The US Food & Drug Administration (FDA) has proposed a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.
The new approach would update the FDA’s existing policy to better address homeopathic treatments that are being marketed for serious diseases and/or conditions in which there is no evidence of clinical benefit. It also covers situations in which products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
The FDA is prioritizing enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients. Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers. The FDA intends to focus its enforcement authorities on the following:
- products with reported safety concerns
- products that contain or claim to contain ingredients associated with potentially significant safety concerns
- products for routes of administration other than oral and topical;
- products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
- products for vulnerable populations
- products that do not meet standards of quality, strength, or purity as required by law
Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns and products marketed for serious conditions, such as cancer and heart disease.
“Homeopathic products have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness, and quality,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “The draft guidance is an important step forward in the agency’s work to protect patients from unproven and potentially dangerous products.”
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs [news release]. U.S. Food & Drug Administration. December 18, 2017. Accessible at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm