The U.S. House Committee on Oversight and Accountability will hold a hearing on April 11, 2024, tiled “Oversight of the Food and Drug Administration.” The hearing will examine the Oversight Committee’s ongoing investigations into the FDA response to several issues, including the infant formula crisis and food safety, drug shortages, facility inspections, hemp regulation, regulation of tobacco and nicotine products, and over-the-counter decongestants.
“The Oversight Committee has highlighted several crises occurring on the FDA’s watch which have negatively impacted the lives and health of American people and families. From a botched response to a nationwide infant formula crisis, failure to regulate safe tobacco products, failure to prepare for and address critical drug shortages, and more, we have identified how dysfunction at the FDA could be worsening many of these preventable crises. We will hold the Commissioner accountable for what the FDA is doing to address ongoing crises, how they are conducting inspections to prevent nationwide crises in the future, and how they intend to ensure the FDA is first and foremost protecting American consumers,” said Oversight Committee Chairman James Comer (R-Ky.).
The hearing will be livestreamed online on April 11 at 1:00pm ET.
The FDA has launched a new webpage listing food-related regulations that it plans to publish by October 2024 as well as longer-term regulations it is prioritizing for publication at a later date. The list includes 22 Foods Program regulations ranging from Certifications Concerning Imported Foods to Nutrient Content Claims and Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation.
The three long-term action items relate to color and food additives.
The FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024 to include five new guidances. They include:
Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry
The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry
Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.
The FDA has provided an update on actions the agency has taken, and those underway, to strengthen the safety and resiliency of the supply of nutritious infant formula, including the release of a progress report specific to actions the agency has taken to meet the recommendations in the FDA’s Evaluation of the Infant Formula Response. Actions taken include:
Hiring and providing specialized training to personnel dedicated to the oversight of critical foods, including infant formula. This includes setting up a dedicated critical foods inspectional cadre and establishing a new Office of Critical Foods. Both actions arm the FDA with resources and expertise that are focused solely on critical foods, and which facilitate enhanced oversight of these commodities.
Updating and improving the FDA’s infant formula compliance program, which outlines the agency’s inspectional and compliance approach to infant formula, to help ensure that infant formula products in the U.S. food supply are safe and nutritious.
Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, to better understand how these illnesses occur, spread, who is most at risk and what the FDA can do to prevent Cronobacter-related illnesses.
Increasing the diversity of infant formula available in the U.S., especially through the FDA’s transition plan for firms that had previously received a letter of enforcement discretion.
Updating and streamlining infant formula related materials on fda.gov to provide consumers, industry and medical professionals with more accessible information, including materials on Infant Formula and Cronobacter sakazakii and a new resource on handling infant formula safely (available in both English and Spanish).
Issuing warning letters to infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that manufacturers are producing infant formula under the safest conditions possible.
As we saw with the recent large scale recalls of infant formula, Cronobacter has become a pathogen of growing public health concern for vulnerable populations. Our guest experts, Sally Powell Price, Regulatory Expert Food and Beverage Safety at MilliporeSigma, and Andrew Lienau, Food Regulatory and Validation Senior Expert at MilliporeSigma, detail the importance of Cronobacter in food manufacturing, summarize detection solutions and provide a glimpse into the future of this potentially deadly pathogen.
Why is Cronobacter detection important?
Cronobacter are ubiquitous pathogens that have been isolated from a wide variety of sources including dried herbs and spices, soil, starches and milk products. They are found naturally in the environment, for example, in our yards, kitchens and living rooms. They even can live on surfaces including kitchen counters, sinks and food facility manufacturing equipment.
Andrew Lienau
Infant formula, as we have seen in recent years, can be contaminated by this type of bacteria. While Cronobacter infections are rare, they can be fatal to newborns and immunocompromised individuals. When these infections are diagnosed in infants, they are often linked to consumption of powdered formula.
According to CDC, the potential mortality rate for Cronobacter infection is 40%. It has high risks for newborns, especially low-birth weight infants. Cronobacter is highly resistant to stress and can survive in products such as powdered infant formula for more than two years, which is the major risk factor. Almost all Cronobacter species are linked to human infections (adults and infants).
How is MilliporeSigma’s Assurance® GDS method fit-for-purpose for detection of Cronobacter?
Ensuring an assay is robust is a lengthy process. Microbiology methods are reviewed and approved by standards or certification bodies. Certification organizations for food microbiology include AOAC International and Health Canada in North America and AFNOR Groupe and MicroVal in Europe. Approved testing methods undergo rigorous, systematic scientific scrutiny and validation to ensure they are credible and legally defensible and thus can be used with confidence by industry, regulatory agencies, research organizations, testing laboratories and academic institutions. It is important during this validation process to demonstrate that the methods are reproducible and provide consistent results across a variety of sites and users.
During the certification process, methods are compared against standard reference methods or a “gold standard.” For example, there is a reference method developed by ISO for enrichment of Cronobacter from foods. Through the certification process, the MilliporeSigma Assurance® GDS method performed as well as the reference method. But the GDS Cronobacter method requires less time, materials and personnel to obtain comparable results. This certification improves both industry confidence and access to a rapid, reliable method for detection of Cronobacter in food.
The GDS for Cronobacter method has been reviewed and approved by both MicroVal (MicroVal 2017LR77) and AOAC International (AOAC PTM 121903; AOAC OMA 2021.08). These review processes can take more than one year from initial submission of protocol to generation of the validation data, including final review of the results by the certification organization. Outside expert peers also review the method for approval.
This year MilliporeSigma was honored that the Assurance® GDS Cronobacter method was recognized as the Method of the Year Award in Microbiology by AOAC International.
What are the regulatory implications and outlook for Cronobacter & infant formula?
The recent move towards restructuring the FDA and Human Foods Program was in part driven by the high-profile recalls and subsequent infant formula shortages due to Cronobacter contamination. Over the next year, we can expect to see continued regulatory scrutiny of Cronobacter and similar pathogens or analytes that put infants and other vulnerable populations at risk.
Sally Powell Price
Last year, the U.S. FDA released a strategy to help prevent Cronobacter illnesses, and in 2023, they expanded their approach by increasing inspection capacity and updating the Infant Formula Compliance program.
Beginning in 2024, Cronobacter infection will be a nationally notifiable disease as recognized by the US Centers for Disease Control (CDC). The FDA will collaborate with states and public health labs to bolster testing efforts. This will provide more clinical isolates, complementing the FDA’s environmental and product sample collection and sequencing strategies. It will also increase sequencing data available in the NCBI database in hopes of bridging scientific gaps related to Cronobacter.
Furthermore, the FDA is reviewing existing testing criteria to potentially enhance finished product safety with a focus on infant formula regulations led by the Office of Critical Foods. The Agency is collaborating with Congress to explore legal avenues to require firms to report Cronobacter-positive product test results, among other requirements.
For infant formula manufacturers it’s not all about regulation, however. Manufacturers and stakeholders now have expanded opportunities for collaboration with the FDA and related working groups like the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). These partnerships offer a unique chance for productive dialogue and the potential to engage in valuable initiatives aimed at providing scientific insights into Cronobacter and its prevention, including elective surveillance programs. Additionally, stakeholders in the infant formula industry can strengthen efforts to be transparent with consumers. They may actively participate in public meetings and engage with industry associations such as the Association of Food and Drug Officials (AFDO) or The Partnership for Food Safety Education (PFSE), fostering open discussions and sharing best practices to enhance safety and quality standards in the production and preparation of powdered infant formula. This proactive engagement not only fosters consumer confidence but also contributes to a safer environment for infants and vulnerable populations.
The FDA has updated its infant formula compliance program for FDA investigators, laboratory analysts and compliance officers. The updates build on lessons learned over the last several years to elaborate on FDA’s approaches for inspections, sampling, laboratory analysis and imported infant formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities and instruction for FDA notification should a sample test positive for Cronobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the agency’s infant formula regulation.
The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.
Additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, are also included in the updated compliance program.
Inspectors are directed to perform environmental sampling once a year at each domestic powder infant formula manufacturing facility during annual or compliance follow-up inspection for both Cronobacter and Salmonella analysis if there are no significant adverse supply-chain implications.
The Division of Field Programs and Guidance (DFPG) and ORA Critical Foods Coordination Team will prioritize the annual inspection schedule based on:
the facilities’ previous inspection results
number of consumer complaints since the last inspection
number of violative samples collected by FDA in the last twelve months
the previous environmental sampling results performed by FDA
Per the instructions, environmental sampling should focus on zone two sites near potential product exposure points in the process (i.e., transfer points, fluid bed, sifters, rotary valves, man doors into drying system, filling lines, blending equipment, raw material handling equipment, etc.) including any areas indicating water accumulation. Additional sampling should also be done from zone three sites which may suggest a route of contamination (i.e., doorways, traffic routes, etc.) to dry production areas, finished product or food contact surfaces. Zone one sites should not be swabbed as these zones can be hard to reach and may introduce contamination during swabbing of a closed system. Unless conditions observed indicate a possible route of contamination, FDA does not recommend swabbing zone four areas at a high frequency.
Inspectors are advised to collect between 100-300 environmental swabs for Cronobacter spp. and 100-300 environmental swabs for Salmonella spp. at each firm, depending upon the size of the facility.
A new study, published in the Journal of Food Protection, found that spacing out samples over time, called “stratified” sampling, is better at catching risky pathogens like Cronobacter in powdered products, such as infant formula, than randomly sampling from the product as it is being produced. In addition, the study found that that while taking more samples of a product generally increases the chance of catching the pathogen, there is a point after which it is unlikely that additional sampling will increase safety.
All efforts were based on detecting a realistic hazard, here defined by testing samples from Cronobacter-contaminated batches produced in Europe in the 2010s, using the most current data available. The paper found that safety plans with 30 or more grab samples had a very high probability of detecting the hazard. And that there was a point of diminishing returns, such that very high sample numbers—for example, testing every can produced—would not be meaningfully more powerful.
“This shows that existing sampling and testing guidance is powerful, at least for the one hazard profile our team had access to for the study,” said project lead Matthew J. Stasiewicz of the University of Illinois Urbana-Champaign. “This also highlights the need for additional research and data-sharing efforts into patterns of contamination in current infant formula production, so that sampling and testing can be better matched to current needs.”
“In additional to analyzing scenarios we found relevant, we built a web app that allows industry stakeholders to simulate various sampling scenarios and gain deeper understanding of the effectiveness of sampling plans specific to their plants. With this knowledge, producers can proactively address risks and optimize current sampling practices,” added Minho Kim, lead author.
The USDA Food Safety and Inspection Services (FSIS) and the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) will be holding a virtual public meeting on August 30, 2023, from 11 a.m.-1 p.m. ET to discuss and vote to adopt NACMCF’s recent report on Cyclospora cayetanensis in produce. Written comments must be submitted by August 25, 2023. The committee will also provide an update on the Cronobacter spp. in powdered infant formula charge.
The report was requested by the FDA, as the agency seeks more information on the factors that can contribute to C. cayetanensis contamination of domestically grown and imported produce, as well as recommendations for developing an effective prevention and management strategy.
As the report highlighted, cyclosporiasis previously was associated with travel outside of the U.S. or consumption of contaminated imported foods. However, in recent years, the U.S. has seen an increase in cases and positive samples associated with produce, both as raw agricultural commodities, and fresh-cut produce, grown in the U.S. In the last three years, the number of cyclosporiasis cases has increased approximately 300%, often linked to fresh produce consumption, specifically leafy herbs and ready-to-eat salads.
Attendees must pre-register by Friday, August 25, 2023, to receive details on how to access the meeting. During pre-registration, attendees may also express interest in delivering comments during the meeting. Oral comments will be limited to three minutes per speaker. The agenda will be shared on the FSIS Events & Meetings page prior to the event.
Infant food safety, including new arsenic and cadmium action levels, are among the new priorities the FDA plans to address before the end of 2023. On July 6, the FDA Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2023.
The following guidance topics have been added to the 2023 agenda:
Draft Guidance on Dietary Supplement Master Files
Draft Guidance on Low-Moisture Ready to Eat Foods (including infant formula)
Draft Guidance on Action Levels for Arsenic in Food Intended for Babies and Young Children
Draft Guidance on Action Levels for Cadmium in Food Intended for Babies and Young Children
Amendment to the Menu Labeling Supplemental Guidance
Guidance on Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein.
Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA – 2021-N-0553.
The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website.
Does your company need to worry about regulations relating to foods designed for infants (considered to be anyone aged 0-12 months)? If you manufacture infant formula, then of course the answer is yes. But what if you manufacture baby food—those cute little jars of liquified goodness? Traditionally, those types of food haven’t been subject to any special FDA regulations. Manufacturers simply need to follow the regulations that govern all foods designed for consumption by humans of any age. That, however, is changing.
There is a growing push to limit, and ultimately eliminate, heavy metals, such as inorganic arsenic, lead, cadmium, and mercury, present in baby food. These elements are present in our food chain in amounts that are concerning to members of the U.S. Congress and other stakeholders because of modern manufacturing techniques, and they have an outsized effect on infant health.
Pending Legislation
On March 25, 2021, the Baby Food Safety Act was introduced in Congress. As of the time this article was written, it had not yet passed. If it passes, it will require manufacturers, within one year of its enactment, to reduce levels of inorganic arsenic in non-cereal foods to 10 ppb and in cereals to 15 ppb, levels of cadmium and lead to 5 ppb in non-cereals and 10 ppb in cereals, and levels of mercury to 2 ppb in non-cereals and cereals. Within three years of enactment, the Act requires that final regulatory levels be set that reduce these levels to an even lower amount. It also requires reevaluation of the current regulatory levels every five years thereafter.
But the Act would do much more than simply setting limits for heavy metals in baby food. It would also:
Add regulations to the Food Drug and Cosmetics Act requiring FDA to specifically regulate foods for consumers up to 36 months old
Require manufacturers to report levels of heavy metals biannually on their websites
Give FDA mandatory recall authority
Mandate creation of public awareness campaigns
Offer grants for farming research
Current FDA Actions
The FDA is already working to reduce heavy metals in baby foods. In August 2020, the FDA finalized guidance setting the limit for inorganic arsenic in baby rice cereals to 100 micrograms per kilogram. Fortunately, most manufacturers had already achieved those limits; sampling from 2018 showed that 76% of manufacturers were in compliance, up from 47% in 2014 and from just 36% between 2011 and 2013.
In early 2021, FDA launched an action plan to address heavy metals in foods consumed by infants and young children, called Closer to Zero. The overarching purpose of the plan is to gather data about heavy metal levels and then set tolerances for those substances, with the input from all stakeholders. Thus, the FDA has signaled its intent to act regardless of what Congress has in store.
More recently, the FDA issued draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children,” recommending that levels of lead be limited to 10 ppb in fruits, some vegetables, and yogurt, and to 20 ppb in root vegetables and dry cereal. The guidance is focused on processed foods, including foods served in jars, pouches, tubs, and boxes intended for children under two.
Whatever the ultimate outcome of these initial steps taken by Congress and FDA, one thing is clear: Concerns about heavy metals in the foods consumed by our tiniest citizens isn’t going away. So, if the product you manufacture or grow may be destined for a jar of baby food—even if you don’t think you manufacture baby food—it’s time to begin working to address the issue in your facilities and your fields.
On March 8, the FDA sent a letter to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our infants.
The agency notes that since the 2022 infant formula recalls and resulting shortages, it has been working to improve the resiliency of the infant formula supply by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate products in the U.S. marketplace through the exercise of enforcement discretion. The FDA has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacterprevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate.
In addition, over the past two months, food safety staff have been meeting regularly with manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula. The letter sent to manufacturers reflects the information the agency gained through interactions with industry as well as the latest available science on improving the microbiological safety of powdered infant formula.
The FDA called on members of the infant formula industry to use the information in the letter to take prompt action to improve processes and programs for the protection of infants. In addition to this call to action, Congress recently added new requirements for manufacturers aimed at mitigating supply chain disruptions through mandatory shortage notifications and risk management plans.
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