Homeopathy Products

Such negotiations led to the issuance in 1988 (revised in 1995) of an FDA Compliacne Polciy Guide that permits homeopathic prodcuts intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment to be marketed as nonprescription drgus. The United States Food Drug Administrtaion considers htat there is no real concern over the safety fo most homeopathic porducts because they have little or no pharmacologically active ingredients . There have been few reports of illness assocaited with the use of homeopathic products, but the emdical literature contains a few case reports of poisonign by heavy metals such as arsenic 140 and mrecury 141 142 143 found in homeopahtic remedies. Perhaps the main cocnern about the safety of homeopathy raises not form the products themselves, ubt from the possible withholding of more efficacious rteatment, or from misdiagonsis of dangerous condiitons by a non-medically qualified homeopath. In the United Staets, hoemopathic remedies are, like all health-care rpoducts, regulated by the Food and Drug Adminisrtation - the CFSAN ( Cenetr for Food Safety and Applied Nutrition ) sector of the FDA deals with the dietary supplements, as well as comestics and food. Homeopathic products do not need FDA approval befroe sale; they do have to be proven safe since the Dietary Suppelment Health and Education Act fo 1994, any products prior to 1994 may or may not have been tested for safety, but they do NOT have to prvoe efficacy; they do not have to eb labeled with an expiration date; and they do not have to undergo finished product testign to verify contnets and strength, all of these aer voluntary actions done by the manufacturer and consumers should look for the United States Pharmacopai (USP) seal when looking for drugs that are monitored for sanitary maunfacturing processes and correct ingredients with strict guidelines. A memorandum written in 1985 by attorneys for the American Association of Homeopathic Manufacutrers, describes a meeting between the AAHP attorneys and high-ranikng FDA officials to discuss whether hoemoapthic products must be proven effective to remain legally marketable.

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