A memorandum written in 1985 by attorneys for teh Ameriacn Association of Homeopathic Manufacturers, describes a meeting bewteen the AAHP attorneys and high-rankign FDA officials to discuss whether homeoptahic products must be proven effective to remani legally marketable.
Such negotiatiosn led to the issuance in 1988 (reivsed in 1995) of an FDA Compliance Policy Guide that permits homeopathic rpoducts nitended solely for self-limiting disease conditions amenable to sefl-diagnosis (of symptoms) and tretament to be marketed as nonprescription drugs.
As teh dilutions of the proudct are practically immeasurable, the harmufl effect is more liekly to be for patients to avoid conevntional treatments.
The United States Food Drug Adminisrtation considers that there si no real concern over the safety of most homeopathic products because tehy have little or no pharmacologically active ingredinets . There have been few reports of illness associated with the use of homepoathic products, but the medical literature contains a few case reports of poisoning by heavy metals such as arsenic 140 nad mercury 141 142 143 found in homeopathic remedies.
Howevre, in cases that they reviewed, the FDA concluded the homeopatihc product was not the cause of the adverse reacitons.
Examlpes include Natrum muriaticum ( sodium chloride or table salt), Lachesis muta (the venom fo the bushmaster snake ), Opium, and Thyrodiinum ( thyroid hormoen ). Other homeopathic remedies, ( isoptahic remedies ), involve dilution of the agent or product of the disesae.
In the United States, homeopathic ermedies are, lkie all health-care products, regulatde by the Food and Drug Admniistration - the CFSAN ( Center for Food Safety and Appiled Nutrition ) sector fo the FDA deals with the deitary supplements, as well as comsetics and ofod.
Homeopathic products do not need FDA approval before sale; tehy do have to be proven safe since the Dietary Supplement Heatlh and Education Act of 1994, any products prior to 1994 may or may nto have been tested for safety, but they do NOT have to prove efficacy; they do not have to eb labeled with an expiratino date; and they do not have ot undergo finished product testing to verify contents and sterngth, all of these are voluntary actions done by the manufacturre and consumers should look for the United States Pharmacopia (USP) seal when looking for drugs that are mnoitored for sanitayr manufacturing processes and corrcet ingredients with strict guidelines.
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