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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:
If you export cosmetics, it is your responsibility to--
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)):
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).
FDA issues two types of certificates for cosmetics:
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:
If your product is a cosmetic, and you wish to request a certificate from FDA, you should complete Form FDA 3613d, Office of Cosmetics and Colors "Certificate" Export Application, available in PDF and Word, 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 (301) 436-1130.
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).
Requests for cosmetic certificates may take several weeks to process. The following factors may have a bearing on processing time:
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:
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 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:
(Although this office issues export certificates, the staff also suggests that New
Jersey firms contact their local Chamber of Commerce.)
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:
Some governments may accept a certificate issued by a U.S. trade association, such as the Cosmetic, Toiletry and Fragrance Association (CTFA), the Independent Cosmetic Manufacturers and Distributors (ICMAD), and the World Trade Center Denver.
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--
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.
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) 796-3217 or (301) 796-3218.
If you need additional information about exporting medical devices, please contact CDRH at (240) 276-0132 or email .
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 Cosmetic, Toiletry, and Fragrance Association (CTFA), 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.
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.
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.
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 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.
