The lawsuit contends that the FDA violated the plain meaning of the authoritative statement provisions of the Food, Drug, and Cosmetic Act, the Constitutional Avoidance Doctrine and the First Amendment by suppressing these claims.
“FDA has apparently still not learned the lesson of the landmark 1999 health claims decision of the U.S. Court of Appeals in Pearson v. Shalala, that it may not suppress health claims unless it marshals empirical evidence that they are false and that no claim qualification will suffice to eliminate potential misleadingness,” stated Jonathan Emord, Esq., general counsel at ANH, in a press release. “Instead, it has refused to follow Pearson v. Shalala and is now asked to be accountable for that failing.”
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. Emord argued the Pearson case.
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.
First Amendment
The new ANH-USA case asserts the First Amendment right of dietary supplement sellers and consumers to access nutrient-disease risk reduction information at the point of sale that is already published on federal agency websites.
“A win over FDA in this case will usher into the market 114 vital nutrient-disease risk reduction claims at the point of sale, enabling consumers to better exercise informed choice in their quest to improve their own health and that of their families,” Emord stated.
“Allowance of nutrient-disease risk reduction information to reach consumers is an indispensable component of the MAHA agenda, vital to reducing the risk of chronic disease in America and extending the human lifespan. Ironically, FDA currently stands foursquare against that part of the MAHA agenda, acting contrary to the transparency we have been promised by Secretary Kennedy and Commissioner Makary.”
ANH-USA seeks court enforcement of FDAMA and the First Amendment.
