Sep 13 2022
Under the regulation of the FDA, cosmetic products and ingredients do not need FDA premarket approval, with the exception of color additives. However, FDA can pursue enforcement action against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.
In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided that--
the ingredient and the finished cosmetic are safe under labeled or customary conditions of use,
the product is properly labeled, and
the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.
Q. Do cosmetics firms need to register with FDA or get an FDA license to operate?
Manufacturers are not required to register their cosmetic establishments or file their product formulations with FDA, and no registration number is required to import cosmetics into the United States.
However, FDA encourages cosmetic firms to participate in FDA's Voluntary Cosmetic Registration Program (VCRP) using the online registration system. Cosmetic manufacturers, distributors, and packers can file information on their products that are currently being marketed to consumers in the United States and register their manufacturing and/or packaging facility locations in the VCRP database.
Q. Does FDA regulate your product as a cosmetic or drug?
The U.S. Food and Drug Administration (FDA) regulates your product as cosmetics if they are:
Intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance
Common Example of Cosmetics:
Skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants
The U.S. Food and Drug Administration (FDA) regulates your product as drugs if they are:
Intended for a therapeutic use, such as treating or preventing disease
Intended to affect the structure or any function of the body
Common Example of Drugs:
Sun Protection Factor (SPF) indicates intention to prevent sunburn
Antiperspirants prevent sweating by affecting the sweat glands
Toothpaste containing fluoride intends to prevent tooth decay
Anti-Dandruff shampoo intends to treat and prevent dandruff
Acne-clearing face washes intend to treat acne by affecting pores
Q. Can FDA inspect cosmetics manufacturers?
FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.
Q. Does FDA test cosmetics or recommend testing labs?
Although FD&C Act does not subject cosmetics to premarket approval by FDA, the FDA inspector collects samples for examination and analysis as part of cosmetic facility inspections, import inspections, and follow-up to complaints of adverse events associated with their use. FDA may also conduct research on cosmetic products and ingredients to address safety concerns.
FDA does not function as a private testing laboratory, and in order to avoid even the perception of conflict of interest, we do not recommend private laboratories to consumers or manufacturers for sample analysis.
FDA can and does inspect cosmetic manufacturing facilities to assure
cosmetic product safety and determine whether cosmetics are adulterated
or misbranded under the FD&C Act or FPLA.
If you have any questions about FDA regulation of OTC Drugs and Cosmetics,
Registration and labeling compliance... , please CONTACT US.