Which category would an OTC ingredient that is not generally recognized as safe or effective be placed in?

• A. Category I
• B. Category II
• C. Category III
• D. Category IV

Answer: (B)

The idea tested here is how OTC ingredients are categorized by safety and efficacy. If an ingredient is not generally recognized as safe or effective, it belongs to the category that denotes not safe and not effective for OTC use. That status means the ingredient cannot be considered suitable for over‑the‑counter products based on current evidence. The other categories describe different situations: one category marks ingredients that are safe and effective for OTC use, another covers items with insufficient data to judge safety or efficacy, and the remaining category covers scenarios outside these classifications. So the best fit for “not generally recognized as safe or effective” is the category that signals not safe or not effective.