FDA revised selenium health claims, but would you want to use them?

Alliance for Natural Health US, a trade group who sued the FDA after the agency denied their health claim petition, announced last week that it has reached a partial settlement with the FDA regarding the case.

According to Natural Products Insider, the following claims may now be used on labels and in labeling of selenium-containing dietary supplements in the U.S. effective immediately:

• "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."
• "Selenium may reduce the risk of colon cancer. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of colon cancer."
• "Selenium may reduce the risk of bladder, colon, prostate, and thyroid cancers. Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers."

Previously, one the claims read: "Two weak studies suggest that selenium intake may reduce the risk of prostate cancer.  However, four stronger studies and three weak studies showed no reduction in risk.  Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer."

The trade group asserted that the FDA's previous claim is at odds with the Supreme Court's mandate that there be a "reasonable fit" between the government's goal (of protecting public health and preventing consumer fraud) and the restrictions it imposes on commercial speech.  Specifically, the agency re-wrote the trade group's proposed claim, instead of inserting an appropriate disclaimer after it.  The new claims appeared to remedy that issue.

Although the new claims are shorter and can get the point across more directly, one has to wonder who would put the statement "FDA concludes that it is highly unlikely that" the claim is true on their products.