Homeopathic Drug Regulation

Somewhat below the radar screen, in late October the FDA has changed the ground rules concerning manufacture and distribution of homeopathic drugs.

Refusing to endorse the then-status quo policy by issuing an official regulation, the FDA stated that the current policy does not reflect the “current thinking” of the Agency as it is inconsistent with the Agency’s “risk-based approach to enforcement generally.”  This “new” approach apparently requires premarket approval from the FDA.  The current Agency thinking appears to be that homeopathic drugs continue to have certain related health issues.  The FDA also warned that consumers opting for homeopathic products were likely bypassing “medical products that have been scientifically proven to be safe and effective.”

This is a complex area.  The FDA is receiving comments on its current position until January 23, 2020.  Those interested in further detail will need a deep dive; one good place to start is reading the Federal Register FDA announcements during the last week of this past October.

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