If a dietary supplement contains a new ingredient, how is it reviewed by the FDA?

• A. It is approved before marketing
• B. It is reviewed for safety but not approved
• C. It is treated as a drug requiring extensive trials
• D. It is automatically approved

Answer: (B)

The main idea here is how the FDA handles new ingredients in dietary supplements. Dietary supplements aren’t approved by the FDA before they reach the market like drugs are. When a supplement includes a new dietary ingredient, the company must submit safety information to the FDA before marketing so the agency can review it. The FDA evaluates the safety data and how the product is labeled, but this review does not amount to an approval. If safety concerns come up, the FDA can take action such as requiring warnings, restricting use, or removing the product from stores. In short, a new ingredient is reviewed for safety, not approved, before it can be sold, and the FDA continues to monitor safety after it’s on the market.