This week, the U.S. Food and Drug Administration (FDA) proposed a new, risk-based enforcement approach to homeopathic drug products with the highest potential of causing harm to consumers. Since 1988, some prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval.
The goal of the new proposal is to update the FDA’s current policy for addressing unproven homeopathic treatments marketed for serious diseases and/or medical conditions. According to the agency, the new approach will also cover products labeled “homeopathic” that contain potentially harmful ingredients or that do not meet manufacturing standards.
Under the new approach, homeopathic products that fall outside of certain risk-based categories outlined in the guidelines will remain available to consumers. The new enforcement approach will focus on products with reported safety concerns, those marketed to treat or prevent serious or life-threatening diseases and conditions, those geared towards vulnerable populations, those that do not meet standards under the law, and others.