To protect consumers, the agency plans to target alternative medicines that pose the greatest safety risk, such as those marketed as treatments for serious diseases without proven benefits, those that contain potentially harmful ingredients and those marketed toward vulnerable populations.
Since 1988, due to the agency’s enforcement policies, prescription and nonprescription drug products labeled homeopathic have managed to avoid regulatory oversight. Due in part to the lack of regulations, the homeopathic drug market has grown to a $3 billion industry over the past decade and now the FDA wants to update its regulations to ensure safety.
“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer,” said FDA Commissioner Scott Gottlieb, M.D. “In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse — that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients.”
Before any regulations are implemented, there is a 90-day public comment period for the proposed guidelines.
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