According to the details posted online by the FDA, the recall was initiated on June 16, 2023, and is ongoing.

The recalled products were distributed in Illinois, Alabama, Iowa, Georgia, Mississippi, Indiana, Arkansas, Colorado, Florida, Virginia, Ohio, Wisconsin, Pennsylvania, New Hampshire, Arizona, Kansas, Texas, Tennessee, North Carolina, Lousiana, Missouri, Kentucky, Delaware and Wisconsin.

Recalled products:

Parent’s Choice brand Sensitivity Premium Infant Formula

• 638g
• packaged in plastic tubs

Tippy Toes brand Sensitivity Premium Infant Formula 

• 942g 
• packaged in composite cans

Code information:

• D05LVJV
• USE BY 05MAR2025 
• D06LT7VA 
• USE BY 06MAR2025

UPC Codes: 36800496644 and 681131045513

Anyone who purchased the recalled products should immediately dispose of it and not consume it.

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According to the FDA, this action is occurring within the context of its ongoing commitment to enhance regulatory oversight and reflects the agency’s determination to ensure optimal conditions for producing infant formula. These letters, arising from inspections carried out over several months, cite violations of the Federal Food, Drug, and Cosmetic Act and the FDA’s Infant Formula regulations. The issuance of these warnings coincides with recalls conducted by the manufacturers in December 2022, February 2023 and March 2023 to remove potentially contaminated Cronobacter sakazakii-tainted products from the market.

Despite these actions, the FDA does not advise parents and caregivers to avoid specific infant formulas. According to the FDA, no confirmed contamination has been reported in distributed products, and the recalls have been effective in removing potentially unsafe batches from the market. Furthermore, these warning letters are not tied to ongoing recalls, and as such, they are not expected to affect the availability of infant formula.

2021-2022 Cronobacter outbreak
Between December 2021 and March 2022, the US FDA received two reports of infant deaths linked to powdered infant formula produced by Abbott Nutrition in Michigan. These reports were part of 128 complaints. While two deaths were connected to a confirmed outbreak of Cronobacter sakazakii, others were reported through the FDA’s consumer complaint system, with two mentioning Salmonella. An additional 25 incidents were categorized as life-threatening, and 80 as non-life-threatening. A variety of symptoms were reported, such as fever, vomiting, diarrhea, and blood in stool. Investigations revealed Cronobacter sakazakii in Abbott’s manufacturing environment, although genetic matches weren’t found for the strains infecting the babies. All affected infants had consumed Abbott powdered formula.

Summary of warning letters
The issuance of these letters aligns with the FDA’s customary regulatory process and aims to reinforce the significance of implementing and maintaining appropriate corrective actions in the presence of pathogens. Manufacturers are required to conduct thorough root cause investigations, subsequent cleaning and sanitation activities, and comprehensive evaluations of cleaning and sanitation practices before releasing products. Each manufacturer is allotted 15 working days to provide the FDA with an explanation of the corrective actions they are taking. The agency will review the responses and evaluate the adequacy of corrective measures during its next inspection of each facility.

ByHeart Inc.
New York, NY

An infant formula producer in New York is on notice from the FDA  for significant violations of the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. 

In an Aug. 30, 2023, warning letter, the FDA described a Dec. 21, 2022, through Feb. 17, 2023, inspection of ByHeart Inc.’s powdered infant formula facility in (redacted).

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Specifically:

a. On Oct. 17, 2022, the firm notified (redacted) that a batch of ByHeart Whole Nutrition Infant Formula finished product had tested positive for Cronobacter spp. and was later confirmed as Cronobacter sakazakii (“C. sakazakii”). The infant formula base, which was a component of the contaminated finished product, was manufactured during a continuous production campaign at the (redacted) facility from July 13, 2022, through Aug. 23, 2022. The infant formula base from this campaign was then blended and packaged as a finished product at one of their third-party contract manufacturer’s facilities from Sept. 15, 2022, through Oct. 7, 2022.

In response to the finished product positive, (redacted) conducted a root cause analysis. (Redacted) root cause analysis concluded that post-production sample handling by a third-party laboratory was the source of the contamination, essentially resulting in a laboratory error. However, the third-party laboratory provided an “OOS Result Investigational Report for Microbiological Testing” regarding the C. sakazakii findings in finished product, which concluded that “Laboratory error was not found or supported.” The third-party laboratory reached this conclusion after reviewing its internal protocols and testing conditions, finding no basis to attribute the sample results to laboratory error. Typically, a conclusion of lab error within an RCA is supported with confirmed evidence, such as written confirmation from the third-party laboratory attesting to the error. Here, there is no attestation; there is evidence to the contrary.

Despite the discrepancy between the third-party laboratory and the internal conclusion within (redacted) root cause analysis, neither the firm nor their subsidiary company, (redacted), took any additional efforts to evaluate other routes of contamination that may have contributed to this event. FDA’s review of their records obtained during the (redacted) inspection show that they did not work with their third-party contract manufacturer to further investigate the origins or root causes of the finished product positive findings.

In response to the C. sakazakii finished product findings, the firm directed their third-party contract manufacturer to hold and destroy the lot of product that tested positive for C. sakazakii and the first pallet of the subsequent lot in the same production campaign. However, they directed the release of all other ByHeart Whole Nutrition Infant Formula finished product manufactured as part of their third-party contract manufacturer’s continuous production campaign. Upon further evaluation of (redacted) sanitation and production records, and following discussions with FDA, their firm subsequently conducted a voluntary recall of the remaining five lots of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron from the same Sept. 15, 2022 – Oct. 7, 2022 campaign that they had previously released into U.S. commerce.

The full warning letter can be viewed here.

Reckitt/Mead Johnson Nutrition
Parsippany, NJ

An infant formula producer in New Jersey is on notice from the FDA for significant violations the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications at two of their facilities.

In an Aug. 30, 2023, warning letter, the FDA described a  Feb. 7-23, 2023, inspection of Reckitt/Mead Johnson Nutrition’s Zeeland, MI, powdered infant formula manufacturing facility and a Nov. 28, 2022, through Jan. 9, 2023 inspection of their Wanamingo, MN, facility.

Both of the FDA’s inspections revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment. Specifically:

Zeeland Facility
a. On Sept. 4, 2022, a batch of the firm’s Enfamil Prosobee Simply Plant-Based Infant Formula (Prosobee) powder product, tested positive for Cronobacter sakazakii (“C. sakazakii”). The Prosobee product that tested positive was manufactured in a continuous production campaign that ran from Aug. 29, 2022, through Sept. 1, 2022, which produced three batches of the Prosobee product. The Prosobee product that tested positive for C. sakazakii was produced in the first batch of this continuous campaign. The firm’s Critical Deviation Investigation Report, which includes their root cause analysis, concluded that their third-party manufactured base powder, Prosobee Lipil Synergy, was the source of the contamination. While they identified a probable source of contamination, the FDA noted that their root cause analysis did not include further investigation of the finished product isolate or the environmental isolates recovered from the facility of their third-party supplier responsible for manufacturing their base powder.

Wanamingo Facility
d. On Oct. 15, 2022, the firm’s third-party customer notified them that a finished product, non-exempt milk-based powdered infant formula tested positive for C. sakazakii. This product was blended at the firm’s facility on thier (redacted) line between Sept. 15 – 20, 2022, and then packaged on Packaging Line #1 between Sept. 30 – Oct. 7, 2022.

Upon receiving notification of this result, the firm failed to conduct an independent root cause analysis or investigation and they did not evaluate whether other products may have been impacted by this contamination event. 

The full warning letter can be viewed here.

Perrigo Wisconsin, LLC
Eau Claire, WI

An infant formula producer in Wisconsin is on notice from the FDA  for significant violations the Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications. 

In an Aug. 30, 2023, warning letter, the FDA described a March 6 through April 26, 2023  inspection of Perrigo Wisconsin, LLC’s powdered infant formula manufacturing facility (Gateway facility) in Eau Claire, WI.

Based on the information the firm provided to FDA investigators during their inspection, Perrigo Company PLC (“Perrigo”) purchased the Gateway facility from Nestle on Nov. 1, 2022. The acquisition included the facility along with the U.S. and Canadian rights to the Good Start infant formula brands. Nestle remains responsible for Nestle’s current WIC contracts, with Perrigo supplying product through the Gateway facility for those contracts. Both Perrigo and Nestle indicated they will be working closely together in the transitional period following the purchase of the Gateway facility.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. Some of the significant violations are as follows:

1. The firm did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment Specifically:

a. The firm identified Cronobacter spp. in the following finished products:

i. During a continuous production campaign that ran from Oct. 23, 2022, to Nov. 2, 2022, two products tested positive for Cronobacter spp. The positive products were identified as Parent’s Choice Infant Formula Milk-Based Powder with Iron, which was spray dried on Oct. 26, 2022, and packaged on Oct. 27-28, 2022, and Parent’s Choice Infant Formula Milk-Based Powder with Iron, which was spray dried on Nov. 2, 2022, and packaged on Nov. 2, 2022.

Prior to the initiation of this production campaign, on Oct. 21-23, 2022, the firm conducted a major clean-in-place (CIP)/Top Down 4-Step Cleaning. On Nov. 2, 2022, when the firm received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

ii. During a continuous production campaign that ran from Jan. 3, 2023, through Jan. 18, 2023, a batch of their Gerber Good Start Soothe Pro powder product tested positive for Cronobacter spp. The positive product was spray dried on Jan. 11, 2023, and packaged on Jan. 12, 2023.

Prior to the initiation of this production campaign, on Dec. 31, 2022, to Jan. 2, 2023, the firm conducted a major CIP of the dryer equipment and a Top Down 4-Step Cleaning of the packaging equipment. On Jan. 18, 2023, when they received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

iii. During a continuous production that ran from March 26, 2023, through April 5, 2023, a batch of the firm’s Gerber Good Start Plus Iron and Calcium Fortified Milk-Based (“Gerber Good Start Plus”) powder product tested positive for Cronobacter spp. The positive product was spray dried on March 26, 2023, and packaged on March 27, 2023.

Prior to the initiation of this production campaign, on March 22, 2023, to March 26, 2023, the firm conducted a major CIP of the dryer equipment and a Top Down 4-Step Cleaning of all tote areas and the packaging room. On April 5, 2023, when they received notification of the positive Cronobacter spp., they ceased production and packaging operations, placed all products on hold, and immediately initiated cleaning and sanitation activities, which entailed a major CIP/Top Down 4-Step Cleaning. FDA investigator’s review of their sanitation records indicated that there were no intervening sanitation breaks during this production campaign.

The full warning letter can be viewed here.

Comments from the FDA
In a written statement, Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, emphasized, “Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns.” The FDA aims to proactively identify and address issues before they escalate to the level of concern that triggered the significant recalls and contributed to the infant formula shortage observed last year.

The actions represent the FDA’s continuing endeavors to reinforce the safety and robustness of the infant formula supply chain in the United States. In November 2022, the FDA outlined a prevention strategy to curb Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. This approach involves collaborating with Congress to enhance regulatory tools and funding for oversight of the infant formula industry. Additionally, the FDA has partnered with the U.S. Centers for Disease Control and Prevention to support the addition of invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List. To further strengthen regulatory oversight, the FDA has begun hiring staff to establish an Office of Critical Foods and a dedicated cadre of infant formula investigators.

Recommendations for parents
For parents and caregivers, the FDA underscores the importance of adhering to manufacturer instructions when preparing powdered infant formula. The CDC recommends using ready-to-feed liquid infant formula for babies under 2 months old, those born prematurely, or those with weakened immune systems. Alternatively, extra precautions can be taken when preparing powdered formula by heating water to at least 158 degrees F or 70 degrees C to counteract pathogens, adding powdered infant formula, mixing, and then cooling the formula to body temperature before feeding.

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The council is the body that recommends what diseases are “reportable.” That list already includes illnesses from other foodborne pathogens, including E. coli, Salmonella, and Listeria. About 120 other illnesses are on the list of “nationally notifiable” pathogens. The council and the CDC manage the list. 

When the recommendation becomes active, cronobacter infections identified in infants less than 1-year-old will be reported by doctors and laboratories to state health departments. Those departments will then notify the CDC.

Consumer advocacy groups, including STOP Foodborne Illness, Consumer Reports, and the Environmental Working Group, have advocated for change for years but stepped up efforts during the outbreak in 2021-22.

Although little data is available because infections from the bacteria have not routinely been tracked, current numbers show that 40 percent of babies infected with cronobacter die.

Minnesota and Michigan are the only states that have been reporting cronobacter infections to the CDC. The recommendation can be adopted now by any state but will not formally go into effect until 2024.

Based on a recommendation from the Council of State and Territorial Epidemiologists, U.S. Centers for Disease Control and Prevention officials announced their decision Thursday, June 29. 

Minnesota officials discovered the first infant cronobacter infection of the 2021-22 outbreak and reported it to the FDA. That led local, state, and federal public health officials to pool information and discover patients in Texas and Ohio. After the outbreak, consumer groups said that if cronobacter infection had been a reportable disease, illnesses could have been prevented, and lives could have been saved.

“These efforts will assist public health agencies in quantifying and identifying the cause of cronobacter infections,” Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists, said in a statement. “(It) will help protect the health of those most vulnerable. Ultimately, we want these infections to be prevented.”

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According to the details published online by the FDA, the recall was initiated on May 17, 2023 and is ongoing.

The recalled products were distributed in Alaska, California, Connecticut, Florida, Illinois, Kansas, Louisiana, Maine, Minnesota, Mississippi, Nebraska, New Mexico, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Puerto Rico.

Recalled product:

• Net Wt. 14.1 oz (400g) 
• UPC: 749735002186 
• Product is a powder packed metal cans. 6 cans per case.
• Expiration date: 03/30/2024 
• Batch/lot code 101175408 
• Case EAN code: 749735102183 
• Vendor product code: 90218

Anyone who purchased the recalled product should immediately dispose of it and not consume it.

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The product was distributed in the U.S. and was manufactured at the Company’s Gateway Eau Claire, WI, manufacturing facility from Jan. 2 to 18, 2023. 

Associated Wholesale Grocers, Inc. (AWG) is releasing this additional notice because one of the recalled products being distributed to its Nashville Division retailers after the initial recall notice was published on March 18. The initial recall can be found here.

AWG is a cooperative food wholesaler distributing to independently owned supermarkets. This recalled product was distributed from its Nashville Division only to independent retailers located in Alabama, Georgia, Indiana, Kentucky, Ohio, Tennessee, Virginia, and West Virginia under the following retail banners: Belle Foods, Bellview Price Cutter, Booneville Shopwise, Brown County IGA, Buehler’s, Buehler’s Cash Saver, Buehler’s IGA, Camridge City Market, Campbell’s Market, Camron’s Foodliner, Cash Saver, Cash Saver Harlan, Chappell’s Hometown, Country Mart, Crossroads IGA, Food City, Food Giant, Food World, Foodland, Frabergs Foods, Fresh N Low, Gallion’s Market, Gregerson’s Cash Saver, Hilltop Cee Bee, Hometown IGA, Houchen’s, Howard’s IGA, Laurel Grocery Company, Liberty IGA, Market Place, Noble’s IGA, Parkview IGA, Noble’s IGA, Parkview IGA, Piggly Wiggly, Piggly Wiggly Warrior, Price Cutter, Price Less Foods, Price Less IGA, Quality Foods, Riesbeck’s, Rivertown IGA, Simpson’s Supermarket, Spencer Cash Saver, Stop to Save, Sureway, Sureway Henderson, Swafford and Sons IGA, Tietgens Mt. Pleasant IGA, Valu Market, Versailles IGA, Vevay IGA, Village Market & Café, Walnut Creek Country Market, Winburn Fruit Market, and Woodruff’s Supermarket.

Recalled products:

• Gerber Good Start SootheProTM 12.4 oz:
  300357651Z – USE BY 04JUL2024
  300457651Z – USE BY 05JUL2024
  300557651Z – USE BY 06JUL2024
  300557652Z – USE BY 06JUL2024
  300757651Z – USE BY 08JUL2024
  300857651Z – USE BY 09JUL2024
  301057651Z – USE BY 11JUL2024
  301057652Z – USE BY 11JUL2024
  301157651Z – USE BY 12JUL2024

Consumers who purchased this product through these retail locations in these states are urged to check any product they may have at home. Consumers who purchased the product should look for the following Lot Codes and “use by” dates, which can be found on the bottom of the package.

About Cronobacter
Food contaminated with Cronobacter may not look or smell spoiled but can still cause serious illness. In rare cases it can cause fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns. Severe cases often lead to death.

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Editor’s note: This is the March 28 written statement of Frank Yiannas, M.P.H.Prior FDA Deputy Commissioner, Food Policy & Response (Nov 2018 – Feb 2023) for the Subcommitte On Health Care And Financial Services U.S. House Of Representatives FDA Oversight Part I: The Infant Formula Shortage March 28, 2023

Introduction 

Chair McClain, Ranking Member Porter, and members of the Subcommittee, thank you for inviting me here today to testify before you and, more importantly, for your interest in better understanding what happened, so we can prevent an infant formula crisis of this nature from ever happening again. 

Our bosses, the American people, and especially the most vulnerable of consumers – infants – deserve that from us, so I thank you for scheduling and conducting this hearing. 

Background 

In late February of 2022, already amid unprecedented supply chain challenges brought upon by the pandemic, our nation’s parents and caregivers learned of a very large recall affecting trusted household brands of powdered infant formula (PIF) products, such as Similac, Alimentum, and EleCare manufactured in a facility located in Sturgis, Michigan. The company that produced these products, Abbott Nutrition (AN), voluntarily recalled these products after learning of multiple cases of infant illnesses caused by a rare and often fatal microorganism, called Cronobacrer sakazakii, which is often associated with PIF. Several confirmed cases of ill infants indicated that all had consumed PIF produced in AN’s Sturgis facility. The illnesses, along with conditions detected at that facility during a FDA inspection, such as insanitary conditions, an environment contaminated with multiple strains of Cronobacter sakazakii, and critical equipment in disrepair, led AN to execute a voluntary recall on February 17, 2022. All in all, there were four infant illnesses of Cronobacter sakazakki linked this incident and, tragically, 2 of them resulted in death. 

My Reason for Being Here Today 

It has been over a year since this incident began. There has already been a Congressional oversight hearing held by a House Subcommittee on Oversight and Investigations in May of 2022. The FDA issued its own version of what transpired in a report in September of 2022 titled, FDA Evaluation of Infant Formula Response. And there has been extensive media coverage of the incident. 

Yet, despite these actions, a clear and transparent understanding of what took place and the contributing factors that allowed it to occur – have remained elusive. It is most critical that we learn from this experience and take collective action as a nation to prevent something like this from ever happening again. 

Consumers deserve better. And there is more that the industry and regulators can and MUST do. 

Therefore, I come to you today without regard to partisan politics, but as a professional who has dedicated my life’s work to protecting consumers, both in the public and private sectors. The organism that caused these tragic illnesses, Cronobacter, does not recognize political parties, so as we search for solutions, neither should we. 

I also come before you today with a balcony level view of what happened. While being made aware of the incident much too late, on February 10, 2022, a complete 4 months since the first of a series of illnesses and a whistle blower report were received by the agency, once I became aware, me and my team jumped into action and began coordinating daily meetings with executives of the various, decentralized offices and centers at the FDA involved with this issue. I also led the FDA’s Incident Management Group (IMG) for the infant formula response, subsequent to the recall taking place. 

What Follows 

For the remainder of this testimony, my intent is to lay out the critical elements or factors that allowed this crisis to occur. My intent is to do that in a fact-finding – rather than a fault-finding – manner. And I hope to place a heavy emphasis in my testimony on the root cause and contributing factors that allowed it to happen, in hopes that it will allow us to focus on preventative solutions. 

Why? Because, a year later, it is my view that the state of the infant formula industry today is not much different than it was then. The public health surveillance system for this pathogen remains insufficient, the necessary safeguards have not been advanced or strengthened at an adequate pace to prevent a re-occurrence or future illnesses, and the infant formula supply chain continues to lack resiliency. In other words, the nation remains one outbreak, tornado, flood, or cyber-attack away from finding itself in a similar place to that of February 17, 2022. 

That place is a repeat scenario where parents hear of infants becoming severely ill due to Cronobacter sakazakii, finding shelves at their local grocery store empty for their desired infant formula products, and having to worry about the safety of what they are feeding their infants. 

Below, I would like to spend the next few minutes walking you through my recollection of events, which I hope will paint a picture of why I am focused on these key areas. 

Inadequate Public Health Surveillance for Illnesses caused by Cronobacter sakazakii 

In 2011, Congress passed the Food Safety Modernization Act, known as FSMA. Their mandate to the industry and FDA then is still true today. It’s not enough to respond to illnesses, outbreaks, or recalls of food after they happen. We must do more to prevent them from happening in the first place. 

Much of what we know about foodborne illnesses, their frequency, severity, the foods that serve as primary vehicles for transmission, as well as common routes of contamination, is a result of progress made possible by foodborne disease surveillance efforts. Foundational to improvements to the food safety system is a modern foodborne disease surveillance program. As stated by Dr Scharff and Dr Hedberg in the book Food Safety Economics, published by Springer Scientific, “a foodborne illness surveillance system is designed to collect, analyze, and disseminate information about foodborne illnesses. Consequently, they help solve critical information problems faced by consumers, firms, and government agencies. By providing better information to the market, these surveillance systems create incentives (accountability) that leads to safer foods and better consumer awareness.” 

In this instance, the foodborne disease surveillance system for Cronobacter sakazakii failed us and it MUST be improved. 

Unlike other foodborne illnesses, Cronobacter sakazakii infections are NOT a nationally notifiable condition and is not reportable in most states. According to the Centers for Disease Control and Prevention (CDC), Minnesota and Michigan are the only states that require reporting and the CDC reports that they typically receive reports of only 2 to 4 Cronobacter infections in infants per year. That means that there are likely cases of severe infant illnesses and deaths, although presumably rare, occurring in the United States due to Cronobacter and that those cases remain anonymous, unreported, and invisible to most of the nation. 

A study by the CDC in 2014, published in the Journal of Emerging Infectious Diseases, titled Incidence of Cronobacter spp. Infections, United States, 2003–2009, estimated that the incidence of Cronobacter sakazakii among infants (zero to one year of age) was 0.49 per 100,000 population. 

As illustration, for the incidence of another pathogen that is of low frequency but high severity, Listeria monocytogenes, the CDC estimates that there are 0.31 laboratory-diagnosed, domestically acquired infections per 100,000 population. This incidence rate is lower than that of Cronobacter among infants, the most vulnerable of consumers, yet Listeria is a reportable disease, but Cronobacter is not. It is only through reporting, and utilization of tools such as whole genome sequencing (WGS) of the isolates of Listeria monocytogenes detected that we have advanced what we know about Listeriosis. Because of that, today, we now know that many of the cases of Listeriosis that were once assumed to be isolated or sporadic, are not isolated at all. Increasingly, these cases are linked to a common food vehicle, allowing implicated foods to be taken off the market quicker, preventing additional illnesses, and outbreaks from getting larger. This, in turn, is enhancing our ability to create strategies to strengthen future prevention. 

Lastly, in regard to making Cronobacter sakazakii a nationally notifiable condition, you have probably heard that this is not something the CDC, nor FDA can do on their own. There is a process through a body called the Council of State and Territorial Epidemiologists (CSTE) that meets annually to deliberate and vote on position statements and changes to national policy on notifiable conditions. This is a complicated process that is hard to explain to concerned parents, consumer groups, or public health advocates that wanted a change in notification policy to happen immediately after this issue was recognized. The CSTE is scheduled to meet in June of this year and I’m grateful that the FDA has been working to get this issue on the agenda. We MUST change this and make Cronobacter a nationally notifiable condition just like Salmonella, E. coli O157, and Listeria. 

Early Signal Detection and the Need for Rapid Response 

As previously reported, the FDA began receiving a series of reports or complaints of infants who had been confirmed to have been infected with Cronobacter sakazakii, all who had also consumed infant formula products produced from a single manufacturing plant located in Sturgis, Michigan. 

In addition, on October 26, 2022, the agency received a Whistle Blower complaint, submitted to various FDA personnel through various means (hard copies via Fed X, as well as electronic copies submitted via email). 

In summary: 

• The first report of an infant ill with C. sakazakii (which resulted in death) was reported to the FDA on Sept 20, 2021
• On October 26, the Agency received a Whistle Blower complaint alleging egregious conditions and practices at the Sturgis facility.
• The second report of an infant ill with C. sakazakii was reported to FDA on Dec 1, 2022
• The third report of an infant ill with C. sakazakii was reported to FDA on January 11,
  2022, and
  
• The fourth report of an infant ill with C. sakazakii (which resulted in death) was reported to the FDA on Feb 18, 2022.
  It should be noted that while the FDA conducted an inspection of AN’s facility located in Sturgis on September 20, with the inspection lasting until September 24 of 2021, the inspectors on site were unaware of the complaint the agency had received of an infant illness due to Cronobacter on the same date, September 20, the day the inspection began. It would have been useful for investigators to have had that information on hand, as it could have potentially resulted in a different or more in-depth path of investigation.
  While FDA did conduct notifications to the company of the illness reports as they came in and did slowly take steps to follow-up on the Whistle Blower complaint, it wasn’t until January 31, 2022 (four months later) that the FDA began an official inspection of the AN’s Sturgis facility and it wasn’t until February 10, 2022 that I personally became aware of the series complaints, the whistle blower report, and the findings from FDA’s January inspection that resulted in multiple environmental swabs being found positive for Cronobacter sakazakii in the facility.
  Some have questioned if quicker action by the agency on some of the earlier signals could have avoided or lessened the magnitude of the crisis. While there is disagreement within FDA on this point, I believe most professionals experienced in crisis management would say the answer is yes. The literature is full of examples of organizations that either failed to piece together early signals or failed to heed early warnings that eventually allowed a crisis to grow worse, 

rather than being contained. I believe that the literature of the future will also conclude that this incident is a sad example of how FDA’s siloed organizational structure and culture impeded rapid critical problem identification, communication, and response. 

Taking Whistleblower Complaints Seriously 

In the Congressional hearing last spring, there was a lot of discussion about the whistleblower letters addressed to Drs. Woodcock, Mayne, and McMeekin being lost in the various FDA mailrooms for months. But what also concerns me greatly is the fact that the 30-plus page complaint was also sent by email to staff in the Office of Regulatory Affairs and CFSAN, but the concerns were not handled with the appropriate sense of urgency. Given the concerns expressed and the vulnerability of infants, this should have been elevated to leadership immediately. As Deputy Commissioner for Food Policy and Response, I was not sent the October 26, 2022 whistle blower complaint, and I did not get an opportunity to see the complaint until I was made aware of the incident in February 2022. 

I would argue that FDA’s structure and culture exacerbated these delays. With siloed groups in the FDA’s decentralized Foods Program, it is impossible for leaders, even leaders like me that had titles that might indicate otherwise, to have clear line of sight on what was happening or to set processes in place to help catch these critical public health concerns. The current structure results in regular communication breakdowns, and results in the potential for food safety concerns to fall through the cracks altogether. 

Eventually, the informant was interviewed by FDA personnel on December 22, approximately 2 months after the letter was received. While the concern over why it took so long to interview the informant is valid, as well as who were the individuals that received the letters, there is one significant conclusion that was not mentioned in the timeline and that did not come up during the initial hearing last spring. Upon completion of the interview with the confidential informant along with their lawyer present, the FDA investigators concluded that the complaint was “too vague” and did not warrant follow-up. Having read the letter myself and the very specific allegations of falsification of records, attempting to deceive federal relators, and more, it’s hard for me to agree with outcome of the investigators’ determination and, this too, could have played a role in delaying a greater sense of urgency by agency personnel aware at the time of the matter. 

Again, FDA’s future structure needs to be one in which the leader of the Foods Program can have clear line-of-sight on issues such as these and to take steps to ensure that the culture at FDA is one in which investigators recognize the need to take rapid action to follow-up on allegations like these. To accomplish this, FDA will need to empower a food safety leader with accountability for not just the Foods Center, but also the field inspectional resources in the Office of Regulatory Affairs. 

The Weight of the Evidence Against Abbott 

The inspection of the Abbott Sturgis facility initiated in January 2022 resulted in a number of findings that led to great concern for me and my colleagues and resulted in the large recall. 

Abbott Nutrition and some others have suggested that their products were not the source of illnesses, because the genetic strains of Cronobacter sakazakii were never found in product, nor in the Sturgis facility. This information is misleading. 

Thus, I would like to present a series of facts, regarding the weight-of-the-evidence of the problem at Sturgis that I was considering as we made the decision to request action by Abbott. 

1. Increased Reports of Cronobacter infections over a Short Period Time – the FDA received 4 reports of confirmed C. sakazakii infections in infants over a short period of time, which is unusual, given that it is NOT a reportable illness in most of the U.S. Again, the CDC reports they have historically received 2 to 4 cases reported per year. 

2. Traceback – all 4 infants that were infected had ingested PIF products manufactured at a single location (AN’s Sturgis facility), which is significant. While AN certainly had a large market share, it was only one of 21 formula plants servicing the US market at that time. 

3. Microbiology – FDA investigators readily found multiple environmental samples positive for C. sakazakii in the Sturgis plant in just a two-day period. 

4. Genetic Diversity – five (5) different strains of C. sakazakii were detected using WGS of isolates in found the environment at the Sturgis facility, indicating contamination with multiple strains could occur. 

5. Lack of Environmental Control – FDA’s subject matter experts, well versed in infant formula production, described environmental conditions at the Sturgis facility as “out-of-control” and a potential source of recontamination. 

6. Old Spray Dryer with Large Cracks – FDA investigators observed two sprayer dryers, one purchased in the 1960s, with large, unrepaired cracks, potentially serving as harborage points and sources of recontamination. This same scenario has been documented in the literature to have caused a PIF outbreak. 

7. Known Product Contamination – FDA investigators learned that AN previously destroyed 2 batches of PIF contaminated with Cronobacter produced at Sturgis, even though it is well documented in the literature that low levels of sporadic contamination is unlikely to be detected by PIF sampling plans. Therefore, it is more likely than not that other batches of PIF produced in this plant were likely to have been contaminated with a variety C. sakazakii strains, which evaded end-product testing, and were released into commerce. 

8. Lax Standards – events were recorded such as 

• contract workers moving from the roof to a production line in dirty boots, highlighting yet further avenues of potential contamination in the plant. 
• numerous water events were documented including water leaks, moisture, and condensation in dry powdered infant formula production areas. 
• spray dryer inspections in August 2021 showed six instances of cracks and pits in the main chamber recorded for spray dryer #3 and six instances of cracks, pits, and damage in dryer #4 

9. PIF as a Vehicle of C. sakazakii – contamination of PIF with C. sakazakii is well documented and has been the cause of small outbreaks and sporadic infections, sometimes with serious sequelae or death. 

10. Low Significance of Lack of WGS Match – because C. sakazakii infections are not reportable in most states, it makes it more difficult to identify & link infections that may appear as sporadic in nature (i.e. Listeria). In this incident, four C. sakazakii infections were passively reported to FDA. Isolates were available for only two infants for WGS characterization. Having only two of four clinical cases characterized by WGS, and a scarce library of previous sequences, made it more difficult to compare limited infant infections with the multitude of strains (5) recovered from the firm, as well as previous documented human cases. 

Based on the points summarized above, Abbott’s Sturgis facility lacked adequate controls to prevent the contamination of powdered infant formula with C. sakazakii. There is also evidence that sporadic contamination of finished product actually did occur, and it is likely that other lots of PIF produced in this plant were contaminated with multiple C. sakazakii strains over time, which evaded end-product testing, were released into commerce, and consumed by infants. 

Lastly, and in summary, the factors presented above supported a conclusion that PIF made at Abbott’s Sturgis plant was produced under insanitary conditions and a likely source of ongoing, sporadic contamination of PIF with multiple strains C. sakazakii over time, notwithstanding a lack of a match by WGS between the plant’s environment and/or finished product and two clinical isolates. 

Need for Strengthening Preventive Controls within the Infant Formula Industry (Modern Facilities, Sanitary Design, Environment Monitoring, & Enhanced Verification) 

A key lesson learned for me is that we need to update infant formula policies to strengthen prevention. While the conditions at the Sturgis plant were egregious, the Sturgis plant is not the only plant that has experienced problems with Cronobacter. As you may have seen in the news, there have been multiple recalls recently associated with the potential for Cronobacter at other facilities. We need to incorporate the lessons learned from recent events and update FDA’s infant formula rule. One key example is our current testing regulations. Using the current testing requirements, the chances of detecting Cronobacter are much smaller than they should be. 

These standards need to be updated so that firms have a greater chance of detecting contamination events. 

We also need to work more with industry to ensure production facilities are state of the art. In 2023, we should no longer be producing food for infants using equipment that is showing its age and increasing the risk of potential problems. Some of the equipment still being used in some of the biggest production facilities today was installed before I was born. Back then, we knew far less than we do now. 

Fulfilling Our Public Health Mission – Protecting Infants 

From the time I first learned of the incident, on February 10, 2022 to the time it took Abbott Nutrition to conduct a voluntary recall to protect infants, it was 7 days. Seven days contrasted to the 4 months of time in which the series of events unfolded. 

Beginning on February 11, 2022, as Deputy Commissioner of the Office for Food Policy and Response, I begin a series of daily meetings, sometimes more than once a day, with all Food Program principles and offices to include ORA, CFSAN, Legal, and Media Relations to coordinate activities and to work as one FDA Foods Program Team. 

I wish that the communications silos had not existed and that I would have been notified earlier, so I could have initiated these steps sooner. I also believe that had we been able to initiate these steps and act sooner, the recall may have been smaller in size. 

Addressing the Impact of the Recall 

My Office initiated a prompt and escalated level of communication that informed major parts of the United States Government (USG) including the USDA and White House, of the evolving incident and its likely effect on infant formula supply availability. 

The series of actions taken at all levels of the USG were well summarized in the hearing testimony provided in May of 2022 and, in my view, those collective actions were quite heroic. Below is a recap of select and notable actions. 

o Asking retailers to quickly place limits on the number of units that could be purchased.

o Meeting regularly with major infant formula manufacturers to better understand and maximize their capacity to increase production of various types of infant formulas and essential medical foods.
o The prompt acquisition of needed data and monitoring the status of the infant formula supply by using the Agency’s 21 Forward food supply chain continuity system, combined with external data.
o Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go.
o Implementing a new process to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula. These flexibilities allowed for a small volume of infant formula to augment existing and newly produced supplies. 

o The Administration invoking the Defense Production Act, directing firms to prioritize and allocate the production of key infant formula inputs to help increase production and speed up supply chains. 

o Launching Operation Fly Formula and coordinating with the Department of Health and Human Services and U.S. Department of Agriculture (USDA) to leverage Department of Defense contracts with commercial air cargo lines to pick up overseas infant formula that met U.S. health and safety standards, so it could get to store shelves faster. 

o USDA offering state health commissioners flexibilities through WIC to determine products that may be substituted for recalled products, allowing families to purchase different container sizes and physical forms, and allowing purchase of noncontract brands, and waiving retailer minimum stocking requirements to allow formula to transfer to where it was most needed. 

o Congress passing the Access to Baby Formula Act of 2022 to expand access to baby formulas for certain American families during the supply chain disruption. 

The Recall’s Effect on the Infant Formula Shortage and Additional Factors that Could Have Minimized Disruptions 
Clearly, the overarching measure that could have prevented this crisis from happening in the first place was Abbott Nutrition’s operating conditions, procedures, standard of care, and commitment to maintaining a strong food safety culture. Simply put, what was found at Abbott’s Sturgis facility was unacceptable and Abbott Nutrition bears the primary responsibility for this crisis. 

Also, as previously mentioned, earlier detection of signals by Abbott, public health officials, and/or regulators could have allowed this incident to unfold in a less catastrophic manner. 

However, after the series of events were allowed to escalate and build upon each other, by the time February of 2022 came along, containment of this incident became much harder. 

There were longstanding gaps in Federal action on supply chain monitoring and resiliency actions that both helped to create a situation in which a single plant going offline could have such a tremendous impact. It also made it hard to have the intelligence needed at our fingertips to inform decision-making. 

Even before the recall on Feb 17, 2022, the United States was already facing infant formula supply chain stress. Thus, as evidence of this cascading situation unfolded, the FDA knew that it had to act to protect infants, but that with an impending large recall of infant formula by a major market player, it also had to do everything it could, along with other USG partners, to minimize disruptions and potential shortages. 

Per FDA’s own Regulatory Procedures Manual, in Chapter 7 titled Recall Procedures, it states that “ORA and the Center (in this case, CFSAN) will also determine whether the recall could cause a shortage of regulated products.” However, the FDA’s Food Program was ill equipped to do a proper analysis of the effects of the recall on supply availability, as the team at CFSAN responsible for infant formula products lacked the type of quantitative infant formula supply chain insights, data and analytical capabilities to conduct a more thorough analysis of the potential impact, simulate scenario planning, nor an ability to quickly determine what measures could be taken to accelerate a recovery. 

21 Forward – a Food Supply Chain Data Analytical Platform 
Prior to 2020, the Foods Program had no data system in place to monitor key food supply chains. During the COVID-19 crisis, many in federal service, including myself, felt it was our duty to do all that we could to gain better, data driven insights into the structure, function, and resilience of food supply chains, so that we could continue to meet the needs of the American people. Food and agriculture was one of those critical infrastructures that had to stay in operation to serve the public, and those of us working on this recognized that food security (ensuring people have access to food) was a matter of national security. Thus, we quickly realized that to protect and harden FDA-regulated food assets against the risk of SARS-Cov-2 transmission among food workers, we would need better data, insights, and additional data sets. And, thus, the idea of 21 Forward was born. 

In record time and on a shoestring budget, my team, in partnership with other offices and an outside vendor, built the 21 Forward System, a first of its kind food supply chain data analytical platform that could be used to increase resiliency of the high priority food supply chains against COVID-19 related disruptions. It was achieved by transposing several ideas, leveraging disparate, but relevant data sets, and combing them with different computational capabilities. The system was used to strengthen FDA-regulated food assets from COVID-19 disruptions, including infant formula plants. As the infant formula crisis unfolded, we built on this system and turned it into the data platform for the entire USG response. 

What the cross-governmental team did to build this platform was amazing and is a shining example of the dedication of public servants who worked around the clock to make this happen. But really, we shouldn’t have been building this on the fly – it should have been in place years ago. 

FDA had not made these investments because historically, the Agency’s food mission has centered around food safety and nutrition. Even as COVID created the biggest challenge to the food system in a hundred years, there was internal debate at the agency on whether there was really a role for the FDA in monitoring food supply chains. 

Requests for funding to further develop the 21 Forward system were met with resistance by the previous Acting Commissioner and Director for the Center for Food Safety and Applied Nutrition. In fact, one very specific request in advance of the infant formula crisis was declined by Agency leadership, despite Congress giving the agency unprecedented levels of money in the way of a COVID supplement funding to develop such capabilities. In hindsight, this was a big miss that would have enabled the Agency to respond to the infant formula crisis in a quicker, more thorough, and data-driven manner. 

It was particularly frustrating to me and my staff that our early work on 21 Forward more than a year before the Abbott recall had highlighted for us the concentration of infant formula manufacturing, and we wanted to build out the monitoring tools to get a better handle on critical supply chains like these. In interagency discussions, we were raising infant formula as a good case study to advance supply chain actions – we had the right initial insights, and we were trying to make the case for resources – the emergency just came before the USG was ready. 

Having lived this experience, I am grateful that Congress has directed the Center for Food safety and Nutrition to establish an Office of Critical Foods and the necessary capabilities to monitor these critical foods for potential disruption. I urge you to ensure that this office builds the appropriate monitoring tools and I urge you to continue to clarify expectations for the roles this new office and other parts of the Federal Government as they pertain to supply chain monitoring and mitigation actions. 

A Fragile and Inelastic Infant Formula Supply Chain 
Lastly, one should wonder, how does the shutdown of 1 of 21 infant formula plants serving the U.S. market cause such a shortage and disruption. And what were the factors that led to the creation of such an inelastic and fragile infant formula supply chain system. 

The reality is that the FDA has had minimal authorities and levers to affect the system, other than the safety and nutrition standards they create and their ability to approve new markets submissions in a quick manner. However, like most supply chains, financial implications, incentives, and disincentives play a huge role in ultimately influencing how supply chains evolve. Thus, I am grateful that Congress, through the Omnibus, has requested that an Infant Formula Supply Chain Resiliency report be completed and submitted to them for review. 

It is critical that Congress look for ways to encourage competition and redundancy of manufacturing in this industry. FDA has a role to play with its infant formula policies, but FDA is not alone. American taxpayers pay for about half of the infant formula sold in the U.S. through the USDA-WIC program. I would argue that the sole-source state WIC contracts helped to create the current concentrated supply chains. But WIC may also provide unique opportunities to address the need for greater competition and redundancy going forward. Congress must stay laser-focused on the resiliency report and create a more holistic approach that will keep us from repeating a scenario in which a single facility is the only manufacturing site for specialty formulas, and there is no back-up production capacity. Congress must insist that critical foods like formula not be one outbreak, tornado, flood, or cyber-attack away from a scenario similar to that of Feb 17, 2022. 

Recommendations 
In closing, I would like to leave this subcommittee with a brief list of select recommendations. 1. It’s time to make Cronobacter sakazakii a nationally notifiable disease.  

2. We should conduct WGS on all isolates of Cronobacter whether they come from clinical, environmental, or food samples and enter those genomic sequences into the National Center for Biotechnology Information (NCBI) database.
   
3. The FDA must enhance its ability to detect signals of potential safety concerns with regulated products and act on them with a greater sense of urgency.
   
4. Congress should address the cultural, siloed, structural, and leadership issues in the FDA Food Program that contributed to a less than desirable response to this incident.
   
5. Demand that the Infant Formula Industry set higher standards of care for themselves that include more modernized productions facilities and equipment, stronger preventative controls, enhanced sanitary design, more aggressive environmental monitoring, and statistically strengthened verification procedures.
   
6. Strengthen regulatory requirements for infant formula manufacturers to include more robust sanitary design, environmental monitoring, a revaluation of sampling plans beyond N=30 for Cronobacter, and mandatory reporting of product positives to the FDA.
   
7. Re-evaluate the thoroughness and frequency of FDA inspections conducted at infant formula manufacturers.
   
8. Re-invent the process used by FDA and health officials to investigate confirmed reports of Cronobacter sakazakii linked to a particular infant formula product. Right now, the process used is unscientifically overweighted on testing a few cans, without knowledge to how closely where those cans were produced in relation to the consumed product and without emphasize on the lack of statistical significance to the test results.
   
9. Dramatically improve consumer and physician education on the appropriate use and handling of PIF in hospitals and homes, as well as recommendations to use alternative sterile, liquid formulations for at-risk and premature infants.
   
10. Support the development of more modern, data-driven Food Supply Chain Analytic Platforms, such as 21 Forward, as a tool to address food supply chain challenges using data-driven insights.
    
11. Complete an in-depth Analysis of the Structure and Resilience of the Infant Formula Supply Chain in the U.S. and implement policies that will promote competition, diversification, resiliency, redundancy, and every day low costs for consumers.
    

Conclusion 
In closing, ensuring the safety and availability of an often sole-source of nutrition, such as infant formula, is a tremendous responsibility for the industry that makes them and for the agencies that regulate them. The infant illness and deaths due to Cronobacter, the Abbott Nutrition recall, and the cascading and devasting effects it had on infant formula availability in our country was a preventable tragedy. It is my hope that we transparently seek the lessons learned and take the necessary actions to prevent such a crisis from ever happening again. Clearly, there is more the industry and regulators can and MUST do. 

I thank this subcommittee and its members for your interest and I look forward to answering any questions you may have. 

Editor’s note: Following is Tuesday’s testimony of Peter Lurie, MD, MPH, President and Executive Director, CSPI, before the U.S. House of Representatives Committee on Oversight and Accountability Subcommittee on Health Care and Financial Services

I want to thank Chairwoman McClain, Ranking Member Porter, and other committee members for inviting me as a witness on behalf of the Center for Science in the Public Interest (CSPI). CSPI is an over 50-year-old advocacy group that acts as a watchdog on food and health issues on behalf of US consumers. We do not accept donations from either government or industry. I am its President and Executive Director and a former Associate Commissioner at the Food and Drug Administration (FDA). While there I worked on drug shortages, with which the powdered infant formula shortage situation shares many similarities.

If we are to apportion blame for the now-resolving powdered infant formula crisis, we should start at the Abbott Nutrition plant in Sturgis, MI that produced the formula associated with an outbreak tied to four hospitalizations, including two deaths. It was there that infant formula contaminated with Cronobacter sakazakii was destroyed years before the outbreak without FDA being notified. 

It was there that, according to a whistleblower, there were lax cleaning practices, falsified records, and relevant information hidden from FDA inspectors.

And it was there that repeated FDA inspections revealed standing water, decaying dryers, failure to follow sanitary practices and, eventually, multiple environmental samples on medium- and high-care areas positive for Cronobacter sakazakii. While many questions remain about the outbreak, including how the Cronobacter may have entered the product (the outbreak strain was not one of those captured among the environmental strains FDA detected), these conditions, the increasing numbers of cases, and the deadly nature of Cronobacter infection left FDA with little choice but to insist that the company recall affected product.

If the U.S. infant formula market had been characterized by vigorous competition, the ensuing recall of Abbott formula would likely not have catapulted the market into a full-blown shortage, with parents having to go from shop to shop in search of dwindling supplies. But, prior to the recall, Abbott was estimated to control about 40% of the U.S. formula market, with about half of that coming from the Sturgis plant. Moreover, just four companies controlled about 90% of the domestic market. This left the U.S. with few alternative suppliers as the recall hit. Market concentration is one of the factors behind the ongoing drug shortage problem as well.
 

These conditions had existed for years, but it took the addition of a pandemic, with its own supply chain problems, Abbott Nutrition’s deficient manufacturing practices, and, later, the war in Ukraine, to produce a full-blown shortage

Much of the FDA response was entirely appropriate and drew from its drug shortage experience. The agency convened an Agency-wide Incident Management Group, sought to identify alternative suppliers that could increase their production, exercised enforcement discretion on a case-by-case basis to allow product to reach the market, facilitated the importation of products from abroad, and used a risk-benefit approach to release the most critical products, such as specialty metabolic and amino acid formulas. Other parts of the government contributed, too, including invoking the Defense Production Act to give formula suppliers priority access to critical ingredients and Operation Fly Formula in which the Department of Defense flew in formula from abroad.

In other respects, FDA’s performance failed to live up to the high standards American consumers expect and deserve from the agency responsible for keeping our food supply safe. A whistleblower report went undelivered to senior agency staff for months and the agency took too long to schedule a repeat inspection of the Sturgis facility, even as Cronobacter sakazakii cases continued to be reported, thus delaying the resultant recall. The agency ordered an internal review of its own response but that report, while offering many strong recommendations, failed to provide a clear account of the events surrounding the recall or the mistakes made by agency officials.

Better prevention and management of future crises requires at least three elements: authority, funding, and an effective organizational structure.

On the first, the Food and Drug Omnibus Reform Act provided FDA with some important additional authorities. It required formula and medical food manufacturers to develop a redundancy risk management plan to identify and evaluate risks to their supply. It mandated the creation of an Office of Critical Foods at FDA, which will manage the regulation of infant formula and medical foods. Perhaps most critically, it required critical food manufacturers to notify FDA of interruptions in manufacturing likely to lead to meaningful disruptions in supply.

To better protect U.S. infants, the agency needs additional authorities. It should have the authority to require manufacturers to notify the agency of positive test results for relevant pathogens and to require more frequent environmental testing in production facilities. FDA should also have the authority to compel manufacturers to submit supply chain data, allowing the agency to analyze and respond to evolving issues. In addition, the Office of Critical Foods should be able to designate additional foods in a public health emergency and require notification of potential shortages related to those foods. Finally, the Council of State and Territorial Epidemiologists and Centers for Disease Control and Prevention should add Cronobacter to its list of nationally notifiable diseases and conditions and more states should join Minnesota and Michigan in including Cronobacter as a reportable disease.

Second, the food program at FDA requires more funding.

Despite efforts by Congressional appropriators to boost funding for FDA’s Center for Food Safety and Applied Nutrition (CFSAN)  and to fully fund the Food Safety Modernization Act, rising costs have left the food program with a number of FTEs similar to what it had in 1978.

Yet, not only has the food industry evolved dramatically since the 1970s, but FDA has been given more and more responsibilities from Congress, including broad new mandates over infant formula, dietary supplements, food labeling, and food safety.

The President’s FY 2024 budget calls for $152 million in necessary new funding for FDA’s foods program, which will allow the agency to hire 195 additional FTEs. This amount will include $64 million for Healthy and Safe Food for All, including support for improved oversight of infant formula, as well as $12 million for Nutrition, a critical funding stream as FDA seeks to establish a Center for Nutrition that will house its Office of Critical Foods.

CSPI believes the number dedicated to nutrition in the Presidents’ budget is in fact too small, and a figure closer to $24 million is needed to adequately fund this important work. Adequately funding the food program is critical to assuring an optimal infant formula supply.

Such funding would support increased review capacity for infant formula premarket notifications, improving surveillance of formula-related adverse events, the development of laboratory methods for Cronobacter sakazakii, and more rapid review of inspection findings.

Finally, Americans deserve a food program that is transparent, effective, and accountable. The formula crisis laid bare the high level of dysfunction, breakdowns in communication and lack of clear lines of authority that characterized the agency’s response.

The reorganization plan announced by FDA Commissioner Robert Califf on January 31, 2023, is an important step on the path towards addressing these issues.  This proposal follows from a report on the human foods program ordered by Dr. Califf and conducted by the Reagan-Udall Foundation. The proposed reorganization captures the spirit of the Reagan-Udall Foundation report, addresses the most critical problems identified, and does so in a manner that minimizes internal disruption:

• It elevates the food program to the Deputy Commissioner level (higher than any other FDA product Center).
• It dissolves a dysfunctional structure whereby three senior officials with authority over the human foods program all reported to the Commissioner and none had clear authority over the program.
• It clarifies the relationship between the human foods program and the Office of Regulatory Affairs, which inspects facilities. FDA has stated that “the Deputy Commissioner would set the priorities for field activities, direct how the resources will be used, what risks will be prioritized, and inspection strategy.”
• It establishes a new Center for Excellence in Nutrition.
• It creates a new Office of Critical Foods.

While additional detail on exactly how these new structures will be operationalized is still necessary, this proposal is a significant step forward, creating a foods program led by a leader who is more empowered and accountable than any food program leader in recent history. The proposal lays a strong foundation for a newly enhanced food program at FDA, one that could ensure a safer and healthier food supply for us all. No mother, no father, should ever again face a desperate, store-by-store search for a product to nourish their infants.

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The former Food and Drug Administration officials who submitted the comments to the U.S. House of Representatives Subcommittee on Health Care and Financial Services for the Committee on Oversight and Accountability are:

• Stephen Ostroff, M.D., Former FDA Deputy Commissioner for Foods and Veterinary Medicine and Acting Commissioner 2016-2018;
• Michael R. Taylor, Former FDA Deputy Commissioner for Foods and Veterinary Medicine 2010-2016;
• David Acheson, M.D., Former FDA Associate Commissioner for Foods 2007-2009.

While the comments submitted to the committee’s official record are made in the context of the 2022 infant formula crisis, which shed light on communication problems at the FDA, they focus on the overall problem of a lack of a clear chain of command for the agency’s foods program.

“The infant formula events are one sign that FDA has not accomplished the food safety transformation FSMA (the Food Safety Modernization Act of 2011) envisioned and is not organized for success on food safety, but there are many others,” the former FDA food safety leaders say in their comments. 

“The problems begin with the program’s low priority in the FDA commissioner’s office and include its fragmented organizational structure, insular culture, bureaucratic infighting, slow decision making, and failure to follow through on FSMA implementation.”

The comments repeatedly refer to the current FDA Commissioner Robert Califf and his apparent lack of willingness to effectively overhaul the food side of the FDA. The three former officials say Califf presides over an effective drug side of the agency, but they disagree with the commissioner’s handling of recommendations from an expert panel on how to make the food side of the agency work to ensure food safety.

“. . . they (the panel of experts) called for FDA to unify the program under a single leader with full line management authority to lead its essential culture change and program modernization,” the three former FDA deputy commissioners say in their comments.

“Inexplicably, FDA leadership has rejected this recommendation. . . Even more critically, the Deputy Commissioner for Human Foods (planned by Califf) does not even have authority over all of FDA’s human food components. That is because the large field-based units within FDA that manage food inspections, field laboratories, and import oversight – and consume some two-thirds of FDA’s food-related budget – remain organizationally separate, with no direct management accountability to the new deputy commissioner.”

The former FDA deputy commissioners say that Califf is focused on operations of the drug side of the agency — even though the FDA is responsible for more than 80 percent of the American food supply. They say the commissioner keeps pushing for an unrealistic option for the operation of the food side of the agency.

“The matrix management approach Dr. Califf touts from his private sector experience has been tried and failed at FDA, as we know from our personal experience and as exemplified by the lags in FDA’s action on infant formula,” according to the comments submitted to the committee hearing record.

“It is unclear why FDA leadership has rejected the recommendations of its stakeholders and independent experts who have deep experience and expertise on food matters.  One possibility is that, while the agency’s top leaders are highly expert in medical product oversight, they lack personal experience and expertise on food safety and what it will take to transform the Food Program’s culture and performance.

“Medical products certainly deserve all the attention they get at FDA, and for years that’s been the focus of FDA’s top leadership, which helps explain why food regulation has a lower priority within FDA and is chronically underfunded.  The focus of FDA leadership on medical products may also explain why the commissioner’s proposed reorganization of the Food Program is patterned after the model that works for drugs and other medical products but won’t work for food.”

The three former FDA deputy commissioners say quick action is required to ensure the safety of the country’s food supply and that Congress should step in if Commissioner Califf fails to take appropriate action.

“Ideally, the Commissioner would change course and replace the announced reorganization with one that truly unifies the Food Program and empowers the new deputy commissioner position.  Absent that, Congress must act by directing FDA to make these critical changes.  Or Congress could elevate and reset the Food Program by removing food from FDA altogether and creating a separate agency under a Commissioner for Food Safety and Nutrition,” the former deputy commissioners say. 

“With decisive action now, Americans can get the unified, efficient and forward-leaning food program they deserve and expect. With half steps, disunity and dysfunction that was so evident during the infant formula crisis will persist and history will surely repeat itself.”

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I am writing in response to the opinion piece published on March 13, 2023, titled “Be Best or Be Better,” by Bill Marler. The article references a letter sent by FDA on March 8 to the infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our most vulnerable population. In the opinion piece, Mr. Marler charges the agency to do three things, which I would like to respond to.

First, Mr. Marler says FDA should “put an inspector in every plant 24/7”
Manufacturers are responsible for ensuring the safety of the formula they sell to consumers, and it’s FDA’s responsibility to verify through the use of inspections that they are taking the appropriate steps and meeting the legal requirements to keep the food they produce safe. We believe that gaining access to additional information regarding positive product samples discovered during production, as requested in the letter, would allow the agency to verify that appropriate corrective actions are taken by firms when positive samples are found. This kind of robust food safety data can allow us to make risk-informed compliance decisions while also continuing to support the much-needed growth and diversity of this market.

Importantly, the FDA has set targets to inspect facilities that produce infant formula annually, even prior to a requirement to do so established in the Food and Drug Omnibus Reform Act of 2022. This is above and beyond what is required in the FDA Food Safety Modernization Act (FSMA), which mandates high-risk facilities to be inspected at least once every 3 years and non-high-risk facilities to be inspected at least once every 5 years. We’ve taken this approach because annual routine inspections provide us with valuable insight into the operations within these facilities, but we can, and do, conduct additional follow-up or for-cause inspections as appropriate. In addition, through our prevention strategy, we are working to establish a specialized, dedicated cadre of investigators to conduct infant formula inspections. While we have been continuing to ensure that our staff who conduct or support infant formula inspections are receiving the latest and most relevant training, the dedicated cadre will allow us to have our most knowledgeable and experienced staff with the necessary expertise to focus on infant formula products.    

Second, Mr. Marler says FDA should “mandate testing of products and the facility”
FDA does not have the authority to require firms to notify us of product positives if the product has not left their facility, and we don’t have authority to mandate firms conduct Whole Genome Sequencing (WGS) or share the isolates to upload into the NCBI database. We agree, however, that requiring manufacturers to report positive product samples to us would serve the public health; that’s why the agency has explicitly sought that authority as part of the President’s FY24 budget request. As the FDA conducted our investigation at the Abbott Nutrition facility in Sturgis, Michigan, and inspected other infant formula facilities, it became increasingly apparent that having additional information about positive product samples, even if those products did not leave the facility, would help to ensure appropriate corrective actions are taken by the firms, and would help us to better understand the overall picture of infant formula safety. Therefore, the FDA included a notification requirement in the consent decree with Abbott that was entered on May 16, 2022 regarding the Sturgis facility. A month later, in a follow up to the May 25 and May 26 congressional hearings, we also made Congress aware of the gap in authority to require all manufacturers to report to us when positive product samples are found. Our current regulation in 21 CFR 106.150 requiring notification only when adulterated or misbranded product has left the facility is rooted in the authority Congress provided in section 412(e)(1)(B) of the Federal Food, Drug & Cosmetic (FD&C) Act. Therefore, only Congress can mandate that infant formula manufacturers provide the FDA with notification outside of that limited set of circumstances. 

However, food safety cannot wait for new laws to be enacted. And ultimately, under current law, it is the responsibility of infant formula manufacturers to ensure the safety of the formula they allow to enter into the market. That is why our letter – sharing the latest information we have on safety — is so important.

Third, Mr. Marler says FDA should “work to get Cronobacter a reportable bacterial infection in all states so we know what the scope of the problem is.”
The FDA supports elevating Cronobacter sakazakii infection among infants as a nationally notifiable disease and we have included this action as part of our prevention strategy. However, adding a disease to the Nationally Notifiable Disease list is something that is led by the Council of State and Territorial Epidemiologists (CSTE) with support from CDC. 

Because Cronobacter is not a reportable disease and because severe infections are rare, WGS is rarely performed on cases, so we have less genomic data to work with to help us link cases to each other, to a product, or to a food production environment. For example, the National Center for Biotechnology Information (NCBI) database has only 1,249 isolates of Cronobacter compared to more than 500,000 isolates of Salmonella enterica, a nationally notifiable disease. When we have illnesses of salmonellosis, we have compiled a lot of genomic data to work with right from the start.  This challenge surfaced earlier on during our investigation at the Abbott Sturgis facility, and we immediately began working with CSTE and CDC to explore a path forward toward making Cronobacter a nationally notifiable disease.  Therefore, we agree that increased genomic data, particularly through the uploading of sequences to the NCBI database, would be extremely helpful and we are encouraging industry to do this as we work with them on the prevention strategy. 

The FDA remains committed to strengthening the resiliency and safety of infant formula in the U.S., however there are significant gaps in data and authority that we have identified and are seeking support to address. We are tackling much of this work through the continued development of our Cronobacter prevention strategy, and an upcoming National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, as directed by Food and Drug Omnibus Reform Act of 2022. We would like to work with all our stakeholders to elevate these issues, implement new approaches, and pursue additional resources, so that together we can protect the health of our youngest, and most vulnerable populations.

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This product is sold at retailers across the U.S. 

Consumers who purchased the product after March 5, 2023, should look for the following Lot Codes and “use by” dates, which can be found at the bottom of the package. 

Any consumers who purchased products with matching codes should discontinue use and dispose of the product.

Gerber® Good Start® SootheProTM 12.4 oz:
300357651Z – USE BY 04JUL2024
300457651Z – USE BY 05JUL2024
300557651Z – USE BY 06JUL2024
300557652Z – USE BY 06JUL2024
300757651Z – USE BY 08JUL2024
300857651Z – USE BY 09JUL2024
301057651Z – USE BY 11JUL2024
301057652Z – USE BY 11JUL2024
301157651Z – USE BY 12JUL2024

Gerber® Good Start® SootheProTM 30.6 oz:
301357652Z – USE BY 14JUL2024
301457652Z – USE BY 15JUL2024
301557651Z – USE BY 16JUL2024

Gerber Good® Start® SootheProTM 19.4 oz:
301557652Z – USE BY 16JUL2024I

According to the company’s recall posted by the Food and Drug Administration, no distributed product has tested positive for the presence of this bacteria, no adverse events have been reported and no other products manufactured at this facility or any other of Perrigo’s facilities are affected by this recall.

Consumers can request refunds for impacted products and find more information about Gerber® Good Start® by contacting the Gerber Parent Resource Center on behalf of Perrigo at 1-800-777-7690 anytime 24/7. Consumers with any health-related questions should contact their healthcare provider.

This recall is being conducted in consultation with the U.S. Food and Drug Administration (FDA).

About Cronobacter
Food contaminated with Cronobacter may not look or smell spoiled but can still cause illness. Although Cronobacter Is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns. Severe cases often lead to death.

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The report, from the Sedgwick organization, quarterly collects and analyzes data and also compiles yearly totals. The organization uses data from the U.S. Food and Drug Administration and the U.S. Department of Agriculture.

The FDA oversees 80 percent of the country’s food supplies with the USDA responsible for the other 20 percent. In addition to food, the FDA oversees drugs, medical devices, and cosmetics. The food side of the agency has a much smaller budget than the medical side.

Sedgwick reports that the number of Food and Drug Administration food recalls rose marginally at a rate of 2.2 percent from 414 recalls in 2021 to 423 recalls in 2022. However, the number of “units,” such as individual bags of salad or containers of infant formula, went up 700.6 percent. There were 52.1 million recalled units in 2021 with an average size of 125,796 units compared to 416.9 million units in 2022 with an average recall size of 985,658 units.

“A recall of infant formula that (was connected to) two deaths was the biggest story of the year in terms of food recalls,” states the report. 

“While it was not the largest recall by volume, it had lasting repercussions on the supply of formula for months and led to calls for reform in the industry and within the FDA itself. The bacteria that led to the recall of 14.89 million units of infant formula and the closing of major production facilities had been reported on eight separate instances between 2019-2022 at one of the facilities, but no further action seemed to have been taken by the FDA.

“The food industry faced another crisis when a major recall of peanut butter products impacted 21 different food items and led to the recall of 12.2 million units. However, the widespread damage was not as great as it was with the infant formula event.”

Recall activity under the FDA’s realm of responsibility has remained constant during the past three years with 418 recalls in 2020, 414 in 2021, and 423 in 2022.

Undeclared allergens were the leading cause of food recalls under the FDA jurisdiction at 43.5 percent of all food recalls. Undeclared allergens have been the leading cause of FDA recalls for the past five years, according to the agency. 

Prepared foods have been the dominant product category of food recall events since the first quarter of 2018. Baked goods and dairy products were once again tied for second, as they were in the third quarter, with 13 recalls. Produce was third with 12 recalls.

USDA jurisdiction
“Trends with the USDA data are very different than those seen with the FDA numbers,” according to the Sedgwick report. “Annual totals for recalls year-over-year are almost identical between 2021 and 2022, with 47 and 46 events respectively. However, there was an 87.0 percent drop in the number of pounds recalled, with 13.35 million in 2021 and only 1.73 million in 2022.”

The average recall size was 284,055 pounds in 2021 and only 37,611 pounds in 2022.

For USDA-regulated foods — which are meat, poultry, and processed egg products — the top reason for recalls was contamination with foreign materials, which was linked to five recalls. No inspection was cited as the reason for three recalls and an undeclared allergen, bacterial contamination, and other contamination each had one recall, according to Sedgwick.

By unit count, foreign material was also the top reason for recalls, with one recall accounting for 148,000 pounds of chicken. No inspection was second, linked to 33,911 pounds of recalled product across three different recalls.

About Sedgwick: The Sedgwick brand protection Recall Index is a leading resource for manufacturers, suppliers, and retailers looking for an unbiased, informed perspective on past, present, and future product safety trends and recall data. It reviews five product categories: Automotive, Consumer Products, Food, and Drink, Pharmaceuticals, and Medical Devices.

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I must admit, I seldom borrow anything from the former President or the First Lady, but this seemed to fit all too well.

Late in 2022 the public learned that infants may have been sickened, and possibly died, due to the consumption of Cronobacter tainted infant formula.  The possible outbreak and the FDA investigation that followed, caused formula to be pulled from shelves and parents to be worried about how their children were going to be fed.  So, what has been the FDA’s response? Tepid at best.

On March 8, 2023, the FDA wrote a letter to the infant formula manufacturers asking the formula industry to Be Best or Be Better.  Here is part of the 2023 letter’s “Call to Action”:

This letter is directed to manufacturers, packers, distributors, exporters, importers, and retailers involved in the manufacturing and distribution of powdered infant formula. In late 2021 and early 2022, a series of Cronobacter spp. illnesses among infants in the U.S. was associated with feeding a certain brand of powdered infant formula. The U.S. Food and Drug Administration (FDA or “the Agency”) inspection of the associated manufacturing facility revealed the presence of Cronobacter spp. within the production environment, as well as other insanitary conditions, leading to a nationwide recall. This recall and the temporary shutdown of the plant was a major contributing factor to the infant formula shortage experienced across the U.S. in 2022. In response, the FDA developed a strategy to prevent future Cronobacter spp. illnesses associated with powdered infant formula and is issuing this letter to share current information to assist industry in improving the microbiological safety of powdered infant formula. 

Get this straight, the FDA, despite being humiliated by its own findings, a whistleblower report and the political fallout of babies dying, and shelves empty of formula, asks the industry to “voluntarily” – Be Best or Be Better.  

What should the FDA do given the critical nature of infant formula and the fact that there are so few manufacturers? 1) put an inspector in every plant 24/7; 2) mandate testing of products and the facility and upload any positive tests to the CDC to compare with illnesses; and 3) work to get Cronobacter a reportable bacterial infection in all states so we know what the scope of the problem is.

Why does the FDA asking an industry to Be Best or Be Better sound a bit too familiar? Let’s go back to the fall of 2005 when the FDA asked the Leafy Green Industry to “Be Best or Be Better.”

In view of continuing outbreaks associated with fresh and fresh-cut lettuce and other leafy greens, particularly from California, we are issuing this second letter to reiterate our concerns and to strongly encourage firms in your industry to review their current operations in light of the agency’s guidance for minimizing microbial food safety hazards in fresh fruits and vegetables, as well as other available information regarding the reduction or elimination of pathogens on fresh produce. We encourage firms to consider modifying their operations accordingly to ensure that they are taking the appropriate measures to provide a safe product to the consumer. We recommend that firms from the farm level through the distribution level undertake these steps. 

Months later an E. coli O157:H7 swept through the spinach industry, causing all spinach in the U.S, to be recalled (Mexico banned imports), with over 200 sickened across the U.S., many with acute kidney failure with five dead. Since that disaster, the FDA continues to ignore the “Cow in the Room” – leafy greens grown near cattle operations.

What should the FDA do to help the leafy green industry help itself? 1) gain access to nearby cattle operations and do testing for E. coli and upload any positive tests to the CDC to compare with illnesses; 2) work with both the leafy green industry and the cattle industry to set workable land and water use controls; and 3) scientifically test products and upload any positive tests to the CDC to compare with illnesses.

Will my ideas stop all illnesses – no.  Will it bend the curve of illnesses and help businesses help themselves – yes.  It is past time for the FDA to ask industries to “Be Best or Be Better.”  

In a letter this week Robert M. Califf, FDA Commissioner, and Susan T. Mayne, Director of the Center for Food Safety and Applied Nutrition, addressed concerns about infant formula along the food chain, speaking to manufacturers, packers, distributors, exporters, importers and retailers.

“FDA is sharing this information with you 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, especially given the critical nature of these products,” a letter from the FDA leaders states.

“. . . The FDA has reviewed conditions during recent inspections of powdered infant formula manufacturers, including routine surveillance inspections, for-cause inspections to follow up on consumer complaints and other interactions with manufacturers.”

The letter is part of the FDA’s response to a series of Cronobacter spp. illnesses among infants associated with feeding Similac and other brands of powdered infant formula produced by an Abbott Nutrition plant in Michigan.

An inspection of the facility found Cronobacter spp. within the production environment, as well as other insanitary conditions, leading to a nationwide recall. The recall and months-long shutdown of the plant were a major contributing factors to the infant formula shortage experienced across the U.S. in 2022.

“In response, the FDA developed a strategy to prevent future Cronobacter spp. illnesses associated with powdered infant formula and is issuing this letter to share current information to assist industry in improving the microbiological safety of powdered infant formula,” according to the letter.

In a statement put out with the release of the letter, Califf and Mayne said the FDA has reviewed food safety and operating conditions during ongoing inspections of powdered infant formula manufacturers. In addition, during the past two months, food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula.

As part of the steps suggested by the FDA, the agency wants companies to “voluntarily notify the agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been distributed.”

The FDA isn’t happy with the manner in which companies monitor the presence of bacteria and indicators of Cronobacter in their facilities, according to the letter from Califf and Mayne.

“Manufacturers of powdered infant formula must 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 formula or in the processing environment,” the FDA leaders say in their letter.

“. . . The presence or absence of EB (Enterobacteriaceae) on environmental surfaces is not a reliable indicator for the presence of Cronobacter spp. In other instances, when responding to the detection of Cronobacter spp. in a product sample, some facilities immediately initiated sanitation activities on suspected environmental or equipment surfaces and then collected samples from these surfaces to verify sanitation effectiveness. 

“This approach limited their ability to determine whether those surfaces contributed to the contamination event. FDA encourages firms conducting an RCI (root cause investigation)  to thoroughly investigate the potential sources of contamination by collecting environmental samples before performing sanitation activities, in addition to other RCI activities such as evaluating incoming ingredients and reviewing production records,” according to the letter.

The FDA leaders are calling on the manufacturers to ensure that the raw materials used to make infant formula are free of pathogens, or put in place methods to kill pathogens, before using raw ingredients.

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The allowed concentration of inorganic arsenic in white rice is lowered, while there are new limits for arsenic in some rice-based food items, infant formula, baby foods, fruit juices, and salt.

Arsenic is present at low concentrations in rocks, soil, and natural groundwater, with food and drinking water being the principal routes of human exposure. The inorganic forms of arsenic are more toxic than organic arsenic.

Children under the age of 3 are the most exposed to inorganic arsenic, especially infants who eat rice-based formula. Developmental problems in children have been documented.

High consumers of rice, such as certain ethnic groups, and people who eat a lot of algae-based products are the main groups subjected to inorganic arsenic exposure.

The lower maximum levels are part of Europe’s Beating Cancer Plan to limit or remove the carcinogenic risk associated with chemicals in food.

Reducing the risk
The decision is based on a 2021 scientific report from the European Food Safety Authority (EFSA) and comes after member states were told to monitor the presence of arsenic in foods.

EU rules will follow the Codex Alimentarius maximum level of 0.5 mg/kg for total arsenic in salt. Other products covered are cereals and cereal-based products, non-parboiled milled rice, parboiled and husked rice, rice flour, rice cakes and crackers, and non-alcoholic rice-based drinks. Maximum levels differ depending on the product.

Stella Kyriakides, the commissioner for health and food safety, said: “We are taking additional measures to further reduce the exposure risk of a carcinogenic contaminant from our food chain. Our citizens want the reassurance that the food they eat is safe, and these new rules are yet another proof that food safety standards in the EU remain the highest in the world.”

Safe Food Advocacy Europe said it welcomed any measure that avoids or reduces the exposure of European consumers to harmful substances in food.

Existing maximum levels for arsenic in food products were established in 2015 based on an EFSA opinion that found inorganic arsenic may cause cancer of the skin, bladder, and lungs. 

Due to problems related to the analysis of inorganic arsenic in a number of foods, maximum levels for arsenic were initially only set for rice and rice-based products.

As certain foods covered by the regulation have a long shelf life, items that were lawfully placed on the market before the new rules apply will be allowed to remain on sale.

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New York Times columnist Thomas Friedman once wrote; “Everything really important happens the morning after the morning after…”

In short, focus on what really changes, not what is said will change.

That is a good lesson for the White House and Congress to remember with the proposed “reforms” of the Food and Drug Administration’s (FDA) foods programs.  Commissioner Robert Califf has promised that the structural, political, and cultural obstacles that have made FDA’s assurance of food safety ring hollow will be changed.

Food safety advocates across-the-board have their doubts.  Consumer Reports’ food safety expert Brian Ronholm said the proposal “essentially cements the current dysfunctional structure at the FDA that led to the infant formula crisis and contributed to other longstanding problems that have plagued the agency.”

How dysfunctional was that structure that led to at least four infant hospitalizations and two deaths linked to tainted infant formula from an Abbott facility in Michigan? It took four months until the FDA would go into the plant to conduct a for-cause inspection months.  A resulting, and much belated, recall then contributed to shelves empty of infant formula across the country, and parents of the richest country on the globe Googling DIY infant formulas.

Dr. Califf is in a long line of FDA commissioners trained in medicine with little to no experience in food safety.  A cardiologist trained in clinical research, Califf is well versed in the risk/benefit approach to drug safety.

But for food safety, the approach needs to be different.  Former President Barack Obama perhaps summed it up best in 2009 when he appointed FDA Commissioner Margaret Hamburg: “When we give our kids peanut butter and jelly, we don’t expect them to make them ill…No parent should have to worry that their child is going to get sick from lunch.”

And certainly, no parent should have to worry that their baby is going to get sick from infant formula.  

When Dr. Califf testified before Congress during the infant formula crisis, he argued that, while serious systemic issues existed in the foods program, reorganization was not required.  In eloquent managerial bureaucratic-speak, he said, “An optimal foods program organization must take into account the FDA’s product areas and centers are not silos, but a matrix of interdependent information and operations encompassing product and regulatory organizations and enterprise-wide support organizations.”

Maybe, he meant to say that unless and until there is a single food safety leader overseeing the entire foods program, consumers will remain at risk.

So, food safety advocates can be excused if that is not the change they see coming from the proposed reforms.  It took the relentless and unified calls for reform from a broad coalition of FDA stakeholders, as well as the extensive investigative reporting by Helena Bottemiller Evich, that finally prompted the commissioner to have the Reagan-Udall Foundation conduct an independent review of the foods program that was chaired by former FDA Commissioner Jane Henney.

The panel’s conclusion? “The lack of a single clearly identified person to leads the human foods program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil,” the review stated.

Precisely what the stakeholders have been telling the agency for years.

And the commissioner’s response, while promising change, delivers the same problems: A new “deputy commissioner” will be put in place, but once again not have authority over the agency’s food safety inspectors or laboratory staff as well as compliance and import oversight functions.  While the commissioner said he is uniting the foods program, animal foods are left out despite the well-established principle that foods for animals and humans are inextricably linked.

As for when these “reforms” will actually happen, the most optimistic timetable is some time in 2024.  The commissioner has stated the Department of Health and Human Services will not have a plan to review until late 2023, and he has also said publicly he is not certain of the support of employees and unions.

The morning after the morning after the proposed FDA food safety reform will not see much, if any, change.

That’s why it’s time for the White House and Congress to act: Create a new, independent federal Food Safety Agency.  Then there really will be a morning after the morning after.

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Editor’s note: The Consumer Brands Association and Consumer Reports were featured in The Hill Opinion on Feb. 22 for sounding the alarm on FDA’s refusal to appoint a fully empowered deputy commissioner for foods as a necessary step to fix the structural problems that led to the infant formula crisis.

The piece was written by Consumer Brands’ Vice President of Regulatory and Technical Affairs Roberta Wagner and Consumer Reports’ Director of Food Policy Brian Ronholm who escalated widespread calls for FDA Commissioner Califf to fully incorporate this change in his next public update on FDA’s foods program redesign plan set for the end of the month. It is reprinted here with the author’s permission.

Califf won’t make fixes to help prevent another infant formula-level crisis
A fragmented and indecisive Food and Drug Administration (FDA) is struggling to escape widespread criticism for its major structural and governance problems exposed by the infant formula crisis. FDA’s issues are no secret, but neither are the solutions. In fact, a detailed blueprint on how to restructure the agency for success was presented to Commissioner Califf. But unfortunately, the redesign plan he announced falls short of the profound changes FDA needs to better protect consumers and accelerate getting safe, new food products to the market. Lack of bolder action ultimately jeopardizes public health. 

An external evaluation of the FDA’s food program was conducted by an independent, expert panel at the commissioner’s request. The final report showed immediate functional enhancements could be realized by appointing a fully empowered, specialized leader or “deputy commissioner for foods” with direct line authority over all key units of the foods program. Housing the research, policymaking, inspection, and enforcement components under one food authority will boost functional efficiency and provide much-needed accountability for the food program’s budget. But drastic improvements require revolutionary change. 

Despite broad support for the report’s recommendations, Califf’s initial “redesign” plan didn’t reflect its true substance even though it contained some of the right words. Instead, he signaled that a new “deputy commissioner” would possess watered-down managerial power compared to those who previously held such a role. Rather than unifying the entire food program under a single leader with direct line authority, the major organizations responsible for running food-related operations would still report directly to Califf under his plan. We’ve already seen a splintered structure like this fail. A diluted plan to fix it won’t deliver the full transformation FDA needs.  

In its current state, the commissioner’s plan fails to sincerely elevate the stature of the food program. It largely maintains the status quo. FDA’s apparent intent to write off resounding calls for bolder steps to fully empower an expert foods leader is frustrating as it is puzzling. The foods program is a distinctive part of the agency deserving of a structure and leadership model tailored to its mission – not one improved in name only. The organizational weaknesses that contributed to the infant formula crisis can only be resolved through more decisive action.  

FDA shouldn’t wait for another high-profile mishap that could cause sickness, and even death, to make its “redesign” plan more serious. Consumers deserve an FDA that takes every step possible step to keep structural issues from inhibiting its mission, so it can focus acutely on preventing public health risks. But what we heard from the commissioner puts much-needed agency modernization well out of reach.  

As research expands our understanding of human nutrition, the availability of information at the intersection of health and diet is accelerating changes in consumer behavior. From specialized diets like keto or paleo, to demand healthier convenient food options in grocery stores, to easy access to data on sensitive ingredients like gluten or sesame oil, informed consumers are driving the explosion of new food products on the market. It is, therefore, critical that the agency responsible for food safety match the swift pace of today’s evolving consumer preferences with timely decision-making on innovative products.   

At the end of the day, it’s consumers who will face the consequences if FDA refuses to truly shift away from its existing culture of indecision and inaction. The next public update on FDA’s foods program redesign plan should incorporate modifications that properly designate a deputy commissioner with the full authority needed to drastically improve functionality. FDA must acknowledge the robust record of widespread support from consumer organizations, industry, and state and local regulators – even backed in FDA’s requested third-party report – for this strong course of action. It’s time for FDA to do its job and do it right.  

About the authors: Roberta Wagner served nearly 20 years at FDA and as a top policy official at USDA. She is vice president of regulatory and technical affairs at the Consumer Brands Association, which represents nearly 2,000 iconic brands in the consumer packaged goods industry.  

Brian Ronholm is director of food policy for Consumer Reports, an independent, nonprofit member organization that works with consumers for truth, transparency, and fairness in the marketplace. He is a former deputy undersecretary for food safety at the U.S. Department of Agriculture and previously worked for Rep. Rosa DeLauro (D-Conn.)

According to the company announcement posted by the Food and Drug Administration, all product distributed went through extensive testing and tested negative for the bacteria, and there have been no reported adverse consumer reactions to date.

The recalled product was manufactured between Aug. 2022 and Sept. 2022. The products were distributed through retail stores nationwide in the U.S. and in Guam and Puerto Rico. 

Recalled product:

• ProSobee Simply Plant-Based Infant Formula in 12.9 oz containers.
• The batches in question can be identified by the number on the bottom of the can. 
• Recalled product batches are ZL2HZF and ZL2HZZ both with a UPC Code of 300871214415.
• “Use By Date” of “1 Mar 2024.” 
• The recall involves approximately 145,000 cans.

If parents have any questions, they should consult with their pediatrician.

According to the company, the batches in question tested negative for Cronobacter and other bacteria and this is an isolated situation. After a thorough investigation, the company says they have identified the root cause, which was linked to a material from a third party. 

Consumers who purchased ProSobee Simply Plant-Based Infant Formula should check the bottom of the can to identify whether the batch number is affected. Recalled products should be disposed of or returned to the place of purchase for a full refund.

About Cronobacter
Food contaminated with Cronobacter may not look or smell spoiled but can still cause illness. Although Cronobacter Is not commonly linked to human illness, in rare cases it can cause serious or fatal infections. Cronobacter can cause rare bloodstream and central nervous system infections and has been associated with severe intestinal infection (necrotizing enterocolitis) and blood poisoning (sepsis), especially in newborns. The severe cases often lead to death.

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The dairy company confirmed it was under criminal investigation and said it would cooperate with authorities.

Prosecutors brought charges for fraud, a failure to carry out a product withdrawal and recall, and involuntary bodily harm. The firm’s subsidiary Celia-Laiterie De Craon is also involved.

“This step marks the beginning of the legal investigation in which Lactalis will fully and transparently commit,” said a Lactalis statement.

“All Lactalis employees and managers are fully aware of the hardships experienced by the families whose children have been ill and we would like all clarifications to be provided. It is essential, for them as for Lactalis, that the judicial investigation provides these answers. In the coming weeks, we will have access to all elements of the file and will be able to respond precisely to all the points raised.”

Non-governmental organization Foodwatch filed a complaint alongside affected families in February 2018. The group said the development was the good news that it and many families of those sick had been waiting for.

Background
Production at the Craon site in France was suspended in December 2017 as part of a Salmonella agona outbreak investigation. Lactalis was allowed to restart sales of infant formula made at the plant in September 2018.

The outbreak sickened 38 babies in France, two in Spain, and one in Greece. At least 18 infants were hospitalized.

Lactalis withdrew and recalled more than 7,000 tons of implicated products manufactured from mid-February 2017. The recalled formula was distributed to more than 80 countries and needed the involvement of the International Food Safety Authorities Network (INFOSAN), managed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).

Investigators found it was the same strain that was behind 141 illnesses in 2005 when the Craon production site was owned by Célia. Only one of 176 and four of 27 samples from two implicated food products and six of 420 environmental samples tested positive for Salmonella Agona. 

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“I am honored to have served the American public, alongside each and every one of you, over these past four years,” Yiannas said in an email addressed to FDA Food Partners, colleagues, and friends.

In his letter to Commissioner Califf,  Yiannis cited how he first considered leaving the FDA in February 2022, over his concern that the decentralized structure of the foods program significantly impaired the FDA’s ability to operate as an integrated food team and protect the public.

However, Yiannis delayed his resignation after learning last February of the infant formula incidents that had been reported to various parts of the FDA several months before. Yiannis postponed this decision to help tackle this crisis. 

“With the Abbott facility now reopened, infant formula availability is more prevalent, and – very importantly – the necessary monitoring, data systems, and insights are now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave,” Yiannas said in his letter to Califf.

Yiannas left Califf with several two things to consider. “One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more efficiently make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century.”

Secondly, Yiannas urged Califf to consider transferring the “small, yet exceptional” staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.

Yiannas assumed the position of deputy commissioner for food policy and response at the FDA in December 2018. Since then, he has acted as the principal advisor to the FDA commissioner in the development and execution of policies related to food safety, including the implementation of the landmark FDA Food Safety Modernization Act (FSMA). His responsibilities have included food safety priorities such as outbreak response, traceback investigations, product recall activities, and supply chain innovation.

“In closing, while I’ll soon be departing the agency, rest assured that I’ll continue rooting for you,” Yiannis said in his email to colleagues and friends. “As for me, while I have no immediate plans or next steps to announce today, I’ll continue to seek ways to work together to create a safer, smarter, and more sustainable food system that will benefit consumers, food producers, and the planet for generations to come. “

The full letter can be read below:

Dr. Califf:

This letter is to inform you that I am resigning my position as FDA Deputy Commissioner for Food Policy and Response effective February 24.

In December 2018, I joined the FDA with the goal of helping to modernize the food safety oversight system in the United States and protecting the American people from contaminated food. I wanted to build on my work of protecting consumers by elevating food safety standards and building more effective, modern, and innovative food safety approaches, something I did in the private sector for more than 30 years.

Despite the unprecedented challenges we’ve faced in the past four years (such as a global pandemic, unparalleled food supply chain disruptions, and six different acting or permanent commissioners), thanks to the dedicated staff working on food safety throughout the FDA, I believe we made real improvements towards this goal.

Advancing FSMA

First, almost a decade since its passage and after the agency experienced three separate lawsuits (before my arrival) for failing to achieve several Food Safety Modernization Act (FSMA) mandates, we made needed and strategic progress by tackling two of the most critical, complicated, and outstanding FSMA rulemakings by issuing a Final Food Traceability Rule and a new, proposed Agricultural Water Standard. While the FSMA-projected reductions in foodborne illnesses have yet to be realized a decade later, these two rules, once fully implemented, will be game-changers in allowing those reductions to become a reality.

A New Era of Smarter Food Safety

But we didn’t stop there. Modern times require more modern approaches. Therefore, shortly after my arrival, we assembled some of the brightest minds in food safety from within and outside the FDA to help us prepare for the future. Based on their input, in 2020 and under the auspices of a New Era of Smarter Food Safety, we unveiled a new vision and blueprint for the next decade to modernize the way FDA does its food safety work and to bend the curve of foodborne illness once and for all in this country. And in two short years, we achieved an amazing amount of work. For example, we leveraged smarter tools for prevention used for the very first time in the FDA’s food program, such as employing Artificial Intelligence to strengthen our ability to detect and prevent violative shipments of imported seafood from reaching the U.S. consumer. We also expedited and facilitated the use of Tech-enabled Food Traceability to better track and trace foods and to create a more transparent food system. And at a time of heightened food supply chain disruptions, we unleashed the power of data with the development of 21 Forward, a first-of-its-kind food supply chain analytical platform to identify food facilities at greatest risk of food supply chain disruptions, and to provide focus to areas where we should fortify resilience. We also launched a pilot to evaluate if select third-party food safety standards aligned with FSMA and determine what role they might play in the nation’s food safety oversight system. And we advanced the concept of Food Safety Culture to achieve higher rates of compliance and to mobilize the industry to do the same, realizing that advancing food safety requires going beyond traditional approaches, through a better understanding of human behavior and organizational dynamics.

A Record of Prevention

Importantly, while regulatory activities matter, they’re not what matters most. What matters most is the outcomes or proven results that our work is achieving in reductions in foodborne illnesses. And early indications are that we’ve been successful here too, whether it’s been through our work to rally stakeholders to break the cycle of recurring outbreaks around Thanksgiving linked to fresh leafy greens through FDA’s Leafy Green Action Plan or, after 8 years and 8 outbreaks, breaking the cycle of Salmonellosis during the summer linked to imported papayas, through an enhanced Food Safety Partnership between the U.S. and Mexico, as just a couple of examples.

Tackling Foodborne Outbreaks Faster

And while prevention has been and must always be our focus, tackling foodborne outbreaks faster and revealing their root cause is also essential to preventing future outbreaks, so here too, we made significant progress. For example, we strengthened FDA’s foodborne outbreak investigations and almost doubled the number of outbreak investigation reports the agency now publishes. Also, as a commitment to greater transparency, we began a process of sharing information about the outbreaks the FDA is investigating through a weekly outbreak update table, even before there is any actionable information. And importantly, we completed an independent review of our outbreak investigation processes that led to the development of a Foodborne Outbreak Response Improvement Plan.

I want to THANK all of those in the FDA who have committed themselves to these efforts and I hope they are given the opportunity to continue this important work in the future. I hold the food safety staff throughout the agency in the highest regard, for their expertise, their experience, and – most of all – their commitment to the public.

Looking to the Future

In February 2022, as you rejoined the agency, I shared with you that I was considering leaving, expressing my concern that the decentralized structure of the food program that you and I both inherited, significantly impaired the FDA’s ability to operate as an integrated food team and protect the public. It was also in February of 2022 that I first learned of the infant formula incidents that had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis. With the Abbott facility now reopened, infant formula availability is more prevalent, and – very importantly – the necessary monitoring, data systems, and insights are now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave.

My fervent hope is that American consumers, especially mothers and fathers of infants, never again have to face this type of preventable situation. It is incumbent on any public organization that has undergone a crisis of this magnitude to undergo an “independent” and thorough review to understand how the crisis happened, what can be done to prevent it from happening again, and that the complete findings be transparently shared with the public. I am grateful that Congressional leaders have demanded that this happen and that the Office of the Inspector General has initiated its own investigation.

Lastly, while I respect that these are decisions only you are empowered to make, I do want to leave you with a couple of thoughts for consideration. One, based on my experience these past four years, I (as well as a diverse group of Bipartisan Congressional Leaders and Consumer, State Regulatory, & Industry Stakeholder Groups) firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more efficiently make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century. Secondly, I also urge you to consider transferring the small, yet exceptional staff comprising the Office of Food Policy and Response (OFPR) to a new office of the Deputy Commissioner for Foods.

In closing, I will always remain grateful for the opportunity to have served our one and only true boss, the approximate 340 million American consumers nationwide. Serving them has been an honor and a privilege.

Frank Yiannas

Deputy Commissioner, Food Policy and Response 

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Will 2022 be remembered as the year of Salmonella in chocolate or Cronobacter in infant formula? Or did something else grab and keep your attention in the past 12 months?

Sometimes it feels as if all I’ve been writing about since 2020 is coronavirus, the United Kingdom leaving the European Union, and ethylene oxide contamination. While this isn’t the case, these three subjects did feature again on the 2022 news agenda, so we’ll address them first.

Major outbreaks of Listeria in Italy and E. coli in the UK, Salmonella Mbandaka in several countries, and Hepatitis A in New Zealand surfaced while the Salmonella tahini/halva incident rumbled on.  

This year also threw up some different topics as well as outbreaks and recalls. We had drugs in champagne, pet food contamination, bird flu, poppy seed poisonings, and poisoned alcohol.

• Coronavirus and food outbreak and illness statistics

As predicted last year, in most countries outbreaks and illness reports went up in 2021 from 2020 but are still below levels pre-COVID-19 pandemic. This is backed up by the European Food Safety Authority (EFSA) and European Centre for Disease Prevention and Control (ECDC) report on outbreaks and illnesses in 2021. The virus hasn’t gone away but restrictions have eased so it is likely levels will go up again when we see 2022 figures and we may get back to pre-pandemic numbers.

• UK leaving the EU

It was six years ago when the UK decided to exit the EU in a referendum. We’ve heard plenty about lost access to the Rapid Alert System for Food and Feed (RASFF) portal and networks such as the Heads of Food Safety Agencies. But Brexit keeps throwing up new issues. Whether it is the Northern Ireland protocol, delays to border controls, an impact on resources — highlighted by the Food Standards Agency and Food Standards Scotland recently — or The Retained EU Law Bill that aims to remove EU laws from UK legislation by 2023, although this date can be extended until 2026. Initial analysis by the FSA shows it intends to advise ministers to either preserve, extend or restate the majority of the rules it deals with.

• Ethylene oxide incident

As a quick refresher, Belgium raised the alert in September 2020 concerning sesame seeds from India. It was later found in additives including locust bean gum. The use of ethylene oxide to disinfect foodstuffs is not permitted in Europe. National authorities have taken different approaches including recalls and withdrawals. The European Union has tightened rules several times to tackle the problem. The incident appears to be winding down with the removal of related pages on the EU Commission’s website but RASFF notifications continue. It was the biggest food recall operation in EU history, according to the Alert and Cooperation Network (ACN) report.

• Large French E. coli outbreak

Frozen pizzas were behind the largest E. coli-HUS outbreak ever seen in France. Nestlé has recently been allowed to restart operations at the Buitoni plant in Caudry after production was stopped in April. Overall, 56 confirmed and two probable cases with a median age of 6 fell sick between mid-January and April. There were 50 cases of kidney failure known as Hemolytic Uremic Syndrome (HUS) and two children died. Most illnesses were Shiga toxin-producing E. coli (STEC) O26:H11 but a couple of O103:H2 infections were recorded. In France, STEC surveillance is based only on HUS in children younger than 15, so it is likely many more people were sick. Outbreak strains were isolated from pizzas sampled in patients’ homes and at the manufacturing plant. E. coli was also found in the flour used to make pizzas. Criminal and civil proceedings are ongoing.

• Salmonella in chocolate

Salmonella in confectionery has been a major theme this year. We start with the monophasic Salmonella Typhimurium outbreak from Kinder chocolate made by Ferrero in Belgium that sickened 450 people in multiple countries. Children were particularly affected and many were hospitalized. People fell sick between December 2021 and June 2022. There were four cases in Canada and one in the United States. The Arlon facility was given the all-clear in September after being shut in April. An investigation by the Luxembourg Public Prosecutor’s Office is ongoing.

In Israel, Strauss Group issued a product recall and closed a factory in April due to Salmonella. The plant in Nof Hagalil restarted in August. Elite products were recalled from the United States, Australia, Europe, and the UK with related illnesses reported in Israel. Estimated costs are around $90 million.

Barry Callebaut also felt the impact of Salmonella contamination despite implicated chocolate not entering the retail chain. The cost was $77 million, according to the company’s financial results. The Wieze factory in Belgium paused operations after Salmonella Tennessee was detected in lecithin from a supplier in Hungary in June.

While on the subject of lecithin, it is also worth mentioning an issue with soya lecithin from India because of potential peanut contamination. The problem was raised by Germany via a RASFF alert in April and affected 60 countries including the United States. It was believed to have been caused by cross-contamination during processing. Soybean lecithin is used in a range of foods, such as chocolate, cheese, margarine, and salad dressing.

• Cronobacter in infant formula

The main Cronobacter in the infant formula story is from the United States and involves Abbott Nutrition’s Sturgis, MI, plant. Four infants were infected with Cronobacter and two died. Abbott says there is no conclusive evidence that the illnesses were connected to its product.

In Europe, a brand of infant formula was recalled in November in Slovakia and the Czech Republic because of Cronobacter. The affected goat’s milk formula was made by Goldim.

Cronobacter was also detected in another formula from a different producer in the Czech Republic and sent to Moldova. Numil initial infant milk formula made by Corinos House was recalled in June.

Earlier in 2022, a batch of KetoCal 3:1 was positive for Cronobacter after sampling by Australian customs officials. Nutricia, which is owned by Danone, said the affected batch was made in Europe and was negative before leaving the production plant.

We also found out about an outbreak of Cronobacter sakazakii involving four babies and one death at a hospital in Germany in 2021. It was due to the hospital-mixed probiotic infant formula. 

• MDMA in champagne

In early 2022, a warning about champagne contaminated with ecstasy in Europe was issued by authorities. Eight people fell sick in February in Germany and one died. There were also four illnesses in the Netherlands. Bottles of Moët and Chandon Ice Imperial were emptied of champagne, and the corks changed and filled with pure liquid MDMA, also known as ecstasy. An investigation involved Europol and agencies in France, Italy, Belgium, Germany, and the Netherlands.

• Monoethylene glycol is back in the news

While there were developments in the Cervejaria Backer brewery contamination case of 2020 in Brazil linked to 10 deaths — including fines and the firm being given the approval to restart beer sales — mono ethylene glycol hit the headlines for other reasons.

The toxic substance was used instead of propylene glycol, a permitted additive, in pet food. Six companies that produced dog food were involved: Bassar Pet Food, Peppy Pet, Upper Dog, Petitos, Pets Mellon, and FVO Alimentos. Five suppliers were listed by Brazilian authorities: Tecnoclean Industrial, A, and D Quimica, Atias Quimica, Bella Donna, and Saber Quimica. Local media reported that at least 15 dogs died.

• Food safety strategies

The World Health Organization (WHO) launched its food safety strategy for 2022 to 2030. One target is a 40 percent reduction by 2030 in the global average of foodborne diarrheal disease incidence. The first progress report will be in 2024 at the World Health Assembly.

In early December, the Council of FAO endorsed the strategic priorities for food safety within the FAO Strategic Framework for 2022 to 2031. FAO hopes it will spur investments and secure human and financial resources for the agency to implement its food safety program and to provide international guidance, policy, and advocacy for policymakers.

Work has also started to update estimates on the burden of foodborne diseases published in 2015. The Foodborne Disease Burden Epidemiology Reference Group (FERG) has issued a few calls for help with systematic reviews and other studies. A new report is planned for 2025.

• Other highlights

There are many topics around food safety that I feel don’t get enough column inches — such as heavy metals, mycotoxins, and pesticide residues, and those that are only mentioned occasionally like wild mushroom poisonings, foodborne parasites, and allergens. One issue, in particular, cropped up several times this year — tainted alcohol. It was responsible for illnesses and deaths in India, Peru, Ecuador, Colombia, Uganda, Vietnam, and Turkiye. If food safety is “Everyone’s Responsibility,” as we are often told, then we have a lot of things to be getting on with in 2023.

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Abbott Nutrition let Ohio Gov. Mike DeWine announce that its new $536 million formula manufacturing facility will be built in Bowling Green, providing 450 permanent full-time jobs for northwest Ohio. At about the same time, Abbott said that next year it would begin phasing out its infant formula and child nutrition businesses in mainland China.

in October, Abbott’s Chairman and Chief Executive Officer Robert B. Ford, said his company was putting up $500 million for a new U.S. infant formula manufacturing facility with only the location remaining to be chosen.

Abbott’s troubled infant formula plant in Sturgis, MI, has been at the center of the national shortage with its temporary closures and product recalls. In normal times, its been the nation’s largest infant formula producer.

Gov. DeWine said Ohio is”glad Abbott is advancing its future here” in Bowling Green. He said the investment will support job growth and improve the supply chain for formula products nationwide. Ohio looks forward to ensuring that “life-sustaining formulas” are available and accessible.

Abbott’s Bowling Green announcement said the new plant will expand the U.S. supply of essential formulas with an emphasis on those for individuals with extreme allergies and diet metabolic conditions.

“Abbott has long been part of Ohio and we’re proud to become part of the local community in Bowling Green,” Ford said.

Groundbreaking is set to take place during 2023, subject to state and local approvals. Construction will be complete in 2026. It’s not known if the national formula shortage will still be going on by then.

As for China, Abbott said: “We will cooperate with relevant parties to bring a halt to our baby and child nutrition business in the Chinese mainland market within a year.” The notice was posted on Abbott’s China website.

China’s baby formula market is currently marked by fierce competition with consumers losing confidence in Abbott over the news that FDA was investigating the Sturgis plant over complaints about Cronobacter sakazakii and Salmonella Newport infections.

Meanwhile, the domestic baby formula shortage is not over and may be about to get worse. That’s because Formula Acg is being allowed to expire. It’s the emergency measure that eliminated tariffs on foreign brands of formula entering the U.S. to combat the shortage.

Reckitt, the manufacturer of the well-known Enfamil brand baby formula, warns the national shortage is likely to last until at least the Spring of 2023.

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By Sarah Gallo

When baby formula disappeared from shelves following a recall earlier this year, it raised the question of how something this big, affecting millions across the U.S., occurred under the U.S. Food and Drug Administration’s watch. Consumers rely on the FDA to ensure that safe, quality products are available every day in the marketplace. But the FDA’s reviews and policymaking processes have clearly fallen behind.

The importance of the FDA’s mission cannot be overstated. It can — and must — create a modernized regulatory system, paired with key structural and governance changes, to better provide for consumer safety and keep pace with rapidly evolving consumer preferences and growing opportunities to introduce innovative products to the marketplace.

Change is not only possible, it’s precedented. The FDA successfully modernized its medical products program several years ago,  providing a model to follow and proof that critical updates to the food program are achievable. The Consumer Brands Association identified nine policies that would revitalize the FDA’s Foods Program through enhanced transparency and stakeholder engagement, creating a modernized agency that can more efficiently deliver on its mission:

1. Commit to Timely Reviews – Ensuring more timely agency decisions on the safety and labeling of novel foods and food ingredients will help new products get to the market at the pace of the consumer.
2. Reform Inspections to Improve Oversight – The FDA should move away from one-size-fits-all inspections to tailored, risk-based models for routine facility oversight. Inspections should use proven, data-driven methods, such as remote regulatory activities and federal-state coordination.
3. Update the Recall Process – Harmonizing government recall processes and improving the FDA communication with consumers through updated channels such as text, email and social media will help quickly distribute notices of recalled products to prevent sickness.
4. Make Labeling Flexibilities Permanent – The FDA should maintain and enhance the labeling flexibilities that proved successful during the early stages of the pandemic, ensuring products remained in stock in the wake of ingredient shortages. Additionally, it should embrace digital opportunities to share robust product information beyond the physical label.
5. Improve Industry Collaboration – The FDA should formalize industry collaboration to expeditiously create and publicly share best practices, which successfully minimized disruptions in early pandemic response.
6. Grow Consumer Transparency – Developing implementation plans for food traceability and product visibility will make supply chains more nimble and inform consumers’ purchasing decisions.
7. Strengthen Chemical Management – Developing a transparent regulatory agenda for chemicals in packaging and products will inform the industry and help the FDA modernize risk assessments.
8. Support Industry Sustainability Commitments – The FDA should be a leader and expert in sustainable food packaging initiatives. This will help the industry adhere to state recycled content mandates and packaging material bans, meet environmental commitments and fulfill consumer demand for sustainable packaging.
9. Enhance IT Systems and Data Sharing – Empowering the FDA to collate and mine big data by providing funding to enhance IT will yield better-informed policy and more responsible use of government resources.
   
   The FDA cannot wait any longer to implement significant and lasting change the agency requires and consumers deserve. 

Sarah Gallo is vice president of product policy for the Consumer Brands Association, which represents nearly 2,000 iconic brands. From household and personal care to food and beverage products, the consumer packaged goods industry plays a vital role in powering the U.S. economy, contributing $2 trillion to U.S. GDP and supporting more than 20 million American jobs. 

The Public Health Authority of the Slovak Republic (UVZSR) said the issue was detected as part of official food controls by authorities. No related illnesses have been reported.

The affected goat’s milk infant formula was made in the Czech Republic by Goldim. The product is “Naše mléko 1” with a date of Oct. 31, 2023, and lot number L430. It is intended for infants up to 6 months of age. The production date is Feb. 26, 2022.

The product was analyzed in an accredited regional public health authority (RÚVZ) laboratory and it did not comply with the microbiological legislation for Cronobacter sakazakii.

UVZSR said this means the formula is considered not to be safe and should be withdrawn from the market.

The agency added Cronobacter sakazakii can cause serious illness and strongly recommended that consumers do not purchase or use the implicated products and advised people to return them to the point of sale.

The State Veterinary Administration (SVS) in the Czech Republic also warned that the product had been sold on the Czech market.

Out of 1,024 packs of infant formula, 616 went to the Czech Republic and the rest were sent to Slovakia. Almost 300 packs were for the wholesaler Pharmos, which supplies goods to pharmacies. It was also sold by the online retailer Alza.cz, which only received a few boxes. The rest went to more than 45 small customers. All wholesale recipients of the infant formula were informed and asked to block the product in their warehouses and withdraw it from sale.

Earlier this year, Cronobacter was detected in another formula from a different producer in the Czech Republic and sent to Moldova. Two lot codes of Numil initial infant milk formula made by Corinos House s.r.o. were recalled in June.

Cronobacter was also found during Australian testing of infant formula made in Europe. A batch of KetoCal 3:1 was positive after sampling at the border by Australian customs officials. Nutricia, which is owned by Danone, said testing before the batch left the production plant and after did not find Cronobacter.

Cronobacter infection in infants will usually start with a fever and poor feeding, excessive crying, grunting while breathing or very low energy. Some may also have seizures. If your child develops these symptoms, take them to a doctor as soon as possible. Those more likely to get sick from Cronobacter infections include infants 2 months and younger, and those born prematurely or with weakened immune systems, such as those undergoing chemotherapy.

In the United States, baby formula made by Abbott Nutrition was linked to cronobacter infections in at least four babies in the country from 2021 to 2022, according to the U.S. Food and Drug Administration and Centers for Disease Control and Prevention. Two of the babies died and huge recalls of infant formula trigged a shortage of formula. Abbott says it did not find any contamination in its finished formula and continues to deny any link to the illnesses.

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There are two confirmed patients, but the FDA has not revealed their ages or states of residence.

This outbreak is separate from another outbreak of infections from Listeria monocytogenes announced Nov. 9 by the Centers for Disease Control and Prevention. In that outbreak there are 16 confirmed patients, one of whom has died. Also, one of the patients is a pregnant woman who lost her baby because of the infection. Thirteen of the patients have required hospitalization.

In the two-patient outbreak announced by the FDA, the agency has begun traceback efforts but has not reported what food or foods are being traced. On-site inspection and sample testing have not yet begun.

Ongoing outbreaks under investigation by the FDA

• For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. Recall information was updated on Oct. 28. It reported that seven patients from six different states have been confirmed ill. Five have been hospitalized, according to the CDC.
• In an outbreak involving E. coli O157:H7 from an unknown source, the patient count remains at 11. The FDA has initiated traceback efforts but has not revealed what food or foods are being traced.
• The FDA has begun traceback and sample collection in an outbreak of E. coli O121:H19 linked to frozen falafel sold at Aldi stores in 36 states. At least 20 people had been confirmed sick as of Oct. 7, the date of the most recent update. Sick people have been confirmed in Florida, Iowa, Kansas, Michigan, Ohio, and Wisconsin. The most recent illness onset was Sept. 13.
• An outbreak investigation continues for infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

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The fact that it’s happening may have as much to do with the Biden administration’s recognizing that the shortages exist, which is prompting these market responses:

— Grand Rapids-based Perrigo Company has committed $170 million to expand and strengthen its U.S. infant formula manufacturing to expand its supply of affordable infant formula. Its investment includes the purchase of Nestle’s Gateway infant formula plant in Eau Claire, WI, along with the U.S. and Canadian rights to the Good Start infant formula brand.

— New Zealand’s a2 Milk Company has obtained FDA approvals to supply its a2 Platinum infant milk formula to the U.S market. It’s the first company to receive FDA authorization to sell its infant formula in the U.S. since July despite the continued shortage. The New Zealand company plans to sell 1 million cans or the equivalent of 30 million bottles through June 2023.

— And last month, Abbott Nutrition’s Chairman and Chief Executive Officer, Robert Ford, committed his company to put up $500 million for a new infant formula manufacturing facility at a location yet to be determined.

Such developments are likely to add new infant formula sources and capacity to make the shortages go away. Included in Perrigo’s $170 million investment is a $60 million expansion of Gateway’s 29 million pounds per year production capacity by 7 million pounds.

The a2 Milk Company has sold fresh milk in the U.S. since 2015 with a 30 percent revenue increase making it one of the country’s fastest-growing premium milk brands in 27,000 stores. It is a major international supplier of infant formula. To meet FDA requirements, it’s met “different scoops, mixing instructions and labeling requirements.” It provides a new option for infants with digestive issues. Its a2 Platinum is free of the a1 protein known for causing gastric distress.

When market indicators were already showing signs of shortage, Abbott’s Michigan plant shut down last February and recalled its production, setting off a shortage that even Biden administration officials had to acknowledge. The shortage has since eased but it has not been eliminated.

Biden officials, led by FDA Commissioner Robert Califf, are taking responsibility for infant formulas being hard to get, while also blaming hoarding, supply chain bottlenecks, and fewer varieties being produced. Califf, who is the highest official charged with health with the shortage, sees supplies improving but not back to normal.

Abbott is again producing the popular Similac formula out of its Michigan plant, which was responsible for one-fifth of U.S formula production before the shortage.

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The Food and Drug Administration along with the Centers for Disease Control and Prevention and Florida state officials have been investigating an outbreak of infections from Listeria monocytogenes for months. The culprit was found to be ice cream from Big Olaf Creamery in Sarasota, FL.

As of Nov. 2 the CDC declared the outbreak over with 28 people sick, 27 hospitalized, one death, and one miscarriage. Health officials found the outbreak strain of Listeria in finished ice cream produced by Big Olaf and in equipment at its plant. The business was closed down by state officials.

In a different outbreak involving E. coli O157:H7 from an unknown source, the patient count has increased to 11, up from 10 reported a week ago. The Food and Drug Administration is continuing to investigate the outbreak. It has initiated traceback efforts but has not revealed what food or foods are being traced.

Other ongoing outbreak investigations

• For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. Recall information was updated on Oct. 28. It reported that seven patients from six different states have been confirmed ill. Five have been hospitalized, according to the CDC.
• The FDA has begun traceback and sample collection in an outbreak of E. coli O121:H19 linked to frozen falafel sold at Aldi stores in 36 states. At least 20 people had been confirmed sick as of Oct. 7. Sick people have been confirmed in Florida, Iowa, Kansas, Michigan, Ohio, and Wisconsin. The most recent illness onset was Sept. 13.
• An outbreak of infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

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The products included in the recall were manufactured at the Columbus, Ohio, manufacturing facility.

These products are being recalled because some bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur.

Abbott is continuing production of Similac 2-ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers’ offices on a different production line. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout the global manufacturing network.

The products included in the recall were distributed primarily to hospitals and to some doctors’ offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago.

If a product is included in the recall, do not use the product. To identify if your product is included, please visit similacrecall.com to view a list of impacted lot numbers or use the lot number checker on the webpage.

For questions, please contact Abbott’s Consumer Relations hotlines below in the country where you received product:

• U.S.: +1-800-986-8540
• Puerto Rico: +1-787-622-5454
• Barbados: 246-417-0777
• Bermuda: 279-5568
• Canada: 1-855-733-4201
• Colombia: 1-800-518-9379
• Curacao: 737-2222 Ext. 235, 205
• Dominican Republic: +1-849-200-1564
• Haiti: 868-687-0223
• Jamaica: 876-927-7098
• Panama: 800-0410
• St. Croix: 1(340) 690-7222
• St. Thomas: 1(340) 690-7222
• Trinidad & Tobago: 868-687-0223

On Wednesday the Food and Drug Administration announced a new Salmonella Litchfield outbreak that has sickened at least 28 patients. The source of the pathogen has not yet been identified.

In its outbreak announcement, the FDA did not indicate how old the patients are or where they live. The agency also did not report whether any patients have been hospitalized.

As of Wednesday evening, the Centers for Disease Control and Prevention had not posted any information about the outbreak. This is not unusual because the CDC generally waits until a specific pathogen source has been found. 

The FDA has initiated traceback efforts but has not reported what food or foods are being traced.

The agency has closed its investigation of an outbreak of infections caused by Salmonella Mississippi. The outbreak has been declared over without a source of the pathogen being determined. The FDA first posted the outbreak on Aug. 31. It reported that at least 103 patients were confirmed infected. The agency conducted traceback but did not report what food or foods were traced.

A Listeria monocytogenes outbreak with six patients continues. Traceback efforts have begun but the FDA is not saying what food or foods are being traced. The cause of the outbreak remains unknown. The FDA has not revealed the ages of the patients or where the patients live.

Ongoing outbreak investigations

• The patient count in an outbreak caused by Salmonella Mississippi remains steady at 103. The agency has not made public where the patients live or their ages. The FDA has not identified a source of the pathogen but has initiated traceback efforts. The agency has not reported what food or foods are being traced.
• For a Salmonella Senftenberg outbreak from a not yet identified food, the patient count is steady at 30. Traceback has begun but FDA has not reported what is being traced.
• For a Salmonella Typhimurium outbreak from a not yet identified food, the patient count has increased to 86, up from 84 reported a week ago. Traceback, on-site inspection and sample analysis have been initiated, but the FDA has not reported what is being traced or tested or where the inspection is taking place.
• For a Cyclospora outbreak, the patient count is steady at 81. Traceback has begun but the FDA has not reported what is being traced. Sample collection and analysis has been initiated and an on-site inspection has been initiated.
• For another Cyclospora outbreak, the patient count has remained steady at 42. Traceback has begun but the FDA has not reported what is being traced. Similarly, sample testing has begun but the agency has not reported what is being tested. 
• An investigation related to adverse effects associated with Daily Harvest brand frozen Leeks & Lentils Crumbles is ongoing. The company has received more than 470 complaints of illnesses and as of its most recent report on Sept. 15 the FDA had received 386 complaints. Some of the patients have gone into liver failure and at least 25 have had to have their gallbladders removed. The FDA is working on traceback efforts and has begun on-site inspection and product testing. Some testing has revealed that tara flour is an ingredient unique to the Daily Harvest crumbles product and could be related to the illnesses.
• In an ongoing outbreak of infections caused by E. coli O157:H7 the FDA has initiated sample collection and analysis. The outbreak, reported by the CDC as being linked to lettuce on Wendy’s sandwiches, has sickened at least 84 people. The four-state outbreak has sickened more people according to the state counts, but all of the reports have not reached the CDC. Wendy’s has stopped serving the romaine-iceberg lettuce hybrid on sandwiches in several states, according to a statement from the company.
• The FDA is conducting an on-site inspection at Big Olaf Creamery in Florida, which has been deemed to be behind an 11-state outbreak of Listeria infections. The state of Florida closed the business several weeks ago after tests found multiple places of contamination with Listeria monocytogenes in the plant. Testing also showed Listeria in 16 of 17 flavors of the company’s ice cream. At last count, the outbreak had sickened 25 patients with one having died. A pregnant woman also miscarried. Twenty-four of the patients have required hospitalization.
• An outbreak of infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

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For the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S. Department of Health and Human Services and the U.S. Department of Agriculture, to expand consumer access to infant formula products, while also ensuring that these products meet the agency’s safety, nutrition and quality standards. This has been no small undertaking. Years of consolidation in the infant formula industry and concerning food safety processes and general procedures at some of the facilities producing these products have resulted in a fragile supply chain that is susceptible to production disruptions when quality issues are identified. 

Earlier this year I asked Dr. Steven Solomon, director of the Center for Veterinary Medicine, to conduct a top-down review of agency activities and decision-making related to the shutdown of Abbott’s Sturgis, Michigan, infant formula facility in February 2022. Yesterday, Dr. Solomon released the results of the review in a 10-page report, which includes information gleaned from interviews with FDA staff directly involved in the agency’s response to infant formula shortages as a result of the Sturgis facility closure. I agree with the findings and recommendations identified in the report, but it is important to note that I have also requested a broader and more comprehensive evaluation of the FDA’s Foods Program. This evaluation is being done by an external group led by Dr. Jane Henney and supported by the Reagan-Udall Foundation that will review various aspects of the Foods Program, including structure, function, funding and leadership. 

The report released yesterday highlights detailed findings and recommendations that will support the agency’s ongoing efforts to ensure that our most vulnerable population has consistent access to infant and specialty formula products in the future. Importantly, it also identifies the need for additional resources and authorities that will ensure the agency can fulfill our consumer protection role and gain important visibility into the supply chain with the aim of preventing these issues in the future. 

Based on some of the findings in the report, we don’t need to wait for the broader Reagan-Udall Foundation evaluation to begin implementing some changes. The agency has already updated some existing processes and procedures that will allow the agency to respond more quickly during a public health emergency. Immediate changes that we’ve been able to implement include improving our emergency response structure and streamlining the ways in which the public can contact the agency to report concerns with food products. We have also developed a sophisticated data system to track production, distribution and purchase of infant formula. There is more work to do, but this is a start. 

The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to “do the right thing” without intervention. While domestic infant formula manufacturers have stepped up to meet the call to increase their production capacity and are working diligently, the long-term resiliency of the infant formula supply chain will rely on greater diversification of manufacturers, including new entrants to the U.S. marketplace, investment in new manufacturing facilities by infant formula producers and a commitment by these companies to consistently and continuously adhere to the FDA’s quality and safety standards. Ultimately, these combined approaches will protect the most vulnerable individuals. 

I encourage those who have an interest in strengthening the U.S. food supply and supporting the agency’s ongoing efforts to read this report. 

We recognize the impact the formula shortages have had on parents, caregivers and the children and individuals who rely on these products. Rest assured that we are committed to implementing the necessary changes to help us avoid future supply shortages and ensure parents and caregivers have access to safe and nutritious infant formula whenever and wherever they need it.

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Early this year, Abbott initiated a large recall of some of its infant formula products and closed its Michigan plant in February after reports of serious bacterial infections in infants. According to the FDA, there has been a total of five infants with cronobacter infections resulting in hospitalization and three deaths connected to Abbott formula products produced at its Michigan plant.

The FDA has received 129 complaints linked to Abbott formula products, including 119 since the product recall.

The recall and closure of the plant sparked a shortage of infant formula that caused an interruption in supplies of more than 70 percent, according to Datasembly, which tracks retail data.

The current recall was initiated on Aug. 16 and is ongoing. It was posted by the FDA on Sept. 7. The product was distributed in Michigan and Ohio.

Recalled products:

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