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AAP clinical report: Toddler ‘formulas’ offer no nutritional advantage

October 20, 2023

Parents browsing the formula aisle for their infants older than 6 months or toddlers 12 months and up might do a double take when reading labels that make claims like “improved brain development” or “improved immune function” for these age groups.

Adding to the confusion, the products are cross-promoted with infant formula, sporting similar brands and packaging.

These beverages or drinks should not be promoted as formula, according to a new AAP clinical report. Pediatricians can advise families at well-child visits that such products are not nutritionally complete and do not replace a varied, well-balanced diet that includes human milk (preferred) and/or cow milk.

Advertising messages that position these products as the next stage or next step for toddlers cause confusion and even can discourage breastfeeding or displace infant formula use.

The clinical report Older Infant‒Young Child “Formulas,” from the AAP Committee on Nutrition, is available at and will be published in the November issue of Pediatrics.

In addition, a session titled “Toddler Formula, Young Child Formula, Follow-Up Formula, Growing Up Milk, Transition Formula: What’s in a Name?” will be presented from 7:30-8:30 a.m. EDT today at the AAP National Conference & Exhibition. George J. Fuchs III, M.D., FAAP, a lead author of the report, will review the different names, compositions, benefit claims and co-branding with infant formulas that have created confusion among health care providers and parents.

Nutritional needs, composition

The AAP supports continued breastfeeding along with appropriate complementary foods introduced around age 6 months, as long as mutually desired by mother and child for two years or beyond. Breastfed infants generally need a vitamin D supplement as well.

Nonbreastfed infants under age 12 months receive their nutrition primarily via standard infant formula along with age-appropriate solid foods after 4-6 months of age, which provides key micronutrients including iron, calcium and zinc.

The Infant Formula Act requires infant formulas to meet nutritional requirements as a sole source for infants through the first 12 months. However, unlike standard formulas, the Food and Drug Administration (FDA) does not have a distinct category of older child formulas, so there are no specific criteria for their composition.

“As a result, composition of these drinks is unregulated by the FDA and their promotion typically characterized by misleading claims,” Dr. Fuchs said.

A distinction also needs to be made between these drinks and medically necessary pediatric formulas (polymeric, semi-elemental and elemental) for oral or enteral use which, unlike these drinks, are nutritionally complete, he added.

Packaging claims that tout structure-function health or highlight that the product is recommended by experts are not required to be based on scientific evidence or FDA review or approval.

The clinical report recommends that marketing should make the clear and unambiguous distinction from standard infant formula in promotional materials, logos, product names and packaging, and should not be linked in any way to infant formula.

In addition, these products should be labeled as something other than formula (e.g., toddler drink or beverage) and not positioned alongside infant formulas on store shelves.

Toddler beverages also have been criticized as having components considered to be unnecessary or potentially detrimental, including high or low protein, higher sodium content relative to cow milk and added sweeteners.

Pediatricians and care teams should educate families about these products and assess older toddlers’ nutritional intake, considering mineral- and iron-rich solid food consumption, recommending any changes needed.

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