From Psyllium Seeds to Stoneware: FDA Insures Quality of Imports

by Food and Drug Administration (FDA)

It's morning on the docks of Baltimore, and FDA inspectors Dean Cook and Lorraine Harvey, a list of products to be sampled in hand, set to work checking a truckload of burlap sacks of psyllium seed husks from India. The psyllium seed husks are used in making laxatives.

Using a special funnel-shaped tool, Cook and Harvey siphon a pound of seed from six different sacks, then re-seal the bags. The seed will be analyzed back in FDA's laboratory to check for insects and bird excreta, problems that have plagued psyllium seed husks from India.

Next they open a shipment of stoneware plates and cups from India and remove eight sets of dinnerware. These will be analyzed to make sure the level of lead does not exceed that allowed.

Next they slit open a carton of German Christmas cakes. A quick check for excessive food coloring and proper labeling reveals no problems, and the shipment is allowed to be distributed.

"Some countries we almost never have problems with," says Cook. "But others, such as India, Thailand, China, Korea, and many countries in Africa, require constant vigilance."

Just before Cook and Harvey leave the docks, a U.S. Customs Service official alerts them to a shipment of imported noodles labeled only in Chinese. They open the packages, check the items, and make a note that they should be detained for improper labeling.

"The requirement that all products be labeled in English is a problem for some of the smaller, ethnic shippers, such as those from the Far East," explains Cook. "Perhaps they figure only people who read and speak the [foreign] language are interested in buying the product anyway."

Cook and Harvey are just two of 200 to 300 FDA inspectors, laboratory analysts, and compliance officers at work daily across the country insuring that food and drugs imported into this country are safe. In a crisis, such as the Chilean grape scare in 1989, up to 800 FDA field staff may be called into action.

International Palate

During any given week, Americans may consume coffee from Columbia, fruit from Mexico, shrimp from India, and egg noodles from Korea. They may buy perfume from France, vitamin supplements from Denmark, microwave ovens from Japan, x-ray machines from Germany, cosmetics from Taiwan, and drugs from Hong Kong.

With the exception of beef and poultry, which are regulated by the U.S. Department of Agriculture, all food, drugs, cosmetics, medical devices, and products that emit radiation are subject to examination by FDA when they arrive in the United States.

By law, such products must meet the same standards required for 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.

However, imports do not always meet these standards. It is not unusual, for example, for rice or grain from tropical or subtropical countries to arrive infested with live insects. And it is not unusual for processed food products — such as, say, taco shells from Mexico or imitation crab legs from China — to arrive contaminated with insect, rodent or bird filth. Phony drugs and other "quack" products are a common problem. And shipments of ethnic foods frequently have to be detained because the labels aren't in English.

Sometimes it's a case of outright smuggling, as in a recent conspiracy to sneak illegal bulk veterinary drugs into the country, first by boat through the Port of New York, then through the Port of New Orleans, and finally by truck across the U.S.-Canadian border (see "Sentence Upheld for Animal Drug Smuggler" in the Investigators' Reports section of the January-February 1991 FDA Consumer).

The number of imports has jumped in the past 20 years. In 1971, FDA reviewed approximately 500,000 entries of regulated products. Today more than 1.5 million shipments of FDA-regulated products enter the United States each year. This large increase in imports has meant an increased need for surveillance — a need FDA has met by doubling its import operations.

FDA is directly or indirectly involved in product surveillance at each of the approximately 500 Customs Service points of entry into the country, including major airports. At the many remote crossings along the Canadian and Mexican borders the agency relies on the Customs Service for assistance in detaining suspicious products.

All Imports Screened

Every food, drug, or other FDA-regulated import is screened — one way or another. Although it is physically impossible to personally inspect each of the 1.5 million entries a year, FDA does review records for every entry. Based on this review, the product may be immediately released for distribution, visually examined, or sampled and analyzed in a laboratory. Ten percent of the entries reviewed are identified for further coverage.

Out on the docks and in the airports, FDA inspectors look for signs of filth, spoilage, contamination, or mislabeling. For instance, in a shipment of canned green beans, they check to see if the manufacturer is registered with FDA; look at the labels to make sure they are printed in English and conform with other FDA requirements about weight declaration and contents; and spot-check for swollen, leaking or rusty cans, wet cases, or swarms of fruit flies around cases, which may indicate can damage.

In a shipment of coffee, inspectors look for bag damage, moldy beans, and insects. When examining fresh produce, they check for spoilage and insects and sample for illegal residues of one or more of the 256 most widely used pesticides. When checking seafood, most of which arrives frozen, they look for signs of parasites and for evidence of thawing and decomposition.

If a problem is found or suspected by FDA inspectors, the product is not released and a sample may be collected for analysis. Products with a history of violations or those that are a known or suspected health hazard are targeted in advance for sampling or detention. Approximately 3 percent of all entries reviewed are physically examined. Weekly import alerts and detention lists are used to determine which entries in particular should receive close FDA attention.

In 1989, FDA detained 25,740 entries — an increase of 54 percent over 1985. The vast majority were foods.

"The products most frequently turned back are ready-to-eat foods," says Marvin Blumberg, consumer safety officer in FDA's Import Operations Branch. "We often find they are contaminated with filth such as rodent hairs, insect parts, or bird excreta. Because these foods are finished products, the importer can't recondition them without destroying them. So they have to be exported."

If bulk food products such as grain or rice are found to contain certain insects, they can be fumigated and sifted to eliminate the insects or other filth to enable the product to pass FDA inspection, he says.

Keeping Fraud Out

Other items frequently refused entry, says Blumberg, are those with bacterial contamination, such as cheese contaminated with Listeria, and products that may involve health fraud.

"Quack products are always a problem," says Blumberg. One perennial offender is "medicinal" bracelets.

FDA currently has import bulletins on copper bracelets from France, England, Spain, and Mexico. Marketers claim that these bracelets cure a wide variety of ailments, including circulatory problems, fatigue, varicose veins, high blood pressure, nervousness, and impotence.

Another metal bracelet from Mexico supposedly cures constipation, hemorrhoids, and digestive problems and prevents heart attack.

The most recent entries onto the health fraud market are cures for cancer or AIDS. "Unfortunately," says Blumberg, "when people are desperate, they grasp at anything from any part of the world that might offer hope. And producers of quack drugs know this. The products they promote and try to sell through the mail range from herbal preparations to drugs which could be very dangerous if taken."

One such dangerous cancer drug was Laetrile, a substance derived from apricot kernels and imported from Mexico. In the '70s and early '80s, Laetrile was widely promoted as a "cure" for cancer, and many terminally ill cancer patients were desperate to obtain it. However, its safety and effectiveness had never been tested. When clinical trials sponsored by FDA and the National Cancer Institute finally were run, the drug was found to be derived from apricot kernels and to contain high levels of cyanide. Not only was it ineffective, it was potentially lethal.

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.