FDA Consumer magazine
July-August 2003 Issue

FDA's Response to Food, Dietary Supplement, and Cosmetic Adverse Events

By Linda Bren

A child's throat swells up after she eats a piece of fruit. A man gets short of breath after he takes a dietary supplement. A woman gets an eye infection after she uses mascara. Are these allergic reactions? Effects of chemical properties or contaminants? Or just coincidences?

Determining the cause of incidents like these and helping to prevent their recurrence is the focus of a new system within the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN).
This summer, the center is launching its CFSAN Adverse Event Reporting System (CAERS) to help track and monitor adverse events related to foods, dietary supplements, cosmetics, food additives, and color additives--the five types of products regulated by CFSAN.

CAERS is part of an agency-wide effort to improve the reporting of adverse events to the FDA. Information-gathering tools, data management, and collaborations with health care institutions are being used to improve the systems for reporting and tracking adverse events related to drugs, medical devices, blood products, vaccines, radiation-emitting products, and drugs for animals, as well as the products included in CAERS.

An adverse event is any illness or injury that may be associated with a product or ingredient. Adverse event reporting systems typically detect only a small proportion of the events that actually occur, according to an April 2001 report from the Health and Human Services Office of Inspector General. For example, according to one estimate, the FDA receives reports of less than 1 percent of all adverse events associated with dietary supplements.

CFSAN receives about 7,000 complaints each year concerning the products it regulates--only about half of these are actual adverse events involving illness or injury. "But 7,000 complaints volunteered by consumers is only the tip of the iceberg," says Kenneth Falci, Ph.D., director of CFSAN's Office of Scientific Analysis and Support.

For the most part, reporting adverse events associated with foods, cosmetics, dietary supplements, and food and color additives is voluntary. "When consumers, health professionals and manufacturers are diligent in reporting, it helps the agency to better understand what events are occurring and what can be done to keep them from happening again," says Falci.

Most of the adverse events and other product complaints currently being reported to the FDA come in through two routes: to complaint coordinators in the FDA's district offices around the country, and through MedWatch, the FDA's adverse event reporting program for medical products. "That's the way it has always worked and these options of reporting events will continue," says Falci. But CAERS will make a difference by quickly getting this information about reported events to the right people to analyze it. Complaint data received by telephone, mail, e-mail or fax will be entered into CAERS and electronically transmitted to safety reviewers at CFSAN. Medical records and other hard copy data will be scanned into CAERS and also transmitted electronically. Then the detective work can begin.

CFSAN medical personnel will investigate incidents and look for trends across multiple adverse event reports to help the agency determine the cause and the action needed. If one product is found to cause multiple adverse events, agency actions could result in the product's recall, a consumer advisory, or regulatory action such as improved product labeling.

CFSAN's initial action is to send a letter to the firm whose product is allegedly associated with an adverse event. In the case of a consumer death, the letter is sent within 24 hours of receiving an adverse event report. "We want to be transparent, open, and honest," says Falci, and "let the company know we have received this information." Letters will refer to a report from either a consumer or health care professional but will not provide names or other information that could be used to link the individual to the reported event.

A real-time reporting feature of CAERS will allow the FDA to use the system as a counterterrorism tool. The system is designed to scan and report information for similar occurrences around the nation, and to provide information that can be used to develop an early warning capability for foodborne illness and other adverse events. Even when an adverse event doesn't signal a national security threat, "CAERS can enhance the ability of the agency to respond to consumer injury, in an appropriate manner, with all due haste," says Falci.

Although CAERS is expected to improve the speed of reviewing and analyzing adverse events, Falci sees the new system as the genesis of an even better adverse event reporting system. "CAERS is the beginning of the exercise to improve food adverse event reporting throughout the nation," he says. "The quality of the data reported in a voluntary system ranges from excellent to poor, as there is currently no standard way of reporting," adds Falci. An improvement to CAERS may be the use of a standard questionnaire or form to encourage consistent reporting of events.

Reporting Adverse Events

Consumers can play an important public health role by reporting to the Food and Drug Administration any adverse events or other problems with FDA-regulated products.

Timely reporting allows the agency to take prompt action. Report what happened as soon as possible. Have the following information ready:

Description of the adverse event
Name, address, and phone number of the doctor or hospital if emergency treatment was provided
Name of product and manufacturer
Any codes or identifying marks on the product label or container
Name and address of the store where you purchased the product and the date of purchase.

To report an emergency that requires immediate action, such as a case of foodborne illness or a drug product that has been tampered with, call the FDA's main emergency number, staffed 24 hours a day: 301-443-1240.

To report a non-emergency adverse event, contact the FDA district office nearest you. Look up the FDA's phone number under the Department of Health and Human Services in the blue U.S. government section of the telephone directory. Or check the phone numbers listed by state at www.fda.gov/opacom/backgrounders/complain.html.

Adverse events regarding medical products may also be reported to the FDA's MedWatch program at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Also report the problem to the manufacturer or distributor shown on the product label and to the store where you purchased the product.

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