FDA-Mandated Recalls: Real but Not Inevitable
Updated: Nov 22, 2018
Post co-authored by Roger Hancock, CEO of Recall Info Link
One of the key authorities that FDA gained with the passage of the Food Safety Modernization Act was that of mandatory recall authority. If there is a reasonable probability that a food is adulterated or misbranded and could cause serious illnesses or death, FDA can order its recall if the responsible party doesn’t voluntarily do so.
FDA is serious about this authority. It has used it once to its full extent; has twice started to mandate recall but did not need to complete the mandate, as the companies responded with voluntary recall; and, just recently, released final guidance on the use of mandatory recalls.
As the previous paragraph indicates, there are some caveats, primarily that FDA must give the responsible party an opportunity to conduct a voluntary recall before mandating one. FDA discusses the process in the guidance:
Once the FDA has determined that the criteria for a mandatory recall have been met, it must provide written notification to the responsible party of its opportunity to voluntarily cease distribution and recall the food.
If the responsible party does not comply in the time and manner prescribed, FDA may order that distribution cease and the responsible party give notice to others to cease distribution
However, the responsible party also must be given an opportunity to request an informal hearing to be held not later than two days after the issuance of the order.
After these steps are completed, the FDA Commissioner may order a recall under section 423(d) of the FD&C Act if it is determined to be necessary.
As defined by the FD&C Act, the “responsible party” is the person who submits the registration for a food facility at which the food is manufactured, processed, packed, or held. Under this and the definition of “person,” the owner, operator, or agent in charge of a facility who is responsible for submitting the registration is also responsible for implementing and assuring the recall is performed.
Although recalls occur on a nearly daily basis, a relatively small percentage of the more than 200,000 establishments registered with the FDA have ever had to conduct a recall. But, with many of those 200,000 establishments producing multiple products, the potential for product recall is fairly high – and always costly. A GMA study estimated the average recall cost for a manufacturer to be $10M.
So how do you ensure your facility managers and workers are prepared should a recall be needed – to prevent an FDA recall mandate; perform an effective, efficient recall; and keep costs down?
A product recall has many steps, but at least three fundamental data components:
Complete information on Item(s) to remove from supply.
Listing and contact information of customer(s) that received that item(s).
Instructions on how to handle the item(s) after removal.
Currently, those three fundamentals are completed in thousands of different ways developed in-house, with non-standard methods that are completed in a crisis mode usually prone to errors. Standardizing the recall process would not only benefit your company, but also consumers, as recalls could be conducted more quickly and efficiently.
One way to do this is through the use of the GS1 Rapid Recall Express form. Developed by an industry group led by GS1-US, the Grocery Manufacturers Association (GMA), the Food Marketing Institute (FMI) and the National Grocers Association (NGA), the free and publicly available standard is tailored for U.S. recalls and withdrawal notifications. The form follows GS1 standards to provide unique identification of products and other associated information regarding these items, such as date codes and the reason for the recall. (For a downloadable form, provide your information on the Access Rapid Recall Express webpage for a link to the PDF; or fill in the five-page online form, then click create to save the completed form.)
This easy-to-use standard compiles information needed to efficiently communicate product recalls in a simple, accessible way to speed up the entire recall process. This, then results in simplified regulatory compliance, as well as third-party audits for mock recalls; decreased liability and better protected brands and businesses; and, most importantly, safer consumers.
Regular practice in completing the standard information template and notifying select customers will transform recalls into a normal business practice that’s ready when needed.
Clearly nobody wants to have to deal with a recall. But if you do, having an efficient and well-practiced approach is a key part of success and a significant way to reduce the stress of a recall. Use technology to help you both prepare and manage recalls as they become more a part of life in the food industry. You may feel the investment is not worth it – but should you find yourself in a recall situation you will be very glad you made that investment.
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. www.AchesonGroup.com