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China Agrees to Stepped-Up Food, Drug Inspections

New accord puts more responsibility on China to identify, solve problems

By Joseph S. Enoch
ConsumerAffairs.com

December 19, 2007

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Secretary of Health and Human Services Michael Levitt, fresh from a long visit in China, says that country and other exporters must take responsibility for inspecting food and drug products to be sure they're safe.

“We cannot inspect our way to product safety,” Leavitt said in remarks to the National Press Club in Washington.

Leavitt signed two agreements with the Chinese government last week that puts the onus on the Chinese and their manufacturers rather than the beleaguered inspectors of the dozen U.S. agencies responsible for imported goods.

The agreements cover high-risk food and feed products as well as drugs and medical devices.

In both the agreements, China has agreed to ensure that makers of those high-risk products register with China's food and drug regulatory agency, the SFDA, and that the agency then ensure that any products those companies export to the U.S. comply with U.S. regulations.

The agreements also require that China increase its vigilance against counterfeit products, allow U.S. agents greater access to production facilities and impose greater transparency and 24-hour deadlines for the Chinese government to share data on potentially harmful products.

The risky Chinese exports covered in these agreements must also use bar coding so that if problems are found, it will be easier to track where the products were manufactured and determine where the inspection process failed.

Global problem

“This is truly a global problem that will expand unless we get in front of it,” Leavitt said.

The high risk foods and feeds covered in the agreements are:

• low-acid canned products or acidified food;
• pet food/pet treats of plant origin or animal origin;
• ingredients of food and feed, i.e., wheat gluten and rice protein; and
• all aquaculture farming products other than molluscan shellfish.

The high risk drugs and medical devices are:

• condoms;
• atorvastatin (a cholesterol-lowering drug);
• sildenafil (a drug for erectile dysfunction);
• dietary supplements intended for erectile dysfunction;
• human growth hormone;
• oseltamivir (an antiviral product);
• cephalosporins (a class of antibiotics) manufactured in facilities that also manufacture non-cephalosporin drugs;
• glycerin;
• glucose test strips; and
• gentamicin sulfate (an antibiotic).

A smaller haystack

Leavitt said the way to ensure product safety is to reward good practices. Currently, Leavitt said the Food and Drug Administration's inspectors are so overworked, they are searching for the “needle in a haystack” and that the key to inspection safety is to “shrink the haystack.”

The way to do that, Leavitt said, is to inspect companies with a good history of safe products less often and and to frequently inspect, fine and possibly deny U.S. entry to companies that repeatedly make dangerous products.

Other recommendations in a report Leavitt has prepared include:

• Implement stronger certification. More inspections will bog down an already overworked inspection network, Leavitt said. Products that are inspected and certified by foreign governments and independent inspectors, such as Underwriter's Laboratory, will ease the work load at the 300 U.S. ports of entry that receive products from more than 800,000 sources.

• Inform the market. If there is more public transparency, the market will punish unscrupulous manufacturers more so than any fine or regulation the U.S. can impose, he said.

• Expand the U.S. presence overseas. If the U.S. can plant agents from agencies such as the Consumer Product Safety Commission and FDA, they can not only perform inspections at overseas plants, but also monitor overseas agencies such as SFDA and help teach them about U.S. standards, he said. Currently neither agency has any jurisdiction overseas.

• Enhance standards. Along with teaching overseas manufacturers about U.S. standards, some of those standards, such as lead levels in children's toys, should be both set, if they are not already, or made more strict, Leavitt said.

• Implement stronger penalties. The FDA has a maximum fine of $1.4 million it can levy against companies while the CPSC's maximum is $1.8 million. Bills in Congress are set to increase the CPSC's anywhere from $10 million to $100 million while Leavitt said he hopes Congress increases the FDA's to $10 million.

• Create interoperable inspection systems. Almost every agency uses a different system to track products and many systems within each agency. Leavitt proposed making one system at U.S. ports so that the research of each agency is available to all inspectors.

“This is a master plan that will allow us to build out among the government and private sector,” Leavitt said.

A long journey

Despite the strong language of the accords and the report, Leavitt did not hail it as a victory or even a long-term cure.

“A man who moves a mountain starts by moving small stones,” Leavitt said quoting a Chinese proverb.

The Chinese grudgingly agreed to these accords in the face of a more than year-long public relations disaster and it may be difficult getting them to follow through because most reports out of the country reveal that agency leaders don't actually believe there is a serious problem.

Chinese envoy Wu Yi, told The New York Times that the American news media has exaggerated the issue of food safety, “causing serious damage to China’s national image.”

Perhaps. But Leavitt said only the Chinese can repair the damage that has been done.

“The 'made in China' brand will be seriously harmed over time if they don't meet U.S. standards,” Leavitt said.

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