FDA Cosmetic Regulatory Consulting

FDA Cosmetic Regulatory Consulting is a service that dicentra offers to assist companies that wish to market cosmetics in the United States. Whether the cosmetic is manufactured in the U.S. or imported from abroad the product must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and the Fair Packaging and Labeling Act (FP&L Act)

Our services in FDA Cosmetic Regulatory Consulting include:

  • FDA Cosmetic Product Ingredient Statements (CPIS) filing
  • Advising on product claims, ingredient listings and warning declarations
  • Reviewing scientific studies, data and information to substantiate product claims and establish ingredient safety.
  • Advising on compliant labeling and advertising strategies
  • Providing guidance on compliance issues relating to cGMPs, record keeping, product recalls, market withdrawals and FDA inspections
  • Assistance in registering products in the Voluntary Cosmetic Registration Program

Claims made about a product, whether in advertising or labeling, can be the difference between whether the product is regulated by FDA as a drug, a cosmetic, or both. dicentra offers FDA Cosmetic Regulatory consulting and we will assist you formulating claims for your products that are permissible for cosmetics and help avoid turning your cosmetic into a drug.