Once a product is in widespread use, unforeseen problems can sometimes lead to a recall. Contaminated spinach, for example, led to the recent recall of spinach products under multiple brand names. Contaminated peanut butter led to the recall of thousands of jars of two popular brands. In both cases, FDA responded immediately to minimize harm.
When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. In most cases, a recall results from an unintentional mistake by the company, rather than from an intentional disregard for the law.
Whether it’s because of the flu or seasonal allergies, diabetes or epilepsy, pregnant women must often take prescription medication—usually while worrying about the potential impact on their developing babies.
With studies showing the average woman takes from three to five medications while pregnant, the Food and Drug Administration (FDA) encourages drug makers and moms-to-be to participate in pregnancy registry studies that track the risks from drugs taken during pregnancy or breastfeeding.
Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.
FDA first hears about a problem product in several ways:
A company discovers a problem and contacts FDA.
FDA inspects a manufacturing facility and determines the potential for a recall.
FDA receives reports of health problems through various reporting systems.
The Centers for Disease Control and Prevention (CDC) contacts FDA.
When it comes to illnesses associated with food products, Dorothy J. Miller, Director of FDA's Office of Emergency Operations, says that FDA generally first hears of these kinds of problems from CDC.
"CDC hears about such problems from state health departments that have received and submitted illness reports," she says. "An ongoing outbreak means that we have an emergency, and when there's a public health crisis like this, you need to tell the public immediately."
Alerting the Public
FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people. FDA can hold press conferences, issue press releases, and post updates to its Web site regularly, to alert people.
"It's about being as transparent as possible," says Catherine McDermott, public affairs manager in the Division of Federal-State Relations in FDA's Office of Regulatory Affairs. "If we feel there is that much of a health risk, we will offer media updates every day to give new information, and all that we know gets posted to FDA's Web site."
Not all recalls are announced in the media. But all recalls go into FDA's weekly Enforcement Report. This document lists each recall according to classification (see "Recall Classifications" box), with the specific action taken by the recalling firm.