Top Takeaways:

  • Supreme Court opens doors to industry venue shopping.
    The Court’s 7–2 ruling empowers R.J. Reynolds Vapor and allied retailers to challenge FDA marketing denials in the 5th Circuit, widely seen as favorable to vaping companies.
  • Expanded notion of “person adversely affected.”
    Justice Barrett noted that “because Avail Vapor and the trade association have their principal places of business in Texas and Mississippi … they could both file in the Fifth Circuit,” giving legal force to venue choice.
  • Concern for vaping regulation remains strong.
    While majority granted venue flexibility, liberal justices dissented—Justice Jackson emphasizing that only the manufacturer has standing: “Congress established a detailed scheme for manufacturers … and, in that context, Congress provided a cause of action for the protection of the manufacturers’ statutorily created interests”

It’s a big win. In a sharply divided 7–2 decision authored by Justice Amy Coney Barrett, the Supreme Court on Friday thwarted the U.S. Food and Drug Administration’s attempt to restrict venue-shopping by vaping companies seeking judicial review of denied marketing applications.

The ruling allows R.J. Reynolds Vapor Co. to pursue its challenge to FDA denials of its mint‑flavored “Vuse Alto” e‑cigarettes in the 5th U.S. Circuit Court of Appeals, considered the most conservative and nicotine industry-friendly appellate court in the nation. The company is joined by a Texas vapor retailer and a Mississippi trade association.

Markus Lindblad, head of External Affairs at  Nicokick.com, said that today’s Supreme Court decision isn’t just a legal milestone — it’s a clear signal that the status quo must evolve.

“With what can be seen as a reset at the FDA, we’re presented with a rare opportunity to build a more effective, transparent, and science-based regulatory system,” he said. “It’s time to move past the backlog and toward a process that both protects youth and ensures adult access to modern oral nicotine products.

“U.S. consumers deserve better — a streamlined path to innovation with reduced-risk nicotine alternatives that have real world public health impact. The next phase must be an empowered harm-reduction movement where we get it right.”

Under the 2009 Family Smoking Prevention and Tobacco Control Act, “any person adversely affected” by FDA decisions may challenge them in either the D.C. Circuit or in the circuit where they have their principal place of business. R.J. Reynolds is based in North Carolina (4th Circuit), but both that court and the D.C. Circuit rejected the company’s litigation strategy. The 5th Circuit, however, allowed the challenge via its local retailer allies.

Justice Barrett explained: “Because Avail Vapor and the trade association have their principal places of business in Texas and Mississippi … they could both file in the Fifth Circuit. So when it denied the FDA’s motion to dismiss or transfer, the Fifth Circuit correctly concluded that at least one proper petitioner had venue.”

This interpretation lets manufacturers partner with retailers in favorable circuits to challenge FDA decisions, boosting the potential for strategic forum selection.

But two justices—Sotomayor and Jackson—strongly dissented. Justice Jackson argued that only the manufacturers have statutory standing: “Congress established a detailed scheme for manufacturers to obtain authorization … and … Congress provided a cause of action for the protection of the manufacturers’ statutorily created interests,” she wrote.

Despite this procedural victory, R.J. Reynolds faces steep hurdles ahead. The Supreme Court earlier this term upheld the FDA’s denial of flavored-vape applications in separate cases (e.g., FDA v. Wages & White Lion)—reaffirming that the FDA acted lawfully in rejecting vapor products due to public‑health concerns.

“In today’s decision, the Supreme Court recognized that federal agency action can have downstream effects that can be devastating for parties that are not the most direct target of the agency’s action,” Ryan Watson, a partner at Jones Day who argued the case on behalf of the companies, said in a statement. “The Court’s decision ensures that the courthouse doors are not closed for those adversely affected parties,”

The case returns to the 5th Circuit, which already overturned the FDA’s marketing denial order. However, the FDA will likely mount its defense by emphasizing substantive public-health issues.

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