On May 27, the U.S. District Court for the District of Columbia ruled that the Food and Drug Administration violated the first amendment rights of a dietary supplements manufacturer by rejecting health claims about selenium and cancer risk.
The case, Alliance for Natural Health vs. Sebelius, was brought to court after the FDA insisted that any selenium health claims include disclaimers such as, “Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, the FDA has determined that this evidence is limited and not conclusive.”
The FDA had argued that, because the scientific evidence for selenium was not entirely conclusive, the disclaimers were necessary for consumer protection. The judge, however, ruled that the FDA took a misguided approach to selenium claims and must act quickly to revise its required disclaimers.
“It’s important to note that this case involves health claims, not structure/function claims,” said Daniel Fabricant, vice president of scientific and regulatory affairs for the Natural Products Association, based in Washington, D.C. Unlike structure/function claims, health claims must be backed by scientific evidence and pre-approved by the FDA.
“The important thing here is that the science is the science, and can’t be cherry-picked by FDA,” said Fabricant. “This decision is a victory in that it upholds Pearson vs. Shalala.”
In that landmark 1999 decision, the courts rejected the FDA’s argument for denying health claims for fiber, antioxidants and omega-3 fatty acids due to lack of “significant scientific agreement.” The courts also cited the first amendment rights of the plaintiffs.
The wider implication of the recent decision is that food and dietary supplements manufacturers do have the right to discuss the science behind a product, as long as they represent that science accurately.
Lead attorney Jonathan Emford of Emford & Associates—who also argued the Pearson vs. Shalala case eleven years earlier—said of the decision, “It reestablishes the supremacy of the first amendment over the FDA, confirming that this agency may not escape the strictures of the Constitution to achieve health claim suppression. The court held that the FDA may not demand conclusive profo as a condition precedent for health claim allowance.”