What is homeopathy?
Homeopathy is an alternative medical practice that was developed in the late 1700s. Homeopathy is generally based on two main principles:
- that a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a principle known as “like-cures-like”; and
- the more diluted the substance, the more potent it is, which is known as the “law of infinitesimals.”
Historically, homeopathic products have been identified through “provings,” in which substances are administered to healthy volunteers in concentrations that cause symptoms. Symptoms experienced by volunteers are recorded to indicate possible therapeutic uses for the substances. In other words, if a substance causes a particular symptom, individuals experiencing that symptom would be treated with a diluted solution made from that substance.
What are homeopathic products and how can you tell you are taking one?
There are no FDA-approved products labeled as homeopathic; this means that any product labeled as homeopathic is being marketed in the U.S. without FDA evaluation for safety or effectiveness. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products, and are sold online and in major retail stores.
Products labeled as homeopathic can contain a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals.
Products labeled as homeopathic generally include:
- The word “Homeopathic”
- The ingredients listed in terms of dilution, e.g. 1X, 6X, 2C
Is FDA concerned about the safety of homeopathic products?
While products labeled as homeopathic are generally labeled as highly diluted, some of these products have been found to contain measurable amounts of active ingredients and therefore could cause significant patient harm. Additionally, FDA has tested products that were improperly manufactured, which can cause incorrect dilutions and increase the potential for contamination. Further, some products labeled as homeopathic are marketed to treat serious diseases or conditions. Examples of FDA’s concerns, include:
- FDA warns consumers about homeopathic teething products
- FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic
- Information on Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size
- Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin
What should consumers know about homeopathic products?
Products labeled as homeopathic and currently marketed in the U.S. have not been reviewed by the FDA for safety and effectiveness to diagnose, treat, cure, prevent or mitigate any diseases or conditions. FDA’s evidence-based drug reviews play an essential role in ensuring that drugs are made with quality manufacturing processes, and are safe and effective for their intended uses. Products that have not been evaluated for safety and effectiveness may harm consumers who choose to treat serious diseases or conditions with such products, and consumers may be foregoing treatment with a medical product that has been scientifically proven to be safe and effective.
FDA recommends consumers talk to their doctor or health care professional about safe and effective treatments for their disease or condition.
How are homeopathic products regulated?
Under the Federal Food, Drug, and Cosmetic Act, homeopathic drug products are subject to the same requirements related to approval, adulteration, and misbranding. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the enforcement policies in FDA’s Compliance Policy Guide (CPG) 400.400 since 1988.
This industry has experienced expansive growth since the issuance of the CPG, which has compounded FDA’s concerns about safety of some of the products. FDA held a public hearing in April 2015 to obtain input from stakeholders about the current use of products labeled as homeopathic and the agency’s regulatory framework for such products. FDA also sought broad public input on its enforcement policies related to products labeled as homeopathic, to better protect the public health, and received more than 9,000 comments to the docket.
Since homeopathic drug products have not been approved by FDA for any use, they may not meet modern standards for safety, effectiveness, and quality. FDA has determined that it is in the best interest of public health to issue a new draft guidance that proposes a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without FDA approval.
FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that pose the greatest risk to patients. Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers. FDA intends to focus its enforcement authorities on the following kinds of products:
- with reported safety concerns;
- that contain or claim to contain ingredients associated with potentially significant safety concerns, such as controlled substances;
- with routes of administration other than oral or topical, e.g. for use as an injection or taken nasally;
- that claim to treat or prevent serious and/or life-threatening diseases and conditions, such as cancer;
- marketed to vulnerable populations, including children, pregnant women and the elderly; or
- that do not meet regulatory standards of quality, strength, or purity as required under the law.
Is FDA going to remove homeopathic products from the market?
FDA’s top concern is patient safety. FDA’s draft guidance states that it is intended to provide notice that any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time. FDA intends to prioritize its enforcement and regulatory actions against products that pose the greatest risks to patients as described above. However, the agency recognizes that many homeopathic products will likely fall outside the risk-based categories described in the guidance and remain available to consumers.