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 2022 (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, under the new MoCRA regulations, products can be reviewed by the USFDA, and if found not- compliant, the product can be recalled. Antiperspirants, treatments for dandruff and acne, and mouthwashes marketed with cosmetic therapeutic claims are classified as drugs, losing their ground to be marketed as cosmetics. The stringent monitoring of post-marketing surveillance and adverse events can pose challenges for thorough tracking and reporting of the products, potentially increasing the burden on revenue.

Freyr, with a team of qualified Regulatory experts, provides cosmetics Regulatory services in the USA, including product classification, FDA cosmetic claims review, and cosmetic label review as per FDA cosmetic labeling requirements. These services are crucial for establishing cosmetics in the USA and for US FDA cosmetics registration through the Voluntary Cosmetic Registration Program (VCRP).

Headquartered in the USA, Freyr assists manufacturers with quick market access based on product type. Freyr also helps companies align with the FD&C Act and MoCRA and extends post-marketing surveillance support for cost-effective adverse event tracking and reporting.

Expertise

Cosmetic Product Registration with US FDA - Freyr Expertise

  • Product classification.
  • Formulation review.
  • FDA cosmetic claims review.
  • Cosmetic label assessment as per the FDA cosmetic labeling requirements.
  • Support for the US FDA cosmetics registration through the Voluntary Cosmetic Registration Program (VCRP).
  • Cosmetic artwork support.
  • Regulatory Intelligence (RI) services.
  • Go-to-market Regulatory support.
Freyr Advantages

ADVANTAGES

Cosmetic Product Registration with US FDA - 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 in 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.

 

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