As reported by NutraIngredients, ANH filed the petition in September 2025 asking FDA to permit 118 nutrient–disease statements drawn directly from government publications and public-facing materials produced by scientists at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and other federal health agencies.
FDA denied 116 claims: Two claims, which ANH-USA thought the agency viewed as implied drug claims, were structure/function claims allowable without agency review, Jonathan Emord, general counsel to ANH-USA, told NutraIngredients.
FDA’s denial bars those statements from being shared with consumers at the point of sale and included claims relating to all the vitamins, many minerals, fiber, omega-3 fatty acids and botanicals such as ashwagandha, chamomile, cranberry, elderberry, garlic, ginger, turmeric and many more.
“FDA’s decision to censor at grocery and online stores 116 statements made by the federal government’s own scientists directly violates the First Amendment under the landmark precedent of Pearson v. Shalala,” said Emord in a statement.
“FDA’s act to deprive the public of nutrient-disease associations endorsed by its own scientists is an appalling departure from the Make America Health Again (MAHA) agenda, making a mockery of the promise of transparency.”
ANH-USA stated it will now sue FDA in the United States District Court for the District of Columbia, challenging this unconstitutional censorship of crucial health information.
Robert Verkerk, PhD, executive & scientific director of ANH-USA, added: “FDA rejected every claim we petitioned—signaling it has no appetite to confront Big Pharma or its own censorship regime.
“Even when nutrient–disease statements come from government scientists and are supported by substantial evidence, FDA treats them as off-limits—because it still clings to what seems to be its primary mission: to protect Big Pharma from every source of competition.”
FDAMA
At the center of the issue is the 1997 Food and Drug Administration Modernization Act (FDAMA), which allowed health or nutrient claims on conventional foods if “a U.S. governmental scientific body with public health protection or research responsibility directly relating to human nutrition or the National Academy of Sciences has published an authoritative statement, currently in effect, about the relationship to which the health claim refers or that identifies the nutrient level to which the nutrient claim refers.”
The FDAMA added that the claim must accurately represent the authoritative statement and must be easily understandable by the public.
In 1998, the FDA issued guidance outlining its interpretation of what constitutes an “authoritative statement” and required that health claims be subject to Significant Scientific Agreement (SSA) standard. The guidance noted that, “Not all pronouncements by the designated scientific bodies would meet these criteria.”
This guidance is “at odds with the plain meaning of the statute’s terms,” according to the ANH petition, which was filed with industry partners Living Fuel International, Health Ranger Store, Inc., Sanacor International, Inc. and Evolution Nutraceuticals, Inc. dba Cardio Miracle.
“The agency’s interpretation contradicts the statute which exempts health claims based on authoritative statements from SSA review in advance of market entry and permits continuous use of the claim in the market until such time, if ever, when the Secretary promulgates a rule following notice and comment rulemaking that modifies or revokes the claim or a federal court in an enforcement action acts against the claim,” the petition stated.
The FDAMA only applied to conventional foods and not to dietary supplements, according to FDA.
In its denial letter, the agency admitted that its enabling statute does not define “authoritative” but argues that the statements of government scientists cited by ANH-USA are not “authoritative” under FDAMA. The agency defended a narrow definition of “authoritative”, asserting that consumer-facing educational materials—even when described by the government itself as reliable and science-based—do not qualify.
“FDA’s action to censor the claims plainly violates the D.C. Circuit’s landmark decision in Pearson v. Shalala,” said Emord, who argued the Pearson case. Pearson v. Shalala, ruled that the FDA’s “significant scientific agreement” standard for approving health claims on dietary supplements violated the First Amendment’s commercial speech protections. The court decided that the agency may not suppress truthful, non-misleading health claims unless it can prove, with affirmative evidence, that the claims are false.
“Even if it has power to declare the claims unapproved by FDA, Pearson teaches that it must still allow them to reach the public at the point of sale unless it proves with affirmative evidence that the claims are false. FDA did not do that here. The claims here in issue are ones endorsed by the government’s own scientists in peer reviewed articles. It has no First Amendment power to prohibit those statements from reaching the public at the point of sale."
“We will sue to vindicate that First Amendment right for the benefit of the plaintiffs and all Americans,” Emord added.
