What is the key pre-market approval difference between a new drug and a supplement?

Answer

Drugs require extensive pre-market approval data showing safety and effectiveness.

A fundamental regulatory distinction exists between marketed drugs and dietary supplements regarding market entry requirements. Drugs, intended to treat diseases, must undergo a rigorous, multi-year process involving extensive clinical trials to provide substantial evidence demonstrating both safety and effectiveness before they can be marketed. In contrast, supplements do not require this mandatory pre-market approval. While the FDA retains the ability to intervene against supplements that are found to be adulterated or misbranded after they are already available to consumers, the burden of pre-approval proof for efficacy is absent for supplements that only claim to affect structure or function.

What is the key pre-market approval difference between a new drug and a supplement?

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