U.S. Agent

U.S. Agent Service – Cosmetics

The “Modernization of Cosmetics Regulation Act 2022” (“MoCRA”) was published in December 2022 and introduces extensive amendments to the U.S. Federal Food, Drug, and Cosmetic Act (“FD&C Act”).

MoCRA brings new legal requirements and significantly reshapes the regulatory landscape for cosmetics in the United States.

As your FDA Representative (“U.S. Agent”), MDSS assists your company in the safe and compliant marketing of your cosmetic products in the U.S.

The deadline for product listing and facility registration under MoCRA was December 29, 2023.

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Our comprehensive support

Considering both new and established requirements for cosmetic products, our services include, but are not limited to:

  • Facility registration
  • Product listing
  • Review of relevant documentation and product labeling to ensure compliance with current U.S. regulations
  • Product safety substantiation
  • Acting as the primary point of contact for the responsible U.S. authority (FDA)
  • Management of adverse events
  • Updates on key regulatory changes
  • Consulting on specific regulations in individual U.S. states

*With respect to new legal requirements under “MoCRA”

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Ensure the safety and legal compliance of your cosmetic products with our expertise.
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