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 United States Food and Drug Administration (US FDA). 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, FDA cosmetic claims review, and label review as per the FDA cosmetic labeling requirements, which are crucial for establishment of cosmetics 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 as per the FDA cosmetic labeling requirements
  • Regulatory Intelligence
  • FDA Cosmetic Claims Review
  • Support for the US FDA Cosmetics Registration through Voluntary Cosmetic 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

 

Regulatory support for label and cosmetic claims review as per the FDA cosmetic labeling requirements

 

Regulatory support for the US FDA cosmetics registration

 

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.