2022-09-22

Formula May Be Right for Infants, but Experts Warn That Toddlers Don’t Need It

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.

Pediatricians and federal health officials say that when most children turn 1, they can begin drinking cow milk or an unsweetened plant-based milk substitute. In a 2019 “consensus” statement, the American Academy of Pediatrics and other health and nutrition organizations recommended against using toddler formulas, saying “they offer no unique nutritional value beyond what could be obtained with healthy foods; furthermore, they may contribute added sugars to the diet.” The toddler formulas often contain sweeteners and fats that add calories.

Some of the same companies that produce infant formula — including Enfamil, Gerber, and Similac — 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’s brain, immune system, and eye development, among other benefits. They are different from medical formulas prescribed for children with specific needs.

A 2020 study 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 Jennifer Harris, a marketing and public health researcher at the University of Connecticut. She found that 60% of caregivers falsely believed toddler formulas have nutrients that toddlers can’t get from other foods.

Dr. Anthony Porto, 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’s designed for infants, toddler formula has no nutritional regulations: Experts say standardizing a supplement to toddlers’ diets is impossible because no two children are alike.

In focus groups, Harris said, parents report feeding their children toddler formula to fill nutritional gaps when a child isn’t eating enough, a common concern among parents.

“Infants are often voracious eaters,” said Dr. Stephen Daniels, chair of pediatrics at Children’s Hospital Colorado. But at around a year of age, children’s growth plateaus, he said, and “they’re suddenly not hungry in the way they used to be anymore.” That can worry parents, he added, but “it’s a completely normal phenomenon.”

If parents have concerns about their children’s 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 “nutritional gaps during this period of transition to table foods.” Lincoln, a former U.S. senator from Arkansas, said the drinks “help 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.”

But toddler formula isn’t being ingested by toddlers alone — it’s also being fed to infants. In a recent study, Porto and colleagues found that 5% of infants’ parents reported giving their babies drinks marketed for the older age group. And Harris’ research indicated that 22% of parents 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.

“Infant formulas and toddler formulas tend to be next to each other in the supermarket,” Harris said. “They 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, ‘Oh, this one is less expensive. I’ll get this one instead.’”

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. “Unlike infant formulas, toddler formulas are not necessary to meet the nutritional needs of their intended consumers,” Haake said.

In a statement to KHN, the Infant Nutrition Council of America said, “Toddler 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.”

However, several expensive toddler formula brands made by smaller companies — often advertised as being made from goat milk, A2 whole milk (which lacks one common milk protein), or vegan ingredients that aren’t soy — do meet nutritional requirements for infants, and some advertise that.

Harris argued that this confuses parents, too, and shouldn’t be allowed. Just because a toddler formula has the nutritional ingredients required by the FDA for infant formula doesn’t 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, “The FDA does not comment on potential compliance actions.”

One company, Nature’s One, whose toddler formulas are named “Baby’s Only,” received warning letters a decade ago from the FDA about marketing them for infants. That case was closed in 2016. The company’s website says that Baby’s Only formula “meets nutrient requirements for infant” and that “Baby’s Only Organic® can be served up to 3-years of age.” Critics say that language implies the formula is fine for babies younger than 1. The company’s 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’s One, said that Baby’s Only is clearly labeled as a toddler formula and that the back of the can states that “Baby’s Only is intended for a toddler 1-year of age or older OR when directed by a healthcare professional.” 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’t have to. “We behaved like we are an infant formula, but we were selling it as a toddler formula,” 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’t require a clinical trial. Baby’s 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. “There’s no question that infant formula is very important in the first year of life,” Daniels said. But he doesn’t recommend the toddler version “because it’s not that useful, because it’s confusing, because it’s expensive.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.