FDA targets homeopathic drugs

In late 2022 the Food and Drug Administration issued new guidance on homeopathic drugs, stating it intends to apply a “risk-based” enforcement approach to the manufacturing and marketing of such drugs. “Homeopathic” substances date back to a German physician in the 1700s who embraced the theory that “like cures like.” This thinking holds that a substance that produces a set of symptoms in a healthy person has the ability to cure an ill person with the same symptoms. Critics such as Michael Carome, MD, director of Public Citizen’s Health Research Group, contend there is no medical basis for the theory and no evidence from well-designed and rigorous clinical trials showing homeopathic drugs to be safe and effective. The FDA has not historically reviewed and approved homeopathic drugs with the same criteria used for traditional prescription drugs. It now plans to target specifically homeopathic products that have caused injury, contain suspect ingredients, are promoted as cures for serious diseases, are pitched to vulnerable populations like older persons, or have other significant quality issues.

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