• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Cosmetics

  • Print
  • Share
  • E-mail
-
-

Cosmetic Exports

Is my product really a cosmetic under the law?
What types of cosmetic certificates does FDA issue, and how do I obtain them?
How much does a cosmetic certificate cost?
How long will it take to process my cosmetic certificate request?
Are there other sources of cosmetic certificates, besides FDA?
Do exported cosmetics have to comply with the FD&C Act and FPLA?
What if my product is a drug or medical device?
Does FDA issue any other types of cosmetic certificates?
Does a certificate mean FDA approval?
How do I learn other countries' requirements?
How do I learn about other U.S. government requirements for exports?


Firms exporting products from the United States (U.S.) 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), and
  • FDA does not issue certificates for cosmetics manufactured outside the U.S.

If you export cosmetics, it is your responsibility to--

  • follow U.S. laws and regulations, and
  • know the cosmetics requirements of the countries to which you export.

 

Is my product really a cosmetic under the law?

Persons requesting a cosmetic certificate have the responsibility to ensure that their products are cosmetics as defined under U.S. law. Make sure your product meets the legal definition of a cosmetic before you request a cosmetic certificate. Do not request a cosmetic certificate for a product regulated as a drug or medical device in the U.S. See "What if my product is a drug or medical device?" below concerning drug or device certificates. The terms "drug," "device," and "cosmetic" are defined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Sections 201 (g), (h) and (i)):

  • The term "drug" includes articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and articles (other than foods and dietary supplements) intended to affect the structure or any function of the body.
  • The term "device" includes an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
  • The term "cosmetic" means articles 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 altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap (soap is defined in the Code of Federal Regulations at 21 CFR 701.20.

Generally speaking, the intended use of a product is determined by claims made on the product label, in collateral labeling, and in other promotional materials such as advertising. Information on the company's Internet site is also considered when evaluating intended use. Specific and implied drug or device claims are not appropriate for products marketed solely as cosmetics.

Some examples of intended use that may cause a product to be regulated as a drug are claims for sun protection, including use of a sun protection factor (SPF) rating; prevention and treatment of dandruff or acne; hair restoration; skin bleaching; immune and circulatory system improvement; and skin lesion healing. For more information on determining whether your product is a cosmetic or a drug, refer to our Web page article, Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).

Sometimes you may need to request certificates from different FDA Centers for different items of the same kit you wish to export. An example of this would be a dental kit that includes an anticaries toothpaste (drug), a mouthwash for cleansing and fresh breath (cosmetic), and a toothbrush and dental floss (devices).

 

What types of cosmetic certificates does FDA issue, and how do I obtain them?

FDA issues two types of certificates for cosmetics:

  • General
  • Product-Specific

You will need to determine from the importing country which type of certificate will be acceptable. The certificates are described as follows:

General "CERTIFICATE": A General Certificate (the actual certificate will be titled only "CERTIFICATE") does not list any specific products by name. It states that FDA has on file a letter "regarding The Status Of Products Exported From The United States." You only need to tell us how many General Certificates you require. You need not submit any other information. Attached to each General Certificate is a "To Whom It May Concern" letter, which we supply, with your company's name and address.

Product-Specific "CERTIFICATE": A Product-Specific Certificate (the actual certificate will be titled only "CERTIFICATE") states that FDA has on file a letter regarding specific product(s), listed by name in a Product List, which you supply, and which we will attach to the Product-Specific Certificate. Also attached to each certificate is a "To Whom It May Concern" letter, which we supply, with your company's name and address. If you wish to obtain a Product-Specific Certificate, you should:

  • Determine the number of products to be listed on each certificate. For example, if you need five certificates for five products, decide whether you want a single product listed with each certificate or all five products listed with each certificate.
  • Type a Product List including all products that you want listed for each certificate, listing all products by their brand names, exactly as they appear on the cosmetic product labels. Do not submit labels. Include a Product List for each Product-Specific Certificate you request, since one list will be attached to each certificate. The Product List should be typed on an 8.5" X 11" sheet of paper. The format should include the words PRODUCT LIST centered at the top, with the name(s) of the cosmetic product(s) typed below at the left margin.

If your product is a cosmetic, and you wish to request a certificate from FDA complete Form FDA 3613d (PDF), Office of Cosmetics and Colors "Certificate" Export Application, and mail your completed form, along with your product list(s) if you are requesting Product-Specific Certificates, to:

 

Certificate (Exports) Request
Office of Cosmetics and Colors, HFS-125, CPK-2
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835

 

Additional questions concerning export certificates can be directed to the Office of Cosmetics and Colors at (240) 402-1130.

 

How much does a cosmetic certificate cost?

FDA's fee for each certificate is ten dollars (that is, ten dollars for each Departmental seal; one seal is attached to each certificate). Do not send payment with your request. We will send an invoice when we issue the certificate(s).

 

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

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

  • There may be a delay if your product appears not to be a cosmetic. The Office of Cosmetics and Colors (OCAC) does not issue export certificates for drugs, devices, or other types of products FDA regulates. It is difficult to estimate the additional time it will take to assess the regulatory classification of products that do not appear to be cosmetics. If it is determined that a product is a drug, device, or dietary supplement, your request for a cosmetic certificate will be rejected and returned to you, and you will have to submit a new request to the proper office, making the process even longer.
  • OCAC's regulatory workload at the time your request is received. Remember, FDA is not required to issue export certificates for cosmetics. More urgent activities receive higher priority.

 

Are there other sources of cosmetic certificates, besides FDA?

Some foreign governments may accept certificates issued by a state or local agency, such as a health department or board of trade, or by a trade association. Since FDA's resources are limited, we recommend that firms pursue alternative sources 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.

 

Some states that provide export certificates:

Florida:

Department of Health
Drugs, Devices & Cosmetics
Address: 4052 Bald Cypress Way, Bin C04
Tallahassee, FL 32399
Telephone: (850) 245-4292
Web site: http://www.doh.state.fl.us/pharmacy/freesale.htm

New Jersey:

New Jersey Department of Health and Senior Services
Food and Drug Safety Program
P.O. 369
3635 Quakerbridge Rd.
Trenton, NJ 08625-0369
Telephone: (609) 588-3123
Fax: (609) 588-3135

Direct questions to maria.carin@doh.state.nj.us
(Although this office issues export certificates, the staff also suggests that New Jersey firms contact their local Chamber of Commerce.)

Texas:

Bureau of Food and Drug Safety
Texas Department of State Health Services
P.O. Box 12008
Austin, TX 78711
Telephone: (512) 719-0222 Ext. 409
Fax: (512) 719-0221
Direct questions to melanie.castillo@dshs.state.tx.us

Some trade associations that provide export certificates:

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

 

Do exported cosmetics have to comply with the FD&C Act and FPLA?

Other countries' laws are different from ours, and there may be situations when a product for export does not comply with the FD&C Act or Fair Packaging and Labeling Act (FPLA). A product intended for export will not be considered adulterated or misbranded under the FD&C Act (Section 801(e); U.S. Code, Title 21, sec. 381(e)) if it--

  • meets the specifications of the foreign purchaser,
  • is not in conflict with the laws of the country to which it is intended for export,
  • is labeled on the outside of the shipping package that it is intended for export, and
  • is not sold or offered for sale in domestic commerce.

However, cosmetic products sold or offered for sale in domestic commerce must comply with all applicable provisions of the FD&C Act, the FPLA, and any other related laws, as well as the regulations established under authority of these laws.

 

What if my product is a drug or medical device?

If your product is considered a drug or a medical device under the law, your request will require review by FDA's Center for Drug Evaluation and Research (CDER) or FDA's Center for Devices and Radiological Health (CDRH).

 

If you need additional information about exporting drugs, please contact CDER's Export Certificate Team at (301) 796-3411.

If you need additional information about exporting medical devices, please contact CDRH at (240) 276-0132 or email exportcert@cdrh.fda.gov.

 

Does FDA issue any other types of cosmetic certificates?

No. OCAC only issues the General and Product-Specific Certificates. For example, we do not issue certificates of sanitation, current Good Manufacturing Practice (GMP or cGMP) certificates, certificate of manufacture, or bovine spongiform encephalopathy (BSE) certificates. For BSE certificates you may wish to contact the Personal Care Products Council (formerly the Cosmetic, Toiletry, and Fragrance Association), a trade organization, for further information. We do not notarize our certificates. We do not change the wording of our certificates to meet individual requests.

 

Does a certificate mean FDA approval?

No. 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 and/or the FPLA and related regulations. The issuance of a certificate does not preclude the Agency 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 do I learn other countries' requirements?

If you are an exporter, it is your responsibility to assure that your products comply with regulations in the destination country. Significant differences exist among different countries. FDA cannot provide information on regulations in other countries. Embassies may be of assistance, or you may contact regulatory agencies in those countries directly for information.

 

How do I learn about other U.S. government requirements for exports?

You may need to work with other government agencies before exporting your products due to, for example, possible economic and trade sanctions or hazardous material shipment concerns. Please refer to "Other Government Agencies You May Need to Know About" for a partial list of other government agencies and related links that may affect your domestic or export business.

 

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

-
-
-