FDA’s Hardline Approach to Recalls: Move Along

Departments - Legislative Update

December 5, 2016

By David Acheson

Hearing someone mention “recall” in a food facility has never been a particularly good thing, and with today’s increased regulation and litigation, the very word can make the quality assurance or food safety manager cringe — not to mention the upper executive who now bears the brunt of focus from the Department of Justice (as I wrote in my Legislative Update column in the July/August issue, “DOJ: Respect the Law or Fear It,”).

And because recalls (and the regulation and litigation) impact all aspects of the supply chain — forward and back, your customers are likely to also be increasing the pressure on you to prevent anything that could cause a recall — whether it be due to undeclared allergens, bacterial detection, or even foreign  matter contamination (as is discussed in the article “Foreign Object Detection: Prevent Recalls.”).

WHAT’S REALLY NEXT FOR FSMA? So far, it seems that FDA is taking a fairly relaxed approach to FSMA implementation — publishing guidance on a rather haphazard basis and acknowledging that the rules bring new territory for the agency as well as for food companies. But my guess is that this current soft approach is due more to the fact that FDA is still figuring it all out and working to train its inspectors on how to inspect for compliance, than it is to any soft-hearted desire to indulge industry.

I say that, not only because FDA has stated that it expects the industry to “take the measures required by the new rules — not just the letter of the law but what it represents in terms of transforming the food safety system,”  but also because the agency is substantiating its determination to increase food safety in the U.S. with its relatively recent hard-core approach to recalls through the development of SCORE.

FDA SCORE. If you’ve not yet heard of it, FDA’s new Strategic Coordinated Oversight of Recall Execution (SCORE) program involves a team of key senior agency officials whose mandate is to assist with challenging, complex recall situations, e.g., those complicated by the nature of the product, the scope of available evidence, and the company’s response. The primary goal is to speed up the recall process, which essentially means that this team of senior officials will take a look at all the compliance and enforcement actions for which FDA is authorized and quickly implement any that it believes will bring quick, effective, efficient resolution.

A HARD LINE ON RECALLS. To provide one example of the hardline approach I’ve seen FDA taking: I work with a client that had a product being recalled. It conducted the recall, accounting for all the product in question, and validating that none had reached the consumer level. Because of this, the company assumed no press release was required, but FDA dissented. When asked why, the agency official responded, in effect, “Because you need to be publicly shamed.” I’d say that’s pretty hardcore. In fact, FDA seems to be taking a page out of DOJ’s book — seeing prosecutions/public shaming as beneficial to food safety by having a deterrent effect.

SCORE’s development is a response to a 2011 report and a 2016 early-alert memorandum from the Office of the Inspector General (OIG) in which FDA’s recall program was found to be inadequate, and its recall-initiation process inefficient and ineffective. SCORE was developed earlier this year, and FDA sees it as already making a difference in some complex cases. As stated in the FDA Voice Blog, it has already led to “additional inspections and sampling assignments,” and the suspension of a food facility’s registration “after a reinspection and additional sampling requested by SCORE showed continued contamination.” 

The agency also states that, in some cases, it will act on circumstantial evidence that the conditions in which the food was produced indicates a problem or that the contamination may be more widespread.  How? By invoking the standard in the law that requires that it only demonstrate “may have been”: i.e., that the food was prepared, packed or held under insanitary conditions and may have been contaminated.

MOVE ALONG. So, if the prospect of consumer harm, brand damage, financial impact, or even litigation has not caused you to protect against recalls, you now have the prospect of FDA’s fingers in your soup to not only spur on your food safety program, but also to initiate recalls whenever in doubt and move it along as fast as possible — even if that means having to conduct more than one recall because you had to take action before you had all the information.

The bottom line is that FDA expects the company to take immediate action to remove potentially harmful or implicated food from the market and prevent contamination, and, if the company does not do so, FDA will utilize the enforcement tools at its disposal — from mandatory recall to facility registration suspension to seizure and injunction, if needed and as needed.

Long term, the goals of SCORE are to identify and close the gaps that slow the process and identify trends for which policy action may be needed. An example of this, that could have significant repercussions for the industry, is the Agency’s current initiative to consider whether Class II recalls should require consumer notification, as do Class I recalls. The rationalization for this is that immunocompromised consumers, such as the young or elderly, may be vulnerable to a Class II recall but, currently, they would have no way of knowing it exists.

It all sounds to me like FDA is voicing a soft approach to FSMA compliance while setting up repercussions for not instituting preventive controls to avert recalls, i.e., consumer harm.

David Acheson is Founder and CEO, The Acheson Group