As we are all aware, the COVID-19 pandemic has had a significant impact on the number of routine inspections being conducted by FDA. But the Agency has made it very clear that “For Cause” inspections will continue as usual. Thus, we wondered how the number of recalls has tracked during the first six months of 2020 compared with the same period last year.
What we found is outlined below but the process of searching the databases created their own questions and required us to look very carefully at the data. Read on to learn more.
According to FDA data for 2019 and 2020 Recalls, Market Withdrawals, & Safety Alerts, recalls during the first half of 2020 were 2-1/2 times greater in 2020 than in the same period of 2019. Or so the data appeared to show. But … and it’s a big but for anyone who has relied on this page for current information … if you dig deeper (i.e., click on recall link after recall link), you begin to realize that the 2020 dated recalls were not necessarily 2020 events. Rather the date of the listing is the date that FDA posted the recall – while a number of March and April posts actually occurring in 2018
We can only assume that someone who was newly deskbound found a way to fill time. While it may be advantageous to have all recalls listed, it’s not so advantageous for the companies whose products have been newly posted – and it is distinctly confusing for anyone who uses this public resource for recall information. In fact, we know of publications who have an automatic pull from those pages to keep their readers informed on current recalls.
FDA does include a line on the recall notice stating, “This recall has been completed and FDA has terminated this recall,” but that still seems to be a relatively small concession for a company whose old recall is put back into the spotlight.
Prior to rewriting this article – when it was learned that the high-level data of the Recalls page could not provide an accurate assessment of current recalls at this time, TAG team members conducted further analyses based on FDA’s less visible and less accessible (though still public) data pages at https://open.fda.gov/apis/. So, while TAG generally gathered its recall information from the Recalls, Market Withdrawals & Safety Alerts pages, we will now be conducting our own in-depth analyses based on the Application programming interface (API) data.
So the bottom line is: (1) Be sure to link to every recall announcement to determine its actual date and current states. (2) Keep an eye on this space for TAG’s analyses and updates on recalls and other food safety data.
Industry Commendation. Given all that, TAG’s IT experts provided general data from the open.fda.gov/api reports confirming that, despite the challenges of the COVID-19 pandemic over the last several months, recalls decreased from the first half of 2019 to the first half of 2020 when assessed by either reported date or initiation date:
We know from working with clients doing recalls in the last few months that FDA is continuing to be vigilant with protecting public health. So the drop in recalls does not appear to be a lack of focus from the regulators, but more a good job by the food industry. So TAG would like to commend the industry for its continued focus on food safety while dealing with COVID-19 impacts such as worker absence – due primarily in the early days to childcare needs with school closures; and states, businesses, and workers just beginning to determine the nature of “essential workers.” Whether the food producer opted to bring in temporary workers, make do with fewer workers, or quickly cross-train workers from other areas, the situation was far from ideal and ripe for mistakes – which were, it appears, to a large extent, overcome.
However, with the U.S. seeing a resurgence of COVID-19 cases, the industry needs to not allow itself to become complacent. Even though FDA inspectors are still not going into food facilities for routine inspections, the regulatory system continues to be very active, making it critical to continue to maintain food safety programs regardless of other challenges.
Regardless of the environment in which the food industry is operating, food safety must continue to be of primary focus. With the challenges of the pandemic continuing to be real, TAG can assist your business in risk assessment and management in both the public health issues of COVID-19 and food safety. Give us a call for information and assistance.