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Firms exporting products from the United States are often asked by foreign governments or customers to supply a "certificate" as a required part of the process to import a product into their country. Please note:

  • FDA does not require that you obtain an export certificate.
  • FDA is not required by law to issue certificates for cosmetics (although the agency intends to continue to provide this service as resources permit).
  • FDA does not issue certificates for cosmetics manufactured outside the United States, or for raw or bulk materials.

If you export cosmetics from the United States, it is your responsibility to--

To avoid unnecessary delays, please read the information below before you request a cosmetic export certificate.

How do I obtain a cosmetic export certificate?

You may apply for a cosmetic export certificate through CFSAN’s secure Web-based Certificate Application Process (CAP). CAP is one of three modules within the CFSAN Export Certification Application and Tracking System (CFSAN eCATS), which can be accessed through the FDA Industry Systems (FIS). After you create an account and log in to CAP, you may enter and submit a new application to request a certificate.

Is my product really a cosmetic under the law?

FDA can only issue cosmetic export certificates for products whose intended use is solely as a cosmetic. A cosmetic is an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or alternating the appearance, and articles intended for use as a component of any such articles, except that the term “cosmetic” does not include soap as defined in 21 CFR 701.20(a) (21 U.S.C. 201(i)).  Products that are intended to affect the structure or function of the body (other than foods), or to have a therapeutic effect such as treating or preventing disease, are drugs under U.S. law (21 U.S.C. 321(g)(1)). Products marketed as "soap" may be cosmetics (i.e., if they do not meet the definition of “soap” in 21 CFR 701.20(a)) or drugs regulated by FDA, or they may be consumer products regulated by the Consumer Product Safety Commission, depending upon their composition and intended use.

Intended use may be established based on a variety of factors, including-

  • Claims made on the product label, in collateral labeling, in Internet information, or in other promotional materials such as advertising;
  • Consumer perception; and
  • Ingredients that have a well-known therapeutic use. 

Many personal care products are regulated as drugs under U.S. law, such as products with claims of--

  • Sun protection
  • Prevention and treatment of dandruff and acne
  • Hair restoration and growth
  • Skin bleaching and lightening
  • Skin and lip protectant
  • Collagen production
  • Immune and circulatory system improvement
  • Skin lesion healing  

For more information on whether your product is a cosmetic or a drug, or whether your "soap" is regulated by FDA or the Consumer Product Safety Commission, please refer to "Cosmetics Q&A: Personal Care Products" and "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)."

For information on how to request export certificates for other FDA-regulated products, see--

What types of export certificates does FDA issue for cosmetics?

The title of all FDA-issued cosmetic export certificates is “CERTIFICATE.” FDA does not issue Certificates of Free Sale for cosmetics or other types of cosmetic certificates. We cannot change the wording of our certificates, and we do not notarize them.

When applying for a cosmetic export certificate, you will be asked whether you would like a certificate that is--

  • Product-Specific: This type includes a list of all certified products. You must submit this “Product List,” with all products listed by their brand and product names, exactly as they appear on the cosmetic product labels.

OR

  • General: This type does not include a list of products. We suggest that you determine whether this type of certificate meets the requirements of your importing country before requesting one, because it is not always accepted.

Each certificate package includes a cover letter, certificate(s), “To Whom It May Concern” letter(s) (with your exporting company’s name and address), and an invoice for certificates delivered.  

How long will it take to process my cosmetic certificate request?

Requests for cosmetic export certificates may take several weeks to process. The following factors may have a bearing on processing time:

  • For paper applications sent via mail--It takes time for them to be delivered to our review staff who then must manually record your request into the Certificate Application Process (CAP) system. For this reason, we recommend that you apply online.
  • There may be a delay if your product appears not to be a cosmetic. FDA can only issue cosmetic export certificates for products whose intended use is solely cosmetic. If it is determined that a product is not a cosmetic, your request will be returned to you and you will have to submit a new request to the proper office.
  • FDA’s regulatory workload when we receive your request may affect response time. FDA is not required to issue export certificates for cosmetics. Public health activities are our top priority and take precedence over processing certificates. 

Are there other sources of cosmetic certificates, besides FDA? 

Some foreign governments may accept certificates issued by a state or local health department, board of trade, or trade association. Because FDA's resources are limited, we recommend that firms pursue alternative sources such as these for export certificates whenever possible, provided they are acceptable to the country requiring a certificate.

The states listed below offer cosmetic export certificates. This list may not be all inclusive. If your state is not listed, you may wish to check with state authorities to determine whether your state does provide certificates for cosmetics.

California: California Department of Public Health Food and Drug Branch Export Document Program Telephone: (916) 650-6500 Website:http://www.cdph.ca.gov/programs/Pages/FDBExportDocumentProgram.aspx   Email: fdbinfo@cdph.ca.gov

New Jersey: New Jersey Department of Health Food and Drug Safety Program Telephone: (609) 826-4935 Fax: (609) 826-4490 Website: http://www.state.nj.us/health/foodanddrugsafety/cert_freesale.shtml Email: peter.detroia@doh.state.nj.us

Texas: Bureau of Food and Drug Safety Texas Department of State Health Services Telephone: (512) 834-6626, ext. 2405 Website: http://www.dshs.state.tx.us/fdlicense/cfsinstructions.shtm 

Some governments may accept a certificate issued by a U.S. trade association, such as the Personal Care Products Council, the Independent Cosmetic Manufacturers and Distributors, and the World Trade Center Denver.   

Does a certificate mean FDA approval?

The issuance of a certificate does not suggest or imply that FDA approves or sanctions the labels and labeling of the firm's products or that the firm's products are in compliance with the requirements of the FD&C Act, the FPLA, or related regulations. The issuance of a certificate does not preclude FDA from taking regulatory action against such products in the future, if such action is warranted. Further, a certificate does not constitute an admission, or agreement, or determination by FDA that a product is a cosmetic as defined in section 201(i) of the FD&C Act.  

How to verify the authenticity of cosmetic export certificates?

FDA does not require foreign governments to verify the authenticity of cosmetic export certificates, but some foreign governments may have this requirement.  You will need to check with the country to which you are exporting to learn its authentication requirements.

There are two ways to authenticate your export certificate:

  • The exporting company can request an apostille or authentication from the U.S. Department of State, or
  • An official of a foreign government can verify independently that FDA issues a cosmetic export certificate.

For Exporters - How can I request an apostille or authentication from U.S. Department of State?

The U.S. Department of State offers an apostille and authentication for FDA's cosmetic export certificate.  To request authentication services, send your original cosmetic export certificate that you downloaded and printed from FDA's Certificate Application Process (CAP), a DS-4194 Authentication Request Form, and payment to:

Office of Authentications U.S. Department of State CA/PPT/S/TO/AUT 44132 Mercure Circle P.O. Box 1206 Sterling, VA 20166-1206

Please contact Ms. Dentira Hawkins, Branch Chief, with any questions at 202-485-8000.

For Foreign Government Officials - How can I verify that a cosmetic export certificate was issued by FDA?

If a foreign government receives FDA's cosmetic export certificate without an apostille or authentication, or does not accept these documents, an official of that government can independently verify that a cosmetic export certificate was issued by FDA through the Certificate Application Process (CAP), after creating an account.  To create an account, follow these steps:

  • Visit https://www.access.fda.gov/oaa and select "Create New Account."
  • Select "Certificate Application Process"; select "Yes" when asked if you are a foreign government official, and fill in your contact information.
  • Submist a document verifying your authority to authenticate cosmetic export certificates to CAP-OCAC-CFSAN@fda.hhs.gov. This document should be a copy of your credentials (government employee badge or other official identification) or a letter from an agency official responsible for import operations.
  • You will receive an email notification when your account is activated.

To verify that a cosmetic export certificate was issued by FDA, follow these steps:

  • Log into https://www.access.fda.gov/oaa.
  • Select “CFSAN Export Certification Application and Tracking System (CFSAN eCATS)" and then "Authenticate Certificate."
  • In the space provided, enter the unique Certificate ID located at the top left corner of the certificate (sample of Certificate ID). Select "Continue" to view the cosmetic export certificate issued by FDA. (Pop-up blockers must be disabled in your web browser.)

These instructions are also available on the cosmetic export certificate.

What if I still have questions?

If you still have questions concerning cosmetic export certificates, please direct them to FDA's Office of Cosmetics and Colors at CAP-OCAC-CFSAN@fda.hhs.gov or (240) 402-1375.

For further information, including export certificates for other products regulated by FDA, see Guidance for Industry: Export Certificates. 

 

May 2019. This information is current. It is updated only when necessary.