What is FDA’s Policy on Requiring a Company to Issue a Press Release?
You've initiated a recall for a product that has the potential to be contaminated with Listeria monocytogenes. The product is on retail shelves and/or been purchased by consumers. Do you need to issue a press release?
In the past, I would have said, Absolutely! It is required by FDA. But with FDA's statement in relation to a recent recall, I'm not so sure that is an accurate response.
Last week I received an email from a client. With a subject line of "FDA Threshold???", the email referred to a Food Safety News article on the recent frozen pea recall in which an FDA spokesman said, "We are working with this firm in regard to their recall; however, it does not reach the threshold to require a public communication.”
In the emails, the client stated, "I find this incredible! I never knew FDA has a "threshold." … Can you provide any insights into defining what the threshold is … any insights as to why they would make such a decision? I’m afraid this will start a precedent."
My first thought, and my first response, was that it surprised me as well. There are situations where a press release can be avoided for a Class 1 recall, but that is when you have the product controlled. But when it is at consumer level, this is a very unusual strategy. So, I did not have a good answer as to what FDA's "threshold" might be, but I found it interesting that, as also stated in the article, FDA itself provided no notice of the recall, with it becoming public only because of retailer/wholesaler notices and FDA's Enforcement Report.
Then I got a look at the Enforcement Report, and I saw that the recall is classified as Class II. This shed an entirely different light on the situation, and, in fact, brought up a whole different set of questions and definition of "threshold." Because, even while classifying the recall as Class II, the reason for recall was listed as "Product has the potential to be contaminated with Listeria monocytogenes." An obvious point of confusion is that so many Class 1 recalls for Listeria monocytogenes say exactly the same thing - "Product has the potential to be contaminated with Listeria monocytogenes."
So, rather than questioning what the distribution or amount threshold is for a press release, my question becomes what "threshold" of potential Listeria monocytogenes contamination of a product makes it a Class II rather than a Class I recall? Is this related to the properties of the product – in that it does not support growth and that the levels of Listeria in the product are well below any that would result in a reasonable probability of a serious adverse health event?
FDA's Safety webpage defines the two as:
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
So, with a potential Lm contamination, which certainly can have serious adverse consequences, I am not sure where that line would be drawn? How much contamination potential or reasonable probability of adverse consequences is needed to reach the "threshold"? If only a single routine sample at retail tests positive or no illnesses are reported (as in this case), does that keep it under the "threshold"? Or, is it simply that Lm in a ready-to-eat food would be considered Class I, with other foods falling below the threshold, perhaps taking into consideration other factors as well?
No company is looking to issue a press release about a recall, and I am very happy that in this situation the company was able to avoid a press release. But, what would be nice is if the FDA were to make the process a little more transparent about what the thresholds are for issuing a press release.
On the note of issuing a press release it was only last year when I was working with a client who was undertaking a class I recall in which all the product was accounted for. At the time, the FDA person they were talking to at the district level told them they still had to put out a press release. Upon being asked why, the response was essentially that part of the purpose of a press release was to “name and shame.” Thankfully that is a rare event and I feel confident that it is not the FDA standard approach. But a little more transparency in this area would be helpful.
For food companies, the issuing of press releases is a very important area for which I don't have a solid answers, but I would be interested in hearing from anyone – FDA official or otherwise – who may have the answer or other comments. I will follow back on this in a future newsletter with any responses that are received.
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