The legal actions taken by US electronic cigarette companies against the FDA are listed in chronological order, with the most recent one being presented first.
The DC Circuit Court of Appeals has denied reconsideration requests from four manufacturers - Prohibition Juice Co., Cool Breeze Vapor, Ecig Charleston, and Jay Shore Liquids - whose cases have been consolidated. These companies can now request an en banc rehearing with all judges of the DC Circuit.
July 25, 2022
The Washington D.C. Circuit Court of Appeals has rejected Fontem US's motion to stay the emergency injunction, allowing the myblu MDO to take effect. The court has set a schedule for briefs to be filed during the appeal, with Fontem's first brief due to be submitted on August 10th.
In the year 2022.
In documents submitted to the 9th Circuit Court on July 19th, the FDA acknowledged that it may not make a decision on the administrative appeal for MVO until January 2024.
July 18, 2022
The Fifth Circuit Court of Appeals has ruled that Triton Distribution and Vapetasia have filed an appeal against last year's release of MDO. The vote was 2-1, and Judge Edith Jones issued a strong dissent. The two companies have stated that they will ask the court for a full review of their petition, to be considered by all 17 judges of the Fifth Circuit Court.
July 12, 2022.
In the DC Circuit Court, Fontem US has filed an emergency motion requesting a halt on its MDO for use in myblu devices and refill pods.
July 6, 2022
Juul Labs and the FDA have jointly asked a court to pause Juul's legal challenge (stay proceedings) until the FDA completes its administrative review. Juul has also withdrawn its pending emergency motion to halt the review (which can be resubmitted if the FDA rejects Juul's appeal).
July 5, 2022
The FDA has granted Juul an administrative stay on its MDO, agreeing not to take enforcement action during the FDA's "supervised review" period.
June 27, 2022.
Juul has filed an urgent motion requesting a delay in the review process. The FDA's response is due on July 7th.
June 24, 2022.
Juul Labs has submitted a petition to review its MDO and has requested the court to temporarily suspend the MDO until Juul can file a motion for a comprehensive suspension pending review. An interim stay was granted later on the same day.
May 17, 2022
The 11th Circuit Court heard oral arguments from lawyers representing the FDA and companies involved in a merger case, including Bidi Vapor, Pop Vapor, Diamond Vapor, Johnny Copper, Union Street Brands, and Vapornine. The link to the downloadable MP3 of the session can be found on the court's website.
April 22, 2022.
On April 22, Vapor Voice reported that Simple Vapor has voluntarily withdrawn the petition submitted to the court. The date of the action is unknown.
April 20, 2022
The Seventh Circuit Court heard oral arguments from lawyers representing Gripum and the Food and Drug Administration.
According to Vapor Voice, on March 14, 2022...
The 11th Circuit Court has temporarily suspended the execution of Pop Vapor's MDO for review.
March 1st, 2022.
After undergoing an administrative review, the FDA revoked the Al Khalifa Group MDO (listed on the FDA's MDO list updated on April 25th). The date is unknown, but according to Vapor Voice, Al Khalifa voluntarily withdrew their petition to the Ninth Circuit Court.
According to a report from Vapor Voice, February 10th, 2022.
Breeze Smoke voluntarily withdrew its appeal to the Sixth Circuit Court (originally scheduled for oral arguments on February 22) regarding the MDO.
February 9th, 2022
On April 21, the Washington D.C. Circuit Court scheduled oral arguments for four consolidated cases. Four petitioners - Cool Breeze Vapor, ECig Charleston, Jay Shore Liquids, and Prohibition Juice Co. - are all represented by the Texas-based Najvar Law Firm.
据 Vapor Voice 报道，2022 年 2 月 2 日，美国食品药品监督管理局（FDA） 根据其于去年 10 月撤回的医疗器械设备许可证（MDO）进行了调整。
In standard journalistic English: "According to reports, Fumizer's lawsuit against the FDA was dismissed by the 9th Circuit Court of Appeals due to a failure to prosecute.
February 1, 2022.
Bidi Vapor, Diamond Vapor, Johnny Copper, and Vapor Unlimited MDO have all been granted a stay of review by the 11th Circuit Court. The court has ordered these four cases, along with three others that were not granted a stay - Pop Vapor Co., Union Street Brands, and Vapornine (New Leaf Vapor Co.) - to appear in court for oral arguments on a later determined date.
January 31, 2022.
The Fifth Circuit Court hears oral arguments from lawyers representing Triton Distribution and the FDA.
28th January 2022
The 5th Circuit Court released a statement saying that the litigation against American Vapor, Inc. has been put on hold, pending a decision from Triton Distribution's review (as reported on the updated MDO list by the FDA on February 3rd). Vapor Voice later reported on April 22nd that American Vapor had voluntarily withdrawn their submitted petition from the court.
December 30, 2021
The Amicus Brief supports the petition filed by Gripum by David Abrams, Clive Betts, and David Snow at the Circuit Court.
December 10, 2021
The Supreme Court has rejected Breeze Smoke's emergency request to suspend their Market Denial Order (MDO). The MDO for Breeze Smoke will undergo a comprehensive review at the circuit court, but if the company continues to sell products that have been denied during the court review, they will be subject to forced enforcement by the FDA.
December 7th, 2021
Breeze Smoke responded to the FDA brief submitted yesterday, opposing their application to the Supreme Court to suspend the MDO.
Breeze Smoke also submitted a supplementary statement from their employee, Steven Haddad, in which Haddad claims that Breeze Smoke "developed an ENDS product based on the specifications of Arctic Smoke products for its September 3, 2020 PMTA submission, which was already on the market well before the FDA 'deemed' electronic nicotine delivery systems on August 8, 2016.
December 6, 2021
The FDA has submitted a memorandum to the Supreme Court opposing Breeze Smoke's request to suspend its MDO. In the brief, the agency notes that Breeze Smoke's products were launched after August 8, 2016, which was the deadline for products to remain on the market without first obtaining FDA authorization and a successful PMTA (until September 9, 2020).
November 29, 2021
Supreme Court Justice Brett Kavanaugh has requested that the FDA respond to Breeze Smoke's suspension application by Monday December 6 at 2:00 pm.
November 24, 2021
The amicus brief supports the petition submitted by Bidi Vapor at the appellate court by David Abrams, Clive Bates, and David Sweanor.
The amicus brief in support of My Vape Order petition, submitted to a circuit court by David Abrams, Clive Bates, and David Sweanor, has gained significant backing.
November 23, 2021.
Breeze Smoke has applied for an emergency stay with the Supreme Court while waiting for the appellate court to review its MDO.
Pop Vapor Co. partially recalled (reported on FDA's MDO list updated on February 17th).
November 19, 2021.
Bidi Vapor submitted a court brief and requested permission from the court to conduct an oral argument.
November 17, 2021
Support for the amicus brief filed by Triton Distribution, by David Abrams, Clive Bates, and David Sweanor, in a circuit court petition.
November 12, 2021
The injunction motion filed by Breeze Smoke has been dismissed by the court.
November 4, 2021
Gripum MDO remains at the courthouse awaiting review.
November 3rd, 2021.
The Al Khalifa Group MDO remains under FDA review as reported in the FDA's MDO list updated on February 17th.
November 2, 2021
Humble Juice MDO has had its FDA approval revoked, as indicated by the November 3rd FDA MDO list. The product has therefore been returned to the scientific review phase. According to a report by Tobacco Reporter, Humble Juice has withdrawn its application for review following the FDA's decision to revoke its MDO.
1st November 2021
AVAIL Vapor MDO is under administrative review by the FDA.
October 26, 2021.
ECS Global's MDO has been partially withdrawn by the FDA (according to the FDA's November 3rd MDO list) and the product has entered back into the scientific review phase.
The Triton Distribution and Vapetasia cases have been merged, and both MDOs have been put on hold pending trial by the court.
October 25, 2021
Bidi Vapor has submitted a motion to suspend proceedings while awaiting a court review of their MDO.
October 22, 2021.
Bidi Vapor MDO is under administrative review by the FDA.
Fumizer MDO has been recalled by the FDA and its product is now undergoing scientific review again.
The company Gripum responded to the FDA's opposition to their suspension application in court documents.
October 19, 2021
The legal process for Gripum MDO has currently been put on hold by the court, and there is also consideration for a complete motion to halt proceedings.
October 18, 2021
My Vape Order MDO has been held by the FDA for administrative review.
October 17, 2021.
Gripum has filed an urgent motion requesting that the court temporarily suspend the review of its MDO.
October 14, 2021
Triton Distribution responds to FDA in court documents.
October 13, 2021
Breeze Smoke has proposed an emergency motion requesting that the court suspends the review of their MDO.
October 12th, 2021
FDA responds to Triton Distribution's urgent motion.
October 8, 2021
After the FDA revoked its MDO, Turning Point Brands has withdrawn its review application.
October 7th, 2021.
The FDA has revoked Turning Point Brands' MDO, stating that it missed evidence included in the company's PMTA. The products will undergo scientific review again.
October 6, 2021.
Triton Distribution has submitted an urgent motion, requesting the court to temporarily suspend the review of its MDO and to expedite the hearing.
September 30, 2021.
Turning Point Brands has submitted an emergency motion requesting the court to temporarily halt the review of its MDO (Modified Risk Tobacco Product) and accelerate the evaluation.
For more information on legal battles between the FDA and e-cigarette companies, please click on the "FDA and E-Cigarette Company Legal Battles" topic, which is regularly updated by 2FIRSTS.
Statement:
This article has been compiled from third-party information and is intended for industry exchange and learning.
This article does not represent the views of 2FIRSTS and 2FIRSTS cannot confirm the authenticity and accuracy of its content. The translation of this article is only intended for industry exchange and research purposes.
Due to limitations in translation ability, the translated article may not fully reflect the original text. Please refer to the original text for accuracy.
2FIRSTS maintains complete alignment with the Chinese government's viewpoints and positions regarding any domestic, Hong Kong, Macau, Taiwan, or foreign related statements and stances.
The compilation information is subject to the original media and author's copyright. If there is any infringement, please contact us for deletion.
This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.
