As U.S. recalls hit 5-year low, FDA strengthens guidance on recall notices

February 12, 2019

A guidance document finalized by the U.S. Food and Drug Administration (FDA) last week strengthens the way companies issue public notices about their voluntary recalls, as well as elaborates on situations in which the FDA can issue its own warning about a product.

The document is aimed to help the FDA keep potentially unsafe food out of the hands of consumers by bettering communication about recalls and other food safety concerns, an area that other agencies and the public have asked the FDA to improve upon in recent years.

“Most companies collaborate with the FDA to rapidly initiate voluntary recalls and work with their supply chain partners to remove the product from shelves to prevent further distribution,” said FDA Commissioner Scott Gottlieb in a statement. “And in general, a recall occurs quickly when the problem is discovered. However, there are situations where the FDA may need to provide safety advice to the marketplace to protect consumers.”

In the guidance, the FDA tells companies that public warnings should be issued in “urgent situations,” when the product being recalled “presents a serious hazard to health, and where other means for preventing the use of a recalled product appear inadequate.” The agency gives the example of a product that has already been widely distributed when a safety risk is discovered, or a situation where retailers cannot identify who the recalled product has been administered or sold to.

“The FDA generally recommends public warning for recalls that are likely to be classified as, or have been classified as, Class I recalls,” the document states, continuing on to highlight situations where a warning would be most important: recalls of food products likely to be consumed by vulnerable populations, such as the elderly; recalls due to foodborne pathogens; and recalls of malfunctioning medical devices that could lead to incorrect dosing, among others.

Although companies generally have the opportunity to prepare their own public warnings, the FDA can issue one in situations where it believes its necessary in order to protect public health. The agency can also correct or supplement already existing notices.

What a public warning should include

The document outlines that a public warning should include:

    • Any identifying information about the recalled product, like images, serial numbers, packaging information and brand names
    • Geographic areas related to the recall
    • Dates of distribution
    • Description of the product defect or food safety issue
    • Name and contact info for the recalling company
    • Instructions to consumers
    • The number and nature of any illnesses or injuries associated with the product

“Brief and succinct warnings are generally better at informing consumers of a product hazard and helping consumers understand the importance of avoiding the product,” the document says. It also states that the notice should avoid promoting the product involved and provides guidance for how to distribute the notice.

Recalls down?

In his statement, Gottlieb notes that in fiscal 2018, there were 7,420 recalls, with 831 classified as high-risk.

“That figure represents a five-year low in recalls,” he said. But he notes that some people may feel that there are more recalls than ever, due to the FDA’s increased publicizing of these events in the news and on social media.

“Consumers should expect to continue to see more frequent communication on potential risks to their health,” Gottlieb said. “We’ll continue to seek out opportunities for improved processes, education and awareness. And we constantly strive to learn from every recall, and every issue, so that we can help to prevent future recalls and to work quickly with companies to remove the products from the market.”


Category: Food Safety, Food & Beverage, Public Health, Pathogens, Environmental Monitoring