US Cosmetic Regulatory Compliance

Cosmetic products and ingredients are regulated under the Federal Food, Drug and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The Food and Drug Administration (FDA) does not require premarket approval for these products but does hold cosmetic companies responsible for ensuring that their products are safe and properly labeled, and are not misbranded as drug products. In addition to FDA, cosmetics and personal care products are subject to state regulations, particularly the State of California’s Proposition 65. Therefore, formulation reviews and proper labeling are essential. If a cosmetic or personal care product is found to be misbranded, adulterated or if the firm fails to comply with safety regulations, FDA or another regulatory body may pursue enforcement action.

Cosmetics are products that intend to clean the body or improve its physical appearance. Many types of personal care products fall under this definition including makeup, certain hair care products, nail care products, lotions, and fragrances. If a product’s claims go beyond improving beauty or cleanliness, the product may be regulated as a drug.

TSG can help

  • Perform safety and exposure assessments
  • Prepare and submit color additive petitions
  • Develop compliant labels
  • Review product claims
  • Provide import/export advice
  • Evaluate ingredients for Proposition 65 compliance
  • Assist with the Voluntary Cosmetic Registration Program (VCRP)
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