Formulas for toddlers are a burgeoning business in the United States: Sales of the drinks more than doubled in recent years as companies convinced parents that their little ones needed the liquid boost. But many experts warn that these products, designed for children ages 1 to 3, fill no nutritional needs beyond what is available in a typical toddler diet, are subject to less regulation than infant formula, and are expensive.
In addition, some parents feed the toddler versions to infants even though they do not meet federal standards for infant formula and may not provide babies with adequate nutrients to sustain their growth.
say that when most children turn 1, they can begin drinking cow milk or an unsweetened plant-based milk substitute. In a 2019 , the American Academy of Pediatrics and other health and nutrition organizations recommended against using toddler formulas, saying 鈥渢hey offer no unique nutritional value beyond what could be obtained with healthy foods; furthermore, they may contribute added sugars to the diet.鈥 The toddler formulas often contain sweeteners and fats that add calories.
Some of the same companies that produce infant formula 鈥 including Enfamil, Gerber, and Similac 鈥 also make toddler formulas, as do some smaller, boutique brands that advertise that they have organic or other special qualities. Toddler formulas are available nearly everywhere infant formulas are sold and are marketed as providing extra nutrients to help children鈥檚 brain, immune system, and eye development, among other benefits. They are different from medical formulas prescribed for children with specific needs.
A found that sales of toddler formula in the U.S. rose to $92 million in 2015 from $39 million in 2006.
Parents are often confused by the marketing for the formulas, according to a study led by , a marketing and public health researcher at the University of Connecticut. She found that falsely believed toddler formulas have nutrients that toddlers can鈥檛 get from other foods.
, a pediatric gastroenterologist and pediatrics professor at Yale University, said he is concerned these products could be giving toddlers more nutrients and calories than they need. Unlike what鈥檚 designed for infants, toddler formula has no nutritional regulations: Experts say standardizing a supplement to toddlers鈥 diets is impossible because no two children are alike.
In , Harris said, parents report feeding their children toddler formula to fill nutritional gaps when a child isn鈥檛 eating enough, a common concern among parents.
鈥淚nfants are often voracious eaters,鈥 said , chair of pediatrics at Children鈥檚 Hospital Colorado. But at around a year of age, children鈥檚 growth plateaus, he said, and 鈥渢hey鈥檙e suddenly not hungry in the way they used to be anymore.鈥 That can worry parents, he added, but 鈥渋t鈥檚 a completely normal phenomenon.鈥
If parents have concerns about their children鈥檚 diet, Daniels said, they should consult a pediatrician or family doctor.
Blanche Lincoln, president of the Infant Nutrition Council of America, which represents the makers of Enfamil, Gerber, Similac, and store brands, said in an email that the toddler formulas can be helpful because they can fill 鈥渘utritional gaps during this period of transition to table foods.鈥 Lincoln, a former U.S. senator from Arkansas, said the drinks 鈥渉elp contribute to the specific nutritional needs of toddlers by providing energy and important nutrients, as well as essential vitamins and minerals during this important period of growth and development.鈥
But toddler formula isn鈥檛 being ingested by toddlers alone 鈥 it鈥檚 also being fed to infants. In a , Porto and colleagues found that 5% of infants鈥 parents reported giving their babies drinks marketed for the older age group. And Harris鈥 research indicated that of infants older than 6 months had fed their babies toddler formula in the previous month. Both studies were conducted before the recent infant formula shortage, which may have exacerbated the problem.
鈥淚nfant formulas and toddler formulas tend to be next to each other in the supermarket,鈥 Harris said. 鈥淭hey look similar, but the toddler formulas are cheaper than the infant formulas. So people confuse them, and they grab the wrong one. Or they think, 鈥極h, this one is less expensive. I鈥檒l get this one instead.鈥欌
According to an email from FDA spokesperson Lindsay Haake, toddler drinks do not meet the definition of infant formula, so they are not subject to the same requirements. That means they do not have to undergo the clinical trials and pathogen safety testing that the infant versions do. 鈥淯nlike infant formulas, toddler formulas are not necessary to meet the nutritional needs of their intended consumers,鈥 Haake said.
In a statement to KHN, the Infant Nutrition Council of America said, 鈥淭oddler drinks have a distinctive use and nutritional makeup from infant formula; the two are not interchangeable. The labeling of toddler nutritional drinks explicitly identifies the product as a toddler drink intended for children 12 months and older on the front of the package label.鈥
However, several expensive toddler formula brands made by smaller companies 鈥 often advertised as being made from goat milk, (which lacks one common milk protein), or vegan ingredients that aren鈥檛 soy 鈥 do meet nutritional requirements for infants, and some advertise that.
Harris argued that this confuses parents, too, and shouldn鈥檛 be allowed. Just because a toddler formula has the nutritional ingredients required by the FDA for infant formula doesn鈥檛 mean it has met the other tests required of infant formula, she said.
Federal regulators have not forced any of the companies to withdraw those products. In an email, FDA spokesperson Marianna Naum said, 鈥淭he FDA does not comment on potential compliance actions.鈥
One company, Nature鈥檚 One, whose toddler formulas are named 鈥淏aby鈥檚 Only,鈥 received a decade ago from the FDA about marketing them for infants. That case was closed in 2016. The company鈥檚 website says that Baby鈥檚 Only formula 鈥溾 and that 鈥.鈥 Critics say that language implies the formula is fine for babies younger than 1. The company鈥檚 website and its Instagram account feature customer testimonials from parents who report feeding the formula to their infants, as well as pictures of infants drinking it.
Jay Highman, CEO and president of Nature鈥檚 One, said that Baby鈥檚 Only is clearly labeled as a toddler formula and that the back of the can states that 鈥淏aby鈥檚 Only is intended for a toddler 1-year of age or older OR when directed by a healthcare professional.鈥 He also said that since the company launched in 1999, its formulas have met all the nutritional, manufacturing, and safety standards required of infant formula even though they don鈥檛 have to. 鈥淲e behaved like we are an infant formula, but we were selling it as a toddler formula,鈥 Highman said.
He said that the clinical trials required by the FDA are a huge barrier to bringing a new infant formula to market and that many other countries don鈥檛 require a clinical trial. Baby鈥檚 Only recently completed a clinical trial, he said, and the company expects to be able to sell it as an infant formula soon.
Yet pediatricians and nutritional experts continue to caution parents about using the toddler drinks. 鈥淭here鈥檚 no question that infant formula is very important in the first year of life,鈥 Daniels said. But he doesn鈥檛 recommend the toddler version 鈥渂ecause it鈥檚 not that useful, because it鈥檚 confusing, because it鈥檚 expensive.鈥