FTC Staff Comment: FDA Should Reevaluate Its Current Regulatory Framework for Homeopathic Products

"The staff of the Federal Trade Commission has recommended that the U.S. Food and Drug Administrationreconsider the framework it uses to regulate homeopathic medications because it may appear to conflict with the FTC’s advertising substantiation doctrine in ways that could harm consumers and cause confusion for advertisers.

In a comment submitted to the FDA, the FTC staff states that the FDA should consider amending or repealing its framework for homeopathic medications. The comment was submitted in response to an FDA request for public comment in connection with an April 2015 FDA hearing on this issue.

The staff comment notes that the FDA’s regulatory framework for homeopathic drugs, set forth in a 1988 Compliance Policy Guide, does not require that over-the-counter (OTC) homeopathic drugs be approved by FDA as safe and effective if they satisfy certain conditions, including that the product’s label contains an indication for use. Yet the policy guide does not require sellers to have competent and reliable scientific evidence to support the indication for use..."
Homeopathic products