Key points:

• Supreme Court remands flavored vape appeal: The Court sent FDA v. Wages and White Lion Investments, LLC back to the 5th Circuit for further review of FDA’s denial of flavored e‑cigarette market applications.
• Other petitions left untouched: The justices declined to review three additional challenges to FDA denial orders, leaving those denials in place.
• Fight over flavored vapes continues: Five manufacturers originally sued in 2020, arguing FDA’s blanket rejection of their premarket tobacco product applications (PMTAs) was unlawful.

In a unanimous order issued Monday, the U.S. Supreme Court upheld its April 2 ruling that FDA’s refusal to authorize certain flavored e‑cigarette products was not “arbitrary and capricious,” yet sent one appeal back to the U.S. Court of Appeals for the Fifth Circuit for further proceedings.

The case, FDA v. Wages and White Lion Investments, LLC (Triton Distributing), involves five manufacturers who applied in 2020 to market flavored vaping products. FDA denied their PMTAs, concluding the companies failed to show that any youth-protection measures would outweigh the risk of underage vaping.

Justice Samuel Alito, writing for a unanimous Court, held that the Fifth Circuit must reconsider whether FDA’s decision-making process fully complied with the Administrative Procedure Act, particularly in light of the agency’s prior guidance, according to media reports. The high court did not disturb FDA’s denials, but found that lower courts must apply the Supreme Court’s harmless‑error standards before finalizing any decision.

At the same time, the Court refused to grant certiorari for three other petitions seeking review of market denial orders, effectively leaving those verdicts intact. Industry watchers note that the denials remain in effect unless and until FDA reopens applications or approves them under new criteria.

FDA spokesperson Jonathan Peck said the agency “welcomes the Supreme Court’s reaffirmation of our authority under the Tobacco Control Act and will continue to apply science‑based standards to PMTAs.”

Manufacturers, however, argue that the current approval process remains opaque and overly burdensome. “We are disappointed that the Court did not provide broader guidance,” said attorney Eric Heyer, who represents Triton. “We will pursue our remedies in the 5th Circuit.”

The remanded case now returns to a Fifth Circuit known for its skepticism of FDA’s approach to vaping regulations. Should that court again rule against the manufacturers, further appeals could follow—potentially keeping flavored vaping products off the U.S. market for the foreseeable future.