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IPFS News Link • Drugs and Medications

FDA to scrutinize unproven alternative remedies

• My Way

The Food and Drug Administration says that it will hold a two-day meeting next month on regulations for homeopathic medicines, which have long occupied a place on the fringes of U.S. health care. Similar to dietary supplements, homeopathic products are not required to prove they are safe or effective before being sold on the market. But unlike supplements, homeopathic medicines state that they are designed to treat specific medical conditions.

According to a federal notice published online Thursday, the FDA will ask attendees whether there is data to "better assess the risks and benefits" of homeopathic medicines. Regulators also have questions about the appropriateness of selling some homeopathic drugs without a prescription. Regulators said that many of the medical indications listed on homeopathic drugs "have never been considered for over-the-counter use under a formal regulatory process."

Homeopathic products have grown into a multibillion-dollar U.S. market since the FDA last reviewed its oversight of the products 25 years ago, the agency notes.


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