History of Certifications and Exports

The FDA issuing Certifications on exports is not a recent development. However, changes to the regulatory framework along with an expanding demand for U.S. products have made the demand for export certificates increase dramatically, especially with the enactment of the FDA Export Reform and Enhancement Act of 1996, which eased restrictions on exports and allowed for the FDA to provide certification for products not legally authorized for sale in the U.S. This amendment increased the companies and products that were eligible for certificates.

Even with this broader availability of export certificates, it has been the growth and development of the global economy to previously unreachable countries and markets that fostered the demand for export certificates. As foreign countries develop, they realize the need for regulating the products that cross their borders; however, developing a sufficient regulatory framework and department to oversee imports is an expensive proposition. More and more foreign countries are “piggy-backing” off FDA and requiring export certificates certified by FDA.

This increased demand by foreign countries coupled with the immense growth in U.S. Exports has made the demand skyrocket. Currently, 70% of the world’s purchasing power exists outside of the U.S. That number is set to increase further, as 85% of the world’s economic growth over the next 5 years will happen outside the United States. Exports in 2011 reached $2.1 trillion, eclipsing the prior annual high of 2008 by $300 billion. Since the “Great Recession” ended, exports have accounted for half of U.S. Economic growth. All indicators point to this increasing further; President Obama in his January 2010 State of the Union speech set a goal to double U.S. exports within the next 5 years.

The demand for export certificates will only increase as the U.S. exports more and more products to the rest of the world.