FTC Staff Comment Before the Food and Drug Administration Regarding the Current Use of Human Drug and Biological Products Labeled As Homeopathic, and the FDA's Regulatory Framework For Such Products

Matter Number:

P114505

Docket Number:

80 Fed. Reg. 16327 (Mar. 27, 2015)

Summary

FTC staff has recommended that the U.S. Food and Drug Administration (FDA) reconsider 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. The comment discusses the mistaken belief by some advertisers that homeopathic products that are in compliance with the FDA policy guide do not have to comply with FTC advertising substantiation requirements. The comment also raises the concern that the FDA’s current framework may lead some companies to skirt more stringent regulations for OTC drug products or dietary supplements simply by labeling them as homeopathic or combining homeopathic ingredients with dietary supplements or other non-homeopathic ingredients.