The FDA Reviews Homeopathy Policies and Guidelines

Homeopathy image (1)At public meetings in April, the U.S. Food and Drug Administration (FDA) began evaluating whether current procedures to ensure the safety of homeopathic products are too lax and whether the FDA should start regulating homeopathic remedies more closely. Homeopathy is an area of complementary and alternative medicine that has been highly controversial and heatedly debated because a number of its key concepts do not follow the laws of science.

  • It is debated how something that causes illness might also cure it.
  • It has been questioned whether a remedy with a very tiny amount (perhaps not even one molecule) of active ingredient could have a biological effect, beneficial or otherwise.

Currently the FDA regulates homeopathic remedies only in the sense that remedies are required to meet certain legal standards for strength, quality, purity, and packaging. The FDA requires that all homeopathic remedies list the indications for their use on the label. The FDA also requires the label to list ingredients, dilutions, and instructions for safe use.

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

As with all medicinal products, a person taking a homeopathic remedy is best advised to:

  • Contact his/her 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.

The results of individual, controlled clinical trials of homeopathy have been contradictory. In some trials, homeopathy appeared to be no more helpful than a placebo; in other studies, some benefits were seen that the researchers believed were greater than one would expect from a placebo.

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