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FDA proposes that all pregnancy-related conditions be treated as disease claims

On February 9, the FDA announced that it would revisit its January 6 ruling on structure/function claims as they relate to pregnancy, after receiving letters of concern from a few medical doctors, newspapers, and the Public Citizen's Health Research Group. The FDA's January ruling allows structure/function claims for a variety of common conditions, including mild pregnancy-related conditions such as morning sickness and leg swelling. Examples of conditions the FDA continues to classify as disease claims include toxemia of pregnancy and hyperemesis gravidarum. In the February 24 Federal Register, the FDA announced that it will accept written comments on this issue until March 30, followed by a public meeting on April 24. Many groups have expressed opposition to the FDA's proposal on pregnancy health claims, citing folic acid as an example of a supplement that is essential for preventing birth defects.

The Tan Sheet, February 14, 2000 and The Federal Register, February 24, 2000.


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