An overview of infant and toddler formulas: New guidance, new questions
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For a long time, the only infant formula options available in the United States were cow’s milk-based, soy milk-based or specialty infant formulas.
This past October, the AAP published guidelines on choosing an infant formula that expanded the category to include both cow and goat milk-based infant formulas as first-line choices able to provide optimal nutrition for babies.
Infant formula has long been subject to stringent FDA regulations that were established under the Infant Formula Act passed by Congress in 1980 and then amended in 1986. The act established rigorous quality and safety standards to ensure that infant formula is a reliable source of nutrition. It is a distinct FDA category, and manufacturing facilities undergo annual FDA inspections.
But infant formula manufacturing in the U.S. has become increasingly consolidated and controlled by only a handful of players, leading to problems. In early 2022, two companies controlled about 80% of the market share, with over 90% controlled by four companies. Additionally, before mid-2022, there were virtually no infant formulas legally imported into the U.S. because few companies overseas had FDA clearance for their manufacturing facilities or for importing the formula that was produced in them.
This set the scene for the severe shortage of formula that began with the COVID-19 pandemic.
Formula shortage
Supply chain issues related to the pandemic led to shortages beginning in 2020, but the situation dramatically escalated in February 2022, when Abbott, the biggest U.S. supplier of powdered infant formula, closed its Michigan plant following reports of bacterial infections in four infants.
Overnight, about a third of all infant formula in the U.S. was removed from shelves. Because of the magnitude of the shortage, Operation Fly Formula was initiated by the U.S. Department of Agriculture, HHS and the General Services Administration to import infant formula from other nations that meet U.S. health and safety standards. The FDA exercised enforcement discretion to allow certain foreign infant formulas into the U.S. to help alleviate a product shortage, but now that the emergency use authorization is subsiding, companies must meet U.S. regulations to continue selling their products here.
The FDA has recognized the need to diversify and support a stable supply of infant formula in the U.S. and has provided a pathway for overseas producers to secure long-term authorization to sell their products here. Several companies have demonstrated that they are working to meet all U.S. requirements according to a recommended timetable specified by the FDA. The pathway, however, is still arduous, requiring specific tolerability in clinical trials that evaluate the growth, tolerance and safety of new infant formulas to be submitted to the FDA, aligning with the standard U.S. regulatory process.
Kabrita USA is the first company to receive long-term FDA authorization for its goat milk-based infant formula. According to the company, which is headquartered in the Netherlands, where the formula is manufactured, the product will be available in the U.S. in early January 2024.
Based in the United Kingdom, Kendamil, which was working with the FDA on plans to enter the U.S. market before the formula shortage, is completing its clinical trial and is moving forward on the regulatory pathway. An Australian company, Aussie Bubs, also produces goat milk-based formulas and is pursuing the pathway to permanently market its products in the U.S. It is currently enrolling infants in a clinical trial.
New report on toddler formulas
Toddler formulas, which are intended to be used as supplemental nutrition for older infants and toddlers aged 12 to 36 months, present a contrast to infant formula. Having become increasingly popular during the past few years as a “follow-up” to infant formula or breast milk, toddler formulas are marketed as a transition drink for children when they wean off breast milk or infant formula.
A new guidance report presented at the 2023 AAP National Conference & Exhibition questions if this type of formula is really needed. The report noted that in most cases, the diets of American children are adequate and that toddler formulas do not provide a nutritional advantage. The AAP was also critical of the marketing practices used by manufacturers, in that they may mislead parents and caregivers about product benefits and appropriateness for their child. Toddler milk products are often depicted as a necessary “next stage “or “next step” to ensure optimal nutrition as they get older. There is often cross-promotion with infant formulas, using similar names, packaging, logos, pictures and slogans, and there are currently no requirements that toddler drink packaging must be distinguished from that of infant formula.
Of particular concern is that unlike infant formulas, the FDA does not have a distinct category for toddler drinks, and there are no uniform criteria for the composition or definition of “formulas” geared to this population.
“The toddler formulas are completely unregulated,” said George J. Fuchs, III, MD, FAAP, a member of the AAP Committee on Nutrition, which produced the clinical report, and who spoke about the topic at the AAP meeting. “There are no composition requirements, and the FDA does not have any oversight responsibility for them. The nomenclature used is also at the discretion of the company.”
Various international expert groups have developed recommendations regarding the composition of these products, but regulatory oversight in the U.S. does not currently exist. There is no clear distinction between medically necessary oral or enteral nutrition and these toddler drinks. “They are not nutritionally complete, and they are a heterogeneous group characterized by wide variation in composition,” Fuchs said.
Pathway for toddler formulas?
The recent AAP report cited unnecessary cost and a lack of nutritional advantage as the key reasons why most toddlers do not need these supplemental beverages. It reminds pediatricians to educate parents to offer a nutritionally balanced diet and not rely on a liquid nutritional supplement because their child is a picky eater.
The report does acknowledge that these toddler drinks "can safely be used as part of a varied diet for children," so pediatricians can tailor their advice based on the unique needs of their patients. Discussing this new report with families is an opportunity to reassure parents and support them as they navigate the challenges of feeding a toddler.
References:
FDA authorizes marketing of Kabrita’s goat milk-based infant formula in the US. https://www.prnewswire.com/news-releases/fda-authorizes-marketing-of-kabritas-goat-milk-based-infant-formula-in-the-us-301874068.html. Published July 11, 2023. Accessed Nov. 18, 2023.
FDA warns consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility. Published Feb. 17, 2022. Accessed Nov. 18, 2023.
Fuchs GJ, et al. Pediatrics. 2023;doi:10.1542/peds.2023-064050.
HealthyChildren.org. Choosing a baby formula. https://www.healthychildren.org/English/ages-stages/baby/formula-feeding/Pages/choosing-an-infant-formula.aspx. Last updated Oct. 20, 2023. Accessed Nov. 18, 2023.
Kabrita’s goat milk infant formula meets the FDA’s nutrition and safety requirements. https://ausnutria-nutrition-institute.com/publications/ausnutria-gains-access-to-the-us-market-with-kabrita-infant-formula/. Published July 13, 2023. Accessed Nov. 18, 2023.
Ari Brown, MD, FAAP, is a pediatrician in private practice in Austin, Texas, and the author of Baby411.
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