Over-the-Counter Drugs (OTC) are subject to FDA approval. Generally, drugs must either receive pre-market approval by FDA, or conform to final federal regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Once a regulation covering a specific class of OTC drugs is proposed, reviewed and finalized (in what is known as a FDA OTC Drug Monograph), those drugs must either comply with the requirements of the monograph or be required to submit a New Drug Application (NDA) to FDA for review and approval.
The cosmetic and personal care products industry supports a strong and vigilant FDA. FDA has abundant regulatory and enforcement authority for cosmetics under the federal Food, Drug and Cosmetics Act. Consumers benefit from having FDA as a strong watchdog for their health and safety, and industry benefits when consumers are confident with the cosmetic safety standards set by the Agency. Cosmetic companies work diligently to provide products that are safe, effective and comply with the provisions of the law.