FDA has released an updated infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program is designed to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance as part of its effort to strengthen the safety, resiliency, and oversight of the formula industry.

In September 2022, FDA released its internal evaluation of the ifant formula response, which recommended that the agency review and update its compliance program to ensure it reflected the latest science on Cronobacter.

The agency says the updated program builds on lessons learned over the last several years to expand on its approaches for inspections, sampling, laboratory analysis, and imported formula products. For example, updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. The compliance program provides instruction for FDA notification should a sample test positive for Cronobacter or Salmonella.

The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program.

Additional background on the risks associated with Salmonella and Cronobacter in formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. In addition, it further elaborates on new related requirements included in the Food and Drug Omnibus Reform Act of 2022.

All updates related to the oversight of infant formula can be found on FDA’s infant formula webpage.

The post FDA Updates Infant Formula Compliance Program appeared first on Food Quality & Safety.

Infant formula safety checks can be improved with stratified sampling, according to a new study from the Department of Food Science and Human Nutrition at the University of Illinois in Urbana-Champaign.

“Our lab had a prior project simulating bulk product sampling to improve food safety sampling plans for detecting aflatoxin in corn in bins and bacterial pathogens on leafy greens produce in fields,” Minho Kim, a PhD student and the study’s lead author, tells Food Quality & Safety. “We then wanted to adapt that simulation to bulk products, like powdered products.”

The authors found there was data available for Cronobacter in powdered infant formula produced in Europe in the 2010s, and chose to work on that problem. The subsequent outbreak and recall in the U.S. then provided additional relevance to the work.

Stratified random sampling is a pattern where you first pick an interval of time, e.g., every 10 minutes of production, and then take a sample randomly during each of those production intervals. “Sampling and testing play an important role in the HACCP plan by monitoring if the system is operating properly,” Kim says. “Thus, sampling plans should have enough power to detect pathogens of concern. There is an existing sampling guideline for testing Cronobacter provided by CODEX Alimentarius for powdered infant formula (30 samples of 10g); however, the sampling plan might not always work the same under different contamination profiles or production scales.”

Therefore, the researchers developed a web application for the sampling simulation tool that stakeholders can use to explore the power of sampling plans in different production lot and contamination profiles.

“Our major findings include that existing sampling guideline for detecting Cronobacter spp. in powdered infant formula products will be powerful enough to detect the contamination observed in a previously studied recalled batch from Europe, but not the non-recalled batch profile,” Kim adds. “By simulating different sampling plans with the recalled and non-recalled profiles, we were able to see the trend that taking more samples and adopting the sampling pattern with stratification help increase power to detect the contamination.”

A future discussion, he says, will be to investigate opportunities to reduce this residual risk in the powdered infant formula products. “A few babies getting sick from each outbreak cluster may represent the chance of this residual risk being problematic,” Kim adds. “One possible strategy is to use more active labeling on incorporating hot water reconstitution, like other countries [do]. A risk assessment done by WHO/FAO in 2006 showed that using 70°C water for reconstitution can significantly reduce the risk by inactivating Cronobacter sakazakii without damaging essential nutrients for babies. However, we heard about concerns from doctors in France where babies were coming to the hospital with burned throats. We hope more discussions about using hot water reconstitution between experts can lead to reduced Cronobacter illnesses.”

The post Researchers Propose Sampling Plan to Improve Infant Formula Safety appeared first on Food Quality & Safety.

FDA is no longer accepting requests for enforcement discretion for certain requirements that apply to infant formula, the agency announced in November, based on its temporary guidance released in May 2022 and in effect through earlier this week. Now, FDA has said it will provide a pathway for formula manufacturers to continue marketing these products while they work toward fully meeting FDA requirements. “Under the new guidance, the period of enforcement discretion for these products is being extended until January 6, 2023, with further extensions possible for firms that express interest in and take steps toward remaining on the U.S. market,” FDA said in a statement.

For background, in May 2022, FDA issued new guidance to manufacturers of infant formula as a way to temporarily exercise enforcement discretion on certain requirements that applied to infant formula, an action the agency hoped would help increase the supply of infant formula in the United States. The need for increased supply of formula became even more pressing after two major occurrences—a February 2022 voluntary recall by Abbott Nutrition due to formula contaminated with Cronobacter sakazakii at the company’s Sturgis, Michigan, facility, and increased strains on supply chains experienced during the COVID-19 pandemic.

Additionally, on November 15, FDA announced plans to create a dedicated team of investigators for infant formula production as part of its ongoing strategy to prevent contamination of any product. Part of the agency’s plan would be to realign staff across the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs in hopes of better supporting the regulatory oversight of infant formula.

FDA has also released a proposed rule that Cronobacter infections be added to CDC’s list of national notifiable diseases, an action that would require physicians to report cases of infection to public health officials.

Other actions FDA is considering include reevaluating testing requirements to enhance safety of finished infant formula products; developing and improving consumer education on how to safely prepare and store infant formula; and providing added training for staff who inspect infant formula production facilities.

The post FDA Announces Strategy to Increase Infant Formula Supply, Safety appeared first on Food Quality & Safety.

While the infant formula recall ended in June 2022, supplies currently still remain below normal levels. Robert M. Califf, MD, FDA commissioner, requested that an internal agency review of the situation be conducted, and assigned the task to Steven M. Solomon DVM, MPH, director of FDA’s Center for Veterinary Medicine and a 32-year veteran of the agency, including 23 years in the agency’s Office of Regulatory Affairs (ORA), which, among other functions, houses FDA’s inspectional programs.

Dr. Solomon was charged with identifying the challenges encountered in addressing the circumstances that led to a nationwide shortage of infant formulas that serve as the sole source of nutrition for many infants and for people with certain metabolic conditions that require specialty formulas. He was also tasked with providing recommendations to prevent similar events in the future.

The evaluation team, led by Dr. Solomon, conducted 43 interviews with a total of 61 employees. The employees included many with a lengthy history with the agency. The findings of this internal evaluation were published on September 20, and identified five major areas of need in the agency:

• Modern information technology that allows for the access and exchange of data in real time to all the people involved in response;
• Sufficient staffing, training, equipment, and regulatory authorities to fulfill the FDA’s mission;
• Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously;
• Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how this translates into appropriate control measures and oversight; and
• Assessment of the infant formula industry, its preventive controls, food safety culture, and preparedness to respond to events.

Some of these findings will come as no surprise to most. FDA has operated shorthanded and in need of additional resources for many years. There were 15 specific findings in the report that shed more light on these concerns, with emphasis on findings 8 and 9 to address some of the resource shortages:

Finding 8: The FDA’s foods workforce maintains expertise across the 80% of the food supply regulated by FDA. However, funding limitations have stalled the growth of the foods program, hindering the agency’s ability to keep pace with the growing workload, increased complexity of supply chains, and scientific and technological changes in food manufacturing. FDA’s shortage of investigators, subject matter experts, and compliance personnel with infant formula expertise hinders the agency’s ability to comprehensively inspect infant formula manufacturing facilities, review and evaluate new products, and respond to product concerns or complaints in a rapid manner.

Recommendation: FDA should evaluate its workforce needs related to infant formula regulation and oversight and utilize the appropriations process to help secure the resources needed

Finding 9: The critical nature of infant formula products as a sole source of nutrition posed unique challenges to public health complicating compliance actions compared to typical food compliance actions. This incident required an unusual level of agency leadership involvement to assess and weigh risks associated with potential product contamination against risks of essential products being unavailable due to a shortage. Typically, product safety is the primary driver during food safety incidents and product availability does not impact compliance actions.

Recommendation: FDA should review its compliance procedures for critical food products and determine whether there is a need to clarify roles and responsibilities, consider the need for a decision matrix, and consider alternative activities to minimize product availability concerns when the product is a sole source of nutrition.

The post FDA Report on Infant Formula Shortage Admits Agency Shortfalls appeared first on Food Quality & Safety.

On February 17, 2022, FDA issued a warning to consumers that a variety of powdered infant formulas produced at Abbott Nutrition’s Sturgis, Mich., facility, may not be safe for consumption. The FDA notice came following reports of illness in four infants, which may have resulted in at least two deaths. Abbott initiated a voluntary recall of products and lot numbers identified on the same day, but denies culpability.

An FDA investigation discovered that multiple lots of formula produced at the facility were adulterated due to the unsanitary conditions found in the facility. Testing of environmental swabs and product samples linked the facility to a Cronobacter sakazakii outbreak. The agency also determined that the plant was in violation of current good manufacturing practice requirements, so Abbott temporarily closed the facility to address the corrective actions needed.

The plant closure has reportedly resulted in more than 40% of the U.S. supply of baby formula being sold out nationwide, with retailers rationing existing inventory. It’s been almost four months, and the shortage remains, with desperate parents waiting for a solution. It’s been estimated that millions of babies are currently not receiving the formula they need due to the shortage.

What’s Been Done?

During this time, FDA has leveraged its authority to bolster the supply of products that serve as the sole source of nutrition for many infants, while ensuring that the infant formula can be used safely and that it provides adequate nutrition.

In mid-May, the President Biden invoked the Defense Production Act, which looked to streamline the production and shipping of formula components and ingredients to factories to ensure production increases back to safe levels as quickly as possible. One measure taken to alleviate the growing shortage was to launch Operation Fly Formula, a plan designed to speed up the import of infant formula. FDA has also issued a Draft Guidance Document allowing temporary enforcement discretion on certain formulas and has engaged with global producers on the new expedited importation approval procedures to further bolster supply.

Kendamil, a British baby formula company that has yet to gain approval for sale in the United States, was one of the first to respond to the agency’s request to participate, reaching out to FDA director Robert Calliff offering to help. A few days later, FDA released its guidance and Kendamil pulled together a 100-page report that was submitted to FDA in three days. “The FDA worked long hours with us … to process the approval as quickly as possible,” Will McMahon, co-founder of Kendamil, tells Food Quality & Safety. “Given our formula is already nutritionally compliant with FDA standards and the agency was familiar with our quality control processes, both parties were able to work effectively together.”

Kendamil has pledged two million cans of infant formula—the equivalent of at least 54 million 8-ounce bottles, to the United States over the next six months.

The first shipments as part of Operation Fly Formula will began arriving June 9 on flights donated by United Airlines. These flights over a 10-day period will contain more than 300,000 pounds—or approximately 3.7 million 8-ounce bottle equivalents—of Kendamil infant formula. “Everyone from the FDA to HHS to Customs and Border Patrol have all been extremely responsive and treating this with the urgency it requires, working long hours, through the weekends, to get this over the line,” McMahon adds.

Additional Measures

Other actions taken by FDA include expedited review of notifications of manufacturing changes that will help increase supply; exercising enforcement discretion on minor labeling issues to help increase volume as quickly as possible; and allowing Abbott Nutrition to produce formula for individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas that have been on hold at its Sturgis facility.

FDA expects that the measures it’s taken, along with the June 4 reopening of the Sturgis facility will alleviate the shortage. “We will ramp up production as quickly as we can while meeting all [FDA] requirements,” an Abbott spokesperson tells Food Quality & Safety. “We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America.”

Additionally, USDA has announced that, under the Access to Baby Formula Act signed in late May, it is offering waivers to ensure that families can use benefits from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to purchase formula outside what is typically designated for the program.

Investigation

The U.S. Department of Health and Human Services’ Office of Inspector General has launched an audit into FDA’s overall response to the crisis, examining whether it upheld its duty to safeguard the nation’s food supply and ensure that all ingredients are safe. FDA has stated it will cooperate fully with the watchdog’s review.

The post The Infant Formula Crisis: Where We Are Now appeared first on Food Quality & Safety.

On February 28, Abbott Laboratories voluntarily recalled additional cases of Similac PM 60/40 produced at its Sturgis, Mich., facility, after an infant who was exposed to the powdered infant formula died, FDA has reported. The agency noted that the child consumed Similac PM 60/40 and contracted a Cronobacter sakazakii infection, noting the formula may have been a contributing cause of death.  

Only 10 days earlier, Abbott recalled certain Alimentum, Similac, and EleCare baby formulas made at the same facility after complaints surfaced about bacterial infections in infants who consumed the products. It also impacted digestively compromised individuals who rely on these products for their entire nutritional intake

As part of an ongoing investigation by FDA and the Centers for Disease Control and Prevention (CDC), four reports of Cronobacter sakazakii infections in infants have come to light, with another complaint of a Salmonella Newport infection in an infant. All five illnesses resulted in hospitalization, and two of the patients died. The FDA and CDC are continuing the investigation and the cause of the infants’ infections has not been determined.

The infant in the most recent death reportedly consumed Abbott Nutrition’s Similac PM 60/40 product with the lot code 27032K800. FDA warns that other Abbott products should not be used if the first two digits of the lot code are 22 through 37; the code on the container contains K8, SH, or Z2; and the expiration date is April 1, 2022, or later.

Abbott released a statement explaining that it conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis and testing for Cronobacter sakazakii prior to release. The company says it found evidence of the bacteria at the Michigan plant in non-product contact areas, but that no distributed product tested positive for the bacteria’s presence.

FDA noted that the recalled Similac PM 60/40 cans and cases have been distributed to the U.S. and Israel, while the original recall impacts Alimentum and EleCare formulas in the U.K. as well. None of the recalls involve liquid formula products, so FDA notes that consumers may continue to use those products and any not included in the recall.

FDA is continuing to investigate. Requests for comment from Abbott Nutrition were not immediately returned to Food Quality & Safety.

The post Second Death Linked to Powdered Infant Formula appeared first on Food Quality & Safety.

FDA, CDC, and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, Mich., facility, which were received from September 20, 2021 to January 11, 2022. All cases are reported to have consumed powdered infant formulas produced from the facility.

These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized, and Cronobacter may have contributed to a death in one case.

FDA has initiated an onsite inspection at the facility. Findings to date include several positive Cronobacter results from environmental samples taken by FDA, and adverse inspectional observations by FDA investigators. A review of the firm’s internal records also indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.

On February 17, 2022, Abbott Nutrition initiated a voluntary recall of certain powdered infant formulas. Products made at the Sturgis facility can be found across the United States and were likely also exported to other countries. Canadian health officials have also issued a recall.

FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the seven- to nine-digit code and expiration date on the bottom of the package. Products are included in the recall if they have all three items below:

• The first two digits of the code are 22 through 37;
• The code on the container contains K8, SH, or Z2; and
• The expiration date is 4-1-2022 (APR 2022) or later.

Additional recall information is available on FDA’s website. Parents can also enter their product lot code on the company’s website to check if it is part of the recall. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available.

The post Abbott Nutrition Recalls Several Powdered Infant Formulas Due to Bacterial Contamination appeared first on Food Quality & Safety.