FDA to Speed, Ensure Safety of Imported Food, Drugs

FDA unrolls global strategies aimed to speed and ensure safety of imports

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) As the economy continues to globalize, even the U.S. Food and Drug Administration has taken steps to increase efficiency and safety.

The FDA has unveiled new global strategies designed to ensure the safety of imported food and drugs. The new strategies also are expected to speed the process and improve information sharing.

The new strategy is designed to aid with the rapidly rising number of FDA-regulated imports and is addressed in a report called the "Pathway to Global Product Safety and Quality." In addition to an increase in finished imported products, manufacturers are increasingly using imported materials and ingredients in U.S. production facilities, making the distinction between domestic and imported nearly obsolete.

"FDA regulated drug imports have quadrupled since the year 2000."

The FDA is taking several steps to protect U.S. consumers including partnering with its counterparts worldwide to ensure product safety and quality, developing international data information systems and networks and increasing the sharing of data and regulatory resources across world markets.

FDA officials also plan to increase information gathering and analysis capabilities with an increased focus on risk analytics and information technology and the organization will increasingly allocate FDA resources based on risk.

The new steps build on previous strategies including the FDA's increase in the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and the opening of numerous international offices. The FDA has also collaborated with the European Union and Australia on drug inspections and worked to homogenize aspects of drug regulation.

Additionally, the FDA is broadening its food safety efforts under the FDA Food Safety Modernization Act, a new law that creates a new food safety system with preventative controls and which also allows the FDA to hold suppliers responsible for safety violations and food borne illness.

It also includes new inspection mandates, such as the inspection of more than 19,000 foreign food facilities in the year 2016.

The act also stipulates that importers now have an obligation to verify the safety of the food they bring into the United States. The FDA also is establishing a program for qualified third parties to certify that foreign food facilities are in compliance with U.S. requirements with the option to require certification.

Reviewed by: 
Review Date: 
June 20, 2011
Last Updated:
June 22, 2011