Almost every day, the Food and Drug Administration announces product recalls. Almost none of these recalls, however, were actually ordered by the FDA. Indeed, the FDA often does not have the authority to order a recall of the products it regulates. In most cases, therefore, the FDA depends upon the voluntary cooperation of the regulated community. Typically, when a manufacturer or distributor learns that a product is out of compliance with FDA regulatory requirements, the firm will bring the issue to the attention of the FDA. The firm—usually in the absence of any request by the FDA—then volunteers to recall the product and to accept the FDA’s guidance on how to conduct the recall.

While this cooperative behavior is both typical and generally advisable, it need not be automatic. Before contacting the FDA, a company should pause to consider whether it would be better off correcting the problem without involving the FDA.

This Commentary will examine factors that point toward or against involving the FDA, and will then summarize the procedures followed in an FDA-approved recall.

The Causes of Recalls and FDA Authority

The Federal Food, Drug, and Cosmetics Act (21 U.S.C. § 301 et seq.), and the related regulations, impose a multitude of requirements on businesses that deal with FDA-regulated products. The violation of virtually any of these requirements could lead to a recall. Even a firm that has not itself committed a violation might want to remove its products from the market—an action technically known as a “market withdrawal”—if necessary to protect its consumers. (The classic example of such a market withdrawal is the “recall” of Tylenol in 1982 after an unknown person adulterated Tylenol capsules with cyanide.)

Many recalls of food products result from a failure to properly label the presence of common allergens, such as peanuts, tree nuts, milk, or eggs. Other food recalls, a subset of which attract significant media attention, are initiated due to contamination from harmful bacteria. Recalls of drugs or drug devices are commonly the result of manufacturing errors, and recent recalls of diet supplements highlight that a number of such products contain drugs that are undeclared, unapproved, or both.

The FDA’s authority to order recalls is limited. Certain products, including drug devices, biological products, infant formula, and tobacco products, are subject to mandatory recall. See FD&C Act §§ 412(e)(1), 518(e), 908(c); 42 U.S.C. § 262(d). While a recent statute now authorizes the FDA to recall foods, that power is limited to circumstances where the food is adulterated (or where the labeling fails to disclose the presence of allergens) and the food will likely cause “serious adverse health consequences or death.” FD&C Act § 423(a). Furthermore, exercising this new power requires the personal intervention of the Commissioner of Food and Drugs. FD&C Act § 423(h). There is no statute authorizing the FDA to order the recall of most drugs no matter what the health risk.

The FDA, of course, is not without remedies. It may apply for court orders authorizing the seizure of adulterated or misbranded food, drug, or cosmetic products. FD&C Act § 304. The FDA can refer violations of the Act for criminal prosecution. FD&C Act § 303. In limited circumstances, the FDA can impose civil penalties or can disbar individuals or firms. FD&C Act §§ 303, 306, 307. Furthermore, the FDA may seek court injunctions “to restrain violations” of the Act. FD&C Act § 302. While the scope of permissible injunctions has not been definitively established, recent cases have held that under § 302, courts may order monetary restitution and may compel firms to recall their products. See, e.g., United States v. Lane Labs-USA Inc., 427 F.3d 219, 229 (3rd Cir. 2005).

Why Volunteer for an FDA Recall?

Despite the absence of a mandate, it is commonplace for firms to inform the FDA of the need for a recall and to volunteer to conduct the recall under the FDA’s guidance. There are many reasons for firms to be so cooperative.

First, if the firm’s product is dangerous, a properly executed recall will prevent harm to consumers.

Second, timely cooperation will usually convince the FDA to forebear from harsher remedies. By eliminating the defective products from the market, a recall should render unnecessary forward-looking remedies such as mass seizures and injunctions.

Third, since regulated firms will have repeated interactions with the FDA, it is important that the FDA view the firm as responsible and willing to correct problems when they come to light. Thus, a refusal to be cooperative may come back to haunt a firm if further problems arise down the road. Under the FDA’s internal procedures, a history of uncorrected violations is a significant factor when deciding whether to begin judicial actions such as a criminal prosecution or a civil suit seeking an injunction. FDA, Regulatory Procedures Manual at 6-32, 6-58. The threat of criminal prosecution is of particular importance to firms regulated by the FDA. Violation of the FD&C Act is a strict liability crime, and responsible executives can be convicted without a showing of intent, negligence, or knowledge. See United States v. Park, 421 U.S. 658 (1975).

Fourth, if litigation is expected, performing an FDA-approved recall may serve to reduce liability by preventing further harm from dangerous products, by mooting contractual or warranty claims, and by showing good faith.

Reasons to Not Contact the FDA

There is ample reason for a firm to prevent defective products from reaching consumers, especially where use of the product could prove hazardous. But while firms should promptly remedy dangerous defects, submitting to an FDA-controlled recall is, in most instances, not required. Indeed, while the FDA has a general ability to issue nonbinding requests for a recall, the FDA reserves even this relatively mild remedy for “urgent situations.” 23 CFR § 7.40(b). Thus, since FDA-directed recalls are usually voluntary, a firm should consider whether it would be best served by remedying the problem through its own efforts.

When the FDA becomes involved, the firm effectively loses significant control over the recall effort. The firm is still responsible for the recall—it is the firm that first drafts the recall plan and implements it—but (as set out below) the FDA will insist that the firm submit to FDA guidance regarding all aspects of the recall. Furthermore, the FDA will request significant information from the firm. The purpose of gathering the information is both to support the FDA’s oversight of the recall as well as to inform the FDA regarding the root cause of the problem and whether it has been corrected. To obtain this information, the FDA requests an extensive written submission. 21 CFR § 7.46(a). Where the FDA deems the recall significant, FDA internal procedures dictate that the district office conduct an establishment inspection.

Involving the FDA in a recall may also result in immediate publicity. The FDA posts recall information on its web site. The FDA sends out emails, almost daily, containing the most recent recall information. Any person can sign up to receive all such emails.

FDA Recalls—How They Work

Despite the rarity of administrative and court orders compelling recalls, recalls are a core element of the FDA’s efforts to ensure the safety of regulated products. It has therefore promulgated formal rules governing voluntary recalls, along with extensive internal procedures and informal industry guidance. See 21 CFR § 7.40 et seq.; FDA, Regulatory Procedures Manual.

Firms are well advised to prepare for recalls before a problem arises. Once a firm releases a dangerous product into its distribution chain, time will be of the essence. Accordingly, the FDA recommends (in a nonbinding regulation) that firms develop written contingency plans and code and track their products. 21 CFR § 7.59.

Recalls commonly begin with a call to the FDA’s local district office. The district office will be the main point of contact with the firm throughout the process, although decision making within the FDA regarding recall issues will often be elsewhere. The appropriate “center” will have a prominent role, as will the Office of Regulatory Affairs in significant recalls. One of the FDA’s initial tasks in a recall is to evaluate the potential health hazards and to classify the recall accordingly.

The firm will be asked to provide a written recall submission. See 21 CFR § 7.46; FDA, Guidance for Industry: Product Recalls, Including Removals and Corrections. The requested information includes detailed information identifying the product, the firms involved, the reasons for the recall, an assessment of the hazard, where the affected products are located, how the firm intends to retrieve them, and the wording of proposed communications to customers and the public. The firm may also be asked to provide samples.

The FDA will then review the firm’s strategy, focusing on the depth of recall (i.e., whether the recall should extend beyond immediate customers to retailers and consumers), who should be notified, and how the firm intends to monitor the effectiveness of the recall. The FDA will also seek to control the wording of recall communications and has developed standard templates covering the most common situations.

Finally, the district office will monitor (and at times audit) whether the recall is progressing satisfactorily. Until the FDA concludes that recall efforts can be terminated, the district office will continuously assess whether the firm’s actions are satisfactory, and if not, whether administrative or legal action is warranted. Such actions could include formally requesting a recall, providing initial or further public warnings, or initiating court proceedings to obtain seizure orders or other injunctions.

Conclusion

It is neither an accident nor an act of altruism that regulated firms so commonly volunteer to implement a recall under FDA control. In most cases, where a firm discovers that it has distributed a defective product, the most prudent course of action is to contact the FDA and submit to its guidance. Firms should be aware, however, that this is not the only legal means of remedying a defect. While defects should be swiftly remedied, the determination of how best to do so should be deliberate, rather than automatic.