On June 11, Venable LLP issued a client alert regarding the lawsuit filed by the Alliance for Natural Health USA (ANH-USA) in the U.S. Court for the District of Columbia.
ANH-USA’s lawsuit presents a “potentially significant challenge” to the U.S. Food and Drug Administration’s (FDA) approach to health claims for dietary supplements and conventional foods.
In the lawsuit, ANH-USA argues FDA unlawfully denied the organization’s petition to make more than 100 proposed nutrient-disease risk-reduction health claims. Statements 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.”
ANH-USA argued FDA must approve the claims because they were “drawn from the official websites” of the National Institutes for Health (NIH) and the Centers for Disease Control and Prevention (CDC).
Venable stated the complaint raises important questions about the “authoritative pathway” for health claims under the Federal Food, Drug and Cosmetic Act (FDCA). Under FDCA, heath claims for foods and supplements generally require premarket authorization from FDA. A “health claim” describes a relationship between 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,” Venable wrote.
Venable added the Food and Drug Administration Modernization Act of 1997 (FDAMA) amended FDCA to provide a second pathway—the “authoritative statement,” which avoids both the “significant science agreement” and the need for FDA rulemaking.
“Importantly, FDA’s long-standing position is that the authoritative statement pathway is available only to conventional foods, and not dietary supplements,” Venable wrote. “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.”
For more information, visit www.venable.com or www.anh-usa.org.
