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U.S. Department of Health and Human Services

Food

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Settlement Reached for Qualified Health Claims Relating Selenium to Reduced Risk of Prostate, Colon, Rectal, Bladder, and Thyroid Cancers

Judge Ellen Segal Huvelle of the United States District Court for the District of Columbia issued an opinion and order on May 27, 2010, in Alliance for Natural Health v. Sebelius,[1] which involved a challenge to FDA's decision on a petition requesting the agency to permit the use of several qualified health claims about selenium and reduced risk of various cancers in the labeling of dietary supplements.  The court's order required FDA to reevaluate or modify, as appropriate, certain claims that were the subject of FDA's June 19, 2009 petition response.  Subsequently, FDA and plaintiffs reached an agreement to settle the case.


As part of the agreement, FDA stated its intention to exercise enforcement discretion to permit the following claims to be used on labels and in labeling of dietary supplements containing selenium:

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

The enforcement discretion factors listed in the June 19, 2009 petition response[2] were not challenged in the court case and apply to these claims, as well as to the uncontested claims for which FDA stated its intention to exercise enforcement discretion in the petition response.


Notes:

[1] Alliance for Natural Health v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010).

[2] These enforcement discretion factors are listed in FDA's "Summary of Qualified Health Claims Subject to Enforcement Discretion" at http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm073992.htm.