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TAG November 24, 2016 0 Comments

The “early alert” memorandum on FDA’s lack of an efficient, effective recall-initiation process that was issued by the Office of the Inspector General (OIG) in early June is an unprecedented step, essentially telling FDA that it doesn’t like what it is seeing, and FDA needs to get on the ball to update its policies and procedures with regard to managing recalls. OIG issued the memorandum to alert FDA to a preliminary finding from its ongoing audit of the agency’s food recall program, that FDA does not have an efficient and effective recall initiation process that helps ensure the safety of the nation’s food supply. Specifically, that FDA does not have policies and procedures to ensure that firms or responsible parties initiate voluntary food recalls promptly. The alert goes on to suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes both for FDA to request that firms voluntarily recall their products and for firms to initiate voluntary food recalls. The audit is a follow-up to OIG’s June 2011 report on FDA’s monitoring of imported food recalls in which OIG found FDA’s recall program to be inadequate because it did not have the authority to require firms to recall certain foods and because FDA did not always follow its own procedures. I have to say that I completely agree with OIG’s statement that this issue is a significant matter and needs FDA’s immediate attention. One simply need take a look at the flowcharts included in the report and the summary of OIG’s sampling to understand why. As you will see from the example below, one area that causes some issues with food companies on a regular basis is the time it takes for FDA to report back results on swabs taken during an inspection. But back to the “early alert”; in order to review FDA’s recall program, OIG selected a judgmental sample of 30 imported and domestic voluntary human food recalls reported to FDA between October 1, 2012, and May 4, 2015, and reviewed the processes of the 11 FDA district offices responsible for monitoring the 30 recalls. For none of the 30 did FDA prescribe a timeline for the firm to initiate a recall after it first became aware that an adulterated or misbranded product could be in the food supply chain – and for two of the reviewed recalls, the firms did not initiate a recall until 165 days and 81 days after FDA identified the potentially adulterated product (as described below and in the flowcharts). While there certainly is onus on the firms to conduct recalls as quickly as possible upon discovering a contamination, this report from OIG points out some clear deficiencies in the FDA process. Not only did FDA not give the firms a timeframe in which to voluntarily recall their products, but the flowcharts indicate that FDA didn’t even get the positive results of its swab tests for 10 days to three weeks after its inspections. Had FDA used newer technology for faster test results and provided a short timeframe for product recall, it is very possible that many of the linked illnesses and at least one death would have been prevented. Thus, OIG’s review has shown that consumers can remain at risk of illness or death for several weeks after FDA knows of potentially hazardous food. This is not acceptable. FDA is acting much too slowly and either using outdated testing technology, or simply not conducting the tests in an expeditious manner. What does all this mean to you? It is very probable that FDA will respond to the alert by cracking down on recalls: being less tolerant of delays and turning up the heat on the performance of quick voluntary recalls. In fact, the Agency’s response to OIG’s concerns on its FDA Voice blog states that the agency has established a team to review investigations, and to be involved when a case involves complex policy questions, additional expert support is needed, or response timelines have not been met – with a goal of speeding FDA’s response by evaluating the whole range of options for use of compliance and enforcement authorities as quickly as possible. Let me repeat that: FDA will be looking to use – as quickly as possible – any and all of the authorities it has been given for enforcement authorities. So when you consider the increased authorities FSMA has given FDA to mandate recalls if a voluntary recall is not performed within a prescribed timeframe (a timeframe that is likely to be significantly shortened “as quickly as possible”), then add in OIG’s recommendation that FDA consider the alert findings when implementing FSMA and that it follow its own procedures for monitoring recalls, you can definitely expect that, for any potential contamination and recall issues, the heat will be turned up. Finally, I want to reemphasize the urgent need for FDA to speed up testing. We at TAG have repeatedly run into clients who have had FDA in their plants to do an investigation and the Agency has taken a lot of environmental swabs. The question posed to the inspectors and to me is “When will we get the results?” Unfortunately, the answer is always “don’t know.”  Sometimes it is one week, sometimes two, and sometimes three or longer.  This puts food companies in an impossible position of what to do and when to do it. It creates unnecessary public health risks and, while I am sure food companies will be under pressure to move faster to do recalls, I urge FDA to also move faster with testing results. The technology is there and FDA should use it. 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.


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