EXPORT CERTIFICATES FOR DIETARY SUPPLEMENTS

One way of increasing one’s business is to expand the market by selling a product internationally, but there are some things one should know about before choosing this option. Prior to exporting products regulated by the Food and Drug Administration (FDA), such as dietary supplements, most importing countries will require that the exporter provide it with an Export Certificate (certificate). The certificate generally indicates to the importing country that the FDA regulates the product and that the product is not subject to any enforcement action by the FDA, but the certificate does not necessarily guarantee a product’s safety or quality. Even though the FDA issues the certificates, it does not require exporters to obtain them.

Although a certificate is not required to export a product, most importing countries will typically not accept a product without the certificate. It is important to note that the type of request made to the FDA and the information required may differ according to the type of product exported. In addition to providing the FDA with the required information on the certificate request, it is always a good idea to verify that the importing country does not require additional information. This should decrease the chance of problems at the time of exportation.

How to Request a Certificate

The process of receiving a certificate for dietary supplements is relatively easy. In order to obtain a certificate, the domestic (U.S.) company must request one from the FDA or another authorizing agency. Please note that certain states also provide similar types of export certificates that could satisfy the importing country’s requirements, but for purposes of this article, only the FDA will be mentioned. Please inquire with your State licensing or inspection Agency for more particular information on State-supplied export certificates.

The FDA requires the exporter to provide certain information about the product. The exporter’s request must include the following: (1) an original label or, if no labels have been printed, a detailed draft version of the current label; (2) sufficient information for each product for which a certificate is requested so the reviewer can properly identify the product; (3) adequate identification of the actual manufacturer of each product; 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.”

After the above information is included, the exporter must send the request to the proper office. The office that processes the request will depend on the type of product exported. Currently, the FDA’s Center for Food Safety and Applied Nutrition has five offices that process requests for certificates. An FDA certificate request for dietary supplements should be sent to:

Center for Food Safety and Applied Nutrition
Office of Nutritional Products, Labeling and Dietary Supplements, HFS-800
U.S. Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740-3835

After the FDA receives a properly executed request, it will grant a certificate as long as the product meets the requirements of 801(e) of the Federal Food, Drug and Cosmetics Act. Section 801(e) basically states that (1) the product meets the specifications of the foreign purchaser; (2) the product is not in conflict with the laws of the importing country; (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. If the request is proper and if the product meets the 801(e) requirements, a certificate will generally be issued within four to six weeks of receipt of the certificate request. Prices will vary depending on whether the request is sent to the FDA or to a state agency, but the FDA charges $10.00 (U.S.) for each certificate it provides. This charge will be billed separately, therefore, there is no need to include any payment with the request.

The Importance of Obtaining a Certificate

Obtaining a certificate prior to exportation is always a good idea. One beneficial reason for obtaining a certificate is because it promotes free and open trade in the international community. As mentioned above, the certificate does not necessarily guarantee a product’s safety or quality, but it can provide an inference that the product is credible. A certificate assures the importing country that a product meets certain U.S. standards, and this results in the importing country feeling a little safer and more comfortable about accepting a product that has met U.S. requirements.

Another important reason, and essentially the most important reason, for obtaining a certificate is because it has basically become common trade practice. As established, certificates are not always required, but those international markets that do not require a certificate are very few. Most of the major international markets require some type of certification, and for this reason, exporters are better off to request a certificate well in advance of the date they plan on exporting the product. This will help prevent any delays in exporting the product, as well as help prevent any conflicts with those companies shipping, storing and distributing the product.

The process of requesting and obtaining a certificate for dietary supplements is fairly simple and inexpensive, but it must be reiterated that the process will vary depending on the type of product exported. Products, other than dietary supplements, may require the inclusion of more detailed information, as well as a higher fee, but the end result will be the same – the opportunity to increase sales with the expansion into other markets.

For more information on export certificates, please contact Weaver & Amin.