Source: https://www.chpa.org/Homeopathic.aspx
Timestamp: 2019-04-18 21:13:49
Document Index: 704115220

Matched Legal Cases: ['§201', '§210', '§211', '§210', '§201', '§300', '§210', '§201', '§111']

Regulation > Regulation of OTC Medicines > FAQs About Homeopathic Medicine
What is the difference between homeopathic medicines and dietary supplements?
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:
pharmacologically-active agents, when administered at higher dosages to healthy individuals, produce a characteristic set of symptoms;
individuals who are ill (due to any number of etiologies) also exhibit characteristic symptoms, produced by the body in an effort to heal itself; and
those pharmacologically-active agents producing a characteristic set of symptoms at a higher dose can alleviate or cure similar symptoms when administered at a much lower dose. For example, red onion (Allium cepa) exposure produces runny and watery nose and eyes. Homeopathic preparations of Allium cepa are used to relieve these same symptoms associated with a cold or hay fever.
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.
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
1American Medical College of Homeopathy, Research References
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.
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
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.