U.S. Cosmetics Regulations

The United States Food and Drug Administration (FDA) defines cosmetics as “articles 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”. The FDA does not require that cosmetic products undergo pre-market approval. Furthermore, manufacturers are not required to register products, ingredients, or data, but are encouraged to submit their products on the FDA’s Voluntary Cosmetic Registration Program (VCRP). Demonstration of safety is not required, but may be expected from consumers.

Labelling and labelling claims must also comply with the regulations stipulated in the Food, Drugs and Cosmetics Act and the Fair Packaging and Labelling Act. Misbranded products are illegal and may be a result of false or misleading labelling, failure to provide required information, improper display of label information, and/or violation of the Poison Prevention Packaging Act. Any products with therapeutic claims are subject to compliance to both the cosmetics and drugs regulations.

Intertek Cantox can assist with the following:

• Safety Assessments
  • Toxicological Risk Assessments (TRAs)
• Regulatory Compliance Support
  • Voluntary Cosmetic Registration Program
  • Regulatory advice
• Clinical Studies for Claim Substantiation
  • Design, placement, and monitoring
• Product Labelling Review and Support