Overview

United Stated of America is perceived as the largest market for cosmetics in terms of revenue. Cosmetic products in the USA are regulated by Federal Food, Drug & Cosmetics Act (FD& C) Act and neither the products nor their ingredients are reviewed / approved by Food and Drug Administration (FDA). Claims for a product’s function must be thoroughly reviewed because skin protectants (such as diaper ointments), antiperspirants, treatments for dandruff or acne mouthwashes marketed with therapeutic claims, are classified as drugs thus losing the ground to market them as cosmetics. Since post-marketing surveillance and adverse events are monitored stringently, thorough tracking and reporting can be challenging which may include additional revenue burden.

Freyr extends expert Regulatory support for product classification and claims review which are crucial for establishing a product as cosmetic in the USA. Headquartered in the USA, Freyr can provide assistance to quick market access basing on product type that will prove effective for new products. Freyr also offers assistance in aligning with FD & C Act regulations and extend post-marketing surveillance support for cost-effective adverse event tracking and reporting.

Freyr Expertise

  • Product Classification
  • Artwork Support
  • Ingredient Assessment
  • Label Assessment
  • Claims Review
  • Product Notification through Voluntary Cosmetics Registration Program (VCRP)
  • Product Information/ Technical File Compilation

Freyr Advantages

  • End-to-end cosmetic Regulatory consultation
  • Qualified team of experts with hands-on experience across all categories of cosmetics like skin care, hair care, infant care, oral care, beauty products
  • Support for region specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationship with US FDA
  • Structured and cost-effective approach to ensure speed to market for the cosmetic products