Cosmetics Regulatory Services in USA

Overview

The United Stated of America (USA) is perceived as the largest market for cosmetic products across the world. Though the Federal Food, Drug & Cosmetics Act (FD& C) Act regulates cosmetic products in the region, neither the products nor their ingredients are reviewed/approved by Food and Drug Administration (FDA). The FD&C Act requires claims for a product’s function to be thoroughly reviewed as skin protectants (such as, diaper and ointments). However, in the USA, antiperspirants, treatments for dandruff and acne, mouthwashes marketed with 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 extends expert Regulatory support for product classification and claims review, which are crucial for cosmetic product establishment in the USA. Headquartered in the USA, Freyr assists manufacturers for quick market access based on product type. Freyr helps in aligning with the FD&C Act and extends post-marketing surveillance support for cost-effective adverse event tracking and reporting.

Expertise

Freyr Expertise

  • Product Classification
  • Artwork Support
  • Ingredient Analysis as per PCPC and USFDA norms
  • Label Assessment
  • Regulatory Intelligence
  • Claims Review
  • Support for Product Notification through Voluntary Cosmetics Registration Program (VCRP)
Freyr Advantages

ADVANTAGES

Freyr Advantages

 

Headquartered in the USA

 

Cost-effective services for quick market access

 

Strong relationship with the US FDA; Aids companies for aligning with the FD & C Act

 

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

 

Regulatory support for product classification and claims review

 

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