A series of safety scares involving Chinese exports prompted the Food and Drug Administration (FDA) three years ago to open an office in China to help oversee the quality of products being imported to the United States. Since then, the agency says it has made notable strides toward developing an infrastructure that better ensures product safety.
Since the office opened in Beijing in November 2008, the 13-person staff has trained more than 1,600 manufacturers and regulators on United States safety standards. Much of that training involved a hands-on workshop in the cities of Hangzhou and Zhoushan, which included both classroom instruction and three full days of demonstrating at two plants what all is involved in an FDA investigation. The agency now says it believes the FDA and its Chinese regulators are working toward a common goal.
Public confidence in Chinese products waned after a series of safety scares in 2007 and 2008. That’s when contaminants in the blood thinner Heparin, pet food, toothpaste, seafood, and other products caused illnesses and some deaths in the United States and in other countries.
The Chinese also suffered the consequences of contaminated products. In 2008, about 300,000 Chines babies were sickened and six died from infant formula contaminated with the toxic chemical melamine, which is used to make concrete and plastics. Some manufacturers purposely added melamine to formula because the chemical made it appear that the product contained more protein that it actually had. The incident resulted in numerous criminal prosecutions, and China executed two people connected to the scandal.
Nearly 24 million shipments of FDA-regulated products were imported into the U.S. in the 2011 fiscal year (October 1, 2010-September 30, 2011) from 228 foreign jurisdictions – a fourfold increase over the past decade. The agency says this steadily increasing volume of imports has made it more important than ever for the FDA to rebuild relationships with regulators and industry abroad.