AAP Warns on So-Called Toddler Formulas

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WASHINGTON — Older infant-young child formulas (OIYCFs) are nutritionally incomplete and should not be used as a substitute for prescribed medical formulas, according to new American Academy of Pediatrics (AAP) guidance.

The AAP report aims to clarify “the uncertainty and misperception” around increasingly popular OIYCFs, which currently do not have uniform national or international criteria dictating the composition or definition of formulas for children older than 12 months. Also, the FDA does not have a distinct category for OIYCFs like it does for standard infant formulas.

“The first 2 years of postpartum development is a time of tremendous opportunity, but enormous variability and vulnerability,” said George Fuchs, MD, of the AAP Committee on Nutrition, in a presentation at the AAP annual meeting here.

Neurodevelopment in particular begins in utero and continues from there, and any kind of “insult” to this process can “lead to lifelong consequences,” Fuchs said. “This is relevant to the toddler formula category because nutrients most definitely play a key role in this development.”

OIYCFs include “transition formulas,” “follow-on formulas,” or “weaning formulas,” for children ages 6 to 24 months, and “toddler milks or formulas,” “growing-up milks,” or “young child milks,” for kids ages 12 to 36 months, according to the clinical report, published in Pediatrics.

“The different names, compositions, and purported benefits of this group of formulas have resulted in questions and confusion among child caregivers, pediatricians and other pediatric healthcare professionals, and policymakers,” Fuchs and co-authors wrote. “Although medical or therapeutic formulas are indicated for a variety of conditions, such as chronic gastrointestinal diseases, metabolic disorders, food allergy, and others, such prescribed formulas are different from OIYCFs.”

OIYCFs are “not nutritionally complete,” according to the report, so are not appropriate substitutes for medical nutritional therapy for older infants and young kids with malnutrition, swallowing dysfunction, or feeding aversions or conditions like cerebral palsy. And they are not adequate for those with disease-specific requirements, such as those related to celiac disease.

The new guidance recommends that providers educate families about OIYCFs as part of well-child visits.

“Changes that you might want to make in practice” include implementing a “focused nutritional assessment in 12-months-of-age children,” said Fuchs.

The goal is to ensure that kids are getting enough mineral- and iron-rich solid foods, he said, adding that referral to a pediatric dietitian may be warranted if the clinician determines that is not the case.

Fuchs and colleagues highlighted that the composition of OIYCFs “is characterized by wide variation,” with the potential for contents that are “considered to be unnecessary or potentially detrimental, including high or low protein, higher sodium content relative to cow milk, and added sweeteners, among others.”

However, the authors acknowledged that OIYCFs with the appropriate composition “are designed for healthy, normally growing children, specifically to replace or supplement the usual role of whole cow milk or human milk in the diet.” For instance, compared with kids who consumed unfortified cow milk, some who consumed OIYCFs demonstrated improved vitamin D and E intakes. But most store-purchased cow milk in the U.S. is fortified with vitamin D, and vitamin D supplements can also play an important role, they noted.

Additionally, for children who consume a diet of solid foods that provides sufficient iron and vitamin content, there is no need to consume OIYCFs, according to the report.

Fuchs and colleagues cautioned that caregivers “can be misled” to believe that OIYCFs are acceptable or beneficial for infants, which could undermine breastfeeding or displace standard infant formula. For infants younger than 12 months, the liquid portion of their diet should be provided by human milk or standard infant formula reviewed by the FDA, the report recommended. For kids 12 months and older, caregivers should provide a varied diet with fortified foods to optimize nutritional intake.

OIYCFs “occupy an important business niche” to “offset a decline in sales by volume of infant formula,” the report noted.

Fuchs’ group called for OIYCFs to distinguish themselves from standard infant formula in promotional materials. Product names should not be linked to infant formula, and products should not be labeled as formula, but given names such as “drink” or “beverage.” Also, products should not be placed in store shelves alongside standard infant formulas.

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    Jennifer Henderson joined MedPage Today as an enterprise and investigative writer in Jan. 2021. She has covered the healthcare industry in NYC, life sciences and the business of law, among other areas.

Disclosures

All AAP clinical reports automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.

Fuchs and co-authors disclosed no relationships with industry.

Primary Source

Pediatrics

Source Reference: Fuchs GJ, et al “Older infant-young child ‘formulas'” Pediatrics 2023; DOI: 10.1542/peds.2023-064050.

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