FDA Finds Selenium "Highly Unlikely" To Reduce Prostate Cancer Risk

FDA has concluded that minimal evidence supports the linking of selenium consumption and reduced risk of prostate cancer, likely delivering a further blow to Bayer One A Day Men’s multivitamins products containing the mineral and touting its prostate health benefits.

In a decision dated June 19, the agency informs attorney Jonathan Emord that it “intends to consider the exercise of its enforcement discretion” for a claim stating the following:

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 agency's Center for Food Safety and Applied Nutrition is allowing two similarly weak qualified health claims for selenium and bladder and thyroid cancer. FDA rejected all claims for a number of other site-specific cancers Emord had sought, including lung, brain and breast cancers. In a separate decision, the agency also rejected most of the cancer claims Emord requested relating to vitamins C and E. “The Tan Sheet” noted his 2008 citizen petition submissions here.

In an e-mail, Emord said the agency’s decisions violate First Amendment standards and “reveal a profound and unscientific bias against communication of accurate information concerning the relationship between these nutrients and these disease risks.”

FDA currently allows QHCs linking selenium and vitamins C and E to reduced risk of “certain forms of cancers,” but has not approved the mention of any specific cancers.

“The Tan Sheet” reported here that Bayer’s explicit linking of selenium intake and prostate health in labeling and marketing has led the Center for Science in the Public Interest to threaten a lawsuit and report the firm to the Federal Trade Commission.

Under its new leadership, FDA has shown little willingness to be flexible when claims fall outside approved language and supporting science. Commissioner Peggy Hamburg recently said the agency does not wish “to delve too deeply into the wordsmithing of various claims and labels,” but does want them “to accurately reflect the best available science with respect to the safety and benefits of a given product.” 

CSPI has been a vocal opponent of QHCs, alleging they ultimately confuse the consumer, as “The Tan Sheet” reported here. Following a critical 2008 Government Accountability Office report, dietary supplement industry stakeholders stepped up in defense of QHCs.

- Dan Schiff (d.schiff@elsevier.com)

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