FDA and Over the Counter

FDA Also Has Authority to Regulate Personal Care Products That Contain Active Ingredients That Are Over-The-Counter (OTC) Drugs

Over-the-counter drugs (OTC) are subject to FDA approval. Generally, drugs must either receive pre-market approval by the FDA or conform to final federal regulations specifying conditions whereby they are generally recognized as safe and effective. Once a regulation covering a specific class of OTC drugs is proposed, reviewed and finalized (in what is known as an FDA OTC Drug Monograph), these drugs must either comply with the requirements of the monograph or be required to submit a New Drug Application (NDA) to the FDA for review and approval.

Cosmetic Companies’ Commitment to a Strong FDA

The cosmetics and personal care products industry supports a strong and vigilant FDA. The FDA has abundant regulatory and enforcement authority for cosmetics under the federal Food, Drug and Cosmetics Act (FD&C Act) of 1938 and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. Consumers benefit from having the FDA as a strong watchdog for their health and safety, and industry benefits when consumers are confident in the safety standards set by the Agency. Cosmetics companies work diligently to provide products that are safe, effective and comply with the provisions of the law.