FDA Also Has Authority to Regulate Personal Care Products That Contain Active Ingredients That Are Over-The-Counter (OTC) Drugs
Over the Counter Drugs used in personal care products including cosmetics 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. Currently, certain -- but not all -- over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final rules and regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either be the subject of an approved New Drug Application (NDA), or comply with the appropriate Federal rules for an OTC drug.
Cosmetic Companies' Commitment to a Strong FDA
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.
