Background
Michelle Przybocki, who follows a low-FODMAP diet to manage severe irritable bowel syndrome symptoms, wants food labels to disclose FODMAP levels. Ketan Vakil and his company, Gourmend Foods, sell low-FODMAP products and want to use FODMAP-related statements on their labels.
Gourmend submitted a proposed low-FODMAP beef-broth label to the USDA’s Food Safety and Inspection Service. FSIS required it to remove references to FODMAPs, digestibility, and “gut loving,” explaining that it and the FDA considered the claims impermissible undefined nutrient-content claims. The plaintiffs sued, alleging that the federal labeling rules violated Vakil and Gourmend’s right to speak and Przybocki’s right to receive information. The district court dismissed for lack of standing and, as to Vakil and Gourmend’s USDA claims, failure to exhaust administrative remedies.
The Court’s Holding
The Ninth Circuit reversed the standing dismissals of all plaintiffs’ FDA claims and of Przybocki’s USDA claims. Przybocki adequately alleged listener standing because she is a prospective consumer who needs FODMAP information to follow her doctor’s dietary advice, identified Gourmend as a willing speaker, and plausibly alleged that other food companies would provide FODMAP information absent the challenged restrictions.
Vakil and Gourmend also adequately alleged standing for a pre-enforcement First Amendment challenge to FDA rules. They had a concrete plan to continue or expand FODMAP-related labeling, the agencies had specifically stated that the proposed claims were impermissible, and the government would not disavow FDA enforcement. In a separate memorandum disposition, the panel affirmed dismissal of Vakil and Gourmend’s USDA claims because they had not exhausted available administrative remedies.
Key Takeaways
- A consumer can establish listener standing when restricted product-label information bears concretely on the consumer’s purchasing and use of that product.
- A direct agency rejection and an agency statement that proposed speech violates labeling rules can create a credible threat of enforcement for a pre-enforcement First Amendment challenge.
- Speaker standing against the FDA did not excuse Vakil and Gourmend from exhausting the USDA’s separate administrative process for their USDA claims.
Why It Matters
The decision allows the constitutional challenge to proceed without deciding whether the FODMAP-labeling restrictions are constitutional. It applies recent listener-standing precedent to commercial product information and recognizes that access to similar information on a website does not necessarily eliminate an alleged injury from restrictions on product labels.
For regulated food businesses, the ruling underscores that coordinated agency communications about a proposed label may suffice to support a pre-enforcement challenge even before the FDA issues a warning letter or begins enforcement.