The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives to approved prescription and nonprescription products and are widely available in the marketplace.
Homeopathic products, however, are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. The FDA uses a risk-based approach to monitor these products and to evaluate reports of adverse effects.
Homeopathy is an alternative medical practice developed in the late 1700s that is based on the principle that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, also known as “like cures like.”
Homeopathic drug products are 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.
As the homeopathy industry continues to grow at a rapid pace, the FDA wants to clarify for both consumers and the industry how they assess the potential safety risks of these products.
The FDA is taking two new steps toward clarifying this approach.
1. FDA has revised the 2017 draft guidance to provide further information around their approach and are asking for public input on the revised draft. The draft guidance details a risk-based enforcement policy prioritizing certain categories of homeopathic products that could pose a higher risk to public health, including products with particular ingredients and routes of administration, products for vulnerable populations and products with significant quality issues.
2. The FDA is withdrawing the Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” Risk is an important driver of the FDA’s regulatory and enforcement actions for all drug products, including homeopathic drug products. Since the issuance of CPG 400.400 in 1988, the 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 FDA has issued warning letters to companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations and various other violations. So far in 2019, they have issued more than 10 warning letters to companies for violations concerning homeopathic products.
