FDA Changes Approach to Homeopathic Products

November 4, 2019

The FDA announced that the agency is changing its approach to regulating homeopathic drug products that pose significant risks to patients.

The agency is withdrawing its decades-old policy guide entitled Conditions Under Which Homeopathic Drugs May be Marketed, because it no longer reflects the agency’s current thinking.

The FDA has seen many cases of homeopathic drug products posing a significant risk to patients despite being properly labeled and it issued warning letters to four companies this year for homeopathic eye drops manufactured in non-sterile conditions.

The agency has also issued a revised draft guidance detailing when it intends to prioritize postmarket enforcement and regulatory actions for homeopathic drugs that pose safety or significant quality concerns.

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