What is an Export Certificate?

An Export Certificate is a document issued by FDA certifying to a product’s regulatory status in the United States. Typically, the certificate consists of a statement by FDA that the product complies with federal regulations and may be marketed legally in the United States.

While U.S. law does not require exporters to obtain export certificates, a growing the number of countries and companies require export certificates to import U.S. goods. To accommodate this demand, FDA issues seven different types of Export Certificates covering most of the commodities it regulates (e.g., food, human and animal drugs, biologics, and medical devices.)

The Federal, Food, Drug, and Cosmetic Act (“FFDCA”) requires FDA to issue Export Certificates for food, human drugs and biologics, animal drugs, and devices that meet the applicable requirements of the Act and are legal to market in the United States. In addition to these certificates, FDA issues Export Certificates for other FDA-regulated products such as cosmetics or products that are legal in the importing country, but not the United States.

Exporters of FDA-regulated products may need an Export Certificate for one or more of their products at some point. Many foreign governments require specific Export Certificates before they allow a product into their country. Thus, exporters that cannot obtain the right Export Certificate in a timely fashion risk foreign governments rejecting shipments, delays at foreign ports, and damage to their reputation.

FDA Export Certificates can also add value to your products and brand, even when no certificate is required. Many foreign governments and importers understand that FDA has high regulatory standards for safety and quality. Thus, having an Export Certificate can help improve your product and brand reputation for safety and quality. Your company can even enjoy the benefits of an Export Certificate for products that do not meet FDA standards by meeting FDA’s “Export Only” requirements.

We can help your company take advantage of the benefits provided by FDA’s Export Certificate program, while helping your company avoid costly and damaging consequences by identifying the right Export Certificate for your product and country of export. Our team of experts will navigate the application process for you, obtaining the correct certificate for your product so that will not have to worry about costly delays, shipment rejections, and damage to your reputation. Moreover, our team includes attorneys and regulatory consultants that can also you identify legal and regulatory problems that might prevent your firm from obtaining the necessary Export Certificate(s). Let us help you show your customers the lengths to which you will go to provide them with confidence in your products!

The Role of U.S. Agencies in Export Certificates 

To obtain an Expert Certificate, a company must navigate FDA’s a fairly redundant bureaucracy. For most commodities, FDA issues Expert Certificates through its Centers covering the particular commodity, [e.g. drugs, by the Center for Drug Evaluation and Research (CDER)]. However, in some case FDA further complicates the matter by handing the certification process over to another federal agency, such as Health Certificates for Seafood (destine for the EU) issued by National Oceanic and Atmospheric Administration (NOAA).

Consequently, obtaining the right certificate involves the hassle of identifying the right FDA Center or other federal agency, and then finding competent personnel in that Center/Agency to get the permit issued quickly.

We have years of experience successfully navigating FDA’s bureaucracy. We can help you obtain the right Export Certificate, sparing you the hassle and minimizing the turnaround time.

Read more about the History of Export Certificates, the U.S. Agencies involved or Get Started with obtaining your Export Certificate.