Blog: The Daily Intake
Ninth Circuit Partially Revives ‘Low-FODMAP’ Labeling Suit
- A Ninth Circuit panel has partially revived (Law360 subscription required) a lawsuit alleging that FDA and USDA nutrient content claim regulations violate First Amendment rights by preventing the inclusion of certain information about fermentable oligosaccharides, disaccharides, monosaccharides, and poloyols (FODMAPs) on food labels.
- The lawsuit was initially filed against FDA, USDA, and USDA’s Food Safety Inspection Service (FSIS) in March 2023 after one plaintiff submitted a label to FSIS for approval. FSIS denied the approval, telling the company that it must “remove all references to digestible, gut loving, and fodmap.” According to the plaintiff, FDA had never raised concerns about the claims on labels of FDA-regulated foods.
- According to the Ninth Circuit, FSIS told the company that it discussed the proposed label with FDA, and FDA agreed that the FODMAP claims were impermissible nutrient content claims. The company modified the label, then filed the lawsuit along with a consumer plaintiff. The plaintiffs claim that the challenged regulations violate their rights to speak and to receive information. The district court dismissed the case, concluding that the plaintiffs failed to show they had standing and exhausted their administrative remedies.
- The panel reversed that decision in part, finding that the consumer plaintiff adequately showed standing as a “listener” under the First Amendment, based on needs for a low-FODMAP diet and because she alleged that food producers “would be reasonably likely to include FODMAP-related information on food labels in the absence of the challenged FDA and USDA regulations.” The panel also found that the company plaintiff sufficiently pleaded standing related to claims on FDA-regulated products based on the Agency’s threatened enforcement of its regulations. However, the panel found that the company plaintiff did not exhaust its administrative remedies and, therefore, upheld the lower court’s ruling on that issue.
- While this ruling deals only with the standing issue in the case, it highlights that both consumers and companies may have standing to challenge food labeling regulations on a First Amendment basis. Here, the claims that food products are “low-FODMPAP foods” would currently be considered an impermissible nutrient content claim because “low” claims must be made in accordance with the definitions in 21 CFR 101 Subpart D, 9 CFR 317 Subpart B, and 9 CFR 381 Subpart Y.
- Keller and Heckman will continue to monitor food labeling litigation.