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FDA Adds Homeopathic Enforcement Details, Subtracts Compliance Policy Guide

 
• By Malcolm Spicer

Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.

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The US homeopathic drug industry leaves too much to risk, says the Food and Drug Administration in cancelling a policy guide that linked compliance to industry standards rather than FDA approval and imposing a risk-based enforcement approach.

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