By Erik Mettler, Assistant Commissioner for Partnerships and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration 

Recalls are one of the most effective and efficient ways to protect consumers from potentially harmful FDA-regulated products that are already in the marketplace. Most recalls in the United States are carried out voluntarily by the product manufacturer, importer, or distributor. Under certain circumstances, the U.S. Food and Drug Administration (FDA) can require a recall and has mandatory recall authority for foods and other commodities, including medical devices, certain biologics, tobacco, and cosmetics. In all cases, it is important for us to give the responsible party – such as a manufacturer or distributor – an opportunity to conduct a voluntary recall before ordering a mandatory recall. Recalls, and all compliance activities are best achieved through voluntary actions by a firm. Manufacturers and distributors have real time insight into the processes and products and can therefor respond quickly and efficiently when problems arise. 

Recalling firms are requested to report their recalls to the FDA. Our role is to document, assess the health hazard, notify the public and in some cases other firms, monitor the progress and effectiveness, and review periodic status updates of the recall. Moreover, all FDA-regulated firms have a responsibility to develop a recall strategy that suits the circumstances of the recall. At a minimum, the strategy includes how they will contact their customers, issue a public warning (typically a press release announcing the recall), explain disposition instructions for the recalled product, and a plan to assess a recall’s effectiveness. Firms are responsible for being “recall-ready” and initiating recalls promptly in compliance with FDA policies and procedures. Agency guidance, such as recall initiation, is available to industry and the FDA recall staff are always available to offer suggestions to improve a firm’s proposed recall strategy.   

At the FDA, we know that recalls work the best when people know about them and take action to protect themselves and their families. That’s why we publicize all recalls in the Enforcement Report.  When a firm issues a press release announcing their recall, we post a copy to our Recalls, Market Withdrawals, & Safety Alerts web page. If we believe that additional consumer outreach or clarity is needed, we issue our own press release or web posting. The public can subscribe to receive emails via Enforcement Report Subscription Service whenever new content is posted to these web pages. A new feature of the subscription service allows users to subscribe using up to five keywords so they will be sure to get notifications based on their particular areas of interest. Yet we recognize more can be done, both in our communication efforts and in our overall recall oversight. 

Unfortunately, food and medical products may be on the market for some time before a problem is recognized. Recent foodborne illness outbreaks and associated recalls have emphasized the need for the FDA to engage in an ambitious effort to modernize our recall operations. From technology advances to new analytical tools and social media platforms – opportunities abound for us to enhance and elevate the existing recall framework. Specifically, in the food space, the FDA recently published a final rule on traceability for certain foods. These new traceability requirements will help minimize broad recalls and market withdrawals for covered foods. 

While ideas are leaning forward, we know we can also learn from our broad array of stakeholders including public health partners, regulated industry, academia, consumer groups, media organizations, the public, and others. This is why on September 29, 2023, we are hosting a free, hybrid public meeting, entitled, “Modernizing Recalls of FDA-Regulated Commodities.” The purpose of the listening session is to provide an opportunity for stakeholders to share information and feedback about topics related to FDA recall modernization. The meeting will be an open forum on all things recall-related across all the commodities the FDA regulates, including operational issues and ways that the Agency, industry, and consumers can improve the process. If you are interested in participating, please visit our registration page.   

Although the United States enjoys a supply of food and medical products that is among the safest in the world, there are always improvements that can be made. We take our charge to protect public health seriously and are ready to innovate in collaboration with our many stakeholders. Please join us in our efforts to improve the speedy removal (or correction) of harmful products from the American marketplace and make our communities even safer, healthier, and more prosperous.