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Homeopathy Fact Sheet - Page 4

FDA Regulations on Homeopathy

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How does the U.S. Food and Drug Administration (FDA) regulate homeopathic remedies?

Because of their long use in the United States, the U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be regulated by the FDA in the same manner as nonprescription, over-the-counter (OTC) drugs, which means that they can be purchased without a physician's prescription. Today, although conventional prescription drugs and new OTC drugs must undergo thorough testing and review by the FDA for safety and effectiveness before they can be sold, this requirement does not apply to homeopathic remedies.

Remedies are required to meet certain legal standards for strength, quality, purity, and packaging. In 1988, the FDA required that all homeopathic remedies list the indications for their use (i.e., the medical problems to be treated) on the label. The FDA also requires the label to list ingredients, dilutions, and instructions for safe use.

The guidelines for homeopathic remedies are found in an official guide, the Homeopathic Pharmacopoeia of the United States, which is authored by a nongovernmental, nonprofit organization of industry representatives and homeopathic experts.24 The Pharmacopoeia also includes provisions for testing new remedies and verifying their clinical effectiveness. Remedies on the market before 1962 have been accepted into the Homeopathic Pharmacopoeia of the United States based on historical use, rather than scientific evidence from clinical trials.

Have any side effects or complications been reported from the use of homeopathy?

The FDA has learned of a few reports of illness associated with the use of homeopathic remedies. However, the FDA reviewed these reports and decided that the remedies were not likely to be the cause, because of the high dilutions.

Here is some general information that has been reported about risks and side effects in homeopathy:
  • Homeopathic medicines in high dilutions, taken under the supervision of trained professionals, are considered safe and unlikely to cause severe adverse reactions.

  • Some patients report feeling worse for a brief period of time after starting homeopathic remedies. Homeopaths interpret this as the body temporarily stimulating symptoms while it makes an effort to restore health.

  • Liquid homeopathic remedies can contain alcohol and are permitted to have higher levels of alcohol than conventional drugs for adults. This may be of concern to some consumers. However, no adverse effects from the alcohol levels have been reported either to the FDA or in the scientific literature.

  • Homeopathic remedies are not known to interfere with conventional drugs; however, if you are considering using homeopathic remedies, you should discuss this with your health care provider. If you have more than one provider, discuss it with each one.
As with all medicinal products, a person taking a homeopathic remedy is best advised to:
  • Contact his health care provider if his symptoms continue unimproved for more than 5 days.

  • Keep the remedy out of the reach of children.

  • Consult a health care provider before using the product if the user is a woman who is pregnant or nursing a baby.
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