Vape Corporations vs FDA: Appeals and Authorized Actions

Nov. 16, 2021This text is an try to listing the entire firms difficult the FDA’s Advertising Denial Orders (MDOs) in courtroom, and to observe up on further authorized actions like motions, stays, and different filings. …

Nov. 16, 2021
This text is an try to listing the entire firms difficult the FDA’s Advertising Denial Orders (MDOs) in courtroom, and to observe up on further authorized actions like motions, stays, and different filings. We will even listing administrative stays (or denials) issued by the FDA, based mostly on MDO critiques carried out by the company.

Greater than 30 firms have taken authorized motion to dispute FDA denials.

We’ve overhauled this text, making it simpler to navigate. Now you can view authorized and administrative actions by date (with the latest occasions listed first) or by the businesses concerned (listed alphabetically). You may navigate to both part, or to our listing of Vaping360 articles about MDO occasions, utilizing the short hyperlinks on the high of the web page.

The unique article was posted Oct. 18, however most of the occasions predated the article. It’s potential there are nonetheless firms which have filed authorized challenges to MDOs we aren’t conscious of. If you recognize of any, please remark or contact me. Likewise, when you’re conscious of firms receiving denials of administrative evaluation functions, please tell us.

June 24, 2022
Juul Labs, Inc. filed a movement to remain its MDO a day after the denial was introduced by the FDA

Might 17, 2022
The eleventh Circuit Court docket hears oral arguments from attorneys for FDA and Bidi Vapor, Pop Vapor, and a consolidated case together with Diamond Vapor, Johnny Copper, Union Road Manufacturers, and Vapornine. (The hyperlinks are downloadable MP3s. It’s also possible to pay attention on the courtroom’s web site.)

April 22, 2022
Vapor Voice reported on April 22 that Easy Vapor had voluntarily withdrawn its petition to the courtroom. Date of motion unknown

April 20, 2022
The seventh Circuit Court docket hears oral arguments from attorneys for Gripum and the FDA

March 14, 2022
The eleventh Circuit Court docket stayed enforcement of Pop Vapor’s MDO pending evaluation, in accordance with Vapor Voice

March 1, 2022
FDA rescinds Al Khalifa Group MDO after administrative evaluation (reported in FDA’s MDO listing up to date April 25). Date unknown: Al Khalifa voluntarily withdraws petition to ninth Circuit Court docket, in accordance with Vapor Voice

Feb. 10, 2022
Breeze Smoke voluntarily withdrew its MDO enchantment to the sixth Circuit Court docket (which had been scheduled for oral arguments Feb. 22), in accordance with Vapor Voice

Feb. 9, 2022
The D.C. Circuit Court docket schedules oral arguments in 4 consolidated circumstances for April 21. The 4 petitioners—Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.—are all represented by the Texas-based Najvar Regulation Agency

Feb. 2, 2022
After FDA withdrew its MDO in October, Fumizer’s motion towards the FDA was dismissed by the ninth Circuit Court docket for “failure to prosecute,” in accordance with Vapor Voice

Feb. 1, 2022
Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Limitless MDOs all all stayed by the eleventh Circuit Court docket pending evaluation. The courtroom orders these 4 circumstances, and three others that didn’t obtain stays—Pop Vapor Co., Union Road Manufacturers, and Vapornine (New Leaf Vapor Co.)—to look collectively for oral arguments on a date to be set later

Jan. 31, 2022
The fifth Circuit Court docket hears oral arguments from attorneys for Triton Distribution and the FDA

Jan. 28, 2022
The fifth Circuit Court docket points a “keep of proceedings…for American Vapor, Inc.s petition pending a call in [Triton Distribution’s review]” (reported in FDA’s up to date MDO listing dated Feb. 3). Vapor Voice reported later (April 22) that American Vapor had voluntarily withdrawn its petition to the courtroom

Dec. 30
Amicus transient in help of Gripum’s petition filed in circuit courtroom by David Abrams, Clive Bates, and David Sweanor

Dec. 10
The Supreme Court docket denies Breeze Smoke’s emergency utility for a keep of its MDO. The complete evaluation of Breeze Smoke’s MDO will proceed within the circuit courtroom, however the firm can be topic to FDA enforcement if it continues promoting the denied merchandise throughout the courtroom evaluation

Dec. 7
Breeze Smoke responds to the FDA transient filed yesterday opposing Breeze Smoke’s utility to the Supreme Court docket for a keep of its MDO.

Breeze Smoke additionally recordsdata a supplemental declaration from worker Steven Haddad during which Haddad claims that Breeze Smoke “developed the ENDS merchandise which can be the topic of its September 3, 2020 PMTAs by constructing on the specs of the Arctic Smoke product, which had been in the marketplace properly earlier than FDA “deemed” e-cigarette merchandise efficient August 8, 2016.”

Dec. 6
FDA recordsdata its memorandum in opposition to Breeze Smoke’s utility for a keep of its MDO with the Supreme Court docket. Within the transient, the company notes that Breeze Smoke’s merchandise have been launched after Aug. 8, 2016—the deadline for merchandise to stay in the marketplace (till Sept. 9, 2020) with out first being licensed by FDA with a profitable PMTA

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

Nov. 24
Amicus transient in help of Bidi Vapor’s petition filed in circuit courtroom by David Abrams, Clive Bates, and David Sweanor

Amicus transient in help of My Vape Order’s petition filed in circuit courtroom by David Abrams, Clive Bates, and David Sweanor

Nov. 23
Breeze Smoke applies to the Supreme Court docket for an emergency keep pending circuit courtroom evaluation of its MDO

Pop Vapor Co. MDO partially rescinded (reported in FDA’s MDO listing up to date Feb. 17)

Nov. 19
Bidi Vapor recordsdata opening transient and requests the courtroom enable oral argument

Nov. 17
Amicus transient in help of Triton Distribution’s petition filed in circuit courtroom by David Abrams, Clive Bates, and David Sweanor

Nov. 12
Breeze Smoke’s movement for a keep denied by the courtroom

Nov. 4
Gripum MDO stayed by courtroom pending evaluation

Nov. 3
Al Khalifa Group MDO stayed by FDA pending administrative evaluation (reported in FDA’s MDO listing up to date Feb. 17)

Nov. 2
Humble Juice MDO rescinded by FDA (per Nov. 3 FDA MDO listing) and merchandise moved again into scientific evaluation. Tobacco Reporter stories that Humble Juice withdrew its petition for evaluation after FDA recission of its MDO

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

Oct. 26
ECS World MDO partially rescinded by FDA (per FDA’s Nov. 3 MDO listing) and merchandise moved again into scientific evaluation

Triton Distribution and Vapetasia circumstances are consolidated, and each MDOs are stayed by the courtroom pending evaluation

Oct. 25
Bidi Vapor recordsdata a movement for a keep pending courtroom evaluation of its MDO

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

Fumizer MDO rescinded by FDA and merchandise moved again into scientific evaluation

Gripum replies in courtroom submitting to FDA submitting opposing keep

Oct. 19
Gripum MDO quickly stayed by courtroom whereas movement for a full keep is taken into account

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

Oct. 17
Gripum recordsdata emergency movement for a keep pending courtroom evaluation of its MDO

Oct. 14
Triton Distribution responds to FDA in a courtroom submitting

Oct. 13
Breeze Smoke recordsdata an emergency movement for a keep pending courtroom evaluation of its MDO

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

Oct. 8
Turning Level Manufacturers withdrew its petition for evaluation after FDA rescission of its MDO

Oct. 7
FDA rescinds Turning Level Manufacturers MDO, claiming it missed proof included within the firm’s PMTA. Its merchandise are moved again into scientific evaluation

Oct. 6
Triton Distribution recordsdata emergency movement for a keep pending courtroom evaluation of its MDO and requests expedited consideration

Sept. 30
Turning Level Manufacturers recordsdata emergency movement for a keep pending courtroom evaluation of its MDO and requests expedited consideration

7 Daze LLC – Petition for evaluation filed Oct. 7 – ninth Circuit Court docket of Appeals

Al Khalifa Group LLC – Petition for evaluation submitting date unknown
– Nov.3: Al Khalifa Group MDO stayed by FDA pending administrative evaluation (reported in FDA’s MDO listing up to date Feb. 17)
– March 1, 2022: FDA rescinds Al Khalifa Group MDO after administrative evaluation (reported in FDA’s MDO listing up to date April 25)
– (date unknown): Al Khalifa voluntarily withdraws petition to ninth Circuit Court docket, in accordance with Vapor Voice

American Vapor, Inc. – Petition for evaluation submitting date unknown – fifth Circuit Court docket of Appeals
– Jan. 28, 2022: Court docket “issued a keep of proceedings for American Vapor, Inc.s petition pending a call in [Triton Distribution’s petition]” (reported in FDA’s MDO Checklist up to date Feb. 3)
– (date unknown): Vapor Voice reported April 22 that American Vapor had voluntarily withdrawn its petition to the courtroom

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

Dangerous Modder Fogger (BMF Labs) – Petition for evaluation filed Oct. 4 – 4th Circuit Court docket of Appeals

Bidi Vapor LLC – Petition for evaluation and movement for expedited evaluation filed Sept. 29 – eleventh Circuit Court docket of Appeals
– Oct. 22: Bidi Vapor MDO stayed by FDA pending administrative evaluation
– Oct. 25: Bidi Vapor recordsdata movement for a keep pending courtroom evaluation of its MDO
– Nov. 19: Bidi Vapor recordsdata opening transient and requests the courtroom enable oral argument
– Nov. 24: Amicus transient in help of Bidi Vapor’s petition filed by David Abrams, Clive Bates and David Sweanor
– Feb. 1, 2022: MDO stayed by the courtroom pending evaluation
– Might 17: The courtroom hears oral argument from Bidi Vapor and the FDA

Breeze Smoke, LLC – Petition for evaluation filed Oct. 4 – sixth Circuit Court docket of Appeals
– Oct. 13: Breeze Smoke recordsdata an emergency movement for a keep pending courtroom evaluation of its MDO
– Nov. 12: Breeze Smoke’s movement for a keep denied by the courtroom
– Nov. 23: Breeze Smoke applies to the Supreme Court docket for a keep pending evaluation by the circuit courtroom of its MDO
– Nov. 29: Supreme Court docket Justice Brett Kavanaugh asks FDA to answer Breeze Smoke’s utility for a keep by Monday, Dec. 6 at 2:00 p.m.
– Dec. 6: FDA recordsdata its memorandum in opposition to Breeze Smoke’s utility for a keep of its MDO with the Supreme Court docket
– Dec. 7: Breeze Smoke responds to the FDA transient filed yesterday opposing Breeze Smoke’s utility to the Supreme Court docket for a keep of its MDO. Breeze Smoke additionally recordsdata a supplemental declaration from worker Steven Haddad during which Haddad claims that Breeze Smoke “developed the ENDS merchandise which can be the topic of its September 3, 2020 PMTAs by constructing on the specs of the Arctic Smoke product, which had been in the marketplace properly earlier than FDA “deemed” e-cigarette merchandise efficient August 8, 2016.”
– Dec. 10: The Supreme Court docket denies Breeze Smoke’s emergency utility for a keep of its MDO. The complete evaluation of Breeze Smoke’s MDO will now proceed within the circuit courtroom, however the firm can be topic to FDA enforcement if it continues promoting the denied merchandise throughout the courtroom evaluation
– Feb. 10, 2022: Breeze Smoke voluntarily withdrew its petition to the sixth Circuit Court docket (which had been scheduled for oral arguments Feb. 22), in accordance with Vapor Voice

Cloud Home – Petition for evaluation filed Oct. 8 – fifth Circuit Court docket of Appeals

Cloud 9 Vapor Merchandise – Petition for evaluation filed Oct. 8 – tenth Circuit Court docket of Appeals

Cool Breeze Vapor LLC – Petition for evaluation submitting date unknown – District of Columbia Circuit Court docket of Appeals
– date unknown): Enchantment consolidated with ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: FDA recordsdata transient supporting its MDOs in consolidated petitions for evaluation
– Feb. 9: Court docket schedules oral arguments in consolidated circumstances for April 21

Diamond Vapor LLC – Petition for evaluation filed Oct. 1 – eleventh Circuit Court docket of Appeals
– Feb. 1, 2022: MDO stayed by the courtroom pending evaluation
– Might 17: The courtroom hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Road Manufacturers, and Vapornine

E-Liquid Manufacturers, LLC – Petition for evaluation filed Oct. 7 – 4th Circuit Court docket of Appeals

ECig Charleston LLC – Petition for evaluation submitting date unknown – District of Columbia Circuit Court docket of Appeals
– (date unknown): Enchantment consolidated with Cool Breeze Vapor, Jay Shore Liquids, and Prohibition Juice Co.
– Feb. 4, 2022: FDA recordsdata transient supporting its MDOs in consolidated petitions for evaluation
– Feb. 9: Court docket schedules oral arguments in consolidated circumstances for April 21

ECS World LLC – Petition for evaluation filed Oct. 12 – District of Columbia Circuit Court docket of Appeals. (ECS World obtained MDOs for Phix pod-vape units and prefilled Phix pods)
– Oct. 26: ECS World MDO partially rescinded by FDA (per FDA’s Nov. 3 MDO listing) and merchandise moved again into scientific evaluation

Electrical Clouds – Petition for evaluation filed Oct. 8 – tenth Circuit Court docket of Appeals

Fumizer, LLC – Petition for evaluation filed Oct. 6 – ninth Circuit Court docket of Appeals.
– Oct. 22: Fumizer MDO rescinded by FDA and merchandise moved again into scientific evaluation
– Feb 2, 2022: Court docket dismisses case for “failure to prosecute,” in accordance with Vapor Voice

Gripum LLC – Petition for evaluation filed Oct. 8 – seventh Circuit Court docket of Appeals
– Oct. 17: Gripum recordsdata emergency movement for a keep pending courtroom evaluation of its MDO
– Oct. 19: Gripum MDO quickly stayed by courtroom whereas movement is taken into account
– Oct. 27: Gripum replies in courtroom submitting to FDA submitting opposing keep
– Nov. 4: Gripum MDO stayed by courtroom pending evaluation
– Dec. 27: Gripum recordsdata transient previous oral arguments
– Dec. 30: Amicus transient in help of Gripum’s petition filed by David Abrams, Clive Bates, and David Sweanor
– April 20, 2022: The courtroom hears oral arguments from Gripum and the FDA

Humble Juice Co., LLC – Petition for evaluation filed in October (date unknown) – ninth Circuit Court docket of Appeals
– Nov. 2: Humble Juice MDO rescinded by FDA (per Nov. 3 FDA MDO listing) and merchandise moved again into scientific evaluation. Tobacco Reporter stories that Humble Juice withdrew its petition for evaluation after FDA recission of its MDO

Jay Shore Liquids LLC – Petition for evaluation submitting date unknown – District of Columbia Circuit Court docket of Appeals
– (date unknown): Enchantment consolidated with Cool Breeze Vapor, ECig Charleston, and Prohibition Juice Co.
– Feb. 4, 2022: FDA recordsdata transient supporting its MDOs in consolidated petitions for evaluation
– Feb. 9: Court docket schedules oral arguments in consolidated circumstances for April 21

Johnny Copper LLC – Petition for evaluation filed Oct. 7 – eleventh Circuit Court docket of Appeals
– Feb. 1, 2022: MDO stayed by the courtroom pending evaluation
– Might 17: The courtroom hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Road Manufacturers, and Vapornine

Juul Labs, Inc. – Petition for evaluation filed June 24, 2022 – District of Columbia Circuit Court docket of Appeals
– June 24, 2022: Juul Labs requested the courtroom to remain Juul’s MDO pending courtroom evaluation of the order

Liquid Labs LLC – Petition for evaluation filed Oct. 12 – third Circuit Court docket of Appeals

Lotus Vaping Applied sciences, LLCPetition for evaluation filed Oct. 14 – ninth Circuit Court docket of Appeals

Magellan Expertise, Inc. – Petition for evaluation filed Sept. 24 – 2nd Circuit Court docket of Appeals

My Vape Order, Inc. – Petition for evaluation filed Sept. 30 – ninth Circuit Court docket of Appeals.
– Oct. 18: My Vape Order MDO stayed by FDA pending administrative evaluation
– Nov. 24: Amicus transient in help of My Vape Order’s petition filed by David Abrams, Clive Bates and David Sweanor

New World Wholesale, Inc. & Shenzhen Goldreams Expertise Co., Ltd. – Petition for evaluation filed Oct. 11 – fifth Circuit Court docket of Appeals

Nude Nicotine, Inc. – Petition for evaluation filed Oct. 6 – ninth Circuit Court docket of Appeals

Paradigm Distribution – Petition for evaluation filed Oct. 11 – fifth Circuit Court docket of Appeals

Pop Vapor Co. LLC – Petition for evaluation submitting date unknown – eleventh Circuit Court docket of Appeals
– Nov. 23: Pop Vapor Co. MDO partially rescinded (reported in FDA’s MDO listing up to date Feb. 17)
– March 14, 2022: The courtroom stayed FDA enforcement of Pop Vapor’s MDO pending evaluation, in accordance with Vapor Voice
– Might 17: The courtroom hears oral argument from Pop Vapor and FDA

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

Easy Vapor Firm – Petition for evaluation filed Oct. 12 – sixth Circuit Court docket of Appeals
– (date unknown): Vapor Voice reported on April 22, 2022 that Easy Vapor had voluntarily withdrawn its petition to the courtroom

SV Packaging (SAVEURVAPE) – Petition for evaluation submitting date unknown – fifth Circuit Court docket of Appeals

SWT World Provide, Inc. – Petition for evaluation filed Oct. 1 – fifth Circuit Court docket of Appeals

Triton Distribution (Wages and White Lion Investments, LLC) – Petition for evaluation filed Oct. 6 – fifth Circuit Court docket of Appeals
– Oct. 6: Triton Distribution recordsdata emergency movement for a keep pending courtroom evaluation of its MDO and expedited consideration
– Oct. 12: FDA responds in courtroom submitting to Triton Distribution’s emergency movement
– Oct. 14: Triton Distribution responds to FDA’s opposition to remain
– Oct. 26: Triton Distribution and Vapetasia circumstances consolidated by the courtroom, and each MDOs are stayed pending evaluation
– Nov. 17: Amicus transient in help of Triton Distribution’s petition filed by David Abrams, Clive Bates and David Sweanor
– Jan. 31, 2022: The courtroom hears oral arguments from attorneys for Triton Distribution and the FDA

Turning Level Manufacturers, Inc. – Petition for evaluation filed Sept. 23 – sixth Circuit Court docket of Appeals
– Sept. 30: Turning Level Manufacturers recordsdata emergency movement for a keep pending courtroom evaluation of its MDO and expedited consideration
– Oct. 7: FDA rescinds Turning Level Manufacturers MDO, claiming it missed proof included within the firm’s PMTA. TPB’s merchandise are moved again into scientific evaluation
– Oct. 8: Turning Level Manufacturers withdraws its petition for evaluation after FDA rescission of its MDO

Union Road Manufacturers – Petition for evaluation submitting date unknown – eleventh Circuit Court docket of Appeals
– Might 17: The courtroom hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Road Manufacturers, and Vapornine

Vapetasia LLC – Petition for evaluation submitting date unknown – fifth Circuit Court docket of Appeals
– Oct. 26: Triton Distribution and Vapetasia circumstances consolidated by the courtroom, and each MDOs are stayed pending evaluation

Vapor Limitless LLC – Petition for evaluation filed Oct. 8 – eleventh Circuit Court docket of Appeals
– Feb. 1, 2022: MDO stayed by the courtroom pending evaluation

Vaporized, Inc. – Petition for evaluation filed Oct. 11 – fifth Circuit Court docket of Appeals

Vapornine LLC (New Leaf Vapor Co.) – Petition for evaluation submitting date unknown – eleventh Circuit Court docket of Appeals
– Might 17: The courtroom hears oral arguments from FDA and Diamond Vapor, Johnny Copper, Union Road Manufacturers, and Vapornine

Wages and White Lion Investments, LLC – see Triton Distribution

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