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Pharmaceuticals / Regulatory Affairs

FDA Unveils Risk-Based Enforcement Approach to Homeopathic Drugs

Dec. 22, 2017

In a new policy initiative, the FDA outlined new enforcement measures for homeopathic products.

The new risk-based enforcement approach will prioritize misbranded products — therapies marketed for serious conditions, such as cancer or heart disease, without evidence of clinical benefit — as well as those that run afoul of GMPs or contain potentially harmful ingredients, according to a new draft guidance.

While homeopathic products are subject to approval, misbranding and adulteration rules, they have been manufactured and distributed without agency approval under FDA enforcement policies since 1988.

FDA Commissioner Scott Gottlieb said the new guidance responded to a spike in recent years of products labeled as homeopathic but marketed as treatments for diseases and conditions of varying degrees.

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