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FDA Examination Of Homeopathic Regulation Looks Beyond Safety History

 
• By Malcolm Spicer

CDER Director Janet Woodcock says the current regulatory framework limits FDA’s direct regulation of homeopathics to post-market surveillance. During a two-day public hearing, agency officials question stakeholders about trials, labeling and how well consumers understand their products.

FDA officials agree with the homeopathic industry on its products’ strong safety record, but the agency might not be convinced that the drug category’s history is enough to justify continuing its current policy that defers regulation largely to the industry.

At the opening of a two-day public hearing on April 20 for comment on FDA’s homeopathic product oversight, Center for Drug Evaluation and Research Director Janet Woodcock said the current regulatory framework limits the

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