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FDA Allows Qualified Antioxidant/Cancer Health Claim 37124
April 28, 2003
2 Min Read
FDA Allows Qualified Antioxidant/Cancer Health Claim
WASHINGTON--The Food and Drug Administration (FDA)authorized a new health claim, with appropriate disclaimer language, that wasthe subject of a petition to the agency. Emord & Associates served ascounsel for the petitioners, who sought to use a health claim linking intake ofantioxidant vitamins and a reduced risk of certain kinds of cancer.
FDA's final order follows a decision issued in December 2002 bythe U.S. District Court for the District of Columbia. In the case, Whitakeret al v. Thompson et al, the court determined FDA could not suppress thehealth claim on first amendment grounds; FDA appealed the decision, but withdrewits appeal March 28.
The claim reads: "Consumption of antioxidant vitamins mayreduce the risk of certain kinds of cancer." As ordered by the court, FDAreviewed disclaimer language suggested by the court and submitted by otherparties. FDA offered three disclaimers to run with the claim.
FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.
Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.
Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive.
In the notice to Emord, Christine L. Taylor, Ph.D., director ofthe Office of Nutritional Products, Labeling and Dietary Supplements at FDA'sCenter for Food Safety and Applied Nutrition (CFSAN), said the agency wouldexercise enforcement discretion with respect to antioxidant dietary supplementscontaining vitamin E and/or vitamin C that meet two criteria: The products mustuse one of the FDA disclaimers and recommended intake must not exceed theTolerable Upper Intake Level (established by the Institute of Medicine) of 2,000mg/d of vitamin C and 1,000 mg/d of supplemental alpha-tocopherol.
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