Recall Risk on the Rise: How Exposed is Your Business?

In early 2022, The Acheson Group conducted an analysis of 15 years of recall events based on Department of Agriculture (USDA) and Food and Drug Administration (FDA) data. As would likely be expected, the highest peak occurred in 2009 with the Peanut Corporation of America (PCA) recall for Salmonella peanut butter contamination, which culminated in the recall of more than 3,600 products.

Also coming as no surprise is that recalls were down in 2020, the first year of the pandemic. However, 2021 saw both USDA and FDA recalls increasing, though somewhat below pre-pandemic levels, and 2022 seems to be following the re-escalation.

Although the first quarter of the year saw fewer recalls than the last quarter of 2021, the volume of FDA recalls increased by 274%. This was driven primarily by four large recalls related to caffeine supplements, soy beverage, produce and infant formula.

Not only does high recall volume have significant financial impact on the business(es) involved, but there are distinct correlations of the greater the volume, the higher the impact, and the more widespread the reporting and repercussions — particularly when a susceptible population is impacted. We saw this quite clearly with the reaction from consumers, media and other government agencies to the Abbott infant formula recall and resulting shortages.

It is one of the few (only?) times that Congress has stepped in in the midst of an event to set new policies. Not only were amendments tacked onto the FDA Safety and Landmark Advancements (FDASLA) Act of 2022 (initially aimed at reauthorizing FDA user fees) to address the infant formula crisis and prevent future shortages, but they focused on holding FDA as well as manufacturers more accountable (Sec. 910).

In fact, the U.S. Senate focus on FDA in the amendments was just one of many examples of groups taking FDA to task this year for recall ineptitude. In April, the Association of Food and Drug Officials (AFDO) released a paper on recall modernization, citing a basic reason as to why food recalls are still commonplace as being “the issuance of a recall and communication around it is typically done too late in the outbreak investigation to prevent additional illnesses.” While acknowledging that FDA has made efforts to address improvements around its recall activities, the paper made the argument that recalls and FDA’s collaborative approach with partners are both in need of transformative change and fresh approaches.

With FDA taking such flak for recall issues, it is only natural that the agency would counterstrike, aiming its fire at food establishments where it finds any sort of food safety issue, noncompliance or other potential or actual recall risk. As such, the industry can, and should, expect inspections to be even more meticulous, recall activity speed to be accelerated and FDA tolerance to be reduced.

So, what do food facilities need to do in the face of these issues? Be prepared.

• Be inspection-ready. With food safety being the fundamental purpose of routine or for-cause inspections, facilities should regularly verify and update all food safety processes and practices, ensuring they are effective and being implemented. At a minimum, the Food Safety Plan must be reanalyzed at least every three years and whenever a relevant change is made, a hazard determined or a problem occurs. Being inspection-ready also means having inspection protocols in place, personnel identified for working with the inspector, records accessible and a plan to deal with any issues or noncompliances FDA may find.
• Be recall-ready. In March, FDA issued final guidance on Initiation of Voluntary Recalls. The guidance involves three key components — preparedness, discovery and action — and encourages the use of electronic communication. Having a robust recall plan in place means having a strategy and specified personnel for speedy product traceability, regularly updating direct-account contacts and being prepared for consumer communication, and conducting mock recalls or simulations to ensure recall effectiveness.

Being inspection- and recall-ready has always been essential, but today’s environment is making it as much about business protection as it is about consumer safety. When flak flies, it can catch anything within its range. Is your business at risk?