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Supreme Court widens court options for vaping companies pushing back against FDA rules

  • On June 21, 2025, the U.S. Supreme Court ruled by a 7-to-2 margin in FDA v. R.J. Reynolds Vapor Co., permitting the company to pursue legal challenges against the FDA's denial of its product applications.
  • The ruling followed the FDA’s 2023 refusal to approve Reynolds’ application to sell Vuse Alto e-cigarettes, a decision grounded in federal regulations that require agency authorization before marketing new tobacco products.
  • Justice Barrett wrote the opinion clarifying that retailers adversely affected by FDA denials, not just manufacturers, have standing to seek judicial review, a position opposed by Justice Jackson's dissent.
  • The court's ruling allows Reynolds to proceed with its appeal in the Fifth Circuit Court of Appeals, establishing a precedent that retailers connected to such cases may bring lawsuits in courts beyond their designated jurisdictions.
  • This ruling expands legal routes for vaping companies and retailers to contest FDA denials, which may affect future tobacco product market authorizations and regulatory enforcement.
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Supreme Court widens court options for vaping companies pushing back against FDA rules

The Supreme Court is siding with e-cigarette companies in a ruling that'll make it easier to sue over Food and Drug Administration decisions blocking their products from the multibillion-dollar vaping market.

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The Supreme Court rejected the Government's attempt to restrict legal remedies to appeal decisions of the Food and Drug Administration (FDA) that deny authorization to market e-cigarettes, including those with flavors that, according to health authorities, have contributed to a vaping epidemic among young people.Read more]]>

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Supreme Court Ruling on Where Tobacco Companies Can Sue FDA Is Disappointing, but Doesn't Speak to Merits of Decisions Against Flavored E-Cigarettes

Statement of Yolonda C. Richardson, President and CEO, Campaign for Tobacco-Free Kids

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Saint Albans Messenger broke the news in on Friday, June 20, 2025.
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