FDA Weighs Stricter Regulation for Homeopathic Remedies

FDA_logoThe Food and Drug Administration (FDA) is considering whether to increase regulations and oversight for homeopathic products. Hearings were held by FDA in April, followed by a public comment period that ended June 2.

Widely distributed through retail stores and on the Internet, homeopathic products are not regulated as drugs, so they have not been tested for safety or effectiveness. New FDA regulations would change that.

FDA has issued nearly 40 warning letters since 2009 concerning homeopathic products, including one earlier this year specifically for people with asthma not to rely on over-the-counter asthma products labeled as “homeopathic remedies.”

According to the National Institutes of Health National Center for Complementary and Integrative Health, homeopathic remedies are based on an alternative medical system developed in Germany more than 200 years ago. One of the basic concepts is that active ingredients in the remedies should be highly diluted, but since products sold or labeled as homeopathic are not closely regulated, they can contain widely varying amounts of active ingredients, raising the potential for adverse side effects.

Consumers can identify homeopathic products by looking for the claim written on labels, or checking whether the active ingredient(s) are listed in terms of dilution (e.g., “LM1” “6X” or “30C”).

FDA says homeopathic product labels should not make medical claims and advises people to report any adverse side effects to the MedWatch Safety Information and Adverse Event Reporting Program, available at www.fda.gov/MedWatch/report.