Cosmetics Regulatory Services in the USA

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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 regulates cosmetic products in the region, neither the products nor their ingredients are reviewed/approved by the United States Food and Drug Administration (US FDA). 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 extends expert Regulatory support for 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 extends post-marketing surveillance support for cost-effective adverse event tracking and reporting.

Expertise

Freyr Expertise

  • Product Classification
  • Cosmetic Artwork Support
  • Cosmetic Ingredient Analysis as per PCPC and USFDA norms
  • Label Assessment as per the FDA Cosmetic Labelling Requirements
  • Regulatory Intelligence Services
  • 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

 

A strong relationship with the US FDA and 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 Cosmetic Labelling and Cosmetic Claims Review as per the FDA Cosmetic Labelling requirement

 

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.