Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for FDA staff and industry entitled "Drug Products Labeled as Homeopathic." The revised draft guidance, like the original version, describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.