Recalls: FDA, Industry Cooperate to Protect Consumers

Recalls: FDA, Industry Cooperate to Protect Consumers

by Tamar Nordenberg

The Phoenix New Fiber chocolate chip cookies were promoted as aids in weight control and as cures for colon cancer and other diseases. In 1990, the Food and Drug Administration got the skinny on the "weight control" cookies--they had twice the calories, half the fiber, and five times the fat declared in the products' labeling. The cookies could be dangerous to diabetics, who often need to control their food intake, and to people with other ailments, who might rely on the unsupported disease claims and forego effective therapy.

But FDA didn't take the company to court to get the cookies off the market. The agency didn't have to because the distributor voluntarily recalled the goods.

A recall is a firm's removal or correction of a marketed product when that product violates the laws enforced by FDA. Unlike FDA's other tools for achieving compliance, such as seizures and injunctions, recalls are almost always voluntary. FDA can't order a company to recall a product, except in some cases involving infant formulas, biological products, and devices that present a serious hazard to health.

Before taking a company to court, FDA usually notifies the responsible person of the violation and provides an opportunity to correct the problem. In most situations, a violation results from a mistake by the company rather than from an intentional disregard for the law.

"Recall is by far a better choice than seizure to protect the public, particularly when the product has been widely distributed," says Willie Bryant, emergency operations coordinator in FDA's division of emergency and epidemiological operations (DEEO). Recall is far less costly and time-consuming than a court procedure, and it gets defective products off the market more quickly.

Without Phoenix's cooperation, it would have been difficult to track down and retrieve the hundreds of thousands of cases of Phoenix cookies that had been distributed to 55,000 weight-loss counselors nationwide.

In Phoenix's case, the goods were returned to the firm for correction. But in some cases, a correction is made in the field, where the product is being used.

"There are many factors that come into play in deciding whether to remove the product from the market or correct the problem in the field," Bryant says. "It depends on the type of product, the problem, and how the company intends to correct the problem."

Many recalled devices are not returned to the manufacturer or distributor. An x-ray or dialysis machine, for example, is so large that it is usually more practical to correct the problem on-site. Foods and drugs are almost always returned, but even then some problems may be corrected at the wholesale or retail site. For example, a labeling violation can sometimes be corrected by simply sticking a new label on the product.

Avoiding a Court Action

There are several incentives for a company to recall a product, including the moral duty to protect its customers from harm and the desire to avoid private lawsuits if injuries occur. In addition, the alternatives to recall are seizures, injunctions, or criminal actions. These are often accompanied by adverse publicity, which can damage a firm's reputation.

A company recall does not guarantee that FDA will not take a company to court. If a recall is ineffective and the public remains at risk, FDA may seize the defective products or obtain an injunction against the manufacturer or distributor. A few years ago, FDA seized from an uncooperative recalling firm numerous packets of "Sober-Up-Time," an unapproved new drug that supposedly minimized the effects of alcohol. The firm had refused to provide documentation of its notification to distributors.

If the firm's recall had met FDA's consumer protection goals, there would have been no need for further regulatory action. "For the most part, companies do the recalls in an effective and timely manner," says Cecilia Wolyniak, emergency operations coordinator in DEEO. To help firms conduct recalls, FDA has published guidelines in the Code of Federal Regulations setting forth the agency's preferred recall procedures.

The recalling firm is always responsible for conducting the actual recall by contacting its purchasers by telegram, mailgram, or first-class letters with information including:

the product being recalled

identifying information such as lot numbers and serial numbers
the reason for the recall and any hazard involved