US Supreme Court to Review FDA E-Cigarette Regulations on June 20th

Regulations by 2FIRSTS.ai
Jun.06.2024
US Supreme Court to Review FDA E-Cigarette Regulations on June 20th
The US Supreme Court will review FDA's regulations on e-cigarette products in four cases, including Triton Distribution's appeal.

According to a report from Vaping360 on June 6th, the Supreme Court of the United States has confirmed that it will review the rulings related to the FDA's regulation of e-cigarette products on June 20th.

 

The four cases in question are:

  • The FDA has filed lawsuits against Wages and White Lion Investments, LLC (doing business as Triton Distribution), 
  • Magellan Technology, Inc. has filed a lawsuit against the FDA, 
  • Lotus Vaping Technologies, LLC has filed a lawsuit against the FDA,
  • Logic Technology Development LLC has filed a lawsuit against the FDA. 

 

In the cases of Magellan, Lotus, and Logic, these manufacturers have lost appeals in federal court's Marketing Denial Order (MDO) and have requested the Supreme Court to grant a petition for certiorari in hopes that the court will issue subpoenas to review these decisions.

 

In a highly publicized case, the FDA recently submitted a request to the court to review their loss in the Fifth Circuit Court of Appeals in the MDO appeal case against Triton Distribution. Triton, an e-liquid manufacturer based in Texas, had filed the MDO appeal in October 2021, which was consolidated with a case involving their sister company, Vapetasia. Both companies lost in the Fifth Circuit Court in 2022. Triton then petitioned the court and was granted a rehearing by the current Fifth Circuit Court of Appeals judges. Triton won the rehearing with a vote of 10 to 6.

 

United States Attorney General Elizabeth Prelogar strongly recommends that the court accept this case for review as it encompasses many of the issues present in the other three cases, and when multiple courts reach different conclusions, Triton's case has sparked a "circuit split.

 

On June 20th, the Supreme Court will meet to decide on the petitions submitted for review. The judges may choose to accept one petition, multiple petitions, or reject all four. Triton and other manufacturers who have won at the Fifth Circuit Court of Appeals will be able to continue selling their products until the FDA completes its new review of their Premarket Tobacco Product Applications (PMTA).

 

American legal expert Jonathan Adler believes that Triton's petition is "very likely" to be accepted by the courts. In March of this year, he wrote: "The circuit split and its continued impact on the FDA's ability to manage the PMTA approval process makes eventual Supreme Court review inevitable. If the Department of Justice pushes to address this issue, then the courts are likely to take up the case.

 

In a news release from the relevant Supreme Court, the FDA has filed a petition asking the Supreme Court to determine the proper venue for R.J. Reynolds' challenge to three MDOs related to Vuse menthol flavor pods (for use in Vuse Solo, Vibe, and Alto devices) in the Fifth Circuit. Reynolds has recruited co-plaintiffs in retail or distribution businesses within the Fifth Circuit to appeal the three MDOs. (These three appeals have been consolidated by the court.)

 

The Tobacco Control Act states that appeals of FDA marketing decisions must be filed within 30 days "in Washington D.C. or the circuit court where the company is located." FDA lawyers have stated, "Reynolds is based in North Carolina, therefore they reside and have their principal place of business in Winston-Salem, North Carolina." According to the FDA, Reynolds' appeal should be heard by the Fourth Circuit Court of Appeals or the District of Columbia Circuit Court of Appeals.

 

In each Reynolds appeal, government attorneys have questioned the venue and have been rejected by the Fifth Circuit Court, which believes that as long as one plaintiff resides within the jurisdiction of that circuit court, the venue is deemed appropriate.

 

According to the ruling, other non-circuit court manufacturers have started using the same strategy to file review requests in the Fifth Circuit Court. The Fifth Circuit Court's ruling allows for a review of a retailer of tobacco products who does not have jurisdiction under the law; effectively nullifying the law's restrictions on venue, promoting forum shopping, and undermining precedent in other circuit courts. The court should review and overturn the Fifth Circuit's refusal to lift or transfer the order in the Alto case.

 

Government lawyers have provided reasons why the Supreme Court should review (and overturn) the decision of the Fifth Circuit Court regarding the location issue. The main argument is that the appeal provision in the Tobacco Control Act applies to manufacturers, not to retailers denied marketing authorization.

 

At the same time, the Fifth Circuit Court of Appeals approved Reynolds Company's request to stay the court proceedings on the appeal of the Vuse MDO merger, pending the outcome of the FDA's petition to the Supreme Court regarding Triton Distribution.

 

The government legal team stated:

 

The final judgment on these cases may involve several years of delay. In the meantime, the Fifth Circuit Court of Appeals' stay on the FDA's refusal order will remain in effect, allowing Reynolds Company and other manufacturers to continue selling e-cigarette products not authorized by the FDA. Additionally, motions for review submitted by non-Circuit Court manufacturers will continue to pile up in the Fifth Circuit Court of Appeals.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


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