Source: http://www.chpa-info.org/scienceregulatory/HomeopathicMeds.aspx
Timestamp: 2013-05-19 00:52:27
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Matched Legal Cases: ['§201', '§210', '§211', '§210', '§201', '§300', '§210', '§201', '§111']

FAQs About Homeopathic Medicines
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What is homeopathy? What are homeopathic products? What are homeopathic products used to treat?Is homeopathy safe? How are homeopathic products regulated? What is the difference between homeopathic medicines and dietary supplements? What is homeopathy? 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: 1) pharmacologically-active agents, when administered at higher dosages to healthy individuals, produce a characteristic set of symptoms; 2) individuals who are ill (due to any number of etiologies) also exhibit characteristic symptoms, produced by the body in an effort to heal itself; 3) 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.
What are homeopathic products? Homeopathic products are derived from botanical, mineral or biological substances and are classified as either over-the-counter (OTC) or prescription drug products. 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.
What are homeopathic products used to treat?
Over-the-counter (nonprescription) 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 (available at www.amcofh.org/Research/Research_References.html) back to the top
Is homeopathy safe? Homeopathic medicines contain very small amounts of active ingredient 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 over-the-counter 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. back to the top
How are homeopathic products regulated? 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 an 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 Review2. 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 by to be safe, effective and not misbranded for its intended use.
Regulation of Homeopathic Drugs, Conventional (Allopathic) Drugs, and Dietary Supplements*
Medication Type Governing Law Premarket Approval GMPs Labeling
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
What is the difference between homeopathic medicines 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.