FDA Agrees to Selenium Health Claims


Washington, D.C.— Following negotiations with law firm Emord & Associates, FDA will now allow select cancer-related health claims on selenium supplement product labels. The U.S. District Court for the District of Columbia overruled FDA’s decision to censor four qualified health claims, by finding it in violation of the First Amendment commercial speech standard.These claims were remanded to the FDA in May, and a partial settlement has now been reached over the wording of these claims.

The decision to remand the claims was the result of the District Court case ANH v. Sebelius. “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,” Jonathan Emord, counsel for the plaintiffs in the case, said about the breakthrough.

One of the four now-permissible claims reads, “Selenium may reduce the risk of prostate cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of prostate cancer.” The other three claims are similarly worded, only differing in the types of cancer mentioned, which include bladder, colon and thyroid cancer.

The settlement is significant, as the qualifications contained in these claims are the most succinct FDA has yet permitted for any such claims. Some past qualifying statements concerning FDA’s assessment of a health claim have been long-winded, and even contradictory of, the intended health claim.