The U.S. Supreme Court will review four FDA e-cigarette regulation cases on June 20

The U.S. Supreme Court will review four FDA e-cigarette regulation cases on June 20

The U.S. Supreme Court will consider four cases involving the FDA's regulation of e-cigarettes, including manufacturers' appeals of sales bans and the question of whether the court should limit venue to specific courts. At the same time, the FDA filed a request for the court to rule on the regulation of e-cigarettes.

 

According to Vaping360 on June 6, the U.S. Supreme Court has determined that it will review four rulings related to the Food and Drug Administration's (FDA) regulation of e-cigarette products on June 20.

 

The four cases are:

 

FDA v. Wages and White Lion Investments, LLC (doing business as Triton Distribution)

 

Magellan Technology, Inc v. FDA

 

Lotus Vaping Technologies, LLC v. FDA

 

Logic Technology Development LLC v. FDA

In the Magellan, Lotus and Logic cases, the manufacturers lost their appeals from federal courts' marketing denial orders (MDOs) and have asked the Supreme Court to grant a rehearing order, hoping that the court will issue a subpoena to agree to review these decisions.

 

Among them, the most watched case is the FDA's request to the court to review its case in the MDO appeal case of Triton Distribution, which it lost in the Fifth Circuit. Triton is a Texas-based e-cigarette liquid manufacturer that filed an MDO appeal in October 2021, and its case was merged with the case of its sister company Vapetasia, which both companies lost in the Fifth Circuit in 2022. Triton then filed a petition with the court and obtained a retrial from the current Fifth Circuit Court, which Triton won with a vote of 10 to 6.

 

U.S. Attorney General Elizabeth Prelogar strongly recommended that the court accept this case for review because it covers most of the issues in the other three cases and that Triton's case triggered a "circuit court split" when multiple courts reached different conclusions.

 

The Supreme Court will make a decision at the June 20 meeting to consider the acceptance of the petitions, and the justices may decide to accept one of the petitions, or decide to accept multiple, or reject all four. Triton and other manufacturers that win in the Fifth Circuit will be able to continue selling products until the FDA completes a new review of their premarket tobacco applications (PMTAs).

 

Jonathan Adler, a U.S. legal expert, thinks Triton's petition is "highly likely" to be accepted by the court. "The circuit split and its continued impact on the FDA's ability to manage the PMTA approval process makes an eventual Supreme Court review inevitable," he wrote in March. "If the Department of Justice pushes to resolve this issue, then the court is likely to take the case."

 

In related Supreme Court news, the FDA has filed a petition asking the Supreme Court to rule that the Fifth Circuit is the proper venue for R.J. Reynolds' challenge to the MDO. Reynolds has appealed three MDOs for Vuse mint-flavored pods (for Vuse Solo, Vibe, and Alto devices) by enlisting co-plaintiffs with retail or distribution businesses located within the Fifth Circuit's boundaries. (The three appeals have been consolidated by the court.)

 

The Tobacco Control Act provides that appeals of FDA marketing decisions should be filed "in Washington, D.C., or in a circuit court in which they are located" within 30 days. FDA lawyers said, "Reynolds is incorporated in North Carolina, is domiciled there, and has its principal place of business in

 

Winston-Salem, North Carolina." According to the FDA, Reynolds' appeal should be heard by either the Fourth Circuit or the District of Columbia Circuit.

In each of Reynolds' appeals, government lawyers challenged venue and were rejected by the Fifth Circuit, which held that venue was proper as long as at least one plaintiff resided within the boundaries of that circuit.

 

"In light of this ruling, other non-circuit manufacturers have begun to use the same strategy to file petitions for review in the Fifth Circuit, which has ruled to allow review of a retailer of tobacco products that has no right to judicial review under the Act; to effectively invalidate the Act's venue restrictions; to promote blatant court shopping; and to undermine precedent in other circuits. This Court should review and reverse the Fifth Circuit's order in Alto denying discharge or transfer."

 

Government lawyers provided reasons why the Supreme Court should review (and reverse) the Fifth Circuit's venue decision, primarily because the appeals provision in the Tobacco Control Act applies to manufacturers, not retailers who are denied marketing authorization.

 

Meanwhile, the Fifth Circuit granted Reynolds' request for a stay of court proceedings in the consolidated Vuse MDO appeals pending the outcome of the FDA's Triton Distribution petition to the Supreme Court.

 

The government's legal team said:

 

"Waiting for final adjudication in these cases could involve several years of delay. In the meantime, the Fifth Circuit's stay of the FDA's denial order will remain in effect, and Reynolds and other manufacturers will continue to sell e-cigarette products that the FDA never authorized. Additionally, petitions for review filed by non-circuit manufacturers will continue to pile up in the Fifth Circuit."