FDA Compliance Assistance & Registration for Food, Medical Devices & Cosmetics

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Registrar Corp provides Establishment Registration, Cosmetic Product Ingredient Statement (CPIS) filings, and Label and Ingredient Review Services for U.S. and Non-U.S. Companies in the Cosmetic Products Industry.

If your cosmetics have NOT YET been sold to U.S. consumers (your cosmetics are not yet available for retail purchase in the United States):

Cosmetic Label/Ingredient Reviews and Design

FDA does not accept Cosmetic Establishment Registrations or Cosmetic Product Ingredient Statement (CPIS) Filings until after a cosmetic is sold to consumers in the United States (referred to as a post-market reporting system).

When preparing a cosmetic for sale in the United States, be mindful that FDA has strict laws regarding ingredients and labeling of Cosmetics. Registrar Corp helps companies prepare their cosmetic labeling to meet U.S. requirements by providing:

Graphic Design or Re-Design of your Cosmetic Label
Written analysis of Cosmetic Label and Ingredients

If your cosmetics are ALREADY being sold to U.S. consumers (your cosmetics are currently available for retail purchase in the United States):

Option 1: Voluntary Cosmetic Establishment Registration (VCRP)

FDA requests registration of manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States (although registration may not be used for marketing purposes). Registrar Corp provides:

Cosmetic Establishment Registration
A Certificate of Registration issued by Registrar Corp

Option 2: Cosmetic Label/Ingredient Reviews and Design and Cosmetic Product Ingredient Statements (CPIS)

The United States has strict laws regarding ingredients and labeling of Cosmetics. Additionally, some cosmetic products are regulated in the U.S. as Drugs. Registrar Corp's Label and Ingredient Review Service conducts a review of your Cosmetic labels including:

Graphic Design or Re-Design of your Cosmetic Label
Written analysis of Cosmetic Label and Ingredients
Filing Cosmetic Product Ingredient Statements (CPIS) and Certificates of Registration issued by Registrar Corp

Applicable U.S. Regulations:

Cosmetic Establishment Registration: 21 C.F.R. Part 701 et seq.

The owner or operator of a cosmetic product establishment which is not exempt under 710.9 and engages in the manufacture or packaging of a cosmetic product is requested to register for each such establishment, whether or not the product enters interstate commerce.

Cosmetic Product Ingredient Statements: 21 C.F.R. § 720.2

Cosmetic Product Ingredient Statements "should be filed for each cosmetic product . . . within 60 days after the beginning of commercial distribution . . . "

Cosmetic Labeling: 21 C.F.R. Part 701 et seq.; 15 U.S.C. Chapter 39

A cosmetic shall be deemed to be misbranded . . . if its packaging or labeling is in violation of an applicable regulation . . .

Registrar Corp assists businesses with FDA compliance. Registrar Corp is not affiliated with the US Food and Drug Administration.


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