In 2015, the Food and Drug Administration held public hearings to evaluate its homeopathic regulation. They released a draft of guidance for FDA staff and the industry in December 2017. These are the highlights.
The draft, entitled “Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry,” contains non-binding recommendations. However, once finalized, this will be the document the FDA consults concerning homeopathic matters. It will replace “Conditions Under Which Homeopathic Drugs May be Marketed,” the document that previously kept homeopathic remedies out of the formal FDA approval process.Some highlights • The conditions that existed in 1938 when the FDA first addressed this topic have changed significantly—instead of being prepared by trained homeopaths for their own patients, many homeopathic remedies are now being mass-produced and sold over the counter, sometimes with little concern for safety or effectiveness • Some drugs products that are labeled homeopathic and marketed without FDA approval are considered a risk to public health—these will be the FDA’s first focus • The same regulatory requirements apply to homeopathic drugs and non-homeopathic drugs • The FDA will maintain an evidence-based system of review for new drugs • Human drug products—including homeopathic remedies—will be regulated with a risk-based approach • The FDA will take a closer look in areas of greatest risk, which include products where – Safety concerns have already been documented by professionals and/or the public – A controlled substance or a pathogen is included in the drug – Harm occurs when the multiple components in the remedy are mixed – Ingredients may be toxic if not properly controlled in the dilution or manufacturing process – Administration is neither topical or oral—injections and ophthalmic drops are especially dangerous due to a higher rate of absorption and risk of contamination – Life-threatening illnesses and diseases are involved – The intended audience is children, pregnant women, or the elderly – Current standards for safe manufacturing have been ignored Recommended reading Although the recordings of the original FDA hearings are no longer available online, you can read what I presented with my colleagues Michelle Dossett, David Riley, and Ronald Whitmont of the American Institute of Homeopathy at http://www.fda.gov/downloads/Drugs/NewsEvents/UCM443225.pdf.