Last year, the Citizen's Petition to the U.S. Food and Drug Administration (FDA), created by Americans For Homeopathy Choice (AFHC), attempted to turn FDA Compliance Policy Guide (CPG) 400.400 into a regulation. A CPG is subject to change, but a regulation cannot be easily altered.
However, the FDA has recently determined that it will completely throw out CPG 400.400, erroneously suggesting that homeopathic remedies are not well-regulated by this tried-and-true, 30-year old document.
Since 1988, CPG 400.400 has been in place as a guiding document for the FDA, keeping homeopathic remedies under the Agency’s oversight. It is a comprehensive document with an excellent track record that clearly:
- Establishes conditions under which homeopathic drugs may be marketed.
- Dictates the manufacturing standards under which homeopathic remedies are made. [Homeopathic remedies must be rigorously tested under the direction of the Homeopathic Pharmacopoeia Convention.]
- Outlines how the strength or “potencies” of homeopathic remedies are specified in terms of dilution; they must only contain diluents commonly used in homeopathic remedies.
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