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. This definition includes products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpaste deodorants, and any material intended for use as a component of a cosmetic product.
Cosmetics are not subject to FDA premarket approval, but establishment registration and product listings are mandatory. It is the firm's responsibility to assure that its cosmetic products and ingredients are safe and properly labeled, in full compliance with the law.
FDA authority over cosmetics includes:
- Prohibiting the use of certain ingredients: The FDA has the authority to prohibit or restrict the use of certain ingredients in cosmetics that are known to be harmful or potentially harmful to consumers.
- Setting labeling requirements: The FDA requires cosmetics to be properly labeled with information such as the product's name, ingredients, and net weight. The label must also include warnings and directions for safe use.
- Conducting safety assessments: The FDA may conduct safety assessments on cosmetics to determine if they are safe for consumers to use. This may involve reviewing safety data, conducting tests, and analyzing adverse event reports.
- Inspecting facilities: The FDA may inspect cosmetic facilities to ensure they are in compliance with regulations and are following good manufacturing practices.
- Taking enforcement action: If the FDA finds that a cosmetic product is not in compliance with regulations, it may take enforcement action, such as issuing warning letters, seizing products, or taking legal action.
- Cosmetic Registration
- Cosmetics Labeling Review
- EU Cosmetics Regulations
- NDC Number for Cosmetics
- MoCRA Cosmetic Product Category and Codes