Older Infant-Young Child “Formulas”

The first years of life are foundational for child growth and psychomotor development with lifelong influence and implications. Adequate nutrition in the early years is important for the developing brain as it relates to cognition and long-term brain function.¹  Additionally, these years represent a narrow window of time during which nutritional status and the right nutrients at the right time are primary determinants of health and disease and disease risk, including noncommunicable disease (eg, obesity, diabetes, metabolic syndrome, cardiovascular disease, allergy, and atopy), beginning in childhood and extending through adulthood.

The benefits of exclusive breastfeeding in the first 6 months of life are well documented and indisputable. However, there are a variety of sound reasons that certain infants must depend in part or entirely on iron-fortified infant formulas, the composition of which is relatively standardized based on decades of physiologic and food science evidence. After 6 months of age and with the introduction of complementary foods, human milk and formula constitute a progressively decreased proportion of total nutritional intake with advancing age. The American Academy of Pediatrics (AAP) supports continued breastfeeding along with appropriate complementary foods introduced at about 6 months, as long as mutually desired by mother and child for 2 years or beyond. If the infant is not breastfed, the AAP and others recommend whole cow milk as suitable for infants beginning at 12 months of age as part of a nutritionally complete, balanced diet.²  More recently, a wide array of liquid nutritional products referred to as “formulas” have been developed for the older infant and toddler of separate age ranges and increasingly promoted by manufacturers in North America and elsewhere, with different identities including “transition formulas,” “follow-on” or “follow-up formulas,” or “weaning formulas,” typically for children 6 to 24 months of age, and “toddler milks or formulas,” “growing-up milks,” or “young child milks” generally for children 12 to 36 months of age (Table 1).³  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 health care professionals, and policy makers. 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 older infant-young child formulas (OIYCFs).

Infant formulas are required to be able to meet nutritional requirements as a sole liquid source of nutrition for infants through the first 12 months of life. All infant formulas sold in the United States, therefore, whether manufactured in the United States or imported, must meet the requirements of the Infant Formula Act enacted in 1980 and amended in 1986 and associated regulations, and facilities undergo annual inspections by the US Food and Drug Administration (FDA).^4,5  Unlike for standard infant formulas, the FDA does not have a distinct category of OIYCFs, and there are no US national or uniform international criteria for the composition or definition of formulas for children older than 12 months. Different international expert groups have developed composition recommendations; however, regulatory oversight in the United States to ensure formulas for this age group adhere to a standard does not currently exist.^6–8  It is perhaps not surprising, then, that the composition of this group of formulas is characterized by wide variation. Some of these formulas have been criticized as having elements considered to be unnecessary or potentially detrimental, including high or low protein, higher sodium content relative to cow milk, and added sweeteners, among others. Compared with cow milk, consumption of OIYCFs, which have been considered by some as “sugar-sweetened drinks,” has been associated with greater intakes of sweetened beverages as well as sweetened dairy products, such as fruit yogurts and cream cheese desserts, perhaps because of an influence on taste preference.^9,10  OIYCFs are not nutritionally complete and 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. Therefore, these formulas are not appropriate substitutes for medical nutritional therapy for older infants and children in states of deprivation or growth faltering (eg, malnutrition, so-called failure to thrive), with swallowing dysfunction, or with feeding aversions or conditions such as cerebral palsy, who similarly rely on them for a major proportion of their nutritional intake. They are also not adequate for those with disease-specific requirements (eg, celiac disease, gastrointestinal disorders, inborn errors of metabolism, food intolerance, or allergy).

The diets of US young children are generally adequate for most micronutrients, although possible gaps exist, especially for vitamins D and E and fiber.^11,12  Compared with unfortified cow milk, some children who consumed OIYCFs have demonstrated improved vitamin D and E intakes.^13,14  That nearly all store purchased cow milk in the United States is fortified with vitamin D generally obviates a potential need of OIYCFs for many in this regard. For breastfed infants, including those breastfed after 1 year of age, it is generally best to continue a vitamin D supplement, because other dietary vitamin D sources are minimal. Results of 1 study were interpreted to indicate a possible benefit of OIYCFs for children at nutritional risk because of an imbalanced diet.¹⁵  OIYCFs with an appropriate composition and context can provide key nutrients and make an important contribution to support child health. However, the sum total of attributes of OIYCFs, including those that are undesirable in some, as described earlier, make them unnecessary for most; therefore, emphasis should be on consumer education, nutritionally balanced diets, consumption of fortified foods, and food security to ensure dietary adequacy. Further, OICYFs are more expensive than cow milk and can represent a significant cost burden to families, especially for a child consuming them daily.

A distinction should be made between OIYCFs and medically necessary pediatric formulas for oral or enteral use. For children at nutritional risk secondary to chronic gastrointestinal or neuromuscular diseases, medically necessary pediatric formulas (not OIYCFs) provide essential or supplemental nutrition. These pediatric formulas (polymeric, semielemental, and elemental) assist nutritionally to provide protein, cholesterol, and fat, when enteral support is required, and should be reserved for use when medically necessary.

In assessing nutritional claims, products designed for infants younger than 12 months need to be considered separately from those designed for children 12 months and older. For nonbreastfed infants younger than 12 months of age, nutritional intake is primarily provided by standard infant formula together with age-appropriate solid foods after about 4 to 6 months of age, and that provides goal intakes of key micronutrients including iron, calcium, and zinc.¹⁶  For formula-fed infants, the formula provides most of these, even if solid foods are limited, but breastfed infants may fall short, especially for iron, vitamin D, and zinc.¹⁷  The Pregnancy and Birth to 24 Months Project of the US Department of Agriculture concluded that complementary feeds introduced earlier than 6 months of age offer no benefit to the breastfeeding infant in growth or iron status but may be associated with an increased risk of being overweight or obese, especially if introduced before 4 months. The use of OIYCFs results in displacement of infant formula and has no essential role in providing micronutrients to this age group; infants should instead continue to receive both a healthy mixed diet and human milk or standard infant formula.

For children 12 months and older (toddlers), the situation is more complex. At this age, many toddlers will have begun consuming cow milk-based products, although some families may have switched to other liquids including almond beverages, soy “milk” or beverages, or goat milk. In general, with a nutritionally adequate solid food intake that includes sources of bioavailable iron and zinc, cow milk is entirely adequate to meet a toddler’s needs. For breastfed toddlers in this age group, human milk is also adequate, although generally a vitamin D supplement should be provided. Caution should be exercised to limit cow milk intake to 16 to 17 ounces per day because of concerns regarding its negative effect on iron status.^18,19 

For toddlers receiving other milk type products, nutrient adequacy for calcium, phosphorus, magnesium, and vitamin D is less assured. Some commercial products are fortified with these micronutrients, especially calcium, whereas others may be severely limited in calcium. Some toddler formulas are marketed based on either hydrolyzed cow milk protein or soy protein. Families who, for medical or other reasons, wish to avoid cow milk products may use these toddler products after consulting with their pediatrician, although even then and in most cases, selecting a noncow milk standard product fortified with calcium and vitamin D and ensuring a sufficient solid food balanced intake will meet the toddler’s nutritional needs.

Although micronutrients are provided in OIYCFs, the recommendation is for caregivers to provide a varied diet with fortified foods and supplements to optimize nutritional intake.^7,8  Therefore, for children consuming a diet of solid foods that provide sufficient iron and vitamin content, there is no advantage or need to consume OIYCFs.⁷  The best approach is for the pediatrician to perform a focused nutritional assessment based on intake of mineral- and iron-rich solid foods and consider how best to counsel families. This assessment should consider intake of dairy and meat as well as fruits and vegetables. Families with very low intake of certain micronutrients may be counseled regarding these or referred to a pediatric dietitian. For most families, adjustment of solid food intake will be adequate. For others, consideration of a vitamin D, mineral, or iron supplement may be necessary. A diet-based approach is always preferred, and in the case of toddlers, developing taste preferences for a mixed diet is ideal.

OIYCFs occupy an important business niche as a source of increased sales and revenue that have offset a decline in sales by volume of infant formula. Using Nielsen US retail scanner data, Choi et al observed a decrease in sales of infant formula by volume of 7% during the period 2006 to 2015 (30 to 28 million kg), compared with those of OIYCFs, which increased by more 158% (1 to 3 million kg).²⁰  This represented an increase in sales of OIYCFs (in US dollars) of $53 million ($39 to $92 million) associated with a fourfold increase in OIYCFs advertising, whereas that for infant formula declined.

Marketing of products in this age group potentially discourages continued breastfeeding and is often based on vague concerns parents have that their child is not getting some needed micronutrients and that these are uniquely provided by OIYCFs. Advertisement practices for OIYCFs often convey them as a necessary “next stage” or “next step” to ensure optimal nutritional intake after infant formulas or even human milk and on a formula continuum from infancy through early childhood. Many infant formula and young child milk products are additionally sold in a manner to foster brand loyalty as a line of products, for example labeled as stages 1, 2, and 3. In contrast, the World Health Assembly in 1986 recognized specialty formula milks for older infants as unnecessary, and other expert organizations, including the AAP, have similarly recommended breastfeeding through 2 years of age or longer or whole cow’s milk and other acceptable nonformula dairy sources in conjunction with appropriate complementary solid foods as nutritionally adequate.^21–23  OIYCFs frequently make structure-function health or expert-recommended claims on their packaging that are not required to be based on scientific evidence or be reviewed or approved by the FDA.^1,3  Experience with infant formula marketing is that many consumers mistakenly believe that promoted properties have been tested and scientifically proven.²⁴  Claims of improved brain development or immune function have incorrectly shown to influence parents’ belief that OIYCFs are healthier than cow milk and promotes their intention to provide OIYCFs to their children.^25,26  Romo-Palafox et al observed that 60% of caregivers believed that OIYCFs provided nutrition that was not provided by foods.²⁶  Labeling and messaging of OIYCFs manufactured by infant formula companies commonly show evidence of cross-promotion with infant formula brands through the use of similar names, packaging (colors and designs), logos, pictures, and slogans or images of a child feeding from a bottle or who appears younger.^27,28  In 1981, the World Health Organization adopted the Code of Marketing of Breast-milk Substitutes with several updates over intervening years. The United States voted against adoption of the code in 1981 and has minimally recognized the rules, including those that have extended the guidance to products such as OIYCFs. Manufacturers have used direct-to-consumer marketing of OIYCFs in various countries, including the United States, in violation of the guidance of the codes.²⁹  Not surprisingly, this has resulted in confusion regarding these products by consumers who may not be able to identify often subtle marketing distinctions made by manufacturers.³⁰  As a result, child caregivers can be misled to understand that they are acceptable or beneficial for infants younger than 12 months, undermining breastfeeding or displacing infant formula by these nonrecommended products.^31,32 

• For infants younger than 12 months, the liquid portion of the diet should be provided by human milk or standard infant formula that has been reviewed by the FDA based on the Infant Formula Act.

• For toddlers (children 12 months and older), caregivers should provide a varied diet with fortified foods to optimize nutritional intake. OIYCFs can safely be used as part of a varied diet for children but do not provide a nutritional advantage in most children over a well-balanced diet that includes human milk (preferred) and/or cow milk, and these products should not be promoted as such. OIYCFs have no specific role in routine care of healthy children and are more expensive than cow milk.

• Marketing of OIYCFs should make the clear and unambiguous distinction from standard infant formula in promotional materials, logos, product names, and packaging. OIYCF product name should not be linked in any way to infant formula (numerical, steps, sequential name) and should be labeled as something other than formula—for example, follow-on or toddler “drink” or “beverage” rather than follow-on or toddler “formula.” Product placement in store shelves of OIYCFs should not be alongside standard infant formulas.

• Education of families about OIYCFs by health care teams as part of well-child visits is encouraged.

• Medical providers and care teams should complete a focused nutritional assessment, with consideration of mineral- and iron-rich solid food consumption and offer adjustment of solid food intake and/or vitamin supplementation as needed.

George J. Fuchs, III, MD, FAAP

Steven A. Abrams, MD, FAAP

A. Adjowa Amevor, MD, FAAP

Mark R. Corkins, MD, FAAP, Chairperson

Cynthia L. Blanco, MD, FAAP

George J. Fuchs, III, MD, FAAP

Praveen S. Goday, MD, FAAP

Tamara S. Hannon, MD, FAAP

C. Wesley Lindsey, MD, FAAP

Ellen S. Rome, MD, MPH, FAAP

Andrew Bremer, MD, PhD, FAAP – National Institutes of Health

Andrea Lotze, MD, FAAP – Food and Drug Administration

Cria Perrine, PhD – Centers for Disease Control and Prevention

Ana Sant’Anna, MD – Canadian Pediatric Society

Cheryl Funanich, MEd, RD, LD – United States Department of Agriculture

Debra L. Burrowes, MHA

AAP

American Academy of Pediatrics

FDA

US Food and Drug Administration

OIYCF

older infant-young child formulas