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The Cosmetic Modernization Regulatory Act (MoCRA), voted by the US Congress on December 29, 2022, has profoundly changed the cosmetic regulatory framework in the United States from the end of 2023. The “Responsible Person”, who must fulfill all the obligations of the products according to the MoCRA law, is the natural or legal person named on the label of the cosmetic product. This person can be any of the manufacturer, packer, importer and distributor, provided that they meet the requirements to fulfill all responsibilities during the placing of cosmetic products on the market. The MoCRA law also mandated that facilities be recognized by the FDA.

Brand owners and facilities located outside of the United States must have an authorized representative located in the United States.

As your US Authorized Representative, we represent your products and you in the best way possible before FDA, in line with all legal requirements, by creating a bridge between cosmetics manufacturers and FDA.

The services we offer you in this regard are as follows;

  • Formulation checks, label evaluation and product information file review to ensure your cosmetic products comply with the new US law, MoCRA
  • Preparation of safety assessment reports of products
  • Facility registration and product notifications
  • Keeping all data on your cosmetic products up-to-date
  • Reporting of Serious Undesirable Effects
  • Support on product inspection, recall processes and all post-market surveillance processes
  • To inform you about the legal developments to be experienced and the new requirements that you need to implement regarding your products by following all current developments.
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