Parker, Waichman, Alonso LLP

Home » Articles

FDA Opens China Office

Nov 20, 2008 | Parker Waichman Alonso LLP

The U.S. Food and Drug Administration has been under fire for some time now over lapses in food and product safety, especially in its oversight of imports to the U.S.  As this trend continues, the FDA has been discussing opening offices in key international locations.  Now, USA Today is reporting that the FDA has opened its first such foreign office yesterday in China.  The Associated Press (AP) reported that this is the first such FDA office to open outside of the U.S. and that the office opening “is part of” the FDA’s “new global strategy” to protect imports entering the U.S.

The opening follows an FDA order last week in which it mandated Chinese “food products” be stopped at the U.S. border for melamine testing, said USA Today.  David Acheson, the FDA's associate commissioner for foods, said the broad hold was atypical but necessary given that different foods from a variety of manufacturers were testing positive for melamine, indicating the tainting is not limited to a few importers, reported the AP.  

Melamine and China have been making headlines in recent weeks and months because of global contamination issues that began when melamine-tainted baby formula sickened tens of thousands of children.  Reports initially indicated that four infants died; however, new estimates are placing that number as high as eight.  

Melamine is an industrial chemical notorious for its ability to cheat nutrition tests because of its high nitrogen contents. When added to foods, melamine creates the appearance of high protein levels.  The continuing scandal is proving that this practice is much more widespread than originally thought, affecting not only milk and milk products, but animal food and feed, as well.  This is of particular concern because when animals eat tainted feed and enter the food chain, melamine travels with the animal.  For instance, chickens fed tainted feed were found to have produced melamine-tainted eggs.  Melamine can cause serious kidney problems—including kidney stones and kidney failure—when ingested.

"We are currently importing about 15% of the food we eat in the United States, and it is increasing every year," Acheson told USA Today. "It's much easier if we can build the collaboration at a local level rather than trying to do it from 8,000 miles away," he added.

According to USA Today, Acheson was talking at a ribbon cutting ceremony also attended by U.S. Health and Human Services Secretary Mike Leavitt.  According to USA Today, Leavitt said that—in addition to the new office with eight American employees “with expertise in food, medicine, and medical devices”—the FDA will open offices in Shanghai and Guangzhou this week; in India next month; and in Latin America, Europe, and the Middle East next year.  

The AP explained that the China offices will collaborate with Chinese counterparts in local facility inspection, as well as assisting with implementing U.S. quality standards and eventually training local experts to conduct inspections “on behalf of the FDA.”  The AP reported that Leavitt said that the FDA was planning to develop Chinese product certification processes.