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Infant Formula Concerns Again Spurring Industry Impact

Infant formula is, once again, stirring controversy in the food industry, and it is raising issues of which the entire industry should be aware.

It began with a letter from FDA to the infant formula segment sharing information “with the expectation that you will act to mitigate potential food safety risks in powdered infant formula in accordance with FDA regulations while further striving to improve operations.” That was followed by a retort from FSN publisher and attorney Bill Marler, rebuking FDA for asking the industry to “voluntarily” be best or be better and providing his recommendations for FDA actions. FDA CFSAN Director Susan Mayne then responded with a letter to the editor citing the regulatory limits to which FDA is held, keeping it from implementing such recommendations, and citing the FDA  President’s FY24 budget requests for amendments to the FD&C Act to grant the agency new authorities.

Because the regulations are rooted in the authority Congress provided in the FD&C Act, only Congress can mandate amendments. Following are details of current law, FDA requests, and the purpose:

  • Current law: FDA has limited tools to help reduce exposure to toxic elements in the food supply.
    FDA request: Amend the FD&C Act to grant FDA new authority to establish binding contamination limits in foods, including those consumed by infants and young children, through an administrative order process.

Purpose: To improve the efficiency, timeliness, and predictability of issuing binding and updated limits as new scientific information becomes available.

  • Current law: Industry is not required to test ingredients or final products marketed for infants and young children, to notify FDA of product positives if the product has not left the facility, or to conduct Whole Genome Sequencing (WGS) or share the isolates to upload into the NCBI database.

FDA Requests: (1) Amend the FD&C Act to require industry to conduct toxic element testing of final products marketed for infants and young children and maintain these records for FDA inspection, and provide FDA with new authority to remotely access and/or review these records whenever necessary. (2) Provide FDA with new authority to require firms that manufacture foods marketed for infants and young children to notify FDA of anticipated significant interruptions in the supply of such products when specified circumstances exist; report final product positive test results for relevant pathogens; and conduct more frequent environmental monitoring to identify relevant pathogens and maintain the results of such testing for FDA inspection.

Purpose: To help FDA understand levels of toxic elements in such products, allow the agency to monitor industry progress in reducing levels, and identify where FDA should devote more time and resources to better protect infants and young children.

What does all this tell us?

We, at TAG, would see the combination of all this as moving FDA in an impactful direction for the industry. This is based not only on FDA’s letter to the infant formula segment, budget request, and FSN retort, but also the FSN publisher’s letter likely signifying consumer impatience with the state of the food industry regulation as well.

For industry, we see that “impactful direction” as leading to increased oversight and inspection focus, even while any of the proposed regulatory amendments work their way through the process. For example, in the letter to infant formula businesses, FDA identifies five key areas for improvement. Although the agency’s recommendations are focused to that segment, there are a number of takeaways of which the rest of the food industry, particularly those with dry production areas, should be aware and consider in their risk mitigation efforts:

  1. Controlling water in dry production areas. Reducing the presence of water in dry production environments for low-moisture foods is essential to controlling environmental contamination, including sources such as leaks from roofs, structural features, and equipment; condensation; sanitation activities, etc. Any incidence of water in dry production environments should receive prompt consideration with equipment surfaces fully dried following a CIP or other sanitation procedure, and documentation of the drying procedure.
  2. Verifying the effectiveness of controls through environmental monitoring. Environmental monitoring is an important verification measure to ensure that sanitation and hygiene controls are effectively preventing pathogens from entering or persisting in dry production areas. Manufacturers should establish a system of process controls covering all stages of processing that are designed to ensure that the product does not become adulterated due to the presence of microorganisms in the product or in the processing environment. A well-designed and implemented EMP should provide information about the hygienic conditions at all stages of processing, while focusing the greatest amount of sampling on surfaces from which the risk of contamination to the product is greatest.
  3. Implementing appropriate corrective actions following the isolation of a pathogen from an environmental sample or a product sample. When verification testing detects a pathogen in an environmental or product sample, firms must implement a corrective action plan as required under 21 CFR 106.6. The goals of a corrective action plan are to prevent affected product from entering the market and to determine the root cause of the problem to prevent recurrence. FDA encourages firms to conduct a root cause investigation (RCI) to thoroughly investigate the potential sources of contamination by collecting environmental samples before performing sanitation activities, to evaluate incoming ingredients, and review production records. The best current available science demonstrates that the only adequate remediation for food contact surfaces contaminated by a bacterial pathogen is the application of a sanitizing treatment, with other remediation procedures, such as physical dry-cleaning techniques, not having been proven effective. Additionally, the widespread availability of whole genome sequencing (WGS) has offered an unprecedented opportunity for conducting RCIs following the detection of a pathogen. FDA strongly recommends using WGS (and the public database of genomes available at the National Center for Biotechnology Information) to analyze and investigate any pathogen, as the data from this analysis can provide the most complete information available to identify and implement appropriate and effective corrective actions.
  4. Implementing effective supply-chain controls for biological hazards. Some facilities have processes or process steps that use raw materials or other ingredients in a manner that does not apply a treatment that would be lethal to bacterial pathogens. Manufacturers must evaluate any known or reasonably foreseeable hazards associated with these raw materials or other ingredients, determine if they require control at the supplier, and if they do, establish a supply chain program for those raw materials or other ingredients (see 21 CFR 117.405(a)(1)). Verifying lethal treatments at the supplier, as well as informing the suppliers of the intended use of their raw materials or other ingredients, are the responsibility of the manufacturer.
  5. Identifying all relevant biological hazards. Because there are many known or reasonably foreseeable biological hazards associated with food products, FDA encourages industry to evaluate its practices to mitigate the potential risk of all biological hazard contamination relevant to its products.

As we look at the overall implications of the FDA communications and strategy outlined above, it appears that much of what the agency is suggesting is simply industry best practice – but the FDA appears to be seeking the authority to require these actions, at least for the infant formula industry and for those making food for infants. The request for new authority to protect infants and young children is not a heavy lift for Congress – who would want to oppose such a move?  This is potentially a big game changer for the food industry, opening the door to mandate reporting of positive findings in food that has not left the manufacturer’s control, and moving in a direction to require whole genome sequencing. Right now this is just a set of recommendations, but we all need to watch this space very carefully in the coming months to see what, if any, new authority emerges; and then what FDA does with that new authority in terms of new regulations.


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