ANH-USA asks federal court to overturn FDA suppression of 114 government-backed nutrient health claims

ALEXANDRIA, VA, UNITED STATES, September 18, 2026 /EINPresswire.com/ — In its summary judgment motion ANH argues FDA has unlawfully converted a congressionally mandated notification pathway into a pre-approval system — preventing government-backed truthful nutrient–disease information from reaching the public

The Alliance for Natural Health USA (ANH-USA), together with four dietary supplement companies, filed a motion for summary judgment asking the U.S. District Court for the District of Columbia to rule that the U.S. Food and Drug Administration (FDA) violated the First Amendment and the Food Drug and Cosmetic Act when it suppressed 114 nutrient-disease risk reduction claims based on statements published by federal government health agencies.

The motion, filed September 16, 2026, is the latest step in litigation brought by ANH-USA, Living Fuel International, Health Ranger Store, Sanacor International and Evolution Nutraceuticals, doing business as Cardio Miracle.

The case centers on a provision of the Food and Drug Administration Modernization Act of 1997 (FDAMA), codified at 21 U.S.C. §343(r)(3)(C). That provision creates a pre-market notice alternative to prior FDA approval for health claims based on nutrient-disease risk reduction statements published by FDA sister government health agencies.

The 114 disputed claims were derived from statements published by federal health bodies including the National Institutes of Health (NIH), its Office of Dietary Supplements (ODS), the National Center for Complementary and Integrative Health (NCCIH), and the Centers for Disease Control and Prevention (CDC).
In December 2025, FDA rejected the petition and denied the claims, concluding among other things that the underlying government statements were not sufficiently “authoritative,” and imposing requirements including that statements represent an “official” or “consensus” federal government position.

The plaintiffs argue that these additional tests were never enacted by Congress.

Jonathan W. Emord, counsel for the plaintiffs, said:
“Congress was unambiguous. It created a notice pathway for claims based on authoritative statements of federal health agencies as an alternative to the prior restraint imposed by FDA’s health claims review process. Against the command of Loper Bright, the FDA has crafted requirements nowhere mentioned in and expressly contrary to the statute.

“FDA is flouting the First Amendment and suppressing at the point-of-sale nutrient-disease information derived from statements the federal government itself publishes to the American people. Ironically, a consumer with a cell phone can pull up the government web site and read the nutrient-disease risk reduction statement while shopping for the nutrient, but the maker of that nutrient is forbidden by FDA from placing the exact same statement on its product label. That is not only illogical, it is unconstitutional speech suppression.”

The motion relies in part on the D.C. Circuit’s landmark 1999 decision in Pearson v. Shalala, which held in the context of dietary supplement health claims that disclaimers or qualifications constitute a less restrictive alternative to outright suppression.
The plaintiffs had specifically advised FDA that, if the agency considered qualification of the claims necessary, they were willing to accept reasonable, accurate and unbiased qualifying language.

For ANH-USA, the dispute goes beyond the technical interpretation of a single statutory provision. It concerns whether consumers can receive scientifically relevant information about relationships between nutrients and disease risk at the place where dietary choices are actually made, in stores and online.

Rob Verkerk, PhD, founder, executive and scientific director of the Alliance for Natural Health, said:
“There is an extraordinary scientific contradiction at the center of this case. These are not health relationships invented by supplement companies. They arise from statements published to the American public by some of the U.S. government’s own leading scientific and public health bodies.

“The notification painstakingly linked the proposed claims with the underlying government statements and the scientific references supporting them. Yet information considered sufficiently credible and useful for NIH, ODS, NCCIH or CDC to communicate publicly suddenly becomes unacceptable when consumers encounter substantially the same information at the point of sale.

“That has profound consequences for informed choice. Nutrition science is inherently concerned with the relationships between nutrients, physiological function, health and disease risk. If scientifically supported information about those relationships can be published on a government website but effectively disappears when people are choosing products that supply those same nutrients, consumers are being denied information at precisely the point where it can be most useful.

“This case is ultimately about restoring the bridge between science and informed choice. Consumers should have access to truthful, appropriately qualified information about what the evidence tells us — rather than having scientifically relevant information filtered out simply because it crosses an artificial regulatory boundary.”

The plaintiffs’ motion asks the Court to grant summary judgment on all counts. Among the relief sought is a declaration that FDA’s pre-authorization procedures under the authoritative-statements provision are ultra vires and unconstitutional; that FDA’s December 23, 2025 rejection of the 114 claims be set aside; and that FDA discontinue its suppression of the disputed claims.

The Court has not yet ruled on the motion.

ENDS.

About Alliance for Natural Health USA
www.anh-usa.org

Alliance for Natural Health USA is a nonprofit organization advocating for consumer access to natural health products and healthcare choices through legislative advocacy, public education, regulatory participation and litigation.

ENDS

Media enquiries:
Meleni Aldridge, COO, Alliance for Natural Health USA
Email: mel@anh-usa.org
Tel: 703-301-8916

Case: Alliance for Natural Health USA et al. v. United States Food and Drug Administration, Case No. 1:26-cv-01487, U.S. District Court for the District of Columbia.

Meleni Aldridge
Alliance for Natural Health USA
+1 703-301-8916
email us here

Media gallery