The U.S. Food and Drug Administration (FDA) has announced a finalized guidance that seeks to clarify how the agency will address unapproved homeopathic medicines. The Dec. 7 guidance and announcement in the federal register are a response to the increase in homeopathic medicines being sold to the public.
In the guidance, the FDA describes its intent to prioritize enforcement and regulatory action against homeopathic drug products that “potentially pose a higher risk to public health.” The agency defined a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions . . . listed for those active ingredients in the Homeopathic Pharmacopeia of the United States.”
The FDA sees these products as within their jurisdiction because, unlike supplements, the FD&C Act definition of a “drug” includes products found in the Homeopathic Pharmacopeia of the United States as well as any supplements to that database. The agency reasons that homeopathic drug products, as defined by the FDA, fall within the jurisdiction of drugs requiring FDA approval. This means that any homeopathic product that is not generally recognized as safe and effective by qualified experts for uses prescribed by the labeling meets the FDA’s definition of a “new drug.”
As for why the FDA is creating new guidance for the enforcement and regulation of homeopathic medicine, the FDA states that “the Agency has encountered multiple situations in which homeopathic drug products posed a significant risk to patients” despite adhering to the letter of the current regulatory practice. Additionally, these products either stood to cause or actually caused significant harm to consumers. Furthermore, the FDA documented “many serious violations of Current Good Manufacturing Practice (CGMP) requirements by some
manufacturers of homeopathic drug products,” leading to significant concerns being raised about the safety of the products manufactured under those inadequate processes.
In the new guidance, the FDA has defined specific categories of homeopathic drugs that posed “higher risks to public health.” Those six categories are:
- Products with reports of injury that, after evaluation, raise potential safety concerns.
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns, including substances containing infectious agents, controlled substances, toxic materials, or ingredients that may interact to create adverse reactions.
- Products intended to be administered by neither the mouth nor the skin including injectable products.
- Products intended to be used for the prevention or treatment of serious or life-threatening diseases or conditions.
- Products intended for vulnerable populations such as immunocompromised individuals, infants, children, the elderly, or pregnant women.
- Products with significant quality issues such as those found to be contaminated with foreign materials or objectionable micro-organisms, or are made in facilities with significant deviations from CGMP.
The FDA hopes that by regulating and enforcing these products, public health and safety will be improved.
