US Agent Services - Cosmetics

Getting your cosmetic products ready for MoCRA and the US market

The “Modernization of Cosmetics Regulation Act 2022” (“MoCRA”) was published in December 2022 and establishes a comprehensive amendment to the United States “Federal Food, Drug, and Cosmetic Act” (“FD&C Act”).

MoCRA includes several new legal requirements and substantially changes the regulatory landscape for cosmetic products in the United States.

As your US Agent, MDSS supports your company to market your cosmetic products safe and compliant in the USA in the Food and Drug Administration Agency (FDA).

Considering both new and established requirements for cosmetics, our services include:

• Facility registration and their biennial renewals*
• Cosmetic product listing*
• Review of product documentation and labelling according to established US requirements (e.g. chemical compositions, product labels, etc.)
• Support on Product Safety Substantiation*
• Acting as first point of contact for the US competent authority (FDA)
• Handling of adverse events
• Information on important regulatory updates
• Consulting on state-specific regulations

*Referring to new requirements established by MoCRA