If the number of FDA-regulated products coming in from foreign shores is any indication, the import business in the United States is flourishing. In the last 20 years, the volume of imported goods the agency regulates has tripled from an estimated half million shipments in 1971 to about 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.
To meet the rising demands on the agency of the burgeoning import trade, 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 with lower priorities.
In addition, an internal FDA task force was recently convened to develop new import initiatives. The group recommended that the agency redirect some of its efforts to better use its resources. New or heightened emphasis is being placed on:
These four areas of emphasis will enhance FDA's basic import responsibilities, which center on its inspection program.
With the exception of most meat and poultry, which are regulated by the U.S. Department of Agriculture, all food, drugs, cosmetics, medical devices, and electronic products that emit radiation are subject to examination by FDA when they arrive in the United States.
By law, all of these products must meet the same standards as domestic goods. Imported 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.
Whereas in the mid-1970s on any given day an FDA inspector might inspect one or two bulk shipments of rice or coffee beans, today's inspectors might inspect 5, 10 or 15 smaller, individual shipping containers packed with as many as 50 different finished products.
The inspectors look for signs of filth, spoilage, contamination, or mislabeling. For instance, in a shipment of canned tuna, they check to see if the manufacturer is registered with FDA; make sure the labels are printed in English and conform with other FDA requirements about weight declaration, contents, and so forth; and spot-check for swollen, leaking or rusty cans, wet cases, or swarms of insects around cases (which may indicate damaged cans). When checking seafood, they look for signs of parasites and for evidence of thawing and decomposition.
When examining medical and radiation emitting devices, inspectors check to see that the importer is registered and the device is listed with FDA, look for labeling declarations or certifications, and examine the packing to make sure sterility seals are intact.
If a problem is found or suspected, the shipment is held and a sample is collected for analysis. Approximately 3 percent of all entries are physically sampled in this fashion. In 1991, FDA detained 27,298 entries 62 percent more than in 1985. In the first quarter of fiscal year 1992, more than 13,000 violative shipments were detained. Most were dietary weight-loss products promoted through the mail.
When a product appears to be adulterated or misbranded under the federal Food, Drug, and Cosmetic Act, the importer is given an opportunity to bring it into compliance through reconditioning or relabeling. For example, insect-infested rice could be fumigated and processed by the importer (using FDA-approved methods) to eliminate the insects. Food containing sulfites (preservatives to which some people are allergic) but not identified as such on the label could be relabeled to include that information.
Certain imports that violate FDA regulations cannot be reconditioned and must be exported or destroyed by the importer. This applies to products that appear to have been manufactured, processed or packed under insanitary conditions, drugs or devices that have not been produced in accordance with good manufacturing practices, and products that are prohibited in the country of manufacture, such as perfumes containing chlorofluorocarbons (CFCs).
While most FDA-regulated imports are foods, drug shipments present a special challenge to agency inspectors. FDA randomly checks and samples imported drugs.
Drugs entering the United States for sale must be FDA-approved products from approved suppliers and must meet U.S. requirements for purity and strength. In addition, inspectors check labels and look for tamper-resistant packaging and signs of possible contamination, such as cracked vials and broken bottles. As with other imports, potential problem drugs are targeted in advance for sampling and detention.
FDA permits its field offices to use discretion in allowing entry of small, "personal use" quantities (generally not more than a three-month supply) of foreign drugs not approved in the United States. This applies in cases in which satisfactory treatment for the condition is not available in this country, the drugs pose no unreasonable safety risk, and their use is not promoted in the United States.
The four areas recently identified by FDA's import task force as in need of enhancement begin with an emphasis on cooperative surveillance activities with state governments.
Through its district offices and resident posts, FDA is directly or indirectly involved in surveillance at each of the approximately 500 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. The Association of Food and Drug Officials, an organization of federal and state officials, has set up a committee to explore ways in which these two levels of government can work together to enhance their effectiveness in regulating imports. State inspectors examine certain products once they're on the U.S. market and share data they collect with other state officials and federal regulators.
Although it is impossible to physically inspect each of the 1.5 million shipments a year, FDA does review records for every agency-regulated entry into the country. Based on this review, a product may be immediately released for distribution, physically examined, or sampled and analyzed in a laboratory. Ten percent of the entry records reviewed are marked for further scrutiny.
Sampling and surveillance of imported goods have become more difficult in recent years, not only because of the increasing volume, but because the nature of the products has changed significantly. Previously, raw materials intended for packaging or further processing in the United States comprised the bulk of imports. Many of today's imports are finished, ready-to-use products shipped in smaller quantities in multi-product containers.
To further expedite surveillance, FDA has entered into agreements with foreign governments. Through memorandums of understanding (MOUs), governments agree to ensure that their products are manufactured under sanitary conditions, meet U.S. standards for quality, and are tested and sampled in a specific way before leaving the country. For example, FDA has nine MOUs with countries that export shellfish to the United States. These MOUs help ensure that the shellfish are raised, processed, packaged, and shipped properly.
Sometimes FDA inspects foreign plants to ensure that manufacturing practices meet U.S. requirements. Products from 10 foreign drug manufacturers and 36 foreign medical device manufacturers are currently automatically detained as a result of foreign inspections. Manufacturers of foreign goods that have been detained sometimes request an inspection, seeking advice on how to produce goods that meet FDA requirements.
The number of imports to the United States is expected to continue to grow. To meet the increasing demands for surveillance and to streamline its operations, FDA is working to automate its import operations. The agency has developed a computerized import support and information system (ISIS) that will provide much more immediate data on what products are being imported and where and when they are arriving. This will enable the agency to better track import trends and allocate its resources where they are most needed. 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.
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 for this interface will begin this year in FDA's Seattle district.
One recommendation of the task force focused on a way to quickly gather information on a suspected problem by conducting a "blitz," a short-term intense surveillance of a product at all or selected ports of entry. Recently, the agency concentrated on food-use ceramic ware, looking for excessive lead levels. The surveillance covered every port in the country, and the products ranged from fine bone china to Mexican pottery. Assisted in many instances by state authorities, FDA inspectors examined 5,270 lots of ceramic ware, collected 179 samples, and found 36 violative lots.
Another of the task force's recommendations means that FDA will be clamping down not only on violative imported goods, but also on the importers who continually and flagrantly violate the law.
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 been found to violate FDA laws or regulations. 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. FDA currently has 345 alerts on products and importers.
Products that consistently violate FDA standards or are known or suspected health hazards are automatically detained. Automatic detention alerts are used to determine which shipments should be denied entry without further examination by the agency.
For example, ceramic ware from at least eight countries is currently automatically detained because of possible lead contamination. Swordfish from all countries is automatically detained because it repeatedly has been found to contain high levels of mercury. Canned mushrooms from the People's Republic of China are automatically detained because they have caused several outbreaks of staphylococcal food poisoning.
In addition to identifying and detaining problem products, the agency identifies problem importers and foreign exporters as well. Importers who consistently bring in violative products, engage in "port shopping" (trying to enter goods in a second port after having been refused entry elsewhere), or otherwise attempt to evade FDA regulations are warned that their products may be automatically detained. Once a product is placed on automatic detention, entry cannot resume until the shipper or importer proves that the product consistently meets FDA standards. As of October 1991, 174 different products and 904 shippers were on automatic detention.
Now, as recommended by the import task force, offenders can expect to be held accountable not only through product detention, but through the courts facing possible product seizures, injunctions, and criminal prosecutions.
The primary responsibility for ensuring that foreign goods comply with U.S. regulations lies with the importer who brings the products into the marketplace in this country. FDA has in the past conducted industry education programs, and will increase this activity as the import task force has recommended. Field staff will 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.
All these steps will further ensure that food, drugs, and other FDA-regulated products brought into this country for use by American consumers meet the same high standards as domestic items.