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Nara Organics Formula Recall: Infant Botulism Cases Rise to 4, FDA Confirms Pathogen in Open Can
Four infants have now been hospitalized with confirmed botulism linked to recalled Nara Organics Whole Milk Organic Powdered Infant Formula, according to the most recent update from the FDA and CDC, issued July 6, 2026.

All four infants required hospitalization and were treated with BabyBIG — the only FDA-approved treatment for infant botulism, available exclusively through the California Department of Public Health’s Infant Botulism Treatment and Prevention Program (IBTPP). No deaths have been reported.

Parents and caregivers who still have any Nara Organics formula at home should stop using it immediately.

Why This Matters

Infant botulism is a rare but potentially fatal illness that occurs in babies — primarily those under 12 months of age — when Clostridium botulinum spores are ingested and produce a toxin inside the infant’s immature digestive system. The toxin attacks the nervous system, causing progressive muscle weakness that can lead to breathing failure if untreated.

Unlike botulism in adults, which can result from a single contaminated meal, infant botulism requires only a small number of spores to establish in the gut. That makes even trace contamination in a formula used repeatedly across weeks of feeding a potentially serious risk.

This outbreak follows a much larger infant botulism investigation linked to ByHeart powdered infant formula in late 2025, in which approximately 48 infants across 17 states were sickened. Two formula-linked botulism outbreaks within less than a year has raised urgent questions about manufacturing safety protocols and oversight across both domestic and international production facilities.

What We Know So Far

The four confirmed cases involve male infants who fell ill between April and May 2026. They ranged in age from approximately 68 to 153 days old at the time of illness onset, according to reporting from Food Safety Magazine. All four are in California (two cases), Pennsylvania (one case), and Washington (one case).

Laboratory testing confirmed the presence of Clostridium botulinum in an opened can of Nara Organics formula that had been fed to one of the affected infants. Testing of an unopened can from the same production lot is still underway; results are expected in the coming weeks, per the FDA.

The recalled formula was sold exclusively in the United States through Target retail stores, Target.com, and Nara.com between July 2025 and June 2026. Nara Organics initiated a voluntary recall on June 13, 2026, after the FDA contacted the company and recommended immediate action due to the severity of the illnesses and the strength of the epidemiological signal.

Nara Organics’ formula is manufactured in Germany by Milchwerke Mittelelbe GmbH (Elb-Milch), a subsidiary of the Krüger Group. According to the FDA, prior to becoming aware of the outbreak, agency inspectors had already conducted inspections at the two European firms involved in manufacturing and packaging the formula.

Where the Risk Is Highest

The formula was distributed nationally, meaning families in every U.S. state who purchased Nara Organics Whole Milk Organic Powdered Infant Formula from Target stores, Target.com, or Nara.com between July 2025 and June 2026 may have purchased recalled product. All lots currently on the market were included in the recall.

The three specific lots consumed by affected infants are lot codes 709125280E14F2, 709125288E14F2, and 708125174E14F2, according to Nara Organics’ recall notice. However, given that the recall covers all lots, parents should not limit their concern to these lot numbers — any Nara Organics formula purchased during the distribution window should be treated as recalled.

The Washington State Department of Health has confirmed a case in Thurston County. California has confirmed two cases. Pennsylvania has confirmed one case.

What Doctors and Public Health Officials Say

The FDA issued a direct warning in connection with the July 6 update: “Parents and caregivers should stop using Nara Organics Whole Milk Organic Infant Formula immediately,” the agency stated. “If your child is experiencing symptoms after consuming Nara Organics Whole Milk Organic Infant Formula, seek immediate health care.”

The CDC has stated clearly that botulism can be fatal and that any parent whose infant consumed the recalled formula and is showing symptoms should seek emergency care before contacting health authorities.

Dr. Wendy Schuchat, who has advised on prior infant botulism investigations, has noted that the rarity of this condition makes rapid recognition by parents and pediatricians critically important. “Infant botulism often starts with what looks like constipation or a tired baby — but it can escalate quickly,” she has said in previous guidance contexts. “Delayed recognition is the most dangerous factor.”

The IBTPP at the California Department of Public Health is available 24 hours a day, seven days a week, for physician case consultation at 510-231-7600. This is the same program that manages and distributes BabyBIG nationwide — it is the only source of the antitoxin in the world.

What the Evidence Shows — and What It Does Not

Laboratory confirmation of Clostridium botulinum in an opened can of the recalled formula fed directly to one of the affected infants provides a strong direct link between the product and the illness. Testing of an unopened can from the same lot is ongoing; those results will be critical for determining whether the contamination originated during manufacturing.

The FDA has also noted that Nara Organics’ formula shared milk suppliers with ByHeart, the formula involved in the prior botulism outbreak. Specifically, both used milk supplied by Organic West Milk. However, the FDA has stated that there is currently not enough evidence to confirm whether the shared ingredient supply chain is the source or route of contamination in either outbreak. This connection is being actively investigated.

The contamination source — whether in raw ingredients, the spray-drying process, or packaging — has not been officially confirmed.

MedicalDaily Evidence Check
- Investigation type: Active multistate outbreak; active recall
- Confirmed cases: 4 infants hospitalized (as of July 6, 2026)
- Pathogen: Clostridium botulinum (confirmed in one opened formula can)
- States: California (2), Pennsylvania (1), Washington (1)
- Product: All lots of Nara Organics Whole Milk Organic Powdered Infant Formula
- What is confirmed: Four hospitalizations; pathogen detected in opened can; all lots recalled
- What is not confirmed: Contamination origin (manufacturing vs. ingredient supply); results of unopened can testing
- What readers should know: Stop using any Nara Organics formula immediately; watch for botulism symptoms for up to one month after last use
Who Faces the Greatest Risk?

Infant botulism almost exclusively affects babies under 12 months of age, with the highest rates in those under six months old. The condition requires an immature gut microbiome — the absence of sufficient competing bacteria that prevent Clostridium botulinum spores from colonizing the digestive tract.

Infants at greatest risk include:
- Babies currently consuming or recently fed Nara Organics formula
- Infants under six months old (highest vulnerability)
- Any infant whose parent or caregiver did not yet learn of the recall
No risk is associated with the recalled product for adults or older children. Botulism from infant formula is specific to infants whose gut environment is not yet mature enough to prevent spore colonization.

Symptoms and Warning Signs to Watch For

Parents who fed their infant any Nara Organics formula between July 2025 and June 2026 should watch for the following symptoms for up to one month after the last feeding:
- Constipation (often the first sign)
- Poor feeding or weak sucking
- Weak or altered cry
- Loss of head control
- Drooping eyelids
- Decreased facial expression
- Difficulty swallowing
- Breathing problems
In untreated cases, infant botulism causes a progressive, flaccid paralysis. Respiratory failure can occur and requires mechanical ventilation. Hospitalization typically lasts weeks.

Seek immediate emergency care if any of these symptoms appear. Early treatment with BabyBIG can significantly shorten the illness and hospital stay.

What You Can Do Now
- Stop using any Nara Organics Whole Milk Organic Powdered Infant Formula immediately. Do not feed it to your baby.
- Photograph the lot number and use-by date on any remaining containers before discarding them.
- Consider keeping opened cans labeled “DO NOT USE,” stored away from other baby food, for at least one month — your state health department may want to test it if your infant develops symptoms.
- Discard unopened cans. Customers who purchased from Nara.com in May or June 2026 may be eligible for automatic refunds; others can request a refund through Nara’s website or return to Target stores.
- Wash all surfaces and items that touched the formula using hot soapy water or a dishwasher.
- Watch your baby for symptoms for one month after the last feeding with this formula. Symptoms can take several weeks to appear.
- Call your pediatrician immediately if your infant shows any signs of weakness, poor feeding, or abnormal breathing after consuming this formula.
Cost and Access: What Patients Should Know

BabyBIG — botulism immune globulin intravenous (BIG-IV) — is the only FDA-approved treatment for infant botulism caused by toxin types A and B. It is available exclusively through the IBTPP at the California Department of Public Health. Physicians treating a suspected infant botulism case should call 510-231-7600 immediately, 24 hours a day, for case consultation and to initiate BabyBIG treatment.

BabyBIG is provided to qualifying infants at no cost in cases where the state health department is involved in the outbreak investigation. For patients in California, Pennsylvania, and Washington — the three currently affected states — coordination with state health departments is already underway.

The recall does not create a formula shortage. Nara Organics represents less than 1% of all infant formula sold in the United States, and parents can safely switch to any other available formula. Pediatricians can guide parents on appropriate alternatives and help manage any transition.

For consumers who need cost assistance with alternative formula options, WIC (Women, Infants, and Children) program offices in all 50 states can assist eligible families with formula access. Find your local WIC office at www.fns.usda.gov/wic.

What Happens Next

Laboratory testing of an unopened can from the affected lot is expected to yield results in the coming weeks. Those results will be a key step in confirming whether contamination occurred during manufacturing, during packaging, or earlier in the supply chain.

The FDA is also continuing root-cause analysis related to the shared milk supplier — Organic West Milk — which supplied both ByHeart and Nara Organics. Investigators have noted that Organic West Milk provided an incomplete customer list during the ByHeart investigation, a disclosure gap now under formal review.

Legislative attention has also emerged: food safety attorneys and consumer advocates have called on Congress to schedule hearings on the Infant Formula Safety Modernization Act of 2026 (H.R. 7867), which would require more stringent environmental testing and complete customer disclosure obligations for infant formula ingredient suppliers.

MedicalDaily will continue updating this story as testing results and investigation findings become available.

The Bottom Line

Four infants — all boys under five months old — have been hospitalized with confirmed botulism linked to a single recalled formula brand. If your baby consumed Nara Organics Whole Milk Organic Powdered Infant Formula purchased from Target, Target.com, or Nara.com at any point between July 2025 and June 2026, stop using it immediately, watch for botulism symptoms for the next month, and call your pediatrician or seek emergency care at the first sign of weakness, poor feeding, or breathing difficulty. This investigation is ongoing.
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July 10, 2026
Infant Formula Makers Were Required to Tell the FDA When Babies Died — Records Show They Never Did
When makers of infant formula learn that babies have become seriously ill or died after using their products, federal regulations require them to notify the FDA. But in a major investigative finding published July 2, 2026, KFF Health News revealed that the FDA has no record of a single such notification from any formula manufacturer going back more than 26 years.

That gap in the federal safety record is not because premature infants haven’t died. According to a KFF Health News analysis of federal data, approximately 2,300 newborns died from necrotizing enterocolitis (NEC) in the United States between 2017 and 2023 — roughly one per day. A wave of more than 1,700 lawsuits has alleged that formula made by Abbott (Similac) and Mead Johnson (Enfamil) caused or contributed to these deaths by triggering NEC in premature infants, and that manufacturers knew about the elevated risk without adequately warning parents or physicians.

Why This Matters

Federal regulations give infant formula manufacturers substantial discretion in deciding whether and when to notify the FDA that a product may have contributed to a serious adverse event. According to KFF Health News’s investigation, that discretion has translated to zero notifications — even as hundreds of lawsuits proceeded through the courts and testimony from company executives confirmed that internal records of adverse events existed and were investigated internally.

The practical consequence is significant: parents harmed by formula have been fighting Abbott and Mead Johnson in court, with no government notification system creating an independent safety record. Families who lose a premature infant to NEC are not informed that other families have reported the same outcome to the manufacturer. And the FDA — which does not pre-approve infant formula before it reaches the market — has had no formal mechanism to detect a pattern of harm tied to specific products.

What We Know So Far

From KFF Health News’s FOIA investigation published July 2, 2026, and court records cited in the report:
- Under the Freedom of Information Act, KFF Health News asked the FDA for all notifications from formula manufacturers since January 1, 2020. The agency’s Human Foods Program responded: “did not receive any.”
- KFF Health News extended the request to January 1, 2000. The FDA responded: “After a diligent search of our files, we did not locate any responsive records.”
- John Wallingford, a paid expert witness for Abbott, testified in Missouri court in October 2024 that “Abbott had never reported a single death under any regulation for preterm infant formula.”
- Courtney Colombo, who identified herself in a March 2024 deposition as Abbott’s director of postmarketing medical safety and surveillance, testified she knew of no instance in which Abbott had reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a NEC death.
- An Abbott internal document from 2010, displayed in deposition video clips obtained by KFF Health News, stated that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”
- A Mead Johnson marketing slide deck from 2020 — later used in trial — outlined a plan for “Branding NICU Babies,” a strategy to capture preterm infant feeding contracts through hospital relationships.
- As of late January 2026, approximately 1,760 NEC lawsuits were pending against Abbott alone.
- About 2,300 newborns died of NEC in the U.S. from 2017 through 2023, the equivalent of nearly one per day. The database does not attribute causation.
Where the System Fails Families

The regulatory framework governing infant formula reporting gives manufacturers the authority to determine whether adverse events — including deaths — meet the threshold requiring FDA notification. Unlike pharmaceutical drugs, which are subject to rigorous post-market surveillance and mandatory serious adverse event reporting with specific timelines, infant formula operates under a framework in which reporting is largely at the manufacturer’s discretion.

The FDA does not approve infant formula products before they reach market. It does not license formula labeling for safety claims. And, according to the KFF Health News investigation, its Human Foods Program received zero death notifications from formula makers across a 26-year window — even as internal company documents confirmed the companies were tracking NEC-related complaints internally.

This creates a structural gap: a manufacturer can investigate an adverse event internally, close the file internally, and the FDA may never receive a notification that allows it to identify a pattern of harm.

What the Companies and Agencies Say

Abbott spokesperson Scott Stoffel stated in November that “Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints.”

The FDA stated in a 2024 joint statement with the CDC and NIH that there is “no conclusive evidence that preterm infant formula causes NEC.” Abbott’s chief executive has publicly said that claims linking preterm formula to NEC are “without merit or scientific support.”

However, courts have repeatedly found in favor of families suing Abbott and Mead Johnson. A Chicago jury awarded $53 million to four families in April 2026, and a separate Chicago verdict in the same month awarded an additional $70 million. A Missouri appeals court upheld a $495 million verdict against Abbott. As of June 2026, approximately 798 federal NEC cases remain pending in multidistrict litigation in the Northern District of Illinois, with hundreds more in state courts.

What the Evidence Shows — and What It Does Not

The scientific debate over whether bovine (cow’s milk-based) formula causes NEC in premature infants versus the absence of human milk increasing NEC risk is ongoing and genuinely contested. The FDA, CDC, and NIH have stated there is no conclusive causal evidence. The American Academy of Pediatrics recommends human milk — including pasteurized donor milk — for premature infants when the mother’s own milk is not available.

What is not contested is the reporting record: the FDA received no death notifications from formula manufacturers going back to 2000, and Abbott’s own expert witness confirmed the company made no such reports.

MedicalDaily Evidence Check
- Investigation type: FOIA requests + court record analysis (KFF Health News, published July 2, 2026)
- What it found: Zero FDA death notifications from formula manufacturers from January 2000 through the present; Abbott’s expert witness confirmed Abbott never made a single death report under any regulation for preterm formula
- What it did not prove: That the formula directly caused the deaths — this remains contested between companies and plaintiffs
- Regulatory context: FDA does not pre-approve infant formula; adverse event reporting for formula is largely at manufacturers’ discretion
- What readers should know: The regulatory gap in formula death reporting is confirmed by FOIA records; families of premature infants have been fighting manufacturers in court without a government notification system creating an independent safety record
Who Is Most Affected?

This issue affects:
- Parents of premature infants currently in NICUs who are receiving cow’s milk-based formula or fortifiers
- Families who have experienced a premature infant death from NEC and may not know there is a reporting gap at the regulatory level
- NICU clinicians and hospitals whose informed consent discussions about formula feeding may not have reflected the manufacturer’s internal awareness of NEC-related adverse events
- Policymakers and advocates working on infant formula regulation reform
Symptoms of NEC in Premature Infants

Necrotizing enterocolitis typically develops in premature infants two to four weeks after birth, often around the time feedings begin. Warning signs that require immediate evaluation by the neonatal team include:
- Sudden abdominal swelling or rigidity
- Feeding intolerance after previously tolerating feeds
- Bloody stool
- Temperature instability
- Lethargy or decreased responsiveness
- Skin discoloration over the abdomen
If your premature infant is in the NICU, ask the neonatal team specifically about NEC risk and what the protocol is for early detection.

What You Can Do Now
- If your premature infant is currently in a NICU, ask the neonatologist whether your baby is receiving human donor milk or cow’s milk-based formula, and what the facility’s protocol is for NEC monitoring.
- Ask about your baby’s NEC risk based on gestational age and birth weight — infants born before 32 weeks and those under 1,500 grams face the highest risk.
- Inquire about human milk availability at the facility. The American Academy of Pediatrics recommends human milk — including pasteurized donor milk — as the preferred nutrition for very premature infants.
- If your premature infant previously suffered NEC while receiving cow’s milk-based formula, you may wish to consult a legal professional about your options. As of June 2026, active multidistrict litigation is proceeding in the Northern District of Illinois.
- Report adverse events through the FDA’s MedWatch program if you believe a formula product contributed to a serious adverse event in your infant.
Cost and Access: What Patients Should Know

Human donor milk is more expensive than cow’s milk-based formula, and insurance coverage varies. NICU families should ask the billing department and the neonatology team about donor milk access and coverage. Many NICUs absorb donor milk costs for the highest-risk infants.

For families who believe their infant was harmed by formula, legal consultations are typically offered at no upfront cost by firms handling NEC formula litigation. The Pancreatic Cancer Action Network NICHD page on NEC and infant feeding provides a recent scientific overview of the evidence.

What Happens Next

The KFF Health News investigation is expected to prompt renewed regulatory scrutiny of infant formula adverse event reporting requirements. The ongoing multidistrict litigation will produce additional bellwether trials in 2026 that may increase pressure on Abbott and Mead Johnson to consider broader settlements.

Congress has shown some interest in strengthening formula safety oversight following the 2022 Abbott infant formula shortage and contamination recall. Whether the KFF Health News reporting prompts legislative action on adverse event reporting requirements remains to be seen.

The Bottom Line

The FDA received zero death notifications from infant formula manufacturers going back to the year 2000, according to FOIA records obtained by KFF Health News — confirmed by Abbott’s own expert witness, who testified the company never made a single such report for preterm formula. Approximately 2,300 premature infants died of NEC in the U.S. between 2017 and 2023. The combination of those two facts is not proof of causation — but it is a documented regulatory gap that left families fighting for accountability in court with no independent government safety record to draw on.
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July 5, 2026
Families Struggling With Sudden Infant Death Syndrome Receive Assistance From Local Support Groups

Local support groups are assisting families who are struggling with sudden infant death syndrome (SIDS) due to the unique challenges that they are facing.

In a statement, Texas Tech physician Dr. Ana Montanez said that one child lost for any reason is still “one too many.” The medical professional said that SIDS can be difficult for them to work through with families.

Sudden Infant Death Syndrome

Montanez added that historically, SIDS has been recognized as a syndrome that is associated with children dying unexpectedly in their sleep or unknowingly without symptoms, simply dying while sleeping. This has been expanded to include infants under the age of one who have died unexpectedly for reasons that could not be medically explained.

The physician said that there was no exact way to prevent SIDS, but noted that there are steps that can be taken to lower the risk. It was noted that one of the most important factors to consider is a child’s sleep positioning, according to KCBD.

Montanez said that the first thing parents or caretakers should do is put infants to sleep on their backs. She added that when they are awake, infants can be placed on their tummies without any adverse effects on their health.

Another important factor to consider is that children need a safe sleep environment. Montanez noted that from a newborn baby’s perspective, the entire world is new, and everything they go through is a new sensory experience. It is important to keep the environment dark and quiet, and for the temperature to be appropriate when they go to sleep.

Other factors that should be taken into consideration include smoking, which should be avoided around newborns. Another is letting kids sleep on their own and ensuring that there is no chance they could suffocate while sleeping, Fox34 reported.

Providing Needed Support

The medical professional noted that because it is impossible to reduce the risks of SIDS to zero, everyone should try to support each other as best they can. This is where local support groups come in, including Isabel Espinosa, the chapter leader of The Compassionate Friends in Lubbock.

Espinosa’s daughter died in a car crash, an incident that changed how she viewed the world. She said that when the tragedy happened, she sank, noting she needed to find a chapter or a grief support group that was more specialized towards her loss.

The situation comes after Mississippi health officials in August this year declared a public health emergency as the rate of mortality among young infants hit a decade-long high. State Health Officer Dr. Dan Edney said at the time that too many families were losing their babies before their first birthday, as per People.

Originally published on parentherald.com

© {{Year}} ParentHerald.com All rights reserved. Do not reproduce without permission.

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October 27, 2025
SN-2 palmitate & infant health
Human Milk Oligosaccharides (HMOs) are widely recognised for their vital role in infant health and there’s now a growing body of evidence highlighting the significant benefits of SN-2 palmitate. In this podcast, neonatal nurse, Dr Janet Green, joins us to delve into the latest evidence on these essential nutrients found in premium infant formulas. You’ll learn exactly what SN-2 palmitate is, why its structure is so important and the impact it has on gut health, calcium and fat absorption, and bone mineral content. Janet also offers valuable tips on interpreting the latest research and expert guidelines.

Hosted by Dr Jane Winter

Biography

Dr Janet Green is a Senior Lecturer at Notre Dame University of Australia, and an adjunct Senior Lecturer at The University of Tasmania, based in Sydney. Janet has qualifications in Midwifery, Lactation, Neonatal intensive care, Paediatric intensive care, Emergency Paediatrics and Child and family health. Janet has many years’ experience as a neonatal nurse, and has retained strong ties to the clinical community. Janet holds Masters Degrees in Nursing Education, Bioethics and E-Learning. Her PhD explored the ethical issues surrounding caring for extremely premature babies. She is currently completing the final stages of a Doctor of Education degree, and for several years she was the Nurse Adviser to the NSW Health Care Complaints Commission (HCCC).
In this episode, we discuss:

The role of SN-2 palmitate in infant health

What to look for in a premium infant formula

Where to find current guidelines & expert recommendations
Additional resources
- Click here to watch the Paediatric Symposium: Navigating nutrition in infants and children
- Click here to view a research update on SN-2 palmitate
References
- Béghin L, Marchandise X, Lien E, et al. Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial. Clin Nutr. 2019;38(3):1023-1030. doi:10.1016/j.clnu.2018.05.015
- Yao M, Lien EL, Capeding MR, et al. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014;59(4):440-448. doi:10.1097/MPG.0000000000000443
- Guo D, Li F, Zhao J, et al. Effect of an infant formula containing sn-2 palmitate on fecal microbiota and metabolome profiles of healthy term infants: a randomized, double-blind, parallel, controlled study. Food Funct. 2022;13(4):2003-2018. Published 2022 Feb 21. doi:10.1039/d1fo03692k
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The content, products and/or services referred to in this podcast are intended for Health Care Professionals only and are not, and are not intended to be, medical advice, which should be tailored to your individual circumstances. The content is for your information only, and we advise that you exercise your own judgement before deciding to use the information provided. Professional medical advice should be obtained before taking action. The reference to particular products and/or services in this episode does not constitute any form of endorsement. Please see  here  for terms and conditions.

This episode includes discussion of infant formula and formula feeding and is intended for HCPs only. Breastfeeding is best for babies and a decision not to breastfeed can be difficult to reverse. Social and financial implications should be considered when discussing formula feeding. Views, opinions or recommendations today are those of the speaker, and do not necessarily represent those of Dietitian Connection.
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August 25, 2024
Navigating infant formula shortages – The Nutrition Source
Infant formula shortages in the U.S. have occurred in the past two years largely due to widespread pandemic-related supply-chain problems. A national shortage of infant formula is undoubtedly alarming for families since infants require formula when human milk is not accessible or not available in adequate amounts. Although breastfeeding is encouraged, it is not always a feasible option for mothers who return to work early or do not have access to a lactation support system. Human milk and breastfeeding may also not be possible in infants who have allergies or metabolic or gastrointestinal disorders that require special infant formulas, or who have disabilities that limit breastfeeding.

What you can do now:

Consult first with your child’s pediatrician, especially if your child has allergies or special formula needs. They can inform you of safe alternative brands.

Be flexible in trying different brands, including generic. Many brands advertise special health benefits that have more to do with marketing than an actual difference in their nutrition content.

The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) offers guidelines for alternatives to brand name infant formulas and for special sensitivities in the event of a shortage.

If your child is older than 6 months, encourage a mixture of both infant food and formula. If they are closer to one year of age, they may be able to use toddler formula if approved by your pediatrician. After one year of age, babies no longer need formula and can be weaned off.

What not to do:

Avoid hoarding commercial infant formulas, which only prolongs a shortage. The American Academy of Pediatrics advises buying no more than a 10-day to 2-week supply of formula. [1] In addition to regular supermarkets, check drugstores, smaller store chains, and reputable online sites.

Do not make homemade infant formulas. The U.S. Food and Drug Administration (FDA) warns that they carry a risk of bacterial contamination and may not provide appropriate amounts of nutrients and fluids required for an infant’s growth. [2] Infants have been hospitalized or even died due to use of homemade infant formula recipes lacking nutrients.

Do not add extra water to formula to extend its use. This will dilute the nutritional content of the formula and increase the risk for deficiencies.

Avoid infant formulas from other countries unless they are approved by the FDA. FDA approvals are expected soon for formulas manufactured in Europe, for instance, so contact your health care provider (pediatrician, registered dietitian) with specific questions.

Future Directions

Policy changes are needed to prevent a recurrence of severe formula shortages in the future. An article from the American Journal of Clinical Nutrition outlines the following action steps: [3]

Completion and release of all investigative documents about formula recalls and public hearings to communicate the findings.

The FDA and U.S. Department of Agriculture should create specific rules for formulas that are identified as critical for specialized use to be produced at multiple sites and preferably by multiple companies (as opposed to the current situation of specialized formulas that are produced by a small handful of companies).

Establishment of a national plan related to assessment of formula needs and response to shortages, including those caused by natural disasters or recalls, especially in rural communities and for specialized and medical formulas. This should include considering the use of formulas made by reliable international manufacturers.

Creation of a database of “similar” formulas (e.g., amino acid-based or partial hydrolysate formulas) easily accessible to both consumers and health care providers, so that families can easily identify similar products if their usual formula is out of stock.

Changing of WIC rules to increase flexibility for families to purchase formula alternatives when a shortage occurs, with re-evaluation of the WIC state contracting processes.

Strong advocacy for workplace and postpartum rules to enhance breastfeeding and increase time for breastfeeding at work and before return to work.

A national policy allowing reimbursement for donor breast milk for families, especially when it is medically indicated or when formulas are in short supply.
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August 15, 2024