Americans depend on the U.S. Food and Drug Administration to help ensure that the products they buy are safe. Last month, I committed the agency to further improve our recall processes because I believe that consumers should have actionable information for protecting themselves from any FDA-regulated, recalled product.

Recalls are an important safety tool. The FDA works with companies to get potentially unsafe products out of the marketplace as quickly and efficiently as possible. When we learn about a product in the marketplace that may be unsafe, the FDA must act quickly to keep people from getting sick or being harmed.

Today we published a draft guidance that better describes the FDA’s policy on public warning and notification of recalled products as part of our effort to ensure better, more timely information reaches consumers. Although we often hear the most about recalled food, this guidance also covers other FDA-regulated products including drugs, medical devices and cosmetics.
Specifically, the draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The draft guidance also describes the FDA’s policy for moving forward with posting recalls to FDA’s Enforcement Report before a final health risk determination is made. The FDA’s Enforcement Report is a listing of all recalls monitored by the FDA. You can read more about the changes the FDA made to its Enforcement Report in today’s blog.

The draft guidance is a key step to enhance the recall process. It gives industry clear direction on how to navigate and work with the FDA to make sure that recalls are communicated promptly. Ultimately, it will better empower consumers by providing more timely and more accurate information on recalled products.

Furthermore, we are also developing a new FDA policy on what information the FDA will make available to help the public to identify a hazardous recalled food. With most products that the FDA regulates, consumers can typically identify a recalled product from the information a company provides about the packaging or brand name information.

As part of overseeing thousands of recalls every year, the agency helps provide descriptions, lot codes and photographs to help consumers and others, such as stores identify affected products. The FDA also helps provide some geographic or retail-related information for many recalls. But in some situations, identifying additional information – such as specific stores that may have sold a potentially unsafe, recalled food – may help. As part of these efforts, we’re planning to announce a new approach to the release of recall information this year. In the meantime, the FDA can and will publicize this kind of information if it is necessary to effectuate a recall.

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