FDA Revises Qualified Health Claims for Selenium Dietary Supplements

According to counsel for a company that makes dietary supplements containing selenium, the Food and Drug Administration (FDA) has agreed to allow the company to make qualified health claims for the products that include brief disclaimers. The company will apparently be able to label its products with claims that selenium “may reduce the risk” of prostate, colon, bladder, and thyroid cancers as long as it includes the following: “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers.” The negotiations that led to the breakthrough reportedly followed a federal district court ruling in May that FDA violated First Amendment commercial speech standards by censoring specific qualified health claims for the company’s products and requiring the use of a lengthy contradictory qualification. The parties are apparently continuing to discuss disagreements over the effect of selenium on other cancers. See NutraIngredients-USA.com, October 6, 2010.