Health Law Daily Wrap Up, LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—9th Cir.: Consumer has standing to challenge FODMAP regulations, (Aug 7, 2026)

By Donielle Tigay Stutland, J.D.

A consumer, a health food company, and the owner of the company had Article III standing to bring suit.

A Ninth Circuit panel reversed in part a decision that a consumer, a health food company, and the company’s owner lacked standing to bring claims against the FDA and USDA after the USDA’s Food Safety and Inspection Service (FSIS) rejected Gourmend Foods, LLC (“Gourmend”) labeling of one of its products as low-FODMAP, alleging violations of their First Amendment rights to speak and to receive information. Millions of people suffer from the inability to digest sugars called FODMAPs. “FODMAPs” is an acronym for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. The Ninth Circuit concluded that the consumer adequately pleaded listener standing based on her concrete need as a consumer of low-FODMAP foods and plausible allegations that Gourmend and other producers would include such labeling absent the challenged regulations. The court also found that Gourmend and the company’s owner adequately pleaded speaker standing against the FDA based on the government’s threatened enforcement of the applicable food-labeling laws. In a companion memorandum disposition the court affirmed the exhaustion-based dismissal of Vakil and Gourmend’s claims against the USDA (Przybocki v. United States Department Of Agriculture, No. 24-7174 (9th Cir. Aug. 3, 2026)).

Background. The plaintiffs in the suit are a consumer, who struggles to digest FODMAPs and wants FODMAP levels to be included on food labels, and food manufacturer, and Gourmend Foods, LLC (“Gourmend”), along with its owner, who wishes to sell foods that include FODMAP levels on their labels. The consumer suffers from Irritable Bowel Syndrome and was told by her doctor to follow a low-FODMAP diet to manage her symptoms. To follow her doctor’s recommendation, she wants information about FODMAP levels to be displayed on the labels of the food she buys.

Gourmend’s owner also follows a low-FODMAP diet on the advice of his doctor and he founded Gourmend in 2018 to serve the potentially millions of consumers who seek reliably low-FODMAP foods. Gourmend sells four low-FODMAP spice blends and one low-FODMAP chicken broth, which contain labels that at the products are low-FODMAP, are certified by Monash University as such, and are “deliciously digestible” and “gut loving.” Gourmend has also developed a low-FODMAP beef broth, which unlike the four other products, it has labeling that is regulated by the USDA. The FDA had not previously raised concerns about Gourmend’s spice or chicken broth labels, the USDA Food Safety and Inspection Service (FSIS)told Gourmend that it had to “remove all references to digestible, gut loving, and fodmap” on the beef broth label.

After the FSIS instructed Gourmend to remove the references to FODMAP levels from its beef broth label in order to receive approval, the consumer, company owner and Gourmend sued the USDA, the FSIS, the FDA, and agency officials in the U.S. District Court for the District of Nevada. The plaintiffs alleged that federal law prohibits food companies like Gourmend from including FODMAP information on their products’ labels and indicated that the United States FSIS rejected Gourmend’s proposed beef broth label because it included the broth’s FODMAP levels. The plaintiffs sued the Food and Drug Administration and the USDA, alleging violations of their First Amendment rights to speak and to receive information. The district court dismissed the suit, concluding that the plaintiffs failed to plead Article III standing and failed to exhaust their administrative remedies. The Plaintiffs appeal.

Consumer Standing. The court first addressed whether the consumer had standing as a listener. The Ninth Circuit noted that the Supreme Court most recently addressed the requirements for listener standing in Murthy v. Missouri, a suit regarding social media censorship in which the court held that listener standing exists only where the listener has “a concrete, specific connection to the speaker” and can “identif[y] any specific speakers or topics that they have been unable to hear or follow.” Here, the Ninth Circuit concluded that the consumer pleaded a sufficiently “concrete [and] specific connection” to identified speakers who would like to include FODMAP-related claims on their products’ labels but refrain from doing so as a result of the challenged USDA and FDA regulations. Further, the consumer is a prospective purchaser “who must identify foods’ FODMAP levels in order to plan a diet consistent with her doctor’s recommendation.” The consumer here has also identified willing speakers, including Gourmend and its owner, and she has a concrete, specific connection to those speakers. In addition to those speakers, the consumer alleges that other food companies would include FODMAP-related claims on their labels but for the challenged USDA and FDA regulations.

The plaintiffs identified other producers who would likely label products with FODMAP information absent the regulations due to consumer demand and economic incentives), and she has a concrete, specific connection to those speakers under Murthy v. Missouri and related precedents. Website disclosures or other channels do not eliminate the injury from restricted on-label speech. The court found that the consumer adequately pleaded Article III standing to challenge the FDA and USDA regulations at issue here.

Food Company and its Owner’s Standing. Next the court turned to whether Gourmend and Gourmend’s owner adequately pleaded standing to sue the FDA based on the “alleged chilling of their own speech.” The court stressed that it must analyze whether the company and its owner allege a “credible threat of prosecution” arising from the inclusion of FODMAP-related information in Gourmend’s labels sufficient to plead Article III standing. In determining whether the owner and Gourmend face a “credible threat of prosecution,” the court must consider, first, “whether the plaintiffs have articulated a concrete plan to violate the law in question;” second, “whether the prosecuting authorities have communicated a specific warning or threat to initiate proceedings;” and third, “the history of past prosecution or enforcement under the challenged statute.”

The court found that here, the first two factors clearly favor finding a credible threat of prosecution, while the third factor weakly favors such a finding. First, Gourmend has a “concrete plan to violate the law in question.” Gourmend has been labeling products in potential violation of the FDA’s regulations for years. The complaint also alleges that the challenged regulations “ha[ve] further chilled [Vakil] and Gourmend’s speech by causing them to delay plans for additional speech and additional low-FODMAP food products.” Thus, the court determined that Gourmend either already offers or has a “concrete plan” to offer products that violate the applicable food-labeling laws through the inclusion of FODMAP related information on their labels. Second, the government has provided Gourmend with a “specific warning or threat to initiate proceedings.” Third, the government’s “history of past prosecution or enforcement” weakly favors Gourmend and its owner. As such, the court concluded that Gourmend and its owner alleged a “genuine threat of imminent prosecution” sufficient to establish their Article III standing to sue the FDA.

Administrative Remedies. In a separate memorandum disposition, the Ninth Circuit affirmed the district court’s dismissal of Gourmend and its owner’s claims against the USDA for failure to exhaust available administrative remedies.

The Case is No. 24-7174.

Judge: Pitts, C.

Attorneys: Justin M. Pearson (Institute for Justice) for Michelle Przybocki. Nicole Leibow, Office of the U.S. Attorney, for the U.S. Department of Agriculture.

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