Recalls: FDA, Industry Cooperate to Protect Consumers

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.

(225k PDF file showing the number and types of products recalled and seized in 1994)

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

• instructions to stop distributing the product and what to do with it.

Initiating a Recall

A firm can recall a product at any time. Firms usually are under no legal obligation to even notify FDA that they are recalling a defective product, but they are encouraged to notify the agency, and most firms seek FDA's guidance. FDA may request a recall of a defective product, but it does so only when agency action is essential to protect the public health.

"If we request a recall, we are prepared to seize the product and go to the press," says W. Remle Grove, chief of DEEO's emergency operations branch. In the last five years, there have been only about a dozen FDA-requested recalls, according to Grove.

When a firm undertakes a recall, the FDA district office in the area immediately sends a "24 Hour Alert to Recall Situation" notifying the relevant FDA center (responsible for foods and cosmetics, drugs, devices, biologics, or veterinary medicine) and DEEO of the product, recalling firm, and reason for the recall. FDA also informs state officials of the product problem, but for routine recalls, the state does not become actively involved.

After inspecting the firm and determining whether there have been reports of injuries, illness, or other complaints to either the company or to FDA, the district documents its findings in a recall recommendation ("RR") and sends it to the appropriate center's recall coordinator. The RR contains the results of FDA's investigation, including copies of the product labeling, FDA laboratory worksheets, the firm's relevant quality control records, and, when possible, a product sample to demonstrate the defect and the potential hazard. The RR also contains the firm's proposed recall strategy.

The Strategy

FDA reviews the firm's recall strategy (or, in the rare cases of FDA-requested recalls, drafts the strategy), which includes three things: the depth of recall, the extent of public warnings, and effectiveness check levels.

The depth of recall is the distribution chain level at which the recall will be aimed. If a product is not hazardous, a recall aimed only at wholesale purchasers may suffice. For more serious defects, a firm will conduct a recall to the retail level. And if the public health is seriously jeopardized, the recall may be designed to reach the individual consumer, often through a press release.

But most defects don't present a grave danger. Most recalls are not publicized beyond their listing in the weekly Enforcement Report published by FDA's press office. The Enforcement Report lists the product being recalled, the degree of hazard (called "classification"), whether the recall was requested by FDA or initiated by the firm, and the specific action taken by the recalling firm.

A firm is responsible for conducting "effectiveness checks" to verify--by personal visits, by telephone, or with letters--that everyone at the chosen recall depth has been notified and has taken the necessary action. An effectiveness check level of "A" (check of 100 percent of people that should have been notified) through "E" (no effectiveness check) is specified in the recall strategy, based on the seriousness of the product defect.

"If a recall involves a serious health hazard, we usually require 100 percent effectiveness checks at all levels of distribution, including the points of final retail sale," says Ron Joyce, recall coordinator for the Center for Food Safety and Applied Nutrition. "If it's a very minor violation that does not pose a hazard to health, it may not be worth using any more resources to conduct a check."

The Health Hazard Evaluation

When the center receives the RR from the district office, it evaluates the health hazard presented by the product and categorizes it as a class I, II, or III. The classification is determined by an ad hoc "Health Hazard Evaluation Committee" made up of FDA scientists chosen for their expertise. Classification is done on a case-by-case basis, considering the potential consequences of a violation.

A class I recall involves a strong likelihood that a product will cause serious adverse health consequences or death. A very small percentage of recalls are class I. Recently, a Colorado manufacturer of cardiac pacemaker leads--J-shaped electric cables that connect the pacemakers to the heart--conducted a class I recall of two models because the wires inside the cable were breaking through the outer coating and in some cases puncturing the heart. Two patients died as a result. Other recent class I recalls involved Schwan's ice cream contaminated with Salmonella bacteria (see Investigators' Reports section in the June 1995 FDA Consumer) and Alaska King Seafoods' Seafood Spread, contaminated with Listeria monocytogenes bacteria.

A class II recall is one in which use of the product may cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote. When 408 boxes of Keebler's Graham Crackers were recalled earlier this year due to contamination with glass pieces, the recall was categorized as a class II because injury from swallowing the glass was unlikely. Boxes of corn flakes cereal also recently underwent a class II recall due to glass pieces.

A class III recall involves a product not likely to cause adverse health consequences. When 2,500 bottles of Diet Lemon Nestea were mistakenly labeled as regular Lemon Nestea earlier this year, FDA concluded there was no health hazard. But because the bottles were misbranded, they were recalled by the manufacturer, Coca-Cola USA.

"Many people think a hazard must be involved in a recall," says FDA's Philadelphia district recall coordinator Mary Rosenhagen. "Actually, what you must have is a violative product. The label, for example, may have something missing and then, even though it may not be hazardous, the product shouldn't be on the market."

For class I and II, and infrequently for class III, FDA conducts audit checks to ensure that all customers have been notified and are taking appropriate action. The agency does this by personal visits or telephone calls. "The recall is mainly the firm's responsibility," Grove says. "We're just performing an audit function to protect the public interest."

A recall is classified as "completed" when all reasonable efforts have been made to remove or correct the product. The district notifies a firm when FDA considers its recall completed.

Planning Ahead

FDA recommends that firms maintain plans for emergency situations requiring recalls. Companies can minimize the disruption caused by the discovery of a faulty product if they imprint the date and place of manufacture on their products and keep accurate and complete distribution records.

A recall is often the best tack for protecting the public. "Ultimately, FDA's goal is consumer protection," says New York district recall coordinator Maria Caride. "We're out there to make sure no one gets hurt."

Tamar Nordenberg is a lawyer with the Office of the Director in FDA's Center for Drug Evaluation and Research.

When Is a 'Recall' Not a Recall?

"We set as the number one priority the safety of the consumer," said J & J general counsel George Frazza at an August 1983 American Bar Association meeting. "We took immediate steps to find out as quickly as possible what caused the tragedy, then to do all within our power to contain it, regardless of whether the product was found to be blameless or at fault," Frazza said.

The product was not at fault; a criminal tamperer was. The company stated that it was "recalling" the product from the market. Although the action was a recall according to the common usage of the term, FDA did not consider the action a recall, but a market withdrawal.

A "market withdrawal" is a firm's removal or correction of a distributed product that involves no violation of the law by the manufacturer. A product removed from the market due to tampering, without evidence of manufacturing or distribution problems, is one example of a market withdrawal.

A stock recovery is another action that may be confused with a recall. A stock recovery is a firm's removal or correction of a product that has not yet been distributed.