DA continues to find that some homeopathic drugs are manufactured with active ingredients that can create health risks while delivering no proven medical benefits. Today, the FDA proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency’s enforcement policiessince 1988.
The FDA’s proposed approach prioritizes 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Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers.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 kinds of products:
- 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; and
- products that do not meet standards of quality, strength or purity as required under the law.
The FDA encourages public comments on the draft guidance during the 90-day comment period. While the FDA considers comments to the draft guidance, the FDA intends to examine how the agency is implementing its current compliance policy. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA will consider taking additional enforcement and/or regulatory actions, consistent with the current enforcement policies, which also align with the risk-based categories described in the draft guidance, in the interest of protecting the public.
Link to Draft Guidance: https://www.fda.gov/downloads/
Drugs/ GuidanceComplianceRegulatoryIn formation/Guidances/UCM589373. pdf
Link to Press Release: https://www.fda.gov/
NewsEvents/Newsroom/ PressAnnouncements/UCM589243. htm