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What You Need to Know

The U.S. Food and Drug Administration has issued a final guidance on Homeopathic Drug Products describing the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. The agency anticipates many homeopathic drug products will fall outside the categories of drug products it intends to prioritize for regulatory action. There are no FDA-approved products labeled as homeopathic, and the agency cannot ensure these drugs meet standards for safety, effectiveness, and quality.

Previously, the FDA warned the public about homeopathic products, including those containing a toxic substance and ones recalled due to contamination.

What Does This Mean For You?

Health professionals and patients should report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online
  • Download form
  • Call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Posted in Drugs, FDA and USDA Regulatory Update.