Initiatives for Import Safety

by Food and Drug Administration (FDA)

George Richards knew something was amiss when he went back to the M & T Warehouse in San Francisco to check on some mushrooms.

Three months before, Richards, an inspector with FDA's San Francisco district, had collected a documentary sample (paperwork, photographs, invoices) from a lot of 343 cases of mushrooms imported from the Peoples Republic of China by Tak Yuen Corporation of San Francisco. (Products sampled must be held and kept from distribution until FDA releases them.)

This was in accord with an import alert FDA had issued instructing all districts to automatically detain mushrooms from China because several outbreaks of food poisoning had been associated with them. Richards had noted the numbers on the mushroom cases, marked his initials on three of them, sealed them, and prepared a documentary report for the sample.

When he came back to the warehouse on assignment to collect physical samples from the same lot of mushrooms, Richards discovered that the mushrooms he had originally looked at were gone. The only mushrooms in the warehouse had numbers different from the original cases and were not marked with his initials.

Further investigation showed that Tak Yuen had sold the mushrooms and substituted for them identical mushrooms it had imported through Seattle. FDA referred the case to the Department of Justice, which successfully prosecuted the corporation and its import manager and president.

FDA is cracking down on importers like Tak Yuen that flagrantly violate U.S. import laws. It is part of a new agency initiative to enhance protection of consumers from imports that don't meet U.S. standards. It targets problem importers who, according to FDA Commissioner David Kessler, M.D., "seem to specialize in bringing in goods that violate FDA standards and regulations." Kessler stresses that FDA's strategy to step up enforcement actions against these "willful violators" will not complicate the business of importers whose operations are aboveboard and whose products meet U.S. standards.

The focus, he says, is on "professional lawbreakers and rogues who count on the hectic pace of international trade to get away with substandard goods and excessive profits, regardless of the potential consequences to American public health."

Foods have always been high on the list of violative imports, accounting for 77 percent of imported goods turned back in 1991. This may not be surprising, considering that foods constitute 75 percent of the volume of imports under FDA's purview. Another 14 percent are medical devices, 7 percent are human and animal drugs, and the rest are biologics and cosmetics.

By law, all FDA-regulated imports must meet the same standards as domestic goods. Foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; and all labeling and packaging must be informative and truthful.

A Booming Business

The volume of FDA-regulated imports has tripled in the last two decades from about a half million shipments in 1971 to one and a half million today. During any given week, the United States may import coffee from Kenya, fresh vegetables from Mexico, shrimp from India, perfume from France, drugs from Denmark, surgical instruments from Germany, cosmetics from Taiwan, and suntan beds from Sweden. In another 10 years, the number of FDA-regulated imports is expected to reach two and a half million.

To meet the rising demands on the agency of this burgeoning commerce, FDA has increased its import operations staff over the past several years and expanded surveillance. This boost in strength was accomplished — despite an overall reduction in agency resources — by shifting staff from domestic activities.

Surveillance

Import surveillance is not a glamorous job. It's usually carried out in gray, sprawling warehouses in the least fashionable part of town, or at remote border crossings. But it's a vital activity high on the agency's public health agenda.

Through its district offices and resident posts, FDA is directly or indirectly involved in surveillance at each of the approximately 400 U.S. Customs Service points of entry in the country, including major airports. At the many remote crossings along the Canadian and Mexican borders, FDA relies on the Customs Service for help in identifying suspicious products. On a normal workday, about 200 to 300 FDA inspectors, laboratory analysts, and compliance officers handle imports.

State regulatory agencies also cooperate with FDA on import surveillance. State inspectors examine certain products once they're on the U.S. market and share information with other state officials and federal regulators. The Association of Food and Drug Officials, an organization of federal and state officials, is setting up a committee to explore how FDA and its state counterparts can work together to regulate imports more effectively.

Inspections

Inspecting and sampling imported goods is at the heart of import operations. Inspections have become more complex and time-consuming, not only because the volume of imports is increasing, but also because the nature of the products is changing.

Mary Ayling, acting director of FDA's import policy and enforcement branch, began her career with the agency as an inspector in Oregon. "When I first started in 1972," Ayling says, "most of what we looked at was bulk products — big bags of coffee or rice stuffed in the hold of a ship — on its way to a firm for repacking or processing. In those days you might inspect one or two bulk shipments, looking for chemical contamination among the burlap bags or rodent droppings in the hold. It was like the journey of Fieval in 'An American Tail.' They'd bring the whole family and make a little nest."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.