ALEXANDRIA, VA; September 2. The Alliance for Natural Health USA (ANH), alongside industry partners Living Fuel International, Health Ranger Store, Inc., and Sanacor International, Inc. and Evolution Nutraceuticals, Inc. dba Cardio Miracle, has filed a petition with the U.S. Food and Drug Administration (FDA), challenging the agency’s decades-long misapplication of federal law that has blocked consumers from accessing truthful information concerning how nutrients reduce the risk of disease.
At issue is FDA’s 1998 guidance, which unlawfully imposed the Significant Scientific Agreement (SSA) standard on health claims based on “authoritative statements” issued by federal scientific bodies such as the National Institutes of Health, Centers for Disease Control and Prevention, and National Academy of Sciences. Congress expressly exempted these claims from SSA requirements in the 1997 Food and Drug Administration Modernization Act (FDAMA).
Instead, under FDAMA, such claims were to be made available immediately after FDA notification—unless the agency rescinded them through formal rulemaking. By ignoring the statute’s plain language and congressional intent, FDA has unlawfully suppressed at least 120 nutrient-disease health claims backed by authoritative government science.
“Americans face unacceptably high rates of diet-related diseases—ranging from obesity and fatty liver disease to diabetes, high blood pressure, and cognitive decline,” said Robert Verkerk, Ph.D., ANH’s Executive and Scientific Director. “One major reason is that consumers are denied at the point of sale access to accurate, government published information about how nutrients reduce disease risk. Our petition simply seeks to uphold the law, effectively allowing the republication of government speech, so that this vital information can reach consumers at the point of sale and help reduce disease burdens.”
The petition by ANH aims to open the marketplace to 120 health claims in a single instance, which, if successful would amount to a precedent-setting breakthrough in consumer access to truthful disease risk reduction information. It builds on ANH’s long history of legal victories advancing consumer access to nutrient-disease information, including the landmark Pearson v. Shalala (1999) case spearheaded by Jonathan Emord, Esq., now ANH General Counsel, that established the right to use qualified nutrient-disease risk reduction claims for dietary supplements. Over the last two decades, ANH has helped secure claims for nutrients such as folate, saw palmetto, omega-3 fatty acids, fiber, vitamin E, vitamin B, and selenium.
The legal landscape shifted dramatically in 2024 when the U.S. Supreme Court decided Loper Bright Enterprises v. Raimondo, overturning the Chevron doctrine that gave agencies broad deference in interpreting ambiguous statutes. Under this new precedent, FDA’s 1998 guidance is now vulnerable, as its requirements contradict the clear text of FDAMA and Congress’s express intent.
“For more than a quarter-century, the FDA has acted in open defiance of Congress, blocking the very health claims lawmakers required it to allow,” said Jonathan Emord. “With Chevron deference now gone, FDA must implement fully the FDAMA exception to FDA’s significant scientific agreement prior restraint on speech. This petition is about restoring the rule of law, ending unlawful censorship, and opening the nutrient marketplace to truthful, science-based disease risk reduction information as never before. It will improve health, increase longevity, and save lives.”
With rates of preventable, diet-related diseases at alarming levels, ANH argues that FDA’s unlawful censorship harms the public by keeping science-based information out of the market. The organization is seeking FDA compliance with the law to fulfil one key element of the MAHA agenda: access to critical health claims derived from authoritative government science.