A new lawsuit filed in the U.S. District Court for the District of Columbia tees up a potentially significant challenge to FDA's approach to health claims for dietary supplements and conventional foods.
In Alliance for Natural Health USA et al. v. FDA, a nonprofit advocacy organization and several dietary supplement companies allege that FDA unlawfully denied the organization's petition to make over 100 proposed nutrient-disease risk-reduction health claims. Examples include "Riboflavin may reduce the risk of migraine headaches," "Chromium may reduce the risk of type 2 diabetes," and "Vitamin D supplementation may reduce the risk of infection by pathogenic bacteria and viruses." The plaintiffs assert that FDA must allow the claims because they were "drawn from the official websites" of the National Institutes of Health and the Centers for Disease Control and Prevention.
Although the case is at the pleading stage and FDA has not yet had the opportunity to respond, the complaint raises important questions about the "authoritative statement" pathway for health claims under the Federal Food, Drug, and Cosmetic Act (FDCA).
Under the FDCA, health claims for foods and dietary supplements generally require premarket authorization from FDA. A "health claim" is a claim that describes a relationship between a food substance (a food, food component, or dietary supplement ingredient) and reduced risk of a disease or health-related condition.
In most cases, premarket authorization requires the petitioner to establish that "there is significant scientific agreement" among qualified experts that the claim is accurate, allowing FDA to then promulgate a regulation authorizing the claim. For a variety of reasons, the "significant scientific agreement" standard can be challenging to meet.
However, the Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the FDCA to provide a second pathway. This second pathway, known as the "authoritative statement" pathway, avoids both the "significant scientific agreement" requirement and the need for FDA rulemaking. To qualify, the petitioner must show that:
a scientific body of the United States Government with official responsibility for public health protection or research directly relating to human nutrition (such as the National Institutes of Health or the Centers for Disease Control and Prevention) or the National Academy of Sciences or any of its subdivisions has published an authoritative statement, which is currently in effect, which identifies the nutrient level to which the claim refers.
Importantly, FDA's long-standing position is that the authoritative statement pathway is available only to conventional foods, and not dietary supplements.
The complaint challenges FDA's interpretation that the FDAMA excludes dietary supplements from the authoritative statement pathway and argues that statements on the websites of public health agencies are "authoritative statements" within the meaning of the FDAMA.
If the plaintiffs prevail, the universe of claims available to dietary supplements and conventional foods would significantly increase. For that reason, we are monitoring this case very closely.