The company could now ask for an en banc rehearing with all Ninth Circuit judges
– Aug. 21: Lotus files a motion with the Ninth Circuit for an en banc rehearing

Magellan Technology, Inc. – Petition for review filed Sept. 24 – Second Circuit Court of Appeals
– Feb. 6, 2023: The Second Circuit hears oral arguments in Magellan’s appeal of the MDO for its Juno brand refill pods
– June 16: A Second Circuit three-judge panel unanimously denied Magellan’s petition for review of the MDO for its flavored Juno refill pods

My Vape Order, Inc. – Petition for review filed Sept. 30 – Ninth Circuit Court of Appeals
– Oct. 18: My Vape Order MDO stayed by FDA pending administrative review
– Nov. 24: Amicus brief in support of My Vape Order’s petition filed by David Abrams, Clive Bates and David Sweanor
– Jan. 5, 2022: The court agrees to hold MVO’s appeal in abeyance (put it on hold) pending the outcome of FDA’s administrative appeals process
– Jan. 19: FDA “partially rescinded MDO with respect to certain products”
– July 19: In a court filing, the FDA admits 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 – Fifth Circuit Court of Appeals

Nude Nicotine, Inc. – Petition for review filed Oct. 6 – Ninth Circuit Court of Appeals
– Aug. 4, 2022 update: Court consolidated case with Lotus Vaping Technologies (date unknown). According to Lance Churchill, oral arguments are scheduled for Aug. 11

Paradigm Distribution – Petition for review filed Oct. 11 – Fifth Circuit Court of Appeals
– Nov. 29: Court grants stay of MDO pending appeal (unopposed by FDA), and consolidates five petitions: Cloud House, Paradigm, STW Global Supply, SV Packaging, and Vaporized

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

Prohibition Juice Co. – Petition for review filed Oct. 13 – District of Columbia Circuit Court of Appeals
– (date unknown): Appeal consolidated with Cool Breeze Vapor, ECig Charleston, and Jay Shore Liquids
– Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– Feb. 9: Court schedules oral arguments in consolidated cases for April 21
– July 26: The D.C. Circuit Court of Appeals denies petitions for review filed by Prohibition Juice Co. and three other manufacturers in a consolidated appeal

R.J. Reynolds Vapor Co. (Vuse Ciro and Vibe menthol refills MDO) – Petition for review filing 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 grants 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)
– April 7: The FDA petitions 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”
– June 14: R.J. Reynolds files 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 grants 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 denies 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

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

Simple Vapor Company – Petition for review filed Oct. 12 – 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

STW Global Supply, Inc. (incorrectly named “SWT Global Supply” on FDA’s MDO list) – Petition for review filed Oct. 1 – Fifth Circuit Court of Appeals
– Nov. 29: Court grants stay of MDO pending appeal (unopposed by FDA), and consolidates five petitions: Cloud House, Paradigm, STW Global Supply, SV Packaging, and Vaporized

SV Packaging, LLC (SAVEURVAPE) – Petition for review filing date unknown – Fifth Circuit Court of Appeals
– Nov. 29: Court grants stay of MDO pending appeal (unopposed by FDA), and consolidates five petitions: Cloud House, Paradigm, STW Global Supply, SV Packaging, and Vaporized

Triton Distribution (Wages and White Lion Investments, LLC) – Petition for review filed Oct. 6 – Fifth Circuit Court of Appeals
– Oct. 6: Triton Distribution files emergency motion for a stay pending court review of its MDO and expedited consideration
– Oct. 12: FDA responds in court filing to Triton Distribution’s emergency motion
– Oct. 14: Triton Distribution responds to FDA’s opposition to stay
– Oct. 26: Triton Distribution and Vapetasia cases consolidated by the court, and both MDOs are stayed pending review
– Nov. 17: Amicus brief in support of Triton Distribution’s petition filed by David Abrams, Clive Bates and David Sweanor
– Jan. 31, 2022: The court hears oral arguments from attorneys for Triton Distribution and the FDA
– July 18: The circuit court rules 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 will ask the court to grant an en banc rehearing of their petitions for review with all 17 Fifth Circuit judges participating
– Sept. 1: Triton Distribution and Vapetasia petition the court for both panel and en banc rehearings of their case (panel rehearing means a redo by the original three-judge panel that voted in the FDA’s favor; en banc is a full rehearing by the entire 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 FDA imposed on manufacturers submitting PMTAs
– Sept. 30: FDA files its response to the Triton/Vapetasia motion for en banc review
– Oct. 11: Triton/Vapetasia files reply brief addressing the FDA’s Sept. 30 response
– Jan. 19, 2023: The Fifth Circuit Court grants 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
– May 16: Triton (and Vapetasia) and the FDA engage in oral arguments before the full Fifth Circuit. Triton argues in favor of its petition for review of the agency’s MDOs, and the FDA defends the MDOs

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

Union Street Brands – Petition for review filing date unknown – Eleventh Circuit Court of Appeals
– May 17: The court hears oral arguments from FDA and Union Street Brands (and four co-petitioners)
– Aug. 23: The court rules in favor of Union Street Brands and six other petitioners, nullifying their MDOs and putting their PMTAs back into FDA review

Vapetasia LLC – Petition for review filing date unknown – Fifth Circuit Court of Appeals
– Oct. 26: Triton Distribution and Vapetasia cases consolidated by the court, and both MDOs are stayed pending review
– July 18, 2022: The circuit court rules 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 will ask the court to grant an en banc rehearing of their petitions for review with all 17 Fifth Circuit judges participating
– Sept. 1: Triton Distribution and Vapetasia petition the court for both panel and en banc rehearings of their case (panel rehearing means a redo by the original three-judge panel that voted in the FDA’s favor; en banc is a full rehearing by the entire 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 FDA imposed on manufacturers submitting PMTAs
– Sept. 30: FDA files its response to the Triton/Vapetasia motion for en banc review
– Oct. 11: Triton/Vapetasia files reply brief addressing the FDA’s Sept. 30 response to the Triton petition for en banc review
– Jan. 19, 2023: The Fifth Circuit Court grants 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
– May 16: Triton (and Vapetasia) and the FDA engage in oral arguments before the full Fifth Circuit. Triton argues in favor of its petition for review of the agency’s MDOs, and the FDA defends the MDOs

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

Vaporized, Inc. – Petition for review filed Oct. 11 – Fifth Circuit Court of Appeals
– Nov. 29: Court grants stay of MDO pending appeal (unopposed by FDA), and consolidates five petitions: Cloud House, Paradigm, STW Global Supply, SV Packaging, and Vaporized

Vapornine LLC (New Leaf Vapor Co.) – Petition for review filing date unknown – Eleventh Circuit Court of Appeals
– May 17: The court hears oral arguments from 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

FDA Signals It Won’t Authorize Flavored E-Liquid PMTAs (Aug.26)
FDA Still Sending Warning Letters to “PMTA Dodgers” (Sept. 2)
FDA Denies PMTAs for 300,000 More Flavored E-Liquids (Sept. 3)
PMTA Decision Day: FDA Leaves Vape Industry Twisting in the Wind (Sept. 9)
Sept. 10th: FDA Has Issued 168 PMTA Denials So Far (Sept. 10)
FDA Issues MDOs to Turning Point Brands, Other Large Vape Companies (Sept. 17)
FDA Has Now Denied PMTAs from 295 Vape Companies (Sept. 17)
Who’s Left? Who’s Left? Vape Companies That Have Received MDOs (Sept. 23)
Turning Point Brands Sues FDA, Challenging PMTA Denials (Sept. 23)
More Vape Manufacturers Challenge PMTA Denials (Oct. 4)
FDA Backs Down, Rescinds Turning Point Brands’ MDOs (Oct. 8)
MDO Update: FDA and Triton Argue in Court Filings (Oct. 14)
Judges Reject FDA’s “Surprise Switcheroo,” Issue Stay to Triton (Oct. 26)
Court Denies Breeze Smoke’s Motion for a Stay Pending Review (Nov. 15)
Supreme Court Denies Breeze Smoke’s Stay Application (Nov. 23)
Anti-Vape Groups Ask Judge Grimm to Monitor FDA’s PMTA Progress (Nov. 30)

Court Challenges to FDA Are Heating Up (Feb. 3)
Myblu Is First Major Brand Pod Device Rejected by FDA (April 8)
FDA Will Reject JUUL PMTA, Insiders Say (June 22)
Toxic Politics: FDA’s Flimsy JUUL Denial Will Send Many to Cigarettes (June 23)
Juul Gets a Temporary Stay, Can Sell Products For Now (June 24)
FDA Chaos: Agency Reverses Itself, Grants Juul a Stay (July 6)
Fifth Circuit Court Rules Against Triton (July 19)
FDA Says One MDO Appeal Won’t Be Resolved Till 2025 (July 31)
Federal Court Rules Against FDA in Six MDO Appeals (Aug. 24)
Federal Court Rules for FDA in Latest MDO Appeal (Aug. 29)
Juul Sues FDA After FOIA Requests Are Denied (Sept. 22)
FDA Conveniently Denied Hyde PMTAs Just in Time for NYTS Press Release (Oct. 17)
FDA Issues First Marketing Denials for Menthol Vapes (Oct. 26)
Appeals Court Grants Logic Temporary Stay of Menthol MDOs (Nov. 1 update of above article)

Fifth Circuit Grants Triton a Rehearing of Its MDO Appeal (Jan. 19)
FDA Rejects Menthol Refills for Vuse Vibe and Ciro (Jan. 24)
FDA Denies Vuse Solo Menthol Refills, Cites Youth Appeal (March 17)
Fifth Circuit Slams FDA, Stays Vuse Vibe Menthol Denial (March 23)
Second Circuit Court Rejects Magellan MDO Appeal (June 16)