FDA Seeks to Strengthen Product Recalls


In its bid to enhance the nation’s product recall process, the Food and Drug Administration has issued draft guidance that, according FDA Commissioner Scott Gottlieb, “outlines circumstances when a company should issue a public warning about a recall, describes the general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 document also lays out the agency’s policy for posting recalls to FDA's Enforcement Report, a listing of all recalls monitored by the FDA, before a final health risk determination is made.

In addition to food, the draft guidance encompasses such other FDA-regulated products as drugs, medical devices and cosmetics.

“The draft guidance is a key step to enhance the recall process,” explained Gottlieb. “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.”

Gottlieb added that FDA was currently crafting a new policy on what information it would release to help consumers identify a hazardous recalled food, pointing out that with most products that the FDA regulates, shoppers could usually identify a recalled product from the information that a company provides on the packaging, or brand-name information.

Although the agency already helps provide descriptions, lot codes and photographs to assist with recalls, as well as, some geographic or retail-related information, Gottlieb observed that in certain situations, additional information, including specific stores that may have sold a potentially unsafe recalled food, could be beneficial. “As part of these efforts, we’re planning to announce a new approach to the release of recall information this year,” he said. “In the meantime, the FDA can and will publicize this kind of information if it is necessary to effectuate a recall.”

industry Response

Grocery industry trade organizations expressed their openness to the agency’s efforts to bolster the recall process.

“There is nothing more important to the grocery industry than food safety,” asserted Hilary Thesmar, chief food and product safety officer and VP, food safety programs at Arlington, Va.-based Food Marketing Institute (FMI), and the author of a recent blog detailing the association’s work with regard to recalls.

Added Thesmar: “FMI and our members are committed to looking for ways to improve food safety at every level and function within an organization. We are pleased that U.S. Food and Drug Administration Commissioner Scott Gottlieb shares our industry’s focus. Food retailers and their business partners work closely to prevent, coordinate and respond to recalls effectively with FDA and U.S. Department of Agriculture. The goal is to remove product quickly before it even enters commerce and the supply chain typically removes recalled product in a matter of hours.”

“Independent supermarkets share a bond of trust with their customers to provide safe, high-quality and affordable food choices,” said Greg Ferrara, EVP of advocacy, public relations and member services for Arlington-based National Grocers Association (NGA), which represents the independent grocery sector. “Our industry has long been committed to the safety of the U.S. food supply and ensuring that it continues to be the safest in the world. NGA will review FDA’s notice and continue to work with the agency to ensure recalled product is quickly removed from grocery store shelves, while also relaying information to consumers in a clear and accurate way.”

"We expect that the steps announced by FDA to address its recall processes, along with the ongoing innovations by industry to improve product recall-related communications throughout the supply chain, will significantly enhance the safety of the food supply for consumers in the event of a product recall," observed Brian Kennedy, director of communications for the Washington, D.C.-based Grocery Manufacturers Association.

Noting “that hazardous recalled products can have a devastating impact on human lives,” Gottlieb described the draft guidance as “just the first in a series of policy steps we’ll take this year as part of a broader action plan to further improve our oversight of food safety and how we help implement the recall process.”

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