U. S. Department of Health and Human Services
U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors
August 6, 2002; revised March 4, 2003

Exporting Cosmetics

If you are exporting cosmetic products or ingredients to other countries or plan to do so, you need to be aware of U.S. legal and regulatory issues regarding exported cosmetics as well as the requirements of the countries to which you export.

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 you make a product for export that does not comply with the Food, Drug, and Cosmetic Act (FD&C Act) or Fair Packaging and Labeling Act (FPLA). That product will not be considered adulterated or misbranded under the FD&C Act 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 [FD&C Act, 801(e); U.S. Code, Title 21, sec. 381(e)]

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

Do I need an export certificate, and where do I get one?

FDA does not require that you obtain an export certificate (sometimes referred to by industry by such names as a "certificate of free sale," "certificate to foreign government," or a "certificate of sanitation"), but government authorities in some countries may ask you for one. FDA's Office of Cosmetics and Colors (OCAC) often receives requests from exporters wishing to obtain such certificates. FDA is not required to provide such certificates for cosmetics. However, upon request we will issue a certificate with an accompanying "To Whom It May Concern" letter. Before placing your request, please review the following information:

• If your product is considered a drug under the law, your request will require review by FDA's Center for Drug Evaluation and Research (CDER). Among the many factors that cause products to be considered drugs are claims for sun protection (such as "SPF" numbers), dandruff control, hair restoration, and treatment of varicose veins. In some cases, the presence of certain ingredients will cause a product to be considered a drug. For more information on determining whether your product is a cosmetic or a drug, refer to "Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)".

  If your product is a drug, address your request for a drug export certificate, called a "Certificate to Foreign Government," as follows:

  Food and Drug Administration
  Center for Drug Evaluation and Research
  Export Certificate Program
  Montrose Metro II, HFD-323
  11919 Rockville Pike
  Rockville, MD 20852

  If you are certain your product is a drug, direct questions about Certificates to Foreign Government to Jocelyn Lewis at the above office, at (301) 827-8983. If you are not certain whether your product is a drug or a cosmetic, you may contact CDER's Division of New Drugs and Labeling Compliance, Roma Jeanne Egli, (301) 827-8931 for clarification.

• It is important to determine the certificate requirements of the country to which the cosmetics are being shipped. Some foreign governments may accept certificates issued by a state or local governmental office (such as a health department or board of trade). The following are four states that issue export certificates:

  California:

  Department of Health ServicesFood & Drug Branch
  (mail stop 357)
  601 North 7th Street
  Sacramento, CA 95814
  Fax: (916) 322-6326

  Florida:

  Department of Health
  Bureau of Pharmacy Services
  Address: 2818-A Mahan Drive
  Tallahassee, FL 32308
  Telephone: (850) 487-1257

  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
  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 Health
  100 W. 49th Street
  Austin, TX 78756
  Telephone: (512) 719-0222.

• In addition, some governments may accept a certificate issued by a U.S. trade association. Since FDA's resources are limited, we recommend that firms pursue these alternative sources for export certificates, provided they are acceptable to the country requiring a certificate.

• FDA does not issue certificates for cosmetics manufactured outside the United States.

• If your product is a cosmetic, and you wish to request a certificate from FDA, you should address your request as follows:

  Lark Lambert
  Office of Cosmetics & Colors, HFS-125
  Center for Food Safety and Applied Nutrition
  Food and Drug Administration
  5100 Paint Branch Parkway
  College Park, MD 20740-3835
  Phone: (202) 418-3412

What is the difference between a "general" and a "product-specific" certificate for cosmetics, and how do I request one?

FDA issues two types of certificates for cosmetics, "general" and "product specific." You will need to determine from the importing country which type you need. A description of each type of certificate follows, along with the information you should provide in your request. (Mail your request to FDA's Office of Cosmetics and Colors at the above address.)

• "General" certificates: A general certificate does not reference any specific products. It simply states that FDA has on file a letter "regarding The Status Of Cosmetic Products Exported From The United States." If you wish to obtain a general certificate, you should --

  • submit your request on company letterhead,
  • indicate that you are requesting a general certificate,
  • specify how many certificates you need, and

  • omit any reference to specific products.

• "Product-specific" certificates: A product-specific certificate states that FDA has on file a letter regarding 1) one or two specific product(s), which will be listed by name, or 2) an attached product list if the certificate applies to more than two products. If you wish to obtain a product-specific certificate, you should --

  • submit your request on company letterhead;
  • indicate that you are requesting a product-specific certificate;
  • list all the products by name;
  • submit the label and all labeling (such as instructions, brochures, etc.) for each product as it is sold in this country;
  • specify the number of products to be listed on each certificate (for example, if you request five certificates for five products, state whether you want a single product listed on each certificate, or all five products listed on each certificate); and
  • include the following statement, which indicates that you understand your legal responsibility for submitting truthful information to a U.S. Government agency:

  "The requester hereby presents and acknowledges that the company is aware that in making this request the company is subject to the terms and provisions of Title 18, Section 1001, United States Code which makes it a criminal offense to falsify, conceal, or cover up a material fact; make any material false, fictitious, or fraudulent statement or representation; or make or use any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry."

  Because of the added time needed for label review, product-specific certificates usually take more time to process.

How long will it take to process my request?

The length of time that FDA will need to process your request cannot be predetermined. The following are some factors that will have a direct bearing on processing time:

• Determining whether the product is a cosmetic or a drug. Remember, OCAC does not issue export certificates for drugs. When potentially therapeutic claims are involved, OCAC must refer a certificate request to CDER to determine whether a product is a cosmetic or a drug. This could add weeks or months to the review time. If CDER finds that a product is a drug, your request for a cosmetic certificate will be rejected and you will have to submit a new request to CDER, making the process take even longer.

• The type of certificate you are requesting. Requests for general certificates usually take about three to four weeks to process, while product-specific certificates usually take longer, due to time required for label review.

• 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.

What if I need more than one certificate?

OCAC recognizes that there are times when a firm needs multiple certificates and asks that you limit requests to a maximum of ten (10) certificates at any one time.

How much does a certificate cost?

FDA's fee for each certificate is ten dollars (that is, ten dollars for each Departmental seal). We will send an invoice when we issue the certificate.

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.

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.