U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Backgrounder: May 1992
IMPORTS AND FDA
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
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
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:
- establishing cooperative programs with state regulatory
agencies for surveillance of imported products
- conducting "blitzes" short-term intensified surveillance of
a specific product
- initiating civil and criminal judicial action against both
importers and foreign exporters who repeatedly violate FDA
- educating importers on their responsibilities in adhering to
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
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
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
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
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
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
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