FDA opens new China office

The U.S. Food and Drug Administration opened an office Wednesday in China's capital - its first outside the United States - as part of a new global strategy to ensure the safety of trillions of dollars of imports.

Product safety has become a key issue as American manufacturers shift operations overseas and foreign producers make inroads in the U.S.

Worries about the quality of Chinese exports to America have become a major feature of bilateral trade ties, with substandard Chinese food and toxin-laced toothpaste among product safety scares this past year.

"In the past we have always been at our borders to try and catch things that were not safe or did not meet our standards," U.S. Health and Human Services Secretary Mike Leavitt said at a ribbon-cutting ceremony to mark the opening of the Beijing office. "In the future our new strategy is to build safety into products at every step of the way."

After meetings with Chinese officials on Tuesday, Leavitt said both countries would work on a joint initiative to use better technology for detecting contamination, demand greater corporate responsibility and increase sharing of data and information.

Health minister Chen Zhu has said that Chinese quality officials will soon be stationed in the U.S.

In the past year, China has stepped up inspections and tightened restrictions on food production and other industries, after a series of global product scandals. Still, it's an uphill climb for Chinese authorities to regulate countless small and illegally run operations, which are often blamed for introducing chemicals and food additives into the murky food chain.

Most recently, dairy products tainted with the industrial chemical melamine have been blamed in the deaths of at least three babies in China. Tens of thousands of other children were sickened.

Shao Mingli, a vice health minister and head of the country's food and drug administration, said the opening of the FDA office "provides a very clear signal to the whole world."

"As food and drug regulatory agencies, our first priority is to protect public health and life," Shao said. "This is our top responsibility."

The FDA office in Beijing will be followed by two more in the Chinese cities of Shanghai and Guangzhou. Offices will also be opened in India, Latin America and Europe in coming months as the FDA tries to globalize its presence to reassure consumers. This year alone, the U.S. imported $2 trillion worth of goods, equal to four times the size of Brazil's economy.

Over the past year, the FDA has been criticized for failing to prevent a string of problematic products from entering the U.S., including contaminated blood thinners manufactured in China and salmonella-tainted peppers imported from Mexico.

"FDA is reaching beyond our own borders to be able to work collaboratively and cooperatively with other regulatory agencies around the world" as a way to assure that products are safe and effective, said the agency's commissioner, Andrew von Eschenbach.

The China offices will have eight FDA staff members, including inspectors and senior technical experts on regulation, policy, food, medicines and medical devices, said Christopher Hickey, the FDA's country director.

They will work with their Chinese counterparts to build capacity and offer their experiences and expertise, he said. Their responsibilities will include inspecting local facilities, providing guidance on U.S. quality standards, and eventually training local experts to conduct inspections on behalf of the FDA.

Leavitt said the agency was also working to establish independent Chinese certification of products - a common practice in the private sector - by a trusted source that will be approved and supervised by the FDA. This will help shipments of Chinese goods gain faster clearance into the U.S., he said.

However, Leavitt said there are still legislative hurdles to overcome and that it "will be a continual process for many years." He did not give any details.

The opening of the FDA's Beijing office comes days after U.S. health officials detained foods from China made with milk and other dairy ingredients as a precaution to keep out foods contaminated with melamine. They included snacks, drinks and chocolates.

Importers must pay to have their products tested by an independent laboratory that meets FDA standards. Only products found to be melamine-free will be allowed into the U.S.

It is unusual for the FDA to put such a broad hold on goods from an entire country, not just a few rogue manufacturers. But David Acheson, the FDA's associate commissioner for foods, said Wednesday that multiple tests across a variety of brands from a variety of manufacturers kept showing positives for the chemical.

Von Eschenbach said the U.S. was working closely with China to resolve the issue.