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Dietary supplement allergy claims

This article was originally published in The Tan Sheet

Executive Summary

San Clemente, Calif.-based Metagenics will no longer dispute FDA's contention that the statements "promotes a healthy immune response in people who may be sensitive to environmental substances" and "promotes healthy histamine levels" are disease claims. FDA first flagged four structure/function claims for the allergy supplement Perimine in a March 2003 "courtesy letter." The firm argued allergies do not constitute a disease state because they are not "damage to an organ, part, structure or system of the body such that it does not function properly, or a state of health leading to such dysfunctioning." FDA disagreed, maintaining "an allergic response is, in fact, unambiguously a consequence of damage to a system (the immune system) such that it does not function properly in that it is hypersensitive to allergens." The agency adds that the claims cannot be modified so that they are not disease claims...

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