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USA FDA COSMETIC REGISTRATION

What is USA FDA Cosmetic Registration?

FDA Cosmetic registration (VCRP) is voluntary. Manufacturers are not required to register their facilities nor their products with the US FDA. The FDA’s voluntary cosmetic registration program is for manufacturers, packers, and distributors of cosmetic products within the United States.

VCRP is also called as Voluntary Cosmetic Registration Program. It is a requirement for cosmetics sold in the USA.

As per the definition of FDA, a cosmetic is an article rubbed, poured, sprinkled, or sprayed on, applied into the human body for the purpose of altering the look, appearance, beautifying, cleansing for promoting attractiveness.

Benefits of USA FDA Cosmetic Registration

Reduced risk

Reputation

Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Who can be certified USA FDA Cosmetic Registration?

Concealer

Foundation

Rouge, blush, or blusher

Bronzer

Highlighter

Eyebrow pencils

Eyeshadow

Eyeliner

Mascara

Lip products

Face powder

Nail polish

Document required for USA FDA Cosmetic Registration

  • Technical File, Product Master File (TCF)
  • Product Testing
  • System Manual
  • System Procedure
  • FDA Manufacturing License
  • WHO GMP Certificate
  • Free Sale Certificate
  • Objectives
  • Plant Master File
  • Standard Operating Procedure (SOP)
  • Checklist
  • Forms
  • Formats
  • Records
  • Mission & Vision
  • Policy

The extent of Documented Information differs as per:

  • Import Country Requirements
  • Product and it's uses
  • Composition of the product

Role of Shamkris and Process of USA FDA Cosmetic Registration

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives. 

The implementation process is described below:

Time Frame

Task

Process

Step 1

Manufacturers open a VCRP account with the FDA

  • We are consultants and US Agents who can to complete the VCRP registration for your establishment.

Step 2

FDA Cosmetic Labeling Compliance

  • Make sure the product label complies with the FDA regulation before it reaches the port of entry or selling point. We are Regulatory Consultants who do a complete and thorough review of your label.

Step 3

Cosmetic Product Ingredient Statements (CPIS) Filing

  • Manufacturers, packers, or distributors of the cosmetics in the US should submit Ingredient Information Statements for each cosmetic product intended to be sold.

FAQ

FDA inspects all areas on a sampling basis in a company to determine its adherence with GMP during an inspection. These areas include

  1. Building and Facilities
  2. Equipment
  3. Personnel
  4. Raw Materials & Packing material control
  5. Production Process
  6. Laboratory Control process
  7. Traceability Records
  8. Labeling
  9. Transportation & Complaints

Manufacturers that follow strict GMP for cosmetics can minimize the potential for adulterated cosmetics.

FDA does not approve cosmetics or issue any certificates to cosmetic manufactures

Amazon will make sure the cosmetics listed with them are required to comply with FDA labeling requirements  including net weight, statement of identity, directions for use, warnings, contact information and ingredients.

Obtaining a Certificate of Compliance from third party regulatory consultants is one possible way to get a cosmetic product back on Amazon.

  1. False or misleading labels
  2. labeling that fails to provide the mandatory information under FDA regulations
  3. Not properly display the mandatory information
  4. Labeling that violates the Poison Prevention Packaging Act.

NO, FDA will not approve any label.

FDA does provide labeling guidance. It is the responsibility of the manufacturer/distributor to make sure the labeling complies with all requirements.

Electronically submit each cosmetic formulation followed by FDA will issue a Ingredient Statement Number for each formulation.

VCRP not mandatory. Its Voluntary. Normally manufacturers and distributors must do in due course.