Just as TAG had predicted, the issues that arose during the infant formula Cronobacter outbreak and supply shortage have continued to bear down on, not only infant formula segment, but the food industry as a whole. And from the most recent development – the FDA Evaluation of Infant Formula Response published September 20 – we don’t expect the repercussions to ebb anytime soon.
With the aim to “identify the challenges encountered in addressing the circumstances that led to a shortage in supply of infant formulas” and make recommendations for correction, the evaluation focused primarily on regulatory agency shortcomings during the incident, including five major areas of need and 15 specific findings. But, as has historically been seen, any judgment passed on a regulatory agency ends up flowing downhill to the regulated bodies. And we see no exception to that here.
While all of the findings and recommendations would have ramifications in one way or another if able to be implemented (see below), there are some key areas that we see as having significant potential for impact on the entire food industry:
- Testing speed/Cronobacter focus. With the lag in Cronobacter detection in the formula caused by transit delay, laboratory testing capacity, and scientific gaps in understanding Cronobacter contamination and illness, the report recommended that FDA evaluate procedures for improvements. More timely awareness, notification and escalation could also be achieved through data integration of laboratory findings with complaints and other reports. It also was recommended that FDA expand its scientific understanding of Cronobacter and update its policies, processes, and procedures to better ensure appropriate preventive control measures; and that it consider conducting unannounced surveillance inspections.
- Industry Impact. While these recommendations were designated for infant formula manufacturers, any new FDA actions or regulations for that segment, particularly for testing speed, data integration, and preventive controls, would likely be carried forth to the entire industry.
- Recordkeeping/Remote access. Although FDA’s in-person response to complaints was delayed, in this situation, due to COVID-19 cases at the facility, the issue of access took on a much larger focus in the report, with recommendations made for FDA to evaluate additional authorities, tools and resources needed to remotely gather information during public health emergencies. And in this area, the report went beyond the shortcoming of FDA, citing the dated technology and recordkeeping practices of the infant formula industry as also potential factors in delays in collecting critical information needed to perform and define the scope of recalls. Recommendations were for FDA to act in advising the industry on best practices in areas such as product sampling, hygienic design of facilities, environmental monitoring, traceability information, and recordkeeping based on current science and technology.
- Industry Impact. Any additional authorities, tools, or resources that FDA gains are unlikely to be set for only the infant formula segment. And when combined with the current requirement for records to be able to be retrieved and provided to FDA within 24 hours of request, and FDA’s New Era of Smarter Food Safety focus on leveraging technology and other tools for more digital, traceable food system, it’s easy to see that electronic recordkeeping will continue to become not only the best, but the only, way to do business. Tack onto that the recommendation to relay best practices advise “based on current science and technology,” we could see new guidance being issued – maybe just for infant formula manufacturers … maybe for more.
- Food Safety Culture. Noting that conditions observed at the facility were not consistent with a strong food safety culture, the report stated: “A strong food safety culture is a prerequisite to effective food safety management,” and cited FDA’s New Era action to foster, support, and strengthen food safety cultures in food facilities. Thus the recommendation: The FDA should evaluate this initiative for specific actions to target the infant formula industry.
- Industry impact. Of all the recommendations made, this is the most likely to expand well beyond infant formula. Not only has FDA been heavily focused on food safety culture in recent years (particularly since the agency appointment of food safety culture book author Frank Yiannis), but its general tenets are applicable to all food establishments across the supply chain.
As shown by the analysis of these select few findings and recommendations of the report, no industry segment really stands alone. Not only can FDA set policies for all segments based on the shortcomings of one, there is an entire supply chain behind every segment that is impacted by policies that do remain specific. It is for this reason that the food industry needs to stay in tune with incidents and regulatory actions for all industry segments.
Overall, the report makes note in several places of shortcomings within FDA. Some of which are surprising and indicate a relative deterioration in situation response compared with the past. Internal coordination, leadership, better use of data, sharing of information, escalation of issues are all areas that can be improved without new authority – or, frankly, much funding either.
All this being said, despite the breadth of the report and its recommendations, one factor continues to impede FDA’s implementation of improvements in this area and many others: the lack of resources, but lack of resources is only part of the problem. So, while the industry can expect there to be some fallout from the report, it will likely be a picking and choosing of what is deemed most critical, as even the author states, “it’s important to note that implementation of the recommendations will be contingent, in part, on the agency’s ability to obtain the necessary resources and authorities to conduct this critical work.”
