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November 16, 2021

Updated: Vape Company MDO Appeals and Legal Actions

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.

About 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.

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

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

Nov. 4
Gripum MDO stayed by court pending review

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Humble Juice MDO rescinded by FDA (per Nov. 3 FDA MDO list) and products moved back into scientific review.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 recission

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ECS Global MDO partially rescinded by FDA (per FDA’s Nov. 3 MDO list) and products moved back into scientific review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Fumizer MDO rescinded by FDA and products moved back into scientific review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 withdraws 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 expedited consideration

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

7 Daze LLC – Petition for review filed Oct. 7 – 9th Circuit Court of Appeals

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

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

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

Diamond Vapor LLC – Petition for review filed Oct. 1 – 11th Circuit Court of Appeals

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

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

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 recission

Johnny Copper LLC – Petition for review filed Oct. 7 – 11th Circuit Court of Appeals

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

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

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

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

SV Packaging – 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 are consolidated, and both MDOs are stayed pending review

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

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

Vapor Unlimited LLC – Petition for review filed Oct. 8 – 11th Circuit Court of Appeals

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

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
1 month ago

Really glad to hear this news!

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