At the First Oral Argument Post-Inauguration, Supreme Court Will Hear Arguments About the Contours of Forum Shopping in E-Cigarette Case

On January 21, 2025, the morning after the presidential inauguration, the U.S. Supreme Court will hear oral arguments in FDA v. R.J. Reynolds Vapor Company, an e-cigarette case where the Court will decide whether tobacco companies may select any court of their choosing when challenging Food and Drug Administration (FDA) decisions denying approval of product applications.
In this case, R.J. Reynolds (Reynolds), an e-cigarette manufacturer, sued FDA for issuing marketing denial orders (MDOs) rejecting the company’s applications to market its berry and menthol-flavored e-cigarette products under the brand name Vuse Alto. FDA denied the applications, finding that Reynolds had failed to show that the products would be appropriate for the protection of public health, the standard for marketing authorization established by the Tobacco Control Act. Under that law, an “adversely affected” person may seek judicial review of an FDA order denying an application for marketing authorization. Although Reynolds does not reside in the Fifth Circuit, it claimed that judicial review was appropriate there because it joined a Texas retail store that sells Vuse Alto products and is located within the jurisdiction of the Fifth Circuit. The question presented before the Supreme Court is thus whether a manufacturer may seek review in a circuit where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer’s products that is located within the circuit.
This case is important for two reasons.
First, the case will have significant impacts on public health, particularly on youth. E-cigarettes have been the most used tobacco product among youth since 2014. In 2024, over 1.6 million youth, including 7.8% of high schoolers, reported current e-cigarette use. Vuse, the brand at issue here, is the fourth most popular e-cigarette brand among youth. In its MDOs of Vuse e-cigarettes, FDA found that youth exposure to nicotine “can induce short and long-term deficits in attention, learning, and memory.” The agency has also cited other health harms from e-cigarettes, including “associations between ENDS use and self-reported history of asthma, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease with increased ENDS use (i.e., daily use) relating to increased odds of disease.” E-cigarettes may also function as a gateway to traditional cigarettes, thereby reversing the enormous progress that has been made to curb youth smoking. If the Supreme Court upholds the Fifth Circuit jurisdictional ruling, e-cigarette products, such as Vuse, may remain on the market despite FDA’s finding that these products do not meet the public health standard for marketing authorization.
Second, this case will likely impact the practice of forum shopping, particularly the scope of judicial review over agency actions. Over the last few years, the Fifth Circuit has been jostling with other circuits, particularly the D.C. Circuit, over jurisdiction to review cases involving agency regulations. This choice of forum is consequential because the Fifth Circuit is frequently an outlier on constitutional and statutory issues, and generally confers less deference to agencies. In the e-cigarette context, the Fifth Circuit was a uniquely receptive forum to challenge e-cigarette MDOs. Of the nine courts of appeals to decide such cases, seven have upheld MDOs, with the Eleventh Circuit vacating one MDO on procedural grounds. The Fifth Circuit, by contrast, has vacated at least seven companies’ MDOs on grounds rejected by other circuits. Other out-of-circuit manufacturers of popular e-cigarette brands have since followed Reynolds’ lead by adding retailers located in the Fifth Circuit to obtain a jurisdictional hook for that Circuit. If the Supreme Court upholds the Fifth Circuit’s jurisdictional ruling, it is likely that other entities seeking to reverse agency actions will seek review in the Fifth Circuit.
On behalf of the Campaign for Tobacco-Free Kids and ten other public health organizations, the author filed an amicus brief in support of the Food and Drug Administration in this case.
Information provided on InsightZS should not be considered legal advice and expressed views are those of the authors alone. Readers should seek specific legal guidance before acting in any particular circumstance.
Author(s)

Trillium Chang
Associate
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As the regulatory and business environments in which our clients operate grow increasingly complex, we identify and offer perspectives on significant legal developments affecting businesses, organizations, and individuals. Each post aims to address timely issues and trends by evaluating impactful decisions, sharing observations of key enforcement changes, or distilling best practices drawn from experience. InsightZS also features personal interest pieces about the impact of our legal work in our communities and about associate life at Zuckerman Spaeder.
Information provided on InsightZS should not be considered legal advice and expressed views are those of the authors alone. Readers should seek specific legal guidance before acting in any particular circumstance.