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April 21, 2022

Updated: Vape Company MDO 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.

May 17, 2022
The 11th 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, and Vapornine. (The links are downloadable MP3s. You can also listen on the court’s website.)

April 25, 2022
FDA rescinds Al Khalifa Group MDO after administrative review (reported in FDA’s MDO list updated April 25)

April 20, 2022
The 7th Circuit Court hears oral arguments from lawyers for Gripum and the FDA

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. 1, 2022
MDOs issued to Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited all all stayed by the 11th 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 5th Circuit Court hears oral arguments from attorneys for Triton Distribution and the FDA

Jan. 28, 2022
The 5th 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)

Dec. 30
Amicus brief in support of Gripum’s petition filed in circuit court 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 full review of Breeze Smoke’s MDO will 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

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.

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

Amicus brief in support of My Vape Order’s petition filed in 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 (reported in FDA’s 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 circuit court by David Abrams, Clive Bates, and David Sweanor

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

Nov. 4
Gripum MDO stayed by court pending review

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

Nov. 2
Humble Juice MDO rescinded by FDA (per Nov. 3 FDA MDO list) and products moved back into scientific review. Tobacco Reporter reports that Humble Juice withdrew its petition for review 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 (per FDA’s Nov. 3 MDO list) 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 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 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 pending court review of its MDO

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

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 – 9th Circuit Court of Appeals

Al Khalifa Group LLC – Unknown if company filed a petition for review in court
– UPDATE Nov.3: Al Khalifa Group MDO stayed by FDA pending administrative review (reported in FDA’s MDO list updated Feb. 17)
– UPDATE April 25: FDA rescinds Al Khalifa Group MDO after administrative review (reported in FDA’s MDO list updated April 25)

American Vapor, Inc. – Petition for review filing date unknown – 5th Circuit Court of Appeals
– UPDATE Jan. 28, 2022: Court “issued a stay of proceedings for American Vapor, Inc.s petition pending a decision in [Triton Distribution’s petition]” (reported in FDA’s MDO List updated Feb. 3)

AVAIL Vapor, LLC – Petition for review filed Sept. 30 – 4th Circuit Court of Appeals
– UPDATE Nov. 1: AVAIL Vapor MDO stayed by FDA pending administrative review

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

Bidi Vapor LLCPetition for review and motion for expedited review filed Sept. 29 – 11th Circuit Court of Appeals
– UPDATE Oct. 22: Bidi Vapor MDO stayed by FDA pending administrative review
– UPDATE Oct. 25: Bidi Vapor files motion for a stay pending court review of its MDO
– UPDATE Nov. 19: Bidi Vapor files opening brief and requests the court allow oral argument
– UPDATE Nov. 24: Amicus brief in support of Bidi Vapor’s petition filed by David Abrams, Clive Bates and David Sweanor
– UPDATE Feb. 1, 2022: MDO stayed by the court pending review
– UPDATE May 17: The court hears oral argument from Bidi Vapor and the FDA

Breeze Smoke, LLC – Petition for review filed Oct. 4 – 6th Circuit Court of Appeals
– UPDATE Oct. 13: Breeze Smoke files an emergency motion for a stay pending court review of its MDO
– UPDATE Nov. 12: Breeze Smoke’s motion for a stay denied by the court
– UPDATE Nov. 23: Breeze Smoke applies to the Supreme Court for a stay pending review by the circuit court of its MDO
– UPDATE 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.
– UPDATE Dec. 6: FDA files its memorandum in opposition to Breeze Smoke’s application for a stay of its MDO with the Supreme Court
– UPDATE 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.”
– UPDATE 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

Cloud House – Petition for review filed Oct. 8 – 5th Circuit Court of Appeals

Cloud Nine Vapor Products – Petition for review filed Oct. 8 – 10th Circuit Court of Appeals

Cool Breeze Vapor LLC – Petition for review filing date unknown – District of Columbia Circuit Court of Appeals
– UPDATE (date unknown): Appeal consolidated with ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– UPDATE Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– UPDATE Feb. 9: Court schedules oral arguments in consolidated cases for April 21

Diamond Vapor LLC – Petition for review filed Oct. 1 – 11th Circuit Court of Appeals
– UPDATE Feb. 1, 2022: MDO stayed by the court pending review
– UPDATE May 17: The court hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Street Brands, and Vapornine

E-Liquid Brands, LLC – Petition for review filed Oct. 7 – 4th Circuit Court of Appeals

ECig Charleston LLC – Petition for review filing date unknown – District of Columbia Circuit Court of Appeals
– UPDATE (date unknown): Appeal consolidated with Cool Breeze Vapor, Jay Shore Liquids, and Prohibition Juice Co.
– UPDATE Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– UPDATE Feb. 9: Court schedules oral arguments in consolidated cases for April 21

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)
– UPDATE Oct. 26: ECS Global MDO partially rescinded by FDA (per FDA’s Nov. 3 MDO list) and products moved back into scientific review

Electric Clouds – Petition for review filed Oct. 8 – 10th Circuit Court of Appeals

Fumizer, LLC – Petition for review filed Oct. 6 – 9th Circuit Court of Appeals.
– UPDATE Oct. 22: Fumizer MDO rescinded by FDA and products moved back into scientific review

Gripum LLC – Petition for review filed Oct. 8 – 7th Circuit Court of Appeals
– UPDATE Oct. 17: Gripum files emergency motion for a stay pending court review of its MDO
– UPDATE Oct. 19: Gripum MDO temporarily stayed by court while motion is considered
– UPDATE Oct. 27: Gripum replies in court filing to FDA filing opposing stay
– UPDATE Nov. 4: Gripum MDO stayed by court pending review
– UPDATE Dec. 27: Gripum files brief preceding oral arguments
– UPDATE Dec. 30: Amicus brief in support of Gripum’s petition filed by David Abrams, Clive Bates, and David Sweanor
– UPDATE April 20, 2022: The court hears oral arguments from Gripum and the FDA

Humble Juice Co., LLC – Petition for review filed in October (date unknown) – 9th Circuit Court of Appeals
– UPDATE Nov. 2: Humble Juice MDO rescinded by FDA (per Nov. 3 FDA MDO list) 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
– UPDATE (date unknown): Appeal consolidated with Cool Breeze Vapor, ECig Charleston, and Prohibition Juice Co.
– UPDATE Feb. 4, 2022: FDA files brief supporting its MDOs in consolidated petitions for review
– UPDATE Feb. 9: Court schedules oral arguments in consolidated cases for April 21

Johnny Copper LLC – Petition for review filed Oct. 7 – 11th Circuit Court of Appeals
– UPDATE Feb. 1, 2022: MDO stayed by the court pending review
– UPDATE May 17: The court hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Street Brands, and Vapornine

Liquid Labs LLC – Petition for review filed Oct. 12 – 3rd Circuit Court of Appeals

Lotus Vaping Technologies, LLCPetition for review filed Oct. 14 – 9th Circuit Court of Appeals

Magellan Technology, Inc.Petition for review filed Sept. 24 – 2nd Circuit Court of Appeals

My Vape Order, Inc. – Petition for review filed Sept. 30 – 9th Circuit Court of Appeals.
– UPDATE Oct. 18: My Vape Order MDO stayed by FDA pending administrative review
– UPDATE Nov. 24: Amicus brief in support of My Vape Order’s petition filed by David Abrams, Clive Bates and David Sweanor

New World Wholesale, Inc. & Shenzhen Goldreams Technology Co., Ltd.Petition for review filed Oct. 11 – 5th Circuit Court of Appeals

Nude Nicotine, Inc. – Petition for review filed Oct. 6 – 9th Circuit Court of Appeals

Paradigm Distribution Petition for review filed Oct. 11 – 5th Circuit Court of Appeals

Pop Vapor Co. LLC – Petition for review filing date unknown – 11th Circuit Court of Appeals
– UPDATE Nov. 23: Pop Vapor Co. MDO partially rescinded (reported in FDA’s MDO list updated Feb. 17)
– UPDATE May 17: The court hears oral argument from Pop Vapor and FDA

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

Simple Vapor Company – Petition for review filed Oct. 12 – 6th Circuit Court of Appeals

SV Packaging (SAVEURVAPE) – Petition for review filing date unknown – 5th Circuit Court of Appeals

SWT Global Supply, Inc.Petition for review filed Oct. 1 – 5th Circuit Court of Appeals

Triton Distribution (Wages and White Lion Investments, LLC) – Petition for review filed Oct. 6 – 5th Circuit Court of Appeals
– UPDATE Oct. 6: Triton Distribution files emergency motion for a stay pending court review of its MDO and expedited consideration
– UPDATE Oct. 12: FDA responds in court filing to Triton Distribution’s emergency motion
– UPDATE Oct. 14: Triton Distribution responds to FDA’s opposition to stay
– UPDATE Oct. 26: Triton Distribution and Vapetasia cases consolidated by the court, and both MDOs are stayed pending review
– UPDATE Nov. 17: Amicus brief in support of Triton Distribution’s petition filed by David Abrams, Clive Bates and David Sweanor
– UPDATE Jan. 31,2022: The court hears oral arguments from attorneys for Triton Distribution and the FDA

Turning Point Brands, Inc.Petition for review filed Sept. 23 – 6th Circuit Court of Appeals
– UPDATE Sept. 30: Turning Point Brands files emergency motion for a stay pending court review of its MDO and expedited consideration
– UPDATE 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
– UPDATE 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 – 11th Circuit Court of Appeals
– UPDATE May 17: The court hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Street Brands, and Vapornine

Vapetasia LLC – Petition for review filing date unknown – 5th Circuit Court of Appeals
– UPDATE Oct. 26: Triton Distribution and Vapetasia cases consolidated by the court, and both MDOs are stayed pending review

Vapor Unlimited LLC – Petition for review filed Oct. 8 – 11th Circuit Court of Appeals
– UPDATE Feb. 1, 2022: MDO stayed by the court pending review

Vaporized, Inc. – Petition for review filed Oct. 11 – 5th Circuit Court of Appeals

Vapornine LLC (New Leaf Vapor Co.) – Petition for review filing date unknown – 11th Circuit Court of Appeals
– UPDATE May 17: The court hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Street Brands, and Vapornine

Wages and White Lion Investments, LLC – see Triton Distribution

Vaping360 coverage of FDA Marketing Denial Orders (MDOs)

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep 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 recently joined 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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No Cigs
No Cigs
7 months ago

Really glad to hear this news!

Jcole
Jcole
4 months ago

Any updates coming soon?

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