FDA Tweaks its Approach to Homeopathic Products
The US Food and Drug Administration (FDA) on Thursday announced two steps to revamp its approach to regulating homeopathic products, including revising a draft guidance and withdrawing a more than 30-year-old compliance guide on homeopathic products.The announcement comes after several high-profile cases of homeopathic products harming or even killing patients, in some cases due to the products containing higher levels of toxic substances than claimed on the product’s labeling.
“These products have the potential to cause significant and even permanent harm if they are poorly manufactured, since that could lead to contaminated products or products that have potentially toxic ingredients at higher levels than are labeled and/or safe, or if they are marketed as substitute treatments for serious or life-threatening diseases and conditions, or to vulnerable populations,” Acting FDA Commissioner Ned Sharpless and Center for Drug Evaluation and Research Janet Woodcock said in a joint statement.
The draft guidance, first issued in 2017, sets out a risk-based enforcement policy for homeopathic products. FDA says it has revised the draft guidance in response to comments to add a definition of homeopathic drug products and new information about the safety issues that led to the guidance’s development.
FDA is also withdrawing its 1988 Compliance Policy Guide (CPG) 400.400 Conditions Under Which Homeopathic Drugs May be Marketed.
“Since the issuance of CPG 400.400, the agency has encountered multiple situations in which homeopathic drug products posed a significant risk to patients. There is a broad misconception that all homeopathic products are highly diluted and generally composed of ‘natural’ ingredients, and that they are therefore incapable of causing harm,” FDA writes.
According to FDA, CPG 400.400 did not address critical factors related to drug safety, including “the product’s intended use, dosage form, frequency of use, manufacturing quality, intended patient population, and the quantity and combination of ingredients.”
FDA, Revised Draft Guidance, Draft Guidance Federal Register Notice, Compliance Policy Guide Federal Register Notice,