More stringent FDA requirements for homeopathic medicinal products

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In December 2017, the FDA published a draft for Guidance for Industry "Drug Products Labeled as Homeopathic".

The FDA intends to retract the current requirements of Compliance Policy Guide 400.400 from the year 1988 in the future. Until now, this guide defined under which circumstances homeopathic products may be placed on the American market.

In general, homeopathic products are subject to the same regulatory requirements as other medicinal products. However, they have been exempt from inspection by the FDA so far.

The Guidance's intention is to raise awareness for the fact that each product labelled homeopathic and marketed illegally is subject to the monitoring activities ("Enforcement Action") of the FDA at all times.

In a risk-based approach, the FDA now defined specific categories of homeopathic products for which a higher risk for public health is to be expected. These categories are listed:

• "Products with reported safety concerns."
• "Products that contain or purport 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." (such as children or the elderly)
• "Products deemed adulterated under section 501 of the FD&C Act"

Please also see the complete FDA Draft Guidance for Staff and Industry entitled "Drug Products Labeled as Homeopathic".