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                Importing FDA Regulated Products

Importing FDA Regulated Products

                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
          Importing Human Foods
          Importing Medical Devices
          Importing Radiation-Emitting Electronic Products
          Importing Tobacco Products


                        Importing COVID-19 Supplies Home
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          Import Program – Food and Drug Administration (FDA)
          Importing FDA Regulated Products
          Importing CosmeticsImporting FDA Regulated Products Importing Cosmetics
  
  	
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This page provides an overview of cosmetics and the requirements that the FDA verifies/enforces at the time they are imported or offered for import into the United States. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors is responsible for overseeing the cosmetic program. Visit the Cosmetics page for more information.

What is a cosmetic?
	What cosmetic requirements are verified at the time of importation?
	How can I determine if a cosmetic is listed on an import alert?
	How does FDA verify compliance with the cosmetic requirements?
	Cosmetic Labeling
	Color Additives
	Voluntary Cosmetic Registration Program
	Affirmation of Compliance codes for cosmeticsBack to top

**What is a cosmetic?**

The FDA defines a cosmetic as a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance**.**Cosmetics offered for import into the United States must comply with the same FDA laws and regulations as those that are produced domestically in the United States.

If you are unsure if a product is a cosmetic or a drug, visit the Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) page for more information.

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**What cosmetic requirements are verified at the time of importation?**

The FDA conducts field examinations and collects samples of cosmetics to verify that the products and ingredients are suitable and safe for their intended use (e.g. a color additive in an eye shadow has been approved for use around the eye).

If a cosmetic contains color additives that require certification, the FDA will verify the Color Identification Numbers (CIN).

If a cosmetic establishment has voluntarily registered and the registration number is supplied, it will be verified. See below for more information on the voluntary cosmetic registration program.

For more information visit the information for cosmetics importers page.

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**How can I determine if a cosmetic is listed on an import alert?**

The FDA provides a list of import alerts by industry. To view the list of import alerts related to cosmetics visit the import alert for cosmetics page.

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**How does FDA verify compliance with the cosmetic requirements?**

FDA entry reviewers are trained to verify compliance with cosmetic requirements using the information provided to the FDA in the importer’s entry transmission such as:

Declared Manufacturer
	Declared Importer/Consignee
	Product Description
	Affirmations of Compliance (A of C)These entry declarations are compared to information in the FDA’s internal data systems. The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Supplying this information accurately increases the likelihood that the shipment will be processed electronically and not held for manual review because the FDA’s screening tool, PREDICT, can verify the declared information against the FDA's internal data systems.

Note:  Submitting inaccurate or incomplete information may delay the review of the entry.

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******Cosmetic Labeling**

Product labels and/or labeling are reviewed to ensure the required information is present and declared properly, it is informative and truthful, and it is in English (or Spanish in Puerto Rico).  For more information on required cosmetic labeling information, please visit the Labeling Regulations page.

Additionally, if the label and/or labeling includes claims to treat or prevent disease or otherwise affect the structure or any function of the body, it could cause the product to be considered a drug.  For more information on drug claims, refer to Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) page.

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**Color Additives**

Color additives are permitted in cosmetics only if the FDA has approved those additives for the intended use.  If a cosmetic contains a color additive, it must adhere to the FDA’s laws and requirements for approval, certification, identity and specifications, and use and restrictions. The FDA separates approved color additives into two categories: colors subject to certification and colors not subject to certification. For color additives that are subject to certification, the FDA will verify the Color Identification Number (CIN) at the time of importation.

Please visit the Color Additives and Cosmetics page for more information.

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**Voluntary Cosmetic Registration Program**

The FDA’s Voluntary Cosmetic Registration Program (VCRP) is a reporting system for use by manufacturers, packers, and distributors of cosmetics that are in commercial distribution in the United States. The VCRP provides the FDA information about cosmetics and ingredients, their frequency of use, and firms involved in their manufacture and distribution to evaluate cosmetic products on the market.

For more information on VCRP, please visit the Voluntary Cosmetic Registration Program page.

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**Affirmation of Compliance codes for cosmetics**

Affirmation of Compliance codes (A of C) are three letter codes that can be provided at the time of import to facilitate FDA review.  Submission of A of C codes is not mandatory for cosmetics, however, submitting voluntary A of C codes may expedite initial screening and review of the entry.

Voluntary A of C codes used for cosmetics include:

COS (Cosmetic Registration Number)For information, including a full list of cosmetic affirmation of compliance codes, refer to the ACE affirmations of compliancedocument. To determine the optional A of C’s for the product, refer to the Industry Quick Reference Guide to the FDA ACE Supplemental Guide.

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Useful Links
	Automated Commercial Environment/International Trade Data System (ACE/ITDS)
	Information for Cosmetics Importers
	Cosmetic Labeling Guide
	Prohibited & Restricted Ingredients in Cosmetics
	Cosmetics FAQs



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                                                                                  Content current as of:
      03/17/2021Importing FDA Regulated Products

          
                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
          Importing Human Foods
          Importing Medical Devices
          Importing Radiation-Emitting Electronic Products
          Importing Tobacco Products


                        Importing COVID-19 Supplies
 
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