FDA has taken a major step in consumer safety. As detailed in newly issue draft guidance, FDA will now, when warranted, publicize the names of retailers where recalled foods may have been purchased. This upends its traditional stance of identifying recalled products only through labeling information, product descriptions, lot numbers, photos, and geographic distribution – not disclosing specific retailers who sold the product. The “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Guidance” describes situations when disclosure is appropriate and outlines the circumstances when the FDA intends publicize the retail locations that may have sold or distributed a recalled human or animal food. In a statement issued last week, FDA Commissioner Scott Gottlieb discussed the guidance and new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety. This approach will particularly apply in situations associated with the most serious recalls, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Disclosure also may apply when a recalled food is related to a foodborne illness outbreak, and where the information is most useful to consumers. Based on the new policy, FDA intends to publicize retail consignee lists for food recalls when the food is not easily identified as being subject to a recall from its retail packaging, or lack thereof, and if the food is likely to be available for consumption. Some examples of this may include foods sold directly to consumers with no universal product code or UPC, or bar code. This might include deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually. The traditional policy was based on the fact that certain supply chain information is confidential between the supplier and retailer, and because information publicized by the recalling company is generally sufficient to allow consumers to identify and avoid recalled product. But because there also are cases – particularly when the product has been linked to foodborne illness – in which retailer information would help consumers more quickly and accurately recognize recalled product and take action, FDA is changing its stance. The new draft guidance is actually the second in a series FDA has issued to broaden its oversight of food safety and recalls. The first was released in January in its Public Warning and Notification of Recalls draft guidance which outlined situations for which FDA and firms would publicize public warnings to help carry out a recall. The agency also has been working to more quickly and frequently communicate food safety issues that pose serious threats to the health of consumers, such as the public warning FDA issued earlier this year on imported crab meat from Venezuela as soon as it knew there were associated Vibrio illnesses the U.S. With two new guidance documents issued in the “series” of recall improvements, the food industry should expect that FDA is keeping a close eye on all recalls and the actions that association businesses are taking – or not taking. Gottlieb has committed to increasing the actionable information it provides to consumers on recalls, to seeking out “opportunities for improved processes, education and awareness,” and to constantly striving “to learn from every recall, and every issue, so that we can help to prevent future outbreaks and limit their impact when they do occur.” TAG often has discussions with those in the C-suite of our clients about the changing risk profile for food safety and how the food safety programs that worked several years ago may not work today as risks to brands continue to increase. This new policy form FDA is yet another step in that direction, and while it is not clear what has triggered this new policy, I do wonder if some of the recent recalls where product was still for sale many weeks post-recall may be part of what is driving this. FDA is clearly committed to protecting the public, as it should be, and is responding to demands for this new approach. On a side note, I was recently at the IAFP meeting in Buenos Aires where Bill Marler was speaking and, yet again, explaining how to avoid his attention if you are in the food industry. This new policy from FDA is one for which Bill was a strong advocate – and when FDA issues a new policy that even Bill Marler favors, you can bet it is a policy of which you need to be aware and take to heart. About The Acheson Group (TAG)
Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.achesongroup.com
