Proposed FDA guidance puts homeopathic drug industry on notice to improve its practices – or face federal consequences
In comments filed today with the U.S. Food and Drug Administration, the Center for Science in the Public Interest expressed its support for the agency’s new risk-based enforcement approach to homeopathic drugs. The group says that it hopes the draft guidance signals enhanced federal attention on the homeopathic drug industry, now worth $3 billion a year and growing quickly. It cites several examples of risky homeopathic products, including some linked to consumer injuries and deaths.
“People assume that these products are safe because they are considered ‘natural’ and are available over the counter in chain pharmacies and grocery stores,” said CSPI Deputy Director of Regulatory Affairs Sarah Sorscher. “But up until now there has been virtually no oversight. We hope that will change with this new guidance.”
CSPI generally advises that consumers avoid spending money on homeopathic products.
“At best, these products are drugs whose ingredients have been diluted to a point that renders them both harmless and ineffective,” Sorscher said. “At worst, the products may be contaminated, divert patients from effective medical treatment, or contain dangerous levels of improperly diluted poisonous ingredients that can lead to toxic overdose.”
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