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FDA health claims reg

This article was originally published in The Tan Sheet

Executive Summary

"Disease or health-related condition" definition contained in health claims regulations would be revised under FDA's April 29 proposed rule on dietary supplement structure/function claims. The terms would be changed to "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system (or combination thereof) of the body that is manifested by a characteristic set of one or more signs or symptoms...or a state of health leading to such deviation, impairment, or interruption; except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included." The current definition has proven "too narrow" in limiting itself to "serious or long-term diseases and...excluding certain conditions that are medically understood to be diseases, such as headaches," FDA says. Revision also would make the definition consistent with the proposed new definition of "disease" for regulating structure/function claims. Comments are due Aug. 27...
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