Submission Requirements for Requesting Certificates for Exporting Products to Foreign Countries

Doing business around the globe is no longer the expensive ordeal that may have stymied the growth of a budding company in the past. Thanks to the flattening of the world, business firms can now easily export products made in the United States to countries abroad on a regular basis. Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other statutes administered by the Food and Drug Administration (FDA).

With world trade continuously expanding, the FDA receives an increasing number of requests to issue certificates for U.S. products being exported to foreign countries. While the FDA’s long term goal is to reduce or even eliminate export certificates, the agency understands that there is a high demand for these export certificates.

Certificate Requirements under the Federal Food, Drug, and Cosmetic Act

Certification is the process by which a formal or official attestation is made concerning the regulatory status of a product or the system by which a commodity is manufactured. Requests for certification tend to require verification that the products being exported:

1. are freely marketed in the U.S.;
2. are in compliance with U.S. laws and regulations;
3. are in compliance with the importing country’s requirements;
4. meet certain national or international standards, such as quality standards; or
5. do not contain specific contaminants.

Under the Federal Food, Drug, and Cosmetic Act, the FDA is required to issue certificates for human drugs and biologics, animal drugs, and devices that meet the applicable requirements of the Act. If the FDA issues a certificate within 20 days of receipt of a request for such a certificate, the agency may charge a fee of up to $175. Although FDA is not required by law to issue certificates for foods, animal feeds, feed additives, and cosmetics that can be marketed, sold, and distributed in the United States, the agency intends to continue to provide this service as resources permit.

Six Things to Remember When Requesting an Export Certificate

Persons requesting an export certificate have the burden and responsibility to provide information that will assist the FDA in determining whether a certificate may be issued. Here are six things to remember when requesting an export certificate:

1. Types of Certificates
   • ”Certificate to Foreign Government”: Certificates for human drugs, biologics, animal drugs, and medical devices that may be legally marketed, sold, offered for sale, or distributed in the United States should be entitled, unless required to bear a different name.
   • “Certificate of a Pharmaceutical Product”: Certificates for human drug products, including human biological drugs, that conform to the World Health Organization’s certification
   • ”Certificates of Free Sale”: Certificates for food products and cosmetics
   • “Certificate of Exportability”: Certificates for products that may not be marketed, distributed, or sold in the United States, but which may be legally exported under section 801(e) or 802 of the Act.
2. Filing Certificate​​
   • Ensure to file your request with the appropriate center compliance director or his/her designee that may issue desired certificates.
3. Authentication​​​​​​​​​​​​​​
   • If authentication of the certificate is required, the certificate may be notarized or certified.
4. Procedure and Requirements to Request a Certificate ​​​​​​​​​​​​​​
   • Each center may establish its own internal procedure and requirements for an exporter to request a certificate. At a minimum, the exporter should provide a written statement that:
     • Not only identifies the product or products to be exported, but also demonstrates that the products meet the requirements of this Act or may be legally marketed, sold, offered for sale, or distributed in interstate commerce.
     • Acknowledges that he or she is not knowingly and/or willfully providing false or fraudulent statement through any scheme or device in an attempt to trick the FDA in believing that a material matter does or does not exist.​​​​​​​
5. Possible Statements Included in Certification by the FDA​​​​​​​​​​​​​​
   • A statement that each specific product identified is subject to FDA jurisdiction;
   • A statement indicating the compliance status of the system by which the product is required to be manufactured for approved or licensed products;
   • A statement indicating the premarket clearance status for a product requiring pre-market approval
   • A statement that the named product(s) may be exported under section 801(e) or section 802 of the Act, or may be legally marketed, sold, offered for sale, or distributed in interstate commerce.
   • A statement that the certificate is valid for a period of twenty-four (24) months from the date authorized.
6. Reasons Why a Certificate Will Not Be Issues​​​​​​​​​​​​​​
   • Products do not meet the applicable requirements of the FDA,
   • Products are the subject of a recall by the manufacturer,
   • FDA has initiated an enforcement action on the product (e.g., seizure/injunction),
   • Products are removed from sale or not eligible for legal sale in the U.S.

Failure to satisfy the requirements of this Act will most likely result in a denial of your request for an exporting products certificate. In order to increase the odds that your request will be approved, check out examples of certification for exports that are provided by the FDA. Also, learn more about exporting and other international laws through FindLaw.