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.

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

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 alerts consumers of Kadesh Incorporation’s voluntary nationwide recall of Puriton Eye Relief Drops due to non-sterile production conditions
• FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination
• FDA alerts consumers and pet owners of Silver Star Brand’s voluntary recall of homeopathic drug products
• FDA alerts consumers of HelloLife’s voluntary recall of Neuroveen, Respitrol, Thyroveev and Compulsin
• FDA alerts consumers of Beaumont Bio Med’s voluntary recall of all water- and alcohol-based products
• FDA alerts consumers of BioLyte Laboratories voluntary recall of NeoRelief
• FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
• 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

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.

Under the Federal Food, Drug, and Cosmetic Act, homeopathic products are subject to the same requirements related to approval, adulteration and misbranding as other drug products. There are currently no homeopathic products approved by FDA.

In 1988, the FDA issued Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” which described the agency’s enforcement policy. On October 24, 2019, FDA withdrew CPG 400.400 because it is inconsistent with our risk-based approach to regulatory and enforcement action.  FDA also issued a revised draft guidance: Drug Products Labeled as Homeopathic, for public comment.  Since homeopathic drug products have not been approved by FDA for any use, they may not meet modern standards for safety, effectiveness, and quality.

This revised draft guidance proposes a comprehensive, risk-based enforcement approach to homeopathic products marketed without FDA approval.

FDA’s proposed approach prioritizes regulatory and enforcement actions involving unapproved homeopathic products that pose the greatest risk to patients. Many homeopathic products will likely fall outside the risk-based categories described in the revised draft guidance. FDA intends to focus its enforcement authorities on the following kinds of products:

• with reported safety concerns;
• that contain or purport to contain ingredients associated with potentially significant safety concerns;
• for 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
• with significant quality issues.

What's the Bottom Line?

What do we know about the effectiveness of homeopathy?

• There’s little evidence to support homeopathy as an effective treatment for any specific health condition.

What do we know about the safety of homeopathic products?

• Some products labeled as homeopathic may contain substantial amounts of active ingredients and could cause side effects and drug interactions.

What Is Homeopathy?

Homeopathy, also known as homeopathic medicine, is a medical system that was developed in Germany more than 200 years ago. It’s based on two unconventional theories:

• “Like cures like”—the notion that a disease can be cured by a substance that produces similar symptoms in healthy people.
• “Law of minimum dose”—the notion that the lower the dose of the medication, the greater its effectiveness. Many homeopathic products are so diluted that no molecules of the original substance remain.

Homeopathic products come from plants (such as red onion, arnica [mountain herb], poison ivy, belladonna [deadly nightshade], and stinging nettle), minerals (such as white arsenic), or animals (such as crushed whole bees). Homeopathic products are often made as sugar pellets to be placed under the tongue; they may also be in other forms, such as ointments, gels, drops, creams, and tablets. Treatments are “individualized” or tailored to each person—it’s common for different people with the same condition to receive different treatments. Homeopathy uses a different diagnostic system for assigning treatments to individuals and recognizes clinical patterns of signs and symptoms that are different from those of conventional medicine.

Use in the United States

According to the 2012 National Health Interview Survey, which included a comprehensive survey on the use of complementary health approaches by Americans, an estimated 5 million adults and 1 million children used homeopathy in the previous year. The 2012 survey also reported that although about 1.8 percent of children used homeopathy, only 0.2 percent of children went to a homeopathic practitioner. A 2016 analysis of data from this survey suggests that most adults who use homeopathic products self-prescribe them for colds and musculoskeletal pain.

In 2016, the U.S. Federal Trade Commission (FTC) announced it will hold efficacy and safety claims for over-the-counter homeopathic drugs to the same standard as those for other products making similar claims. It further stated that companies must have the competent and reliable scientific evidence the FTC requires for health-related claims, including claims that a product can treat specific conditions.

In December 2017, the U.S. Food and Drug Administration (FDA) proposed a new risk-based enforcement approach to homeopathic products. The proposed approach would call for more careful scrutiny of products with the greatest potential for risk, including:

• Those with reported safety concerns.
• Those that are not taken by mouth or rubbed on skin.
• Those for vulnerable populations.
• Those that do not meet legal standards for quality, strength, or purity.
• Those intended to be used for preventing or treating serious and/or life-threatening diseases and conditions.

What the Science Says About the Effectiveness of Homeopathy

A 2015 comprehensive assessment of evidence by the Australian government’s National Health and Medical Research Council concluded that there is no reliable evidence that homeopathy is effective for any health condition. However, it is important to note that studies included in the assessment of evidence were required to meet a number of rigorous criteria (e.g., having a sample size of more than 150 participants, the highest rating of methodological quality, and other measures). In total, 57 systematic reviews that contained 176 individual studies were included in this assessment. A new review of evidence by the Australian government is currently underway.

Homeopathy is a controversial topic. A number of the key concepts underlying the theory of homeopathy are not consistent with fundamental scientific concepts as we understand them. For example, homeopathic preparations can be so dilute that a substance considered to be the “active ingredient” becomes unmeasurable, which creates major challenges to the rigorous investigation of such products. However, recent research has begun to examine physical attributes of these preparations to determine if it will be possible to characterize them in the future.

No Evidence To Support Homeopathic Immunizations

Certain homeopathic products (called “nosodes” or “homeopathic immunizations”) have been promoted by some as substitutes for conventional immunizations, but the U.S. Centers for Disease Control and Prevention says there’s no credible scientific evidence to support such claims. The National Center for Complementary and Integrative Health (NCCIH) supports the Centers for Disease Control and Prevention’s recommendations for immunizations/vaccinations. To learn more about vaccines visit www.vaccines.gov.

What the Science Says About Safety and Side Effects of Homeopathy

• While many homeopathic products are highly diluted, some products sold or labeled as homeopathic may not be; they can contain substantial amounts of active ingredients, which may cause side effects or drug interactions. Negative health effects from homeopathic products of this type have been reported.
• A 2012 systematic review of case reports and case series concluded that using certain homeopathic products (such as those containing heavy metals like mercury or iron that are not highly diluted) or replacing an effective conventional treatment with an ineffective homeopathic one can cause adverse effects, some of which may be serious.
• Liquid homeopathic products may contain alcohol. The FDA allows higher levels of alcohol in these than in conventional drugs.
• Homeopathic practitioners expect some of their patients to experience “homeopathic aggravation” (a temporary worsening of existing symptoms after taking a homeopathic prescription). Researchers have not found much evidence of this reaction in clinical studies; however, research on homeopathic aggravations is scarce. Always discuss changes in your symptoms with your health care provider.
• The FDA has warned consumers about different products labeled as homeopathic. For example, in 2017, it alerted consumers that some homeopathic teething tablets had excessive amounts of the toxic substance belladonna; in 2015, it warned consumers not to rely on over-the-counter asthma products labeled as homeopathic, because they are not evaluated by the FDA for safety and effectiveness.

Regulation of Homeopathic Products

Homeopathic products are regulated as drugs under the Federal Food, Drug, and Cosmetic Act and are subject to the same requirements related to approval, adulteration, and misbranding as other drug products. There are currently no homeopathic products approved by the FDA.

In 1988, the FDA issued Compliance Policy Guide (CPG) 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” which described the agency’s enforcement policy. In 2019, the FDA withdrew CPG 400.400 and issued revised draft guidance for public comment. The revised draft guidance proposes a comprehensive, risk-based enforcement approach to homeopathic products marketed without FDA approval.

Licensing

Laws regulating the practice of homeopathy in the United States vary from state to state. Usually, individuals licensed to practice medicine or another health care profession can legally practice homeopathy. In some states, nonlicensed professionals may practice homeopathy.

Arizona, Connecticut, and Nevada are the only states with homeopathic licensing boards for doctors of medicine (holders of M.D. degrees) and doctors of osteopathic medicine (holders of D.O. degrees). In 15 states, a section of the naturopathic medical board examinations is on homeopathy.

More To Consider

• Don’t use homeopathy to replace proven conventional care or postpone seeing a health care provider about a medical problem.
• If you are considering using a homeopathic product, bring it with you when you visit your health care provider. The provider may be able to help you determine whether the product might pose a risk of side effects or drug interactions.
• Follow the recommended conventional immunization schedules for children and adults. Don’t use homeopathic products as a substitute for conventional immunizations.
• Women who are pregnant or nursing, or people who are thinking of using homeopathy to treat a child, should consult their (or the child’s) health care providers.
• Take charge of your health—talk with your health care providers about any complementary health approaches you use. Together, you can make shared, well-informed decisions.