FDA Issues New Draft Enforcement Policy on Unapproved Homeopathic Drugs
The Food and Drug Administration outlined a new risk-based enforcement policy for unapproved homeopathic drugs, in a draft guidance issued Dec. 18. Under the new policy, if finalized, FDA will prioritize enforcement on unapproved drugs labeled as homeopathic based on their risk to human health, though “any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time,” the agency said. Comments are due March 20, FDA said in a concurrent notice in the Federal Register.
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According to the draft guidance document, FDA will focus its enforcement activities on the following categories of homeopathic drugs:
Products with reported safety concerns. For example, products that have been the subject of MedWatch reports.
Products with ingredients associated with safety concerns. For example, unapproved homeopathic drugs that contain or purport to contain infectious agents, controlled substances, toxic ingredients or ingredients that have harmful interactions.
Products administered in ways other than oral and topical. For example, products that are injected or applied to the eye.
Products intended to prevent or treat serious diseases and conditions. These products may cause users to delay seeking treatment that has been found to be safe and effective.
Products for vulnerable populations. For example, unapproved homeopathic drugs meant for use by immunocompromised individuals, children or the elderly.
Products deemed adulterated. For example, products with violations of current good manufacturing practice requirements or products that purport to be a product recognize in an official compendium but that actually have a substandard strength, quality or purity.
Homeopathic drugs are recognized as drug products by FDA and, absent a determination that the drug product labeled as homeopathic is generally recognized as safe and effective, are subject to FDA drug approval requirements, FDA said. “There are no drug products labeled as homeopathic that are approved by FDA,” the agency said.
(Federal Register 12/20/17)