FDA REGISTRATION FOR COSMETIC
FDA’s legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of colour additives. However, FDA can pursue enforcement action against products on the markets that are not in compliance with the law or against firms or individuals who violate the law.
The Federal Food, Drug & Cosmetic Act (FD&C) defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polish, eye and facial make-up preparations, shampoo, permanent waves, hair colours, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product.
Cosmetics are not subject to FDA premarket approval or mandatory establishment registration or ingredient reporting. In general, except for colour additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic product, provided that–
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The ingredient and the finished cosmetic is considered safe under labelled or customary conditions of use,
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The product is properly labelled, and
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The use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.