AAHP is preparing comments to “FDA Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry.” Initially published in December 2017, the guidance was revised and republished in October 2019. FDA has now extended the comment period to March 23.
AAHP victoriously requested that key elements of the 1988 guidance be incorporated into the revised draft guidance. The revised draft now states: “…we define a ‘homeopathic drug product’ as a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).”
To further minimizes the risk of rogue products entering the market that may endanger consumers and tarnish the industry’s reputation, AAHP will continue to request more text from the 1988 guidance be incorporated. Such text will also offer manufacturers, retailers, and regulators clarity and stability.
As is, the draft guidance will not affect the vast majority of products that are manufactured and labeled according to standards. Under the new guidance, the legal status of our products remains the same as it has been since 1962. AAHP addresses concerns by other groups in the homeopathic community in its Dec. 17 explanation of legal terms.
Reach out to us via email with suggestions and comments we may incorporate into our response. Together we can present the solid, unified voice and interests of the homeopathic manufacturing community.