FDA Signals Tough New Regulatory Stance on Homeopathic Drugs

FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on Drug Products Labeled as Homeopathic. The CPG stated the conditions—including regarding ingredients, labeling, prescription status, and current good manufacturing practice—under which homeopathic drugs could lawfully be marketed. The new guidance uses a risk-based approach to determine where FDA will prioritize enforcement and regulatory actions. FDA announced it stance in a press release, FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs. In its press release, FDA makes clear that it regards the market for homeopathic drugs as one that “exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health…

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