COSMETICS

The U.S. Food and Drug Administration (FDA) regulates cosmetics to ensure their safety and labeling compliance.

Product Safety
While cosmetics do not require FDA premarket approval, they must be safe for their intended use. The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and can take action against products that are adulterated or misbranded.

Ingredient Safety
Cosmetic manufacturers are responsible for ensuring the safety of their products and the ingredients used in them. While the FDA does not preapprove cosmetic ingredients, it maintains a list of prohibited and restricted cosmetic ingredients and monitors safety concerns through adverse event reports and scientific research.

Labeling Requirements
Cosmetics must be properly labeled to provide consumers with important information about the product. Labeling requirements include the product name, net quantity of contents, ingredient list, directions for use, and any necessary warnings or precautions.

Ingredient Labeling
The FDA requires cosmetics to list their ingredients in descending order of predominance by weight. This helps consumers make informed decisions about the products they use and allows individuals with allergies or sensitivities to avoid potential irritants.

Cosmetic Claims
Cosmetic labeling must not be false or misleading. Manufacturers are prohibited from making drug claims (e.g., curing or treating a disease) about their products unless the claims are supported by scientific evidence and the product is approved as a drug by the FDA.

Good Manufacturing Practices (GMP)
While there are no specific GMP regulations for cosmetics, manufacturers are expected to follow best practices to ensure product safety and quality. This includes maintaining clean facilities, using appropriate manufacturing processes, and conducting quality control testing.

Registration and Reporting
Cosmetic manufacturers are not required to register their facilities with the FDA, nor are they required to submit product formulations or safety data to the agency. However, the FDA encourages voluntary reporting of adverse events associated with cosmetic products through the Cosmetic Adverse Event Reporting (CAERS) system.

Imported Cosmetics
Imported cosmetics are subject to the same regulatory requirements as domestically produced cosmetics. Importers are responsible for ensuring that their products comply with FDA regulations and may be subject to inspection and enforcement actions by the agency.