Initiatives for Import Safety : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

International Cooperation

To further expedite surveillance, FDA has entered into agreements with foreign governments. Through memorandums of understanding (MOUs), governments agree to make sure their products are manufactured under sanitary conditions, meet U.S. standards for quality, and are tested and sampled correctly before leaving the country. For example, to help ensure that shellfish are grown, processed, packaged, and shipped properly, FDA has nine MOUs with countries that export shellfish to the United States.

"If a foreign firm is listed in a new drug application as a supplier of an ingredient for the drug, FDA inspects the plant to make sure it meets the agency's good manufacturing practices. If the firm refuses to be inspected, FDA will not permit it to be a supplier," says Paul Motise, consumer safety officer in FDA's policy and guidance branch. "Also, firms that plan to bring finished drug products into this country are inspected for GMPs," he says.

Sometimes FDA inspects foreign plants at the invitation of the host country. An invitation may come because the manufacturer wants to sell its product in the United States. Other times, an invitation may come after products have been detained, because the manufacturer wants advice on meeting FDA standards. Products from 10 foreign drug manufacturers and 36 foreign medical device manufacturers are currently automatically detained as a result of findings from foreign inspections.

Computer Support

To meet the increasing demands on FDA for surveillance and streamlined operations, the agency is working to automate its import operations. It is developing a sophisticated computerized import support and information system with the acronym ISIS, which will provide product and arrival data more quickly.

"This will enable the agency to better track import trends and allocate its resources where they are most needed," says Ayling. "It will also help to quickly identify and alert the districts to possible problems and to build national historical data files that can be worked into profiles on specific products, shippers and importers."

Agency officials hope the system will also help them discover and clamp down on importers engaging in the unscrupulous practice of "port shopping," in which a shipper or importer tries to sneak adulterated and misbranded food or other products through the import screening process.

"When they get caught in one port, they brazenly take the same shipment to another U.S. port and try again and again," says Kessler, "and we're determined to put a stop to it."

FDA's closest partner in import surveillance is the U.S. Customs Service, which provides the agency with substantial information about suspected violators. Indeed, much of the data for FDA's ISIS will come through Customs' automated system. The two agencies have agreed to link their systems so that data on FDA-related products entered into Customs' system will automatically be transferred to ISIS. A pilot project will begin this year in FDA's Seattle district.

Industry Education

The importer has primary responsibility for making sure foreign goods comply with U.S. regulations. FDA is stepping up its industry education programs, while field staff continue to meet with brokers and importers to educate them about their legal responsibilities and the need for vigilance in complying with the law. Coupled with state participation, these educational efforts should lead to improved product quality and less likelihood that importers will face enforcement action.

"The whole thrust of the initiative," says Ayling, "is to bring home to the importers that it is their responsibility to see to it that the goods they bring to this country measure up to U.S. standards. We can't use our resources for their quality control process."

Import Alerts and Penalties

To help its inspectors cover the vast number of imports, FDA issues alerts to its district offices. These alerts contain the names and descriptions of products, shippers or importers that have repeatedly violated FDA laws or regulations. FDA currently has 350 alerts on products and importers.

The import alert signals FDA inspectors to pay special attention to a particular product when it arrives in port and, in certain cases, to automatically detain it. Some products FDA inspectors currently detain automatically are:

Ceramic ware from at least 11 countries, because of possible lead contamination

Swordfish from all countries, because of high mercury levels

Canned mushrooms from the People's Republic of China, because they have caused several outbreaks of staphylococcal food poisoning.

Once a product is placed on automatic detention, it will not be allowed into the country until the shipper or importer proves that the product consistently meets all FDA standards. As of October 1991, 174 different products and 904 shippers were on automatic detention.

Product detention is not the only penalty imposed for violating FDA regulations. Offenders may also have to face civil and criminal charges. FDA recently sent warning letters to several importers with significant records of violative practices. The letters say that failure to stop this conduct might result in "regulatory action without further notice, such as seizure, injunction, automatic detention of future shipments, or possible prosecution."

Importers who receive such letters have 15 working days to notify FDA in writing of the specific steps they're taking to correct the violation and what they're doing to make sure it won't happen again.

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.