By Charles Breen, Independent Advisor for FSMA
The December 2017 Department of the Inspector General report on FDA’s food recall process included some particularly harsh criticisms of the agency including inadequate authority, oversight and follow-up on voluntary food recalls. These criticisms came as little surprise as a number of issues surrounding agency oversight of recalls has been identified in recent years. A 2012 GAO report indicated that both FDA’s food advisory and recall processes need strengthening and a 2015 report again showed FDA is not keeping pace with foreign inspections.
The 2012 report findings prompted the agency to undertake significant steps in an effort to strengthen recall processes, including a revision of recall procedures published in the Regulatory Procedures Manual to better define recall categories in FDA’s database and to improve information sharing between federal and state agencies that also have oversight of food safety. Other improvement areas identified by GAO remain open, such as final guidance based on public comments on mandatory food recalls, and others that the agency said were impractical to implement.
Based on preliminary findings of the 2017 GAO report, which had been provided to FDA in 2016, the agency responded with the creation of a new management unit, the Strategic Coordinated Oversight of Recall Execution, (SCORE). It is intended to help the agency better investigate those reports of food illness that could pose a significant health hazard to consumers. Though a good start, the GAO recommends taking SCORE a step further to establish measurable performance expectations, such as timeframes, expedited decision-making, and improved electronic recall data. In other words, GAO wants to see scoring for SCORE.
One area of debate is the GAO’s review of 30 of the 1,557 voluntary FDA recalls between the years 2012 and 2015 where GAO determined in many cases FDA did not assess the hazards in a timely manner, nor did it communicate recall and safety concerns effectively. GAO cited, for instance, an extreme example where an affected product was not removed from commerce until 303 days after receipt of FDA’s warning letter prompting a recall. On average, says GAO, companies took 57 days to remove their recalled products. As well, GAO found the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES) to be deficient. The report noted “Our review found that FDA does not have adequate policies and procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls. This means that dangerous food products may have remained in our nation’s food supply for weeks after FDA was aware of the contamination.”
FDA takes some exception with how the 30 voluntary recalls reviewed were chosen, as GAO self-describes them as “judgementally selected.” In FDA’s view, these companies represent “extreme outliers” and says their own data show that during this 2012-2015 period when FDA “found out about a product problem that eventually resulted in a recall, the recall initiation took place, on average, in less than four days. In the highest risk recalls, when there was a reasonable probability that the use of or exposure to a product would cause serious adverse health consequences or death, recall initiation took place, on average, in less than three days.”
That being said, the agency stresses that it understands the urgency of getting recalls right and is reviewing selected recalls to identify gaps and improve procedures. FDA Commissioner, Scott Gottlieb said in a statement responding to the report, “Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities — and how we deploy them — are a cornerstone of our vital, consumer protection mission.”
HHS Office of the Inspector General rejects the agency’s claim that the 30 selected recalls were “extreme outliers” and says that FDA lacks a reliable tracking system. The current system makes it difficult to capture the recall initiation date and the date FDA became aware of potentially hazardous food products.
Regardless of the back and forth, the importance and urgency of identifying a food safety issue and its subsequent follow-throughs cannot be overstated. Recalls are a unique challenge as a consumer may have already purchased the recalled product.
It is imperative that companies have a robust and well-documented recall plan as part of their standard operating procedures (SOP) and that those plans are routinely practiced, drilling through the process with various scenarios – from a product in the warehouse, in-transit, already on consumer shelves and the type of threat identified.
- How will your company respond?
- Who is the internal point of contact/liaison with FDA?
- How will parties who may be in possession of the product be identified and contacted?
- How will the return and destruction of a product be identified and tracked?
- How and by whom will the media be addressed?
There are many aspects to consider, many contingencies to plan for, and only one opportunity to get this right the first time. The safety of the public and the long-term viability of your company may depend on it.
The Food Safety Modernization Act (FSMA) granted FDA the authority to initiate mandatory food recalls. While the agency is working through their requirements to do so and simultaneously monitor voluntary recalls effectively, so should you. EAS offers assistance in preparing recall strategies as part of our holistic regulatory compliance planning services under FSMA. Take steps now and be prepared.