Reconsidering Supplement Claims for Pregnancy – Brief Article
Dietary supplement manufacturers should not make any pregnancy-related product claims based on FDA’s recent structure/function rule until the agency considers recently-raised concerns, FDA has advised.
The rule, published in the Jan. 6, 2000, Federal Register, was written to clarify the types of claims that are considered to relate to the “structure or function” of the body and so can be made without prior review by FDA. Claims that a product diagnoses, treats, prevents, cures, or mitigates diseases (“disease claims”) do require prior FDA authorization.
The rule stated that certain conditions associated with pregnancy are diseases if they are recognizable to consumers or health professionals as abnormal, but that ordinary morning sickness associated with pregnancy, for example, does not cause significant or permanent harm and is not a disease.
FDA plans to give further guidance on these claims, but only after fully reviewing the pregnancy-related safety concerns, issuing a Federal Register notice describing the issues, and evaluating the results of a public meeting on the topic, which was held March 30.
FDA urges all pregnant women to consult their health-care providers before taking any dietary supplements or medication.
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