FDA 101: Product Recalls
From First Alert to Effectiveness Checks
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.
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, a Press Officer in FDA's Office of Public 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.
FDA evaluates whether all reasonable efforts have
been made to remove or correct a product. A recall is considered
complete after all of the company's corrective actions are reviewed by
FDA and deemed appropriate. After a recall is completed, FDA makes sure
that the product is destroyed or suitably reconditioned, and
investigates why the product was defective in the first place.
These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:
Dangerous or defective products that predictably could cause serious
health problems or death. Examples include: food found to contain
botulinum toxin, food with undeclared allergens, a label mix-up on a
lifesaving drug, or a defective artificial heart valve.
Products that might cause a temporary health problem, or pose only a
slight threat of a serious nature. Example: a drug that is
under-strength but that is not used to treat life-threatening
Class III: Products that
are unlikely to cause any adverse health reaction, but that violate FDA
labeling or manufacturing laws. Examples include: a minor container
defect and lack of English labeling in a retail food.
FDA-regulated Products Subject to Recall
blood and blood products
transplantable human tissue
about 80 percent of the foods eaten in the United States
This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information
Recalls, Market Withdrawals, and Safety Alerts
Weekly Enforcement Report Index
Date Reviewed: September 12, 2008