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What Is a Certificate of Export and When Do I Need One?

June 7, 2005

By Keller and Heckman LLP’s Packaging Practice Group

Companies that export packaging materials from the U.S. to other countries may be requested by foreign customers or by the governments of the destination countries to supply an official certification attesting to the suitable status of their products under the laws administered by the U.S. Food and Drug Administration (FDA). To satisfy these requests, it is possible to obtain a "Certificate of Export" from the FDA, although it is the FDA's ultimate goal to reduce the issuance of the Certificates and assure non-U.S. jurisdictions of the acceptability of FDA-regulated products by other means.[1]

FDA issues Certificates of Export, also known as "certificates to foreign government" or "certificates of free sale" (for food products) for items that may be legally marketed in the U.S. and are not the subject of an enforcement action. FDA is not required to issue Certificates of Export for packaging materials, but does so upon request.[2]

It is important to note that a Certificate of Export for a product does not reflect an "approval" of that product by the FDA; rather, it simply indicates that the product has a suitable regulatory status for sale in the U.S.

Export or Exportability?

Certificates of Export are distinguished from "Certificates of Exportability," which apply to products that meet the export requirements under Section 801(e) or 802 of the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 381(e) or 382), but otherwise may not be marketed in the U.S.[3]

Generally, for Certificates of Exportability, the following conditions must be met: (1) the product conforms to the specifications of the foreign purchaser; (2) the product is not in conflict with the laws of the country to which it is intended for export; (3) the product is labeled on the outside of the shipping package that it is intended for export; and (4) the particular shipment is not sold or offered for sale in domestic commerce.

Obtaining a Certificate of Export

The FDA has described the procedure for obtaining a Certificate of Export in its "Industry Activities Staff Brochure, Procedure for Obtaining Certificates for Export of Foods and Cosmetics" (June 2002), which can be found at www.cfsan.fda.gov/~lrd/certific.html.

In essence, the FDA requires that a company requesting a Certificate of Export provide: (1) an original label or, if no labels have been printed, a detailed draft version of the current label; (2) information on the composition and regulatory status of each product for which a certificate is requested; (3) adequate identification of the manufacturing facility; and (4) the following statement:

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.

Compositional and manufacturing information on the product that is confidential and is submitted with a request for a Certificate of Export should be identified as such, so that the FDA is on notice that the information is exempt from public disclosure under the Freedom of Information Act, 5 U.S.C. § 552 (FOIA), and the FDA's public information regulations at 21 C.F.R. Part 20.

Each Certificate of Export costs $10.00 (a processing-related fee) and takes approximately four to six weeks to be completed.[3]

Is a Certificate of Export Enough?

In response to increasing demand for Certificates of Export, requests by foreign jurisdictions for the FDA to authenticate Certificates, and cases in which Certificates were found to have been falsified, the FDA issued a notice in the Federal Register in December 1998 indicating that, from January 1, 1999, the format of the Certificates would be changed to include more security measures.[5] However, despite the improvements, some countries of destination may still require that Certificates of Export from the FDA be further authenticated by the U.S. State Department and the foreign embassy, which could include additional fees.

In sum, the FDA is not obligated to issue Certificates of Export for packaging materials, but will do so upon request for products that have a suitable status under the applicable laws and regulations. A Certificate of Export, although not often required by foreign companies purchasing U.S. packaging materials, can, in some instances, serve as a crucial customer assurance tool. In other cases, a Certificate of Export may be a prerequisite for entering the market in a foreign country. However, one would expect that, as international commerce continues to expand, customers in jurisdictions outside the U.S. will become familiar enough with the FDA's regulations to rely exclusively on third-party evaluations, regulatory compliance statements, and product certifications.

 

FOOTNOTES

[1] FDA Compliance Policy Guide, 7150.01 ("Certification for Exports").

[2] Section 801(e)(4) of the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §381(e)(4)) states in relevant part that, "Any person who exports a drug, animal drug, or device may request that the Secretary (i) certify in writing that the exported drug, animal drug, or device meets the requirements of paragraph (1) or section 802; or (ii) certify in writing that the drug, animal drug, or device being exported meets the applicable requirements this Act upon a showing that the drug or device meets the applicable requirements of this Act." Foods, food additives, and cosmetics are not included in this requirement.

[3] The FDA describes the different types of export certificates it issues in a guidance document titled, FDA Guidance for Industry—FDA Export Certificates (July 2004).

[4] See Certificate of Export in the FDA's Industry Activities Staff Brochure, "Procedure for Obtaining Certificates for Export of Foods and Cosmetics" (June 2002).

[5] See 63 Fed. Reg. 68774 (December 14, 1998).