Following the remand, the parties entered into negotiations that have culminated in a breakthrough, permitting use of the following qualified health claims on selenium-containing dietary supplements. Each claim bears a succinct and accurate qualification, consistent with the Court’s requirements. The qualifications are the shortest FDA has ever permitted for use with qualified health claims.
The selenium qualified health claims may be used by any company that sells selenium containing dietary supplements in the United States.
“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, said. “I hope this resolution becomes a model for FDA in subsequent qualified claims cases,” he said. “Compliance with the First Amendment requirement in Pearson v. Shalala that FDA favor disclosure of nutrient-disease information over its suppression is long overdue.”
The following claims may be used on labels and in labeling of selenium-containing dietary supplements effective immediately: EMORD & ASSOCIATES, P.C. (202) 466-6937/FAX (202) 466-6938 PAGE 2 OF 2
Prostate Cancer Claim
“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.”
Colon Cancer Claim
“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.”
Certain Cancers Claim and Anticarcinogenic Effects Claim
“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.”
The parties continue to discuss means to resolve disagreements concerning selenium-lung and respiratory tract cancer and selenium-digestive tract cancer claims.
