From heavy metals and chemical residues to repercussions from produce contamination and infant formula adulteration and shortages, 2022 became a year of regulatory embarrassment and new regulations – which we’d expect to lead to some rough times in 2023 for the food industry.
Let’s take a look, first, at the highlights (or lowlights?) of 2022.
The focus on heavy metals began in 2021 with the Congressional Report on Heavy Metals in Baby Foods. Coming down hard on the Trump administration for ignoring an August 2019 “secret industry presentation to federal regulators revealing increased risks of toxic heavy metals in baby foods,” the report challenged the Biden administration to do something about the issue. With the report putting the FDA in a tough spot with a clear push to do something, the agency published its Closer to Zero Action Plan for Baby Foods for Lead, Arsenic, Cadmium, Mercury in October 2022. With the year also seeing a lawsuit declaring that high levels of heavy metals may have caused autism and other neurodevelopment disorders, the industry continues to face challenges on how to control these naturally occurring elements.
Other chemicals, including mycotoxins (aflatoxin, ochratoxin), phthalates, pesticides, and Per-/Polyfluoroalkyl Substances (PFAS), came under the regulatory spotlight with EPA issuing interim updated drinking water health advisories for PFOA and PFOS, US states setting their own standards, and two processors recalled product due to FDA’s finding of “detectable levels” of PFAS.
Add to this, the infant formula adulteration and shortages for which FDA was taken to task for its inadequate response to high-profile incidents. Not only did it energize Congress to take action largely focused on changes at the FDA and for infant formula, the fallout is continuing to impact the rest of the food industry with increased regulatory pressure – not the least of which is a lack of tolerance for slow response or protracted recalls.
Regulatory pressure also increased in 2022 due to the lack of decline in the U.S. rate of foodborne illnesses. Although current FSIS policy has led to a 50% reduction in Salmonella on poultry (2017 to 2021), human illness from Salmonella has not changed in 20 years. So with a goal toward a 25% reduction in Salmonella related illness, FSIS proposed a three-prong approach including the testing of incoming flocks, enhancing facility process control monitoring and FSIS verification, and implementing an enforceable final product standard. There are, however, a number of remaining questions, e.g., Will all 2500 types of Salmonella be adulterants or just those most responsible for human illness? Will FSIS require a specific quantitative approach? Or will some combination be determined?
The media also took shots at FDA with the publication of a negative article in Politico describing a dysfunctional agency, especially around the management of the infant formula situation earlier in 2022. Thus putting even more pressure on the Commissioner to do something.
While it came too late to have much effect in 2022 beyond the general reporting of its recommendations, the Regan-Udall Foundation Review of FDA’s Structure is likely to lead to industry impact in 2023. Among the foundation’s key recommendations were changes in the agency’s structure, enhancements to its organizational culture, increased resources, and the addition of new authorities. While there was little in the report that was new, a few areas with which I am in whole-hearted agreement are the need for better accountability of resources, and the recommendation to develop a Center for Nutrition, as the importance of nutrition does need to be elevated within the Human Foods Program. Another area I see as critical that wasn’t addressed in the report is that of industry collaboration. While it discusses the complexity of the supply chain, food production and distribution, there is no reference to seeking input from those players in any substantive way.
Thus, given the events of 2022, I would expect some rough times in 2023 to include some tough FDA inspections, a major focus on chemical residues, continuing regulatory requirements related to Salmonella, increased focus on produce, and – from the private sector – class-action lawsuits. So what should you be doing as the year rolls over? My top recommendation would be to be prepared for inspections. Check your programs to ensure they are up to regulatory scrutiny. A good way to do this is to develop a pre-inspection checklist focused on the areas FDA is likely to inspect, including your documentation, preventive controls, and regulatory compliance. Additionally, ensure you are prepared for rapid response to FDA requests (particularly if the inspection is due to an outbreak or recall), and take steps to educate your entire team on how to manage inspections.