Cosmetic Product Registration with US FDA

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Cosmetic Product Registration with US FDA - Overview

The United States of America (USA) is perceived as the largest market for Cosmetic Products in the world. Though the Federal Food, Drug & Cosmetics Act (FD& C) Act and Modernization of Cosmetic Regulation Act of 22 (MoCRA) regulate Cosmetic Products in the region, neither the Products nor their Ingredients are reviewed/approved by the United States Food and Drug Administration (US FDA), however, according to the new regulations i.e., MoCRA Product can be reviewed by the USFDA and if it is not compliant with the regulations, the product can also be recalled. Antiperspirants, Treatments for Dandruff and Acne, and Mouthwashes marketed with Cosmetic Therapeutic Claims are classified as Drugs, thus, losing the ground to be marketed as Cosmetics. Since Post-Marketing Surveillance and Adverse Events are monitored stringently, thorough tracking and reporting of the products can be challenging, which may also increase the revenue burden.

Freyr, with a team of Qualified Regulatory experts, provides Cosmetics regulatory services in the USA such as Product Classification, FDA Cosmetic Claims Review, and Cosmetic Label Review as per the FDA Cosmetic Labeling Requirements, which are crucial for the establishment of Cosmetics in the USA. Headquartered in the USA, Freyr assists Manufacturers with quick Market Access based on Product Type. Freyr helps in aligning with the FD&C Act and MoCRA and extends Post-Marketing Surveillance support for cost-effective Adverse Event Tracking and Reporting.


Freyr Expertise

  • Product Classification
  • Formulation Review
  • FDA Cosmetic Claims Review
  • Act as a US agent for cosmetic facilities outside the US
  • Facility registration services with the US FDA
  • Submit and manage cosmetic product listings
  • Cosmetic Label Assessment as per the FDA Cosmetic Labeling Requirements
  • Cosmetic Artwork Support
  • MoCRA Product Compliance
  • Regulatory Reports
  • Go-to-market Regulatory Support
Freyr Advantages


Freyr Advantages


Headquartered in the USA.


Cost-effective services for quick market access.


Interaction with the USA cosmetic Health Authority (HA) i.e., US FDA and aids companies for aligning with the FD&C Act and MoCRA.


Extends post-marketing surveillance support for adverse event tracking and reporting.


Regulatory support for Product Classification.


Regulatory support for Cosmetic Labeling and Cosmetic Claims Review as per the FDA Cosmetic Labeling requirement.


FDA Cosmetics Claims and assessing the claims to comply with the USA cosmetic regulation.


Regulatory support for the US FDA Cosmetics Registration.


Qualified team of experts with hands-on experience across all cosmetic categories, such as skincare, hair care, baby care, oral care, beauty products, etc.