FDA Adds Homeopathic Enforcement Details, Subtracts Compliance Policy Guide
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FDA warns OHM Pharma for promoting topical formula containing homeopathic ingredients as teething product for infants. The firm also warned about drug and supplements GMP violations and was an easy target for FDA following release of draft guidance outlining its enforcement priorities.
A revised draft introduces list of risk-based enforcement priorities but doesn't necessarily tighten FDA oversight of homeopathics manufacturing and marketing, say CHPA and AIH.
"This was an area that the agency thought was just going to disappear on its own," says Freddie Ann Hoffman, who chaired FDA homeopathic working group that helped develop CPG adopted in 1988 to allow sales of homeopathics to continue without pre-market approval.