
© Photodisc/Thinkstock

© Photodisc/Thinkstock
How much do we know about homeopathic products?
What do we know about the effectiveness of homeopathy?
What do we know about the safety of homeopathic products?
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:
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.
According to the 2012 National Health Interview Survey (NHIS), 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:
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.
Homeopathy is a controversial topic. A number of its key concepts don’t agree with fundamental scientific concepts. For example, it’s not possible to explain in scientific terms how a product containing little or no active ingredient can have any effect. This, in turn, creates major challenges to rigorous clinical investigation of such products. For example, researchers cannot confirm that an extremely dilute mixture contains what is listed on the label; nor have they been able to develop objective measures that show effects of extremely dilute products in the human body.
Another research challenge is that homeopathic treatments are highly individualized, and there is no uniform prescribing standard for homeopathic practitioners. There are hundreds of different homeopathic remedies, which can be prescribed in a variety of different dilutions for thousands of symptoms.
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.
Regulation of Homeopathic Products
Homeopathic products are regulated as drugs under the Federal Food, Drug and Cosmetic Act (FDCA). However, under current Agency policy, the FDA does not evaluate them for safety or effectiveness. FDA enforcement policies for homeopathic drugs are described in the FDA’s Compliance Policy Guide entitled Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400).
The FDA allows homeopathic products that meet certain conditions to be marketed without agency preapproval. For example, homeopathic products must contain active ingredients that are listed in the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS lists active ingredients that may be legally included in homeopathic products and standards for strength, quality, and purity of that ingredient. In addition, the FDA requires that the label on the product, outer container, or accompanying leaflet include at least one major indication (i.e., medical problem to be treated), a list of ingredients, the number of times the active ingredient was diluted, and directions for use. If a homeopathic product claims to treat a serious disease such as cancer, it must be sold by prescription. Only products for minor health problems, like a cold or headache, that go away on their own, can be sold without a prescription.
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.
The NCCIH Clearinghouse provides information on NCCIH and complementary and integrative health approaches, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
A service of the National Library of Medicine, PubMed® contains publication information and (in most cases) brief summaries of articles from scientific and medical journals. For guidance from NCCIH on using PubMed, see How To Find Information About Complementary Health Approaches on PubMed.
The FDA oversees the safety of many products, such as foods, medicines, dietary supplements, medical devices, and cosmetics. See its Web page on Dietary Supplements.
The FTC is the Federal agency charged with protecting the public against unfair and deceptive business practices. A key area of its work is the regulation of advertising (except for prescription drugs and medical devices).
The National Institutes of Health (NIH) has created a website, NIH Clinical Research Trials and You, to help people learn about clinical trials, why they matter, and how to participate. The site includes questions and answers about clinical trials, guidance on how to find clinical trials through ClinicalTrials.gov and other resources, and stories about the personal experiences of clinical trial participants. Clinical trials are necessary to find better ways to prevent, diagnose, and treat diseases.
RePORTER is a database of information on federally funded scientific and medical research projects being conducted at research institutions.
To provide resources that help answer health questions, MedlinePlus (a service of the National Library of Medicine) brings together authoritative information from the National Institutes of Health as well as other Government agencies and health-related organizations.
NCCIH thanks David Shurtleff, Ph.D., NCCIH, for his review of the 2018 update of this publication.
This publication is not copyrighted and is in the public domain. Duplication is encouraged.
* Note: PDF files require a viewer such as the free Adobe Reader.
This page last modified August 01, 2018