Selenium Health Claims Revamped

WASHINGTONEmord & Associates announced a partial settlement with FDA regarding the case Alliance for Natural Health (ANH) v. Sebelius. The settlement follows a decision by Judge Ellen Segal Huvelle, U.S. District Court, District of Columbia, in late May, which found the agency violated the spirit of Pearson vs. Shalala, which allows qualified claim approval with less than "substantial scientific agreement." She also found FDA failed to accurately analyze the studies submitted by the petitioner and, in its replacement language, mischaracterized at least one study; Huvelle remanded the claims to FDA, requiring the agency to re-evaluate them consistent with First Amendment requirements.

Following the remand, the parties entered into negotiations to develop qualified health claims for selenium-containing dietary supplements, each with a succinct qualification. "This settlement permits information about the potential of selenium to reduce site specific cancers to reach consumers. It will help guide consumer choice in health enhancing ways," said Jonathan Emord, counsel for the plaintiffs. "I hope this resolution becomes a model for FDA in subsequent qualified claims cases. Compliance with the First Amendment requirement in Pearson v. Shalala that FDA favor disclosure of nutrient-disease information over its suppression is long overdue."

The following claims may be used on labels and in labeling of selenium-containing dietary supplements in the United States effective immediately:

There was no settlement regarding claims related to selenium and lung/respiratory tract cancer or selenium and digestive tract cancer; the plaintiffs and FDA are still in discussion regarding a possible settlement on those claims.

Andrew Shao, Ph.D., senior vice president, scientific and regulatory affairs, Council for Responsible Nutrition (CRN), commented that the settlement seems to have addressed one of the main problems with qualified health claims in the past, basically the convoluted language that made the claim almost uninterpretable. "From an industry perspective, this is greatly simplified language," he said. "However, Im not sure whether it ultimately helps the lay consumer, who is likely left with the same question: does it work or not." Shao said the state of the science in most areas continues to evolve, and relaying it accurately to consumers is a complex task. He advised a key part of this equation for industry, health care providers and others involved in the dialogue is to help manage consumers expectations. "The most important tools in a persons arsenal to maintain health and avoid disease are diet and lifestyle," he said. "We need to help consumers understand that if they add a particular supplement, it provides an important but incremental benefit compared to the effects of diet and lifestyle."