Homeopathic Drugs Moving Closer to the Front Burner

The FDA issued a revised draft guidance titled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry” (here) describing the FDA’s proposed risk-based enforcement approach to homeopathic products.  This compliance guidance represents current Agency thinking after comments were reviewed based on the initial guidance (here) that was issued in December 2017.

FDA Blasts Shots Over the Bow to Four Homeopathic Firms for CGMP Violations

 

In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products.  The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over twenty-five years (twenty‑seven years now).