Overview

The United States (US) is perceived as the largest market for cosmetic products in the world. Although the Federal Food, Drug, and Cosmetic (FD& C) Act and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 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 MoCRA regulations, a product needs to be reviewed by the US FDA, and if it is not compliant with the regulations, it can be recalled. Antiperspirants, products for treating 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 (PMS) and adverse event monitoring are conducted stringently, thorough tracking and reporting of the products can be challenging, which in turn may also increase the revenue burden.

Freyr, with a team of qualified Regulatory experts, provides cosmetics Regulatory services such as product classification, US FDA cosmetic claims review, and cosmetic label review, as per the US FDA cosmetic labeling requirements, which are crucial for marketing cosmetics in the US. Freyr also assists in the US FDA Cosmetic Registration through the Voluntary Cosmetic Registration Program (VCRP).  Headquartered in the US, Freyr helps manufacturers achieve quick market access based on product type, in alignment with the FD&C Act and MoCRA. Freyr also extends PMS support for cost-effective adverse event tracking and reporting.