November 22, 2023
4 minutes of reading
For a long time, the only infant formula options available in the United States were cow’s milk, soy milk, or specialty infant formulas.
Last October, the AAP released guidelines for choosing an infant formula that expanded the category to include cow’s and goat’s milk-based infant formulas as first-line choices capable of providing optimal nutrition for babies.
Infant formula has long been subject to strict FDA regulations, established under the Infant Formula Act passed by Congress in 1980 and subsequently amended in 1986. The law established rigorous standards for quality and safety to ensure that infant formula is a reliable source of nutrition. This is a separate FDA category and manufacturing facilities are subject to annual FDA inspections.
But infant formula manufacturing in the United States is increasingly consolidated and controlled by just a handful of players, leading to problems. At the start of 2022, two companies controlled around 80% of the market share, of which more than 90% was controlled by four companies. Additionally, before mid-2022, there was virtually no infant formula legally imported into the United States because few foreign companies had FDA clearance for their manufacturing facilities or for import the preparations that were produced there.
This set the stage for the severe infant formula shortage that began with the COVID-19 pandemic.
Formula shortage
Pandemic-related supply chain issues led to shortages beginning in 2020, but the situation worsened significantly in February 2022, when Abbott, the largest U.S. supplier of powdered infant formula, closed its Michigan factory following reports of bacterial infections in four infants.
Overnight, about a third of all infant formula in the United States was removed from shelves. Due to the magnitude of the shortage, Operation Fly Formula was launched by the U.S. Department of Agriculture, HHS, and the General Services Administration to import infant formula from other countries that meets U.S. health standards and security. The FDA exercised its discretion to allow certain foreign infant formula into the United States to help alleviate a product shortage, but now that the emergency use authorization declines, companies must comply with U.S. regulations to continue selling their products here.
The FDA recognized the need to diversify and support a stable supply of infant formula in the United States and provided a means for foreign producers to obtain long-term authorization to sell their products here. Several companies have demonstrated that they are working to meet all U.S. requirements within a recommended schedule specified by the FDA. However, the journey remains arduous, requiring specific tolerance in clinical trials that evaluate the growth, tolerability and safety of new infant formulas that must be submitted to the FDA, in accordance with the standard US regulatory process.
Kabrita USA is the first company to receive long-term FDA approval for its goat’s milk-based infant formula. According to the Netherlands-headquartered company, where the formula is manufactured, the product will be available in the United States in early January 2024.
UK-based Kendamil, which was working with the FDA on plans to enter the US market before the formula shortage, is completing its clinical trial and moving forward on the regulatory pathway. An Australian company, Aussie Bubs, also produces goat’s milk preparations and is continuing the process of permanently marketing its products in the United States. She is currently recruiting infants in a clinical trial.
New report on infant formula
In contrast to infant formula, infant formula is intended for use as a dietary supplement for older infants and toddlers aged 12 to 36 months. Becoming increasingly popular in recent years as a “follow-up” to infant formula or breast milk, infant formula is marketed as a transition drink for children as they wean themselves from breast milk or formula. for infants.
A new policy report presented at the 2023 AAP National Conference and Exhibition wonders if this type of formula is really necessary. The report notes that in most cases, the diets of American children are adequate and that infant formula provides no nutritional benefit. The AAP also criticized marketing practices used by manufacturers, as they may mislead parents and guardians about the benefits and suitability of the products for their child. Dairy for toddlers is often described as a necessary “next step” or “next step” to ensure optimal nutrition as they grow. There is often cross-promotion with infant formula, using similar names, packaging, logos, images and slogans, and there is currently no requirement that packages of infant drinks be distinguished from those infant formula.
Of particular concern is that unlike infant formula, the FDA does not have a separate category for toddler drinks, and there are no uniform criteria for the composition or definition of ” preparations” adapted to this population.
“Infant formula is completely unregulated,” said George J. Fuchs, III, MD, FAAP, a member of the AAP Committee on Nutrition, who produced the clinical report and who spoke on the topic at the AAP meeting. “There are no compositional requirements and the FDA has no 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 there is currently no regulatory oversight in the United States. There is no clear distinction between medically necessary oral or enteral nutrition and these toddler drinks. “They are not nutritionally complete and are a heterogeneous group characterized by wide compositional variation,” Fuchs said.
A path for toddler formula?
The recent AAP report cites unnecessary costs and lack of nutritional benefits as the main reasons most toddlers don’t need these complementary drinks. He reminds pediatricians to educate parents to provide a nutritionally balanced diet and not rely on a liquid nutritional supplement because their child is a picky eater.
The report acknowledges that these toddler drinks “can be used safely 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 relationship with families is an opportunity to reassure parents and support them in their challenges related to feeding a toddler.
The references:
FDA clears Kabrita goat’s milk infant formula for sale in the United States. 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 November 18, 2023.
The FDA is warning consumers not to use certain powdered infant formulas produced at the Abbott Nutrition 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 February 17, 2022. Accessed November 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 October 20, 2023. Accessed November 18, 2023.
Kabrita Goat’s Milk Infant Formula meets FDA 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 November 18, 2023.
Ari Brown, MD, FAAP, is a pediatrician in private practice in Austin, Texas, and author of Baby411.
