Jan 19, 2022
The practice of homeopathic medicine, or homeopathy, has existed for more than 200 years and is based on the Principle of Similars (Similia Similibus Curentur, loosely translated; “Let likes be cured by likes”). Homeopathy is centered on three complementary aspects:
Homeopathic products are derived from botanical, mineral or biological substances and are classified as either over-the-counter (OTC) or prescription medicines. In contrast to conventional (allopathic) medicines, homeopathic products are believed to be more clinically useful (i.e., effective) when they are diluted, typically with purified water or an alcohol solution.
The potency of homeopathic products is expressed on the product label immediately following the product name and includes a number, followed either by an X or a C. The number refers to how many times the homeopathic medicine was diluted and the X and C indicate the ratio of the dilution (i.e., 1/10 for X and 1/100 for C). Homeopathic OTC products are available in numerous dosage forms including capsules, creams, eye drops, gels, granules, liquids, lozenges, nasal sprays, ointments, pills, tablets, suppositories, and syrups.
OTC homeopathic products are typically indicated for self-limiting, self-diagnosable conditions (e.g., cold symptoms). Numerous journal publications discuss the efficacy and safety of homeopathic medicines in the alleviation of symptoms associated with various etiologies.1
Homeopathic medicines contain very small amounts of active ingredients and as such, are considered safe for use in adults as well as children. Despite the extensive marketing history of most homeopathic medicines, very few side effects have been reported in association with these products. Homeopathic medicines can also be safely used with other OTC and prescription medicines, as well as dietary supplements. As with all other medicines, the user should read the product label carefully prior to taking any homeopathic product and comply with all dosing instructions.
Homeopathic products are classified as drugs under the Food, Drug, and Cosmetic Act. Specific regulatory guidance for the marketing of homeopathic drugs is given in a U.S. FDA Compliance Policy Guide. OTC homeopathic medicines are indicated for self-limiting, self-diagnosable conditions such as cold symptoms, headaches, indigestion. All homeopathic medicines must comply with FDA labeling requirements (21 CFR §201) and be manufactured in accordance with Current Good Manufacturing Practices (21 CFR §210 and §211). Manufacturers of homeopathic products must also register with the FDA and may be subject to FDA inspections. As with all medicines, OTC homeopathic manufacturers must report any serious adverse reactions to FDA.
Prescription homeopathic medicines are exempt from new drug approval requirements and homeopathic medicines available OTC have previously been excluded from the OTC Drug Review.2 Individual homeopathic ingredients marketed for sale in the United States have been reviewed for homeopathic efficacy, toxicology, adverse effects, and clinical use by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) and are listed (monographed) in the Homeopathic Pharmacopoeia of the United States (HPUS). Compliance with the HPUS alone does not establish that a homeopathic medicine has been shown to be safe, effective and not misbranded for its intended use.
The Appendix table below outlines some of the key aspects of drug regulation associated with homeopathic drugs, conventional (allopathic) drugs, and dietary supplements.
Homeopathic medicines are regulated as drugs according to the Food, Drug, and Cosmetic Act. Dietary supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA). OTC homeopathic medicines must have a therapeutic indication (for a self-limiting, self-diagnosable condition) on the product label whereas dietary supplements cannot make claims for the diagnosis, relief, cure, or mitigation of symptoms of a given condition or illness.
|Regulation of Homeopathic Drugs, Conventional (Allopathic Drugs), and Dietary Supplements*|
|Medication Type||Governing Law||Premarket Approval||GMPs||Labeling||Advertising||Indication on Labeling|
|Homeopathic drugs||FDCA||HPCUS monograph||21 CFR §210 & 211||21 CFR §201; FDA Compliance Policy Guide||Nonprescription: FTC; Prescription: FDA||Required|
|Conventional (Allopathic) drugs||FDCA||NDA (21 CFR §300), or OTC Review Monograph||21 CFR §210 & 211||21 CFR §201||Nonprescription: FTC; Prescription: FDA||Required|
|Dietary supplements||DSHEA||No FDA approval, but notification, and manufacturer must have safety information on file||21 CFR §111||DSHEA||FTC||
Structure-function claims only, or health claims under FDA rules
*Adapted from Borneman, JP and Field, RI, Regulation of homeopathic drug products, Am J Health-Syst Pharm 63: 86-91, 2006; GMPs – Good Manufacturing Practices, FDCA – Food, Drug, and Cosmetic Act (1938), HPCUS – Homeopathic Pharmacopoeia Convention of the United States, 21 CFR – Title 21 of the Code of Federal Regulations, FDA – Food and Drug Administration, FTC – Federal Trade Commission, NDA – New Drug Application, DSHEA – Dietary Supplement Health and Education Act (1994)
237 Federal Register 946, May 11, 1972