The cosmetics distributed in the United States must comply with the labeling regulations published by the FDA under the authority of the FD&C Act and the FP&L Act. Labeling means all labels and other written, printed or graphic matter on or accompanying a product.
The FD&C Act 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 polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product.
Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and anti dandruff shampoos.
A cosmetic is considered misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner.
HYKKON can assist you to
- Review and modify cosmetic labeling to comply with FDA requi
- Review the ingredients of the cosmetic products Cosmetics must be properly
Labeled, contain approved and permitted ingredients (particularly color), and bear lawful cosmetic claims. FDA does not require cosmetics be manufactured in FDA registered establishments, and there is no comparable listing requirement for cosmetic products, although FDA does maintain a voluntary registration and ingredient listing program.