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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