The agency defines these products as: "made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons. 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. In addition, some products may be labeled as homeopathic that do not conform to traditional homeopathic principles."
The agency has revised the2017 draft guidanceto provide further information around their risk-based enforcement approach to drug products labeled as homeopathic, and is asking for public input on the revised draft. The guidance details a policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health based on ingredient, target population, and quality issues. Before finalizing the guidance, the agency will consider the new feedback, the feedback submitted on the original draft guidance, and information from a 2015 public hearing on the current use of homeopathic drug products.
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Second, the agency is withdrawing the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” The statement says that since the guide was issued in 1988, FDA has encountered “multiple situations in which homeopathic drug products posed a significant risk to patients, even though the products, as labeled, appeared to meet the conditions described in CPG 400.400.” The guide also doesn’t fit with the agency’s risk-based approach to enforcement action generally.The statement concludes: “The FDA is committed to a risk-based approach to homeopathic drug products, and we’ll continute taking appropriate regulatory and enforcement actions when we believe patients are being put at risk.” The agency encourages healthcare professionals and consumers to report adverse events or quality problems to FDA’s MedWatch Adverse Event Reporting program.
