FDA Retreats on Supplements During Pregnancy - Brief Article

0 Comments | Family Practice News, March 15, 2000 | by Joyce Frieden

The Food and Drug Administration has revised a rule that would have allowed manufacturers to sell herbs and other supplements for morning sickness and leg swelling in pregnancy without undergoing safety and efficacy testing.

The rule, which took effect last month, allows supplement makers to claim, without prior FDA review, that their products "affect the structure and function of the body" in a certain way.

But the agency asked manufacturers not to include pregnancy claims after several birth defect experts complained that allowing pregnant women to take these supplements without any review of their safety and effectiveness could put them at risk of being exposed to teratogens.

The rule is based on the Dietary Supplement Health and Education Act of 1994. The FDA said that it plans to review the rule further.