FDA Sending Inspectors to Other Nations
After Numerous Problems, China Is First on the List

(Washington Post – China)

By Maureen Fan

Under fire for not having the resources to better protect consumers at home, the U.S. Food and Drug Administration is deploying staff members abroad to work directly with importers and foreign regulatory agencies to guard against contaminated animal feed, counterfeit drugs, toys made with lead paint and dairy products containing melamine.

On Wednesday, the FDA will open it first overseas office here in China, whose growing role as an exporter of food and drug products to the United States has combined with several recent food safety scares to prompt the change in strategy.

The agency will initially have at least eight American employees, in addition to Chinese hires, in three offices in Beijing, Shanghai and Guangzhou to certify inspections of U.S.-bound Chinese exports, officials said at a news conference here Tuesday. Third-party certifiers will be allowed, either private commercial labs or Chinese government agencies working under the supervision and oversight of the FDA.

Although officials said they were not targeting any one country, many recent scandals have originated in China, where enforcement of food and drug regulations has often been nonexistent. The head of the Chinese agency that oversees quality supervision, inspection and quarantine, Li Changjiang, resigned in September after dairy companies producing tainted milk were found to have been exempt from inspection. Last year, a former chief of China's State Food and Drug Administration was executed for taking bribes to approve a deadly antibiotic.

For years, Chinese-made counterfeit glycerin was added to cough syrup in Panama, killing hundreds. Last year, Chinese-made wheat gluten was blamed for the deaths of thousands of pets in the United States.

Recently, melamine-tainted dairy products and animal feed from China have killed at least four Chinese infants and sickened thousands, prompting bans or recalls in 16 countries and last week's FDA directive that all Chinese foods made with milk be detained at U.S. ports unless importers certify them melamine-free.

"The global market has clearly changed the nature of our challenge in keeping products safe," Health and Human Services Secretary Mike Leavitt said at the Tuesday news conference after discussions with his Chinese counterparts, including health, food and drug, agriculture and quality inspection officials.

"In the past, we have been able to catch products coming through our borders and find those that are unsafe," he said. "However, the volume of those goods has become so robust that it requires a change in our strategy."

The United States imported nearly $2 trillion worth of goods last year, including more than $320 billion in products from China.

"While we acknowledge we cannot inspect everything, we believe very strongly that we can, through independent certification, assure that someone we trust is overseeing products that come into the United States," he said.

The aim is to work more closely with Chinese regulatory agencies to set quality standards and to educate companies and their distributors.

"We will be looking for them to take corporate responsibility for assuring quality is built in. We will also be sharing intelligence, as well as inspection data and information," FDA Commissioner Andrew C. von Eschenbach said at the news conference.

Experts welcomed the potential partnership but said it might prove largely symbolic.

"It's kind of like an ant standing against a flood," said Kent D. Kedl, general manager of Technomic Asia in Shanghai, which helps medical-device and pharmaceutical companies navigate the Chinese market. "The Chinese State FDA can't monitor everything, so the U.S. FDA is going to have a huge challenge."

Jiang Weibo, a professor at China Agriculture University's School of Food Sciences, is skeptical that the challenge can be met.

"The FDA can never find all the potential poisons in Chinese-exported food products," Jiang said. "There are dozens of pesticides used. Each product might have more than a thousand different poisonous possibilities."

Jiang also said he doubts that the U.S. agency will be able to test products in China's domestic market, which some experts argue is necessary. "The FDA will never be authorized by Chinese government to supervise the products," Jiang said.

But China's health minister, Chen Zhu, said each country would station food and drug officials in the other country "on an equal basis." 11-19-08

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