Initiatives for Import Safety : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

By the mid-1970s, more finished products were appearing, packed in 30-foot containers. "Instead of just seeing big bags of rice, you started seeing rice products — rice paper, rice flour — ready to be sold directly to the consumer," Ayling explained. "It was like a grocery store in a container — 40, 50, 100 different products in a container."

The new kinds of products made it necessary to conduct a different kind of inspection, looking for different signs of problems.

"For instance," Ayling says, "there's a big influx now of canned foods and products in hermetically sealed pouches. There are incredible health hazards involved with improperly processed canned foods. Low-acid canned foods, such as asparagus, green beans, peppers, and mushrooms, are potential sources of botulism food poisoning."

With these kinds of products, the inspectors check to see if the manufacturer and the manufacturing process are registered with FDA, as required; 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.

Seafood is inspected 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 and pre-market notification has been submitted. They look for labeling declarations or certifications, and examine the packing to make sure sterility seals are intact.

"There's a big increase in imported devices," Ayling says. "In connection with AIDS, the foreign device industry in condoms and surgical gloves has exploded." She says that devices are getting more "interesting" as well, mentioning a recent shipment of boxer shorts. "Of course we don't normally regulate boxer shorts," she says, " but the Customs inspector, noticing that the shorts had little pockets, each with a condom in it, correctly decided that this was an item for FDA."

Drug Shipments

Drug shipments present a special challenge to agency inspectors. Drugs entering the United States must comply with FDA laws and regulations. They must be listed with FDA, properly labeled, and not make any false or misleading claims. 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 lets its field offices use their 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. For an unapproved drug to be entered into the United States for personal use, it must meet certain criteria, including the following: -It must pose no unreasonable safety risk. (Products from unknown sources are considered to pose a safety risk.) -Satisfactory approved treatment for the condition must not be available in this country. -It must not be promoted for sale in this country.

Although it is impossible to physically inspect each item coming into the country, FDA does review records for all shipments of goods it regulates. From this review, the inspector may decide to release the product for distribution or mark it for further scrutiny. Ten percent of the entry records reviewed are marked for a closer look either by physical examination or sampling and laboratory analysis.

Surveillance 'Blitzes'

One way to quickly gather information on a suspected problem is to conduct what inspectors call a "blitz," a short-term intense surveillance of a product at all or selected ports of entry. FDA is making use of this strategy in its heightened focus on imports. Recently, the agency concentrated on food-use ceramic ware, looking for excessive lead levels. From Jan. 31 to Feb. 21, 1992, FDA inspectors in every port in the country examined ceramic foodware products ranging from fine bone china to Mexican pottery.

Assisted in many instances by state authorities, FDA inspectors examined 5,270 lots of ceramic ware. The results were encouraging. They found only 59 violative lots, 31 of which did not meet new, lowered levels for permissible lead content that had been in effect only a couple of months.

Handling Problems

Under routine surveillance, if inspectors find or suspect a problem, they can hold the shipment and collect a sample for analysis. About 3 percent of all entries are sampled this way. In 1991, FDA detained 27,298 shipments — 62 percent more than in 1985.

In the first quarter of fiscal year 1992, FDA detained more than 13,000 violative shipments. Many were dietary weight-loss products promoted through the mail, such as diet pills from Mexico and starch blockers.

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, to recondition insect-infested rice, the importer could fumigate and process it, using FDA-approved methods, to eliminate the insects. Relabeling might be sufficient for a food that contains sulfite preservatives not identified on the label. (Sulfites must be listed on the label because some people are sensitive to them and could have life-threatening reactions.)

Certain imports that violate FDA regulations cannot be reconditioned and must be exported or destroyed by the importer. This includes products that appear to have been manufactured, processed or packed under insanitary conditions, devices that have not been produced in accord with good manufacturing practices, and products that are prohibited in the country of manufacture, such as perfumes containing chlorofluorocarbons (CFCs). (A group of chemicals used widely in a variety of products, CFCs have the potential to destroy the earth's protective atmospheric ozone layer.)

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.