Homeopathic remedies and their regulation in the United States

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Use of homeopathic remedies in the United States

According to the 2007 National Health Interview Survey, which included a comprehensive survey of complementary and alternative medicine (CAM) use by Americans, an estimated 3.9 million U.S. adults and approximately 900,000 children used homeopathic remedies in the previous year.

People use homeopathy for a range of health concerns, from wellness and prevention, to the treatment of diseases and conditions such as allergies, asthma, chronic fatigue syndrome, depression, digestive disorders, ear infections, headaches, and skin rashes.

Regulation of Homeopathic Treatments

Homeopathic remedies are prepared according to the guidelines of the Homeopathic Pharmacopeia of the United States (HPUS), which was written into law in the Federal Food, Drug, and Cosmetic Act in 1938. Homeopathic remedies are regulated in the same manner as nonprescription, over-the-counter (OTC) drugs. However, because homeopathic products contain little or no active ingredients, they do not have to undergo the same safety and efficacy testing as prescription and new OTC drugs.

The U.S. Food and Drug Administration (FDA) does require that homeopathic remedies meet certain legal standards for strength, purity, and packaging. The labels on the remedies must include at least one major indication (i.e., medical problem to be treated), a list of ingredients, the dilution, and safety instructions. In addition, if a homeopathic remedy claims to treat a serious disease such as cancer, it needs to be sold by prescription. Only products for self-limiting conditions (minor health problems like a cold or headache that go away on their own) can be sold without a prescription.