Journal Club by Bobbie Medical

It has been well-established that nutrition during the first 1,000 days of life plays an essential role in an infant’s health and development. The quality of nutrition delivered during this foundational stage can have a lasting impact.¹ To this end, multiple professional societies - such as the American Academy of Pediatrics (AAP) and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) - provide clear guidance on nutrition in early life. These societies recommend exclusive breastfeeding for the first six months of life or the use of a suitable alternative: an FDA-registered infant formula or donor breast milk (DBM) from an accredited milk bank.²,³

The feeding practices recommended by groups like the AAP and NASPGHAN are centered around nutritional adequacy - the ability of the feeding practices to deliver the right amount and combination of nutrients to support an infant’s early growth and development. But beyond this, these practices are also rooted in safety. The safety of products recommended during the first year of life is confirmed by the organizations that provide oversight for these products: the US Food and Drug Administration (FDA),⁴ and in most cases for donor milk banks, the Human Milk Banking Association of North America (HMBANA).⁵

Despite these clear guidelines, it is well-known that the use of feeding practices that deviate from this guidance occurs. These can include informal breastmilk sharing, the use of non-FDA reviewed and  imported European infant formulas, toddler formulas, or homemade infant formulas. Recently, a group of researchers aimed to establish the prevalence of unrecommended and unregulated infant feeding practices that pose nutritional concerns, while also seeking insights into the reasons why parents and caregivers are driven to utilize these practices.⁶

Pediatricians and Parents Lead Research on Infant Feeding Practices

The research was led by two pediatricians who are also parents to young children - Dina DiMaggio, MD, an FAAP board-certified pediatrician, and AAP spokesperson, and Anthony Porto, MD, MPH, FAAP, board-certified pediatric gastroenterologist, AAP Spokesperson, and Associate Professor of Pediatrics and Associate Chief of Pediatric GI at Yale University. Drs. DiMaggio and Porto explain their motivation for taking on this research. Dr. DiMaggio tells us, “As a pediatrician and mother of two young children, it is extremely important to me that infants are receiving optimal nutrition during the critical first 1,000 days of life. Dr. Porto and I have dedicated our careers to studying infant nutrition and trends in infant feeding. We’ve done this so we can provide sound, up-to-date medical advice to parents and help them make informed decisions on how to provide their babies with the best possible start on their feeding journeys.“

Dr. Porto adds, “Infant nutrition has been a special interest of mine not only professionally, but also personally as a dad to two young children. This research stemmed from questions we’re commonly asked when we see families in the office. We wanted to shed light on new trends so that we could arm pediatricians and other health care professionals with the tools they need to ensure that infants get the best and safest nutritional start in life.”

Research Methods

• An anonymous, cross-sectional survey was distributed to all active subscribers of a baby food subscription company’s listserv in April 2021. The 44-question survey contained questions on basic demographics and the utilization of various infant feeding practices.
• The survey was developed based on the National Health and Nutrition Examination Survey (NHANES),⁷ as well as other validated nutrition surveys.⁸
• Once survey data were collected, the frequency of each feeding practice was reported as a percentage of total responses.

Survey Results

Out of a total of 11,903 surveys distributed, 2,315 completed responses were received, resulting in an approximately 20% response rate. Geographic representation is reflected in the survey results, with participants residing in all ten US zip-code regions in the US.

Basic demographics are as follows:

• 59% of responding households earned an annual salary of <$150,000
• 81% of respondents held at least a bachelor’s degree
• 69% of respondents were White
• 83% of respondents held private medical insurance

Eighteen percent of respondents reported utilizing at least one of four infant feeding practices, as summarized in the table below:  

Prevalence of Infant Feeding Trends (DiMaggio 2022)

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Key Insights + Concerns

The four most common unregulated and unrecommended feeding practices identified by the survey are summarized below.

1 - Donor Milk Usage

Overall, respondents were more likely to use donor breast milk if their infant was born prematurely.

Of those who reported using donor breast milk from an unregulated source, 30% obtained it from a personal contact and 6% obtained it from an internet source.

Concerns:

• Safety regulations are lacking for direct “mother to mother” and internet sharing of breastmilk
• There is a risk of bacterial or viral contamination for donor milk that is not collected using sterile methods or stored and transported under safe conditions.⁹
• Informal milk sharing practices remove the ability for milk to be pooled and tested for environmental toxins, illegal drugs, and/or presence of liquids other than human milk.¹⁰

2 - Toddler Formula

One out of 20 respondents was using a toddler formula for their infant less than one year of age.

Of these, 41% reported not discussing their infant’s consumption of a toddler formula with their pediatrician.

Families using toddler formulas for their infants perceived these formulas to be better and made with fewer synthetic ingredients.

Concerns:

• The US FDA regulations for toddler formulas differ from those established for infant formula. In particular, it is not necessary for toddler formulas to demonstrate their ability to support normal infant growth or the presence of proteins with sufficient biological quality.
• Manufacturers of toddler formulas are not required to test powdered formulas for the presence of contamination. Further, they are inspected by the FDA every three to five years, instead of annual inspections for infant formula manufacturers.
• Toddler formulas are not designed to meet the nutritional requirements of infants.

3 - Use of non-FDA Reviewed European Formulas

The use of European infant formula was the most commonly reported Infant Feeding Practice in this survey, with a 14% response rate.

Forty percent of those using European infant formula reported not discussing it with their pediatrician. Of those who did discuss it, one-third perceived their pediatrician to be not or only slightly informed about EIF overall.

Respondents decided to use European infant formula based on the perception that these formulas had better and less synthetic ingredients, and that formula standards in Europe are more strict than in the US.

Concerns:

• Non-FDA-reviewed infant formulas bypass the strict safety guidelines of the Infant Formula Act and the FDA’s infant formula regulations.
• The protein ingredient used in European infant formulas labeled as “hypoallergenic” can differ greatly from that found in US infant formulas bearing the same name. “Hypoallergenic” European infant formulas are not appropriate for use in infants with cow’s milk protein allergy.  
• Safe conditions during storage and shipping of European infant formulas cannot be guaranteed.
• Should a recall of a European infant formula occur, users in the US may not receive timely and important details related to the recall.
• Typical scoop sizes used in European infant formulas differ from those typically provided with US infant formulas, and labels may not be in English. These factors can lead to improper mixing and preparation of the formula.

4 - Homemade Infant Formulas

Respondents using homemade infant formulas were utilizing recipes found online (35%), from a medical professional (19.4%), or from a parent/friend (16.1%).

The majority of respondents using homemade infant formula, 58%,  did not communicate this to their pediatrician.

Concerns:

• The AAP, FDA, and Centers for Disease Control and Prevention (CDC) advise against the use of homemade infant formula, as it is likely to lack essential nutrients for adequate growth and development.¹¹⁻¹²
• These formulas carry a high risk for bacterial contamination. ‍
• Side effects of the use of homemade infant formula can include malnutrition, complications from mineral deficiencies, cardiac failure, seizures, and death.¹³

Take-home Messages

Nearly one of every five parents responding to a recent infant feeding practices survey reported using at least one unregulated infant feeding practice. The practices reported are contraindicated based on expert and regulatory guidelines and present nutritional and safety risks. Many respondents admitted to not discussing these infant feeding practices with their infant's pediatrician.

Pediatricians, Gastroenterologists, and Registered Dietitians caring for infants must engage in dialogue around infant feeding practices being utilized in the home setting. Awareness of the prevalence of practices that present significant nutrition and safety risks to the infants they care for is critical. Further, they should be prepared to discuss these practices with families, discourage their use, and provide feasible and appealing alternatives.

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Download talking points you can use in clinical practice to discuss safety concerns around these infant feeding trends with parents.

Disclaimer: The lead authors of the study discussed above, Dr. DiMaggio and Dr. Porto, are Bobbie Medical Contributors.

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References

¹Nutritional Gaps and Supplementation in the First 1000 Days

²Breastfeeding and the Use of Human Milk | Pediatrics

³Breast-feeding: A commentary by the ESPGHAN Committee on Nutrition

⁴Infant Formula Guidance Documents & Regulatory Information | FDA

⁵Human Milk Banking Association of North America

⁶Nutritional and Safety Concerns of Infant Feeding Trends

⁷NHANES Survey Methods and Analytic Guidelines

⁸National Immunization Surveys | CDC

⁹Microbial contamination of human milk purchased via the Internet

¹⁰Cow's Milk Contamination of Human Milk Purchased via the Internet

¹¹Is Homemade Baby Formula Safe? - HealthyChildren.org

¹²Infant Formula: Safety Do's and Don'ts | FDA ‍

¹³Recipe for Disaster: Homemade Formula Leading to Severe Complications in 2 Infants