FDA’s guidance document, which lays out the agency’s current position on the regulation of homeopathic drugs, says:
- Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
- FDA has not determined that any homeopathic drugs are GRAS/E;
- A new drug cannot be marketed unless it goes through the FDA’s approval process;
- No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.
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