How Fast Are You Required to Announce That Recall?

Posted in Regulatory Compliance

When it comes to selling food, speed is usually an advantage. Many companies pride themselves on their ability to deliver a quality product faster than their competitors, and many consumers when shopping for groceries will seek out foods they can quickly prepare in their homes. No matter where they are located in the distribution chain, virtually all food companies work hard to deliver the highest quality product in the shortest amount of time. 

But, what happens when foods are suspected to be affected with a possible problem? Are those same companies as quick to remove the affected products from their customer’s warehouses, restaurant menus or grocery store shelves? In most cases, they are not. 

When a problem is suspected, most companies wait days, many wait weeks, and some may even wait months before announcing a recall. Interestingly, FDA was recently criticized by the Office of Inspector General (“OIG”) in a June 8, 2016 Early Alert for failing to have an effective food recall initiation process which directs food companies, when a problem is suspected, to announce a recall within a prescribed amount of time. In one instance, OIG complained that 165 days had passed between the date when FDA identified a potentially adulterated product and the date the company finally announced a recall. 

So, how fast should a company pull the trigger after it suspects a problem? Having helped my clients manage hundreds of food product recalls, I can tell you from experience that some recalls can and should be announced very quickly, and some inherently take much more time. If the recall involves a product associated with an emerging foodborne illness outbreak, companies need to react quickly. 

Typically, in these cases, a company will be given a few days of latitude by regulatory authorities to investigate the merits of the suspected problem, identify and contain (if there is a problem) all potentially affected products, and then prepare the appropriate customer recall notification letters and FDA press releases. If the amount of time stretches beyond a few days to a week or more, then it will in most cases appear to the regulators that the company is dragging its feet, and may even subject the company leadership to increased regulatory scrutiny or even possible criminal liability. 

If, on the other hand, the recall involves an issue that does not create an immediate public health threat, then food companies will likely be given more leeway. In these cases, while it is not uncommon for a week or more to pass while the recall issues are worked through and the recall processes administered, it is still important to create the impression that the company is committed to acting efficiently and effectively to resolve the issue and remove any affected products from distribution. 

The most important element when it comes to recall management, is to gather enough information to make the right decision, the first time around, about: (1) whether to recall the product in the first instance; and (2) if, so, how much to recall. Within this context, companies should never act too quickly and, at the same time, they must never act too slow. Thus, just like the rules for selling excellent food as quickly as possible, the best advice in the context of a recall is, similarly, to try to announce the highest quality and most effective recall in the shortest period of time.