Menthol vapes, forum shopping and FDA tobacco control before the justices
CASE PREVIEW
The Supreme Court will hear Food and Drug Administration V. R.J. Reynolds Vapor Co. Tuesday at 11:41 am. (Katie Barlow).
The Supreme Court is set to hear oral arguments in a clash on Tuesday over whether a North Carolina company can challenge the Food and Drug Administration’s denial of their application to market ecigarettes at the conservative U.S. Court of Appeals, based in Louisiana. The company, R.J. Reynolds Vapor Company, joined a lawsuit by retailers based in Texas and Mississippi – two states covered by the 5th Circuit.
Although the dispute may seem like a technical one, the FDA contends that the stakes are high. The FDA warns that if the lower court’s ruling allowing RJR Vapor to proceed with its case stands, other manufacturers may also try to circumvent the federal law restrictions on where to file such challenges. The FDA warns that the 5th Circuit ruling could allow other plaintiffs to challenge federal agency actions by filing their cases in courts they believe will be favourable to them. The FDA was given the power to regulate tobacco products in 2009, and manufacturers must obtain FDA approval before putting a new tobacco product on the market. The FDA was given the power to regulate tobacco in 2009 and manufacturers are required to get FDA approval before putting a tobacco product on the marketplace. RJR Vapor sought permission to market its menthol-flavored Vuse e-cigarettes. This is one of the most popular brands among adults. The Supreme Court heard arguments on a separate dispute in December over the FDA’s refusal to approve two different companies’ applications for flavored vape fluids. The 5th Circuit overturned the FDA’s rejections of those cases, accusing it of sending these companies and other manufacturers on a “wild goose chase.”
RJR Vapor has its main office and is incorporated in North Carolina. This is part of the U.S. Court of Appeals 4th Circuit, which had previously dismissed challenges to the FDA denials of applications for e-cigarettes. RJR Vapor instead filed a petition to review the 5th Circuit. It was joined by Avail Vapor a Texas retailer who sells RJR Vapor products, as well as a trade group for Mississippi gas stations, convenience stores, and RJR Vapor products. Circuit. The majority, made up of Judge Edith Jones – a Reagan appointee and Judge James Ho – a Trump appointment – explained in an unsigned order that Avail Vapor, and the trade association, “are undisputedly located in this circuit,” they were “adversely impacted by” the denial, because the retailers had indicated that they would cease to operate if the ruling stood. He would have moved the case to the D.C. The FDA went to the Supreme Court in October, which agreed to weigh in. Circuit. The FDA tells the court first that the retailers do not have the right to go to court seeking review of the FDA’s denial of RJR Vapor’s application.
The FDA points to the law’s use of the phrase “adversely affected” to describe who can file a petition for review of the FDA’s denial of a marketing application. The FDA claims that the provision requiring the FDA’s decision on a marketing application for e-cigarettes does not affect the interests of Avail or members of the trade group. The FDA asserts that when it issues an order deciding on applications such as RJR’s, it “always or almost always” only regulates manufacturers; any impact on retailers is only indirectly. The FDA states that the Tobacco Control Act “makes it clear that a person can sue in a particular circuit only if they are based there.” A manufacturer may not sue based on a retailer’s residence.”
Although a legal principle known as joinder allow lawsuits that could have been brought separately to be brought and considered together, the FDA acknowledges, that principle does not give the parties more rights or expand the court’s power. RJR Vapor, which is incorporated in North Carolina, cannot file a petition in the 5th Circuit and also join anyone else’s. They claim that the FDA’s reliance on the general federal law, which authorizes the Supreme Court for review, does not allow the Supreme Court to review non-final decisions in cases that started in a court-of-appeals, as opposed to a federal trial-court. RJR Vapor, and the retailers, say that the Supreme Court should not decide the case if the justices don’t dismiss it. The federal law that governs administrative agencies takes a “lenient approach” and allows anyone who is harmed by a government agency’s actions to challenge those actions if their interests even “arguably” relate to the interests protected under the law. Here, RJR Vapor, and the retailers, say the retailers fall within the law’s “any person adversely impacted” definition: The FDA threatened to take enforcement action against them (which could include criminal penalties) for not stopping selling the menthol flavored Vuse The retailers say that if they can’t sell the menthol-flavored Vuse brand e-cigarettes at the center of the dispute, they will lose a lot of money and Avail Texas may go out of business. The law states that only the applicant can take the matter to court in order to challenge the withdrawal or denial of marketing authorization. However, it also states that “any person adversely impacted” can do so – indicating that this is not a restriction on applicants. If “any person adversely impacted” is not limited to applicants then it would apply also to retailers who are most likely to be “adversely effected” after RJR. Congress, it says, has set out three places where lawsuits can be filed: in D.C. The 5th Circuit would allow lawsuits to be brought “anywhere in the country” as long as the plaintiff “finds a local retailer willing to join its petition.” But the 5th Circuit would allow lawsuits to be brought “anywhere in the country so long as” the plaintiff “finds a local retailer willing to join its petition.”
This, the FDA continues, creates incentives for forum-shopping. The FDA states that “
twenty-eight other out-of circuit manufacturers” — located in China, California and Florida, North Carolina, Ohio and Washington — have used the same tactic in seeking judicial review of agency actions in the Fifth Circuit.
The 5th Circuit approach could have a ripple effect beyond the Tobacco Control Act because other laws authorizing challenging agency action contain similar restrictions.
The FDA warns that the 5th Circuit’s method may have a ripple effect The FDA states that the logic of this decision would allow challengers to avoid these restrictions, so long as they can find someone who lives within the circuit in which they want to file a lawsuit and “seek review along with that person.” The FDA insists that the case must be brought in D.C. They note that at least one challenger must be located in the circuit where the lawsuit is filed. “And there are a number of reasons why an out-of-circuit applicant may not be able to find an in-circuit co-petitioner” to bring the case, they add – for example, because the manufacturer sells directly to consumers or because there is not a retailer willing to pursue the litigation.
This article was originally published at Howe on the Court.
