Selenium Claim Ruling Forces FDA's Hand, May Clear Path For More QHCs
This article was originally published in The Tan Sheet
Executive Summary
A court decision obligating FDA to reconsider a slate of qualified health claims for selenium could compel the agency to allow more QHCs for dietary supplements
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FDA OKs succinct selenium QHCs
Jonathan Emord touts a "negotiation breakthrough" with FDA that allows firms to begin promoting the potential cancer risk-prevention benefits of selenium in foods and supplements. The Clifton, Va.-based attorney said Sept. 28 FDA approved qualified health claims for selenium and prostate, colon, bladder and thyroid cancers, all following the format: "Selenium may reduce the risk of [type of cancer]. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of [type of cancer]." Emord said he hopes the QHCs, the shortest ever approved by the agency, will serve as a model for future claims. Emord sued FDA in August 2009 after the agency approved only extremely narrow QHCs for selenium. FDA was obligated to reconsider the claims after Emord prevailed in federal court (1"The Tan Sheet" June 7, 2010)