FDA & Health Canada Cosmetics Consulting

From a compliance standpoint cosmetics are often considered to be relatively straightforward.

However, the regulations governing cosmetics contain potential pitfalls, particularly in the areas of proper classification and appropriate claims. dicentra’s experience, together with our ongoing relationships with cosmetic trade associations and government agencies, keeps us ahead of the curve with respect to cosmetic regulatory affairs.

Cosmetic Services for the Unites 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 include:

  • Product Classification
  • FDA Cosmetic Product Ingredient Statements (CPIS) Form 2512 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
  • Assistance in registering products in the Voluntary Cosmetic Registration Program

Cosmetic Services for Canada

  • Confirmation that product is a cosmetic
  • 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 GMPs
  • Cosmetic Notification Form preparation and submissions
  • Compliant and accurate French translation for labels