ANH-USA asks court to overturn FDA ban on 114 nutrient claims

Alliance for Natural Health USA and four supplement companies asked a federal judge in Washington, D.C., to strike down FDA’s rejection of 114 nutrient-disease risk reduction claims tied to federal health statements. The case could affect whether supplement labels can use government-backed nutrition information at the point of sale.

Why it matters: - The lawsuit could determine whether supplement makers can use government-published nutrient-disease information on labels instead of being blocked by FDA. - ANH-USA says the dispute affects consumer access to scientifically relevant information where nutrition choices are actually made, in stores and online. - The case also tests how far FDA can go in adding requirements to a congressionally created notice pathway for health claims.

What happened: - Alliance for Natural Health USA, Living Fuel International, Health Ranger Store, Sanacor International and Evolution Nutraceuticals, doing business as Cardio Miracle, filed a motion for summary judgment on Sept. 16, 2026. - The motion asks the U.S. District Court for the District of Columbia to rule that FDA violated the First Amendment and the Food, Drug, and Cosmetic Act. - The dispute centers on FDA’s rejection of 114 nutrient-disease risk reduction claims tied to statements published by federal health agencies. - The court has not yet ruled.

The details: - The claims were based on statements from the National Institutes of Health, the Office of Dietary Supplements, the National Center for Complementary and Integrative Health and the Centers for Disease Control and Prevention. - The legal hook is FDAMA, codified at 21 U.S.C. §343(r)(3)(C), which provides a pre-market notice route for health claims based on authoritative statements by certain federal health agencies. - FDA rejected the petition in December 2025 and said the underlying government statements were not sufficiently authoritative. - FDA also required the statements to reflect an official or consensus federal government position. - The plaintiffs say Congress never imposed those extra tests. - The motion seeks a declaration that FDA’s pre-authorization procedures under the authoritative-statements provision are ultra vires and unconstitutional. - The plaintiffs also want the court to set aside FDA’s Dec. 23, 2025 rejection and stop FDA from suppressing the claims. - Counsel Jonathan W. Emord said Congress created a notice pathway as an alternative to FDA’s prior restraint system. - Emord also said FDA is blocking product-label statements that consumers can already read on government websites.

Between the lines: - The suit is not just about supplement labeling. It is about how much discretion FDA has to narrow a statutory pathway that Congress already wrote. - The plaintiffs are leaning on Pearson v. Shalala, a 1999 D.C. Circuit ruling that said disclaimers or qualifications can be a less restrictive alternative to outright suppression. - The plaintiffs say they told FDA they were willing to accept reasonable, accurate and unbiased qualifying language if needed. - Rob Verkerk, PhD, said the case reflects an “extraordinary scientific contradiction” because the same information appears acceptable when published by federal agencies but not on supplement labels. - The plaintiffs argue that blocking the claims at the point of sale deprives consumers of useful information when making purchase decisions.

What's next: - The district court will decide whether to grant summary judgment on all counts. - If the plaintiffs prevail, FDA could be ordered to reverse its Dec. 23, 2025 rejection and stop enforcing the challenged suppression. - The case is being heard as Alliance for Natural Health USA et al. v. United States Food and Drug Administration, Case No. 1:26-cv-01487, in the U.S. District Court for the District of Columbia.

The bottom line: - The case could redefine whether FDA can block supplement labels from repeating federally published nutrient-disease claims that Congress appeared to allow through a notice process.