To market a new dietary supplement ingredient, which action is required?

• A. Provide safety and efficacy data to FDA
• B. Petition to market new ingredients but they do not have to prove safety/efficacy
• C. Obtain drug approval
• D. Obtain FDA marketing clearance

Answer: (D)

For dietary supplements, the big rule is safety first and premarket notification rather than premarket approval. In the United States, the FDA does not approve or clear dietary supplements before they are sold. When a company introduces a new dietary ingredient, it must submit a premarket notification to the FDA with information showing the ingredient is reasonably expected to be safe under its intended use. The FDA then reviews that submission (typically allowing a 75-day window) and can raise safety concerns, but the product can be marketed if FDA does not object within that period. Efficacy data are not required for dietary supplements, and there is no process of “marketing clearance” or drug-style approval for these products. So the key action is to provide safety information to FDA before marketing to support the safety of the new dietary ingredient. This is why the emphasis is on safety data in advance, rather than seeking drug approval or post-market clearance.