Infant Formula Recalls and Shortages: Past Impact and A Look to the Future

By: Caroline Steele, MS, RD, IBCLC, FAND, Clinical Consultant, Timeless Medical Systems, and Suzanne Smith, MS, RD, LDN, IBCLC

The material presented in this blog represents the opinion of the author(s) and not necessarily the views of Synova Associates. Synova Associates does not endorse any specific products or organizations but strives to connect its industry partners with leaders interested in product/educational innovation.

Infant formula recalls are not new.  After the omission of sodium chloride by a formula manufacturer resulted in injury to a substantial number of infants in 1978, regulatory control by the U.S. Food and Drug Administration (FDA) over the manufacture and formulation of infant formulas within the U.S. was increased1  The Infant Formula Act, enacted in 1980 and amended in 1986, requires infant formula manufacturers to ensure that infant formulas sold in the U.S. are produced safely, contain proper nutrients, and are accurately labeled.1  In addition, the FDA requires that formulas be recalled if determined to present a risk to health.1  Formula manufacturers must have specific processes in place to recall any product deemed to be adulterated or mislabeled.1  In turn, healthcare organizations must also have formula recall procedures in place to identify and remove products based on lot numbers.1  Such procedures should include1:

  • A method for identifying all recalled products
    • Products in-stock, not yet used
    • Products used in preparation, but not yet fed to patients
    • Products fed to patients
    • Samples, gift packs, or other products provided to inpatients to take home or to outpatients
  • Notification of appropriate staff
  • A system for providing follow up to impacted patients
  • Detailed reporting, documentation, and retention of records

One area of concern with regards to infant formulas is bacterial contamination, particularly for powdered infant formulas which are not sterile.  Cronobacter is a gram-negative bacteria found in the environment (such as water and soil) which can be present in foods, including powdered infant formula.1  Mortality rates for infants contracting Cronobacter are high (ranging from 50-80%), particularly for preterm and immunocompromised infants.1,3  Salmonella bacteria is the most common cause of food-borne illness in the U.S. and outbreaks in infants have been reported.4  Because of the morbidity and mortality rates of infants exposed to Cronobacter and Salmonella bacteria, the FDA updated infant formula manufacture regulations in 2014 to require manufacturers to test powdered formulas for both of these organisms before a product may be released to the marketplace.1

The Impact of the 2022 Infant Formula Recalls

Complaints received by the U.S. Food and Drug Administration in fall of 2021 ultimately led to a February 2022 consumer warning from the FDA and a manufacturer voluntary recall of certain infant formula products.  Of particular concern were three reports of infant Cronobacter illness including one death and one report of Salmonella illness that were all tied to one manufacturing plant.5  Because the 2022 infant formula recalls involved many products and resulted in the temporary closure of a major manufacturing plant in the U.S., the impact was much greater than that of other recalls in recent decades.

These recalls had significant impact on healthcare organizations and clinicians providing care for the most fragile patients.  Clinicians needed to efficiently identify and remove all recalled products from the facility as well as identify any patients who had already received any of the recalled products so that follow up and monitoring could be initiated.  One of the challenges many facilities faced was identifying patients who were no longer hospitalized that had received any of the recalled products and/or those who had received samples of these products upon hospital discharge.

Because of lingering supply chain issues and import restrictions resulting from the COVID-19 pandemic and the fact that the recall came without warning, hospitals and consumers were left with significant shortages.  Many clinicians were forced to base clinical decisions on what products were available rather than the most clinically appropriate product.  In some instances, clinicians were forced to transition patients back to parenteral nutrition resulting in increased hospitalizations and length of stay.  Consumers struggled to find options to feed their infants and medically fragile children.  Out-of-stock rates for infant formulas in January 2022 were around 3.3%; this jumped to 48% by May 15 and to 74% by May 22.6,7  By the end of May 2022, one in five states were at 90% out-of-stock levels, creating significant problems for families.7  Unfortunately, this led to some parents and caregivers choosing to use homemade formula recipes (which were typically inadequate in nutrients), introducing cow’s milk before developmentally appropriate, or watering down formulas to stretch their supply.  Inadequate nutrition from inappropriately prepared formulas resulted in reported cases where patients presented with dehydration, malnutrition, and poor growth.8

In addition to harm caused to infants and children who could not access appropriate products, the formula shortages also created parental stress and anxiety, created significant work for clinicians, and put a strain on the healthcare system as well as community resources.

What the Future Holds

While most of the impact has been negative, the FDA has used this as an opportunity to make operational improvements in the area of infant/specialty formulas.  Operational improvements include9:

  • Revised internal consumer complaint procedure to strengthen the escalation process to senior officials, including rapid escalation of reports of serious illness or death to the highest levels of the agency and specifically addresses triggers for any hospitalization or death involving an infant
  • Improved required training for investigators to ensure every infant formula inspection thoroughly meets goals and focuses on the most critical areas of the manufacturing process
  • Expanded capacity to analyze samples of infant formula and enhanced system for prioritizing sample analysis
  • Improved routine surveillance inspections and sampling of infant formula and medical food facilities
  • Increased staffing to meet demands

In addition, the Food and Drug Omnibus Reform Act of 2022 was enacted in December 2022 which created a new Office of Critical Foods.9  This office is responsible for oversight, coordination, and activities related to critical foods (defined as infant formula and medical foods) and seeks to:9

  • Expedite review of infant formula submissions in the event of shortages
  • Mandate that manufacturers notify the FDA of any discontinuance or interruption likely to disrupt the infant formula supply
  • Require manufacturers to create redundancy risk management plans to identify and evaluate risks for infant formula shortages and ways to mitigate such risks
  • Work with other agencies to create a National Strategy on Infant Formula to address infant formula supply chain resiliency and provide education and communication for parents and caregivers

As of August 2023, the FDA has named James Jones as Deputy Commissioner for Human Foods who will be responsible for setting priorities pertaining to food safety and medical foods.10

The events of 2022 have also led many hospitals to evaluate their own processes for mitigating risk, including their ability to identify recalled products within their facilities, provide appropriate patient follow up, and ensure proper documentation in the event of an unannounced FDA site visit.  Increasingly more hospital leaders have reported FDA site visits to discuss handling of formula recalls.11  Many hospitals are able to identify which lot numbers came into the facility but are unable to pinpoint which patients actually received the recalled lot number (particularly if the patient has already been discharged).  Organizations should seek to implement processes where lot numbers are tracked throughout the infant feeding process to ensure that all products may be accounted for in the event of a recall.  Such processes may be manual (such as manually tracking lot numbers and performing 2-person verification of lot numbers against lists of recalled lots) or automated through bar code scanning technology capable of tracking lot numbers.  Having such robust systems in place improves patient safety by reducing the risk of a patient receiving a recalled product and provides the ability to track data in the event of a future recall.

The Timeless Medical Systems bar code scanning system allows hospitals to scan all products being used for infant feeding.  By scanning each item, the system confirms use of the correct fortifier or formula and prevents the use of a recalled product.  In addition, lot numbers are tracked in the event of a future recall to ensure timely follow-up and documentation in the event of a post-recall audit.  If you are interested in learning more about the Timeless Medical bar code scanning system, please contact sales@timelessmedical.com.

References

  1. Steele C, Collins E, eds. Infant & Pediatric Feedings:  Guidelines for Preparation of Human Milk and Formula in Health Care Facilities.  Chicago, IL.  Academy of Nutrition & Dietetics, 2019.
  2. US Food and Drug Administration. Infant Formula.  https://www.fda.gov/food/resources-you-food/infant-formula#:~:text=In%202022%2C%20safety%20concerns%20with,Nutrition%20facility%20in%20Sturgis%2C%20Michigan.  Accessed August 29, 2023.
  3. Bai Y, et al. Survival and Environmental Stress Resistance of Cronobacter sakazakii Exposed to Vacuum or Air Packaging and Stored at Different Temperatures.  Frontiers in Microbiology.  Feb 2019; volume 10.https://doi.org/10.3389/fmicb.2019.00303.
  4. World Health Organization. Safe Preparation, Storage and Handling of Powdered Infant Formula: Guidelines.  https://www.who.int/publications/i/item/9789241595414.  Accessed August 29, 2023.
  5. Food Safety News. Urgent Warning Issued About Infant Formula and Cronobacter, Salmonella  February 17, 2022.  https://www.foodsafetynews.com/2022/02/urgent-warning-issued-about-infant-formula-and-cronobacter-salmonella-infections/#:~:text=The%20company%20has%20initiated%20a%20recall.%20All%20of,case%2C%20according%20to%20the%20Food%20and%20Drug%20Administration.  Accessed August 29, 2023.
  6. Datasembly Releases Latest Numbers on Baby Formula.  Published May 10, 2022.  https://datasembly.com/news/datasembly-releases-latest-numbers-on-baby-formula/. Accessed August 29, 2023.
  7. Paris M. One in Five US States Is 90% Out of Baby Formula.  Published June 2, 2022.   https://www.bloomberg.com/news/articles/2022-06-02/us-baby-formula-shortages-hit-74-despite-biden-action.  Accessed Aug 29, 2023.
  8. Harvard School of Public Health. Navigating Infant Formula Shortages. https://www.hsph.harvard.edu/nutritionsource/2022/05/17/infant-formula-shortage/  Accessed August 29, 2023.
  9. S. Food and Drug Administration. Status Update on FDA’s Infant Formula Response Activities.  Published March 2023.  https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information/status-update-fdas-infant-formula-response-activities#:~:text=The%20FDA%20is%20currently%20designing%20implementation%20plans%20for,is%20defined%20as%20infant%20formula%20and%20medical%20foods.  Accessed August 29, 2023.
  10. Doering C. FDA Names Former Environmental Official as Top Food Regulator.  Published August 23, 2023.  https://www.fooddive.com/news/fda-food-regulator-baby-formula-shortage/691665/.  Accessed August 29, 2023.
  11. Steele C, Bixby C. Bar Code Scanning of Human Milk and Enteral Formulas Improves Efficiency and Patient Safety:  A 7-Year Review.  Nutr in Clin Pract.  2022;37(4):921-928. https://doi.org/10.1002/ncp.10765.

Learn more about Timeless Medical Systems

The Timeless Medical Systems bar code scanning system allows hospitals to scan all products being used for infant feeding.  By scanning each item, the system confirms use of the correct fortifier or formula and prevents the use of a recalled product.  In addition, lot numbers are tracked in the event of a future recall to ensure timely follow up and documentation in the event of a post-recall audit.  If you are interested in learning more about the Timeless Medical bar code scanning system, please contact sales@timelessmedical.com.