FDA Targets Specific Homeopathic Drug Categories

The FDA plans to prioritize its enforcement and regulatory actions against specific homeopathic drug categories that pose a significant risk to public health, the agency said in a final guidance.

The guidance, which includes only minor revisions to a previous draft issued in October 2019, says the agency will take a risk-based approach towards the manufacturing, distribution and marketing of these products, and will focus on products marketed without the necessary FDA approval.

“For example, injectable drug products and ophthalmic drug products in general pose a greater risk of harm to users because the routes of administration for these products bypass some of the body’s natural defenses,” the agency said.

Other categories the agency will target include:

• Products with reports of injury that, after evaluation, raise potential safety concerns;
• Products that contain or purport to contain ingredients associated with potentially significant safety concerns;
• Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions;
• Products for vulnerable populations; and
• Products with significant quality issues.