An over-the-counter drug ingredient not generally recognized as safe or effective for the claimed therapeutic indication is classified as

An over-the-counter drug ingredient not generally recognized as safe or effective for the claimed therapeutic indication is classified as CATEGORY II.

Category II is part of the 3 categories that the over-the-counter drug review classify each drug based on its active ingredients.

Here are the categories and its specifications:
Category I: generally recognized as safe and effective for the claimed therapeutic indication
Category II: not generally recognized as safe and effective or unacceptable indications
Category III: insufficient data available to permit final classification

Only OTC drugs classified under Category I is guaranteed as safe by the government.