On March 12, a recall notice was posted on the FDA website for two production lots of Pillsbury Unbleached All-Purpose Flour due to possible Salmonella contamination. While that may sound like a typical recall announcement, this recall was anything but typical. That’s because, although at least some grocery chains were notified of the recall by the parent company, Hometown Food Co., on March 8 – four days prior to FDA’s March 12 listing – the company did not submit it to FDA at that time. Hometown Food did send FDA “a letter in reference to the recall,” according to an FSN article. So FDA was aware of the recall, but the agency’s standard procedure is that it only releases recall information upon receipt of a public recall notice from a company. Since it wasn’t until March 12 that FDA received the notice from Hometown Food, the agency could not post it until then. The fine line between a “letter” and a “public notice” is the wording of the second – that is, it is to be a notice or press release that is publicly issued and submitted to FDA with all the information included in the Guidance for Industry: Product Recalls, Including Removals and Corrections. That guidance also recommends that the information be submitted “to your local FDA District Recall Coordinator as soon as possible after the decision to recall is made and the coordinator notified. It is recommended that you do not wait to submit this information until ALL applicable information is prepared and assembled prior to FDA notification. This ‘early’ notification will allow FDA the opportunity to review and comment on your written notification and to offer guidance and assistance in your recall process.” Again, FDA notes that early notification is simply for it to provide guidance and assistance, it never states that the public will be informed. In fact, a boxed statement on FDA’s recall page for the flour, which is labeled as a “Company Announcement,” states “When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service.” Telling us, it seems, that the agency has no requirement to post these, but it is done for the benefit of the public. Interestingly, a final guidance document also was issued earlier this year that seems to have passed largely unnoticed. That is, the February 2019 guidance on the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls, “Public Warning and Notification of Recalls Under 21 C.F.R. Part 7, Subpart C, Guidance for Industry and FDA Staff.” So what does all this mean to you? It means that as recalls continue and FDA is being held more and more accountable to take swift action, there is ever more a sense of urgency in providing information to consumers on issues that could impact public health. It means that when things go wrong, you have to be on it very fast, know the level of risk, and make a fast decision on when to contact the regulators and what you propose to do about it. This means you have to be very prepared. In my opinion, the number of recalls is going to continue to rise with the better use of molecular diagnostics and regulatory vigilance. So when that happens to you the goal is to come out the other side with an intact reputation and an intact brand. And having a member of the media (or social media) be the one to inform the public of your contaminated product certainly does not provide consumers with trust in your product or brand. If someone were to fall ill – or worse – as a result of this contamination, it would not only further the media coverage and consumer distrust, it could be seen as a lack of due diligence to contain the impact. And with the DOJ’s increased focus on food safety and executive accountability, that’s the last thing a food company would want. It also means that you need to have a good understanding of the recall process and FDA’s requirements. I don’t really know if Hometown Food thought the “letter” it sent to FDA fulfilled the requirements of a recall notice or if they just intended to send a notice at a later date. But large or small (and Hometown Food is quite large, having acquired the Pillsbury Shelf-Stable Baking Business, Hungry Jack Brand and other assets from The J.M. Smucker Company in September 2018), all food companies need to ensure they thoroughly understand and practice both the recall process and crisis response, and follow it with a sense of urgency for consumer (and brand!) protection. 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
