A California-based company has issued a warning over its toddler formula on Thursday after the U.S. Food and Drug Administration (FDA) said it may be unsafe for babies.
Sammy's Milk of Newport Beach, California, put out an announcement after the FDA "identified representations" on the company's website and social media that "could be interpreted to indicate the product is safe for infants to consume."
The company's announcement warned not to use Goat Milk Toddler Formula for babies "because the FDA is concerned that the formula may not meet all FDA requirements for infant formula and may be unsafe and not provide sufficient nutrition when used as an infant formula."
Newsweek has contacted Sammy's Milk for comment via email.
In the statement, shared by the FDA on its website, the company said: "Sammy's Milk wants to emphasize that its product is specifically formulated for children between the ages of 12 and 36 months, as clearly indicated on its packaging and website. The product at issue was only available online, and included lot code SD348, with a 'Best by' date of August of 2025. While Sammy's Milk takes pride in providing a nutritious and wholesome option for toddlers, it is crucial that users adhere to the recommended age range for the consumption of our product."
It added: "As a company dedicated to the health and well-being of children, we prioritize transparency and accuracy in our product information. We encourage caregivers and parents to always follow age-specific recommendations and consult with healthcare professionals for guidance on infant nutrition."
Customers with further questions were urged to contact Sammy's Milk at info@sammysmilk.com.
Infant formulas, usually targeted at babies aged up to 12-month-olds, are held to strict standards and must satisfy all of the nutritional needs of a young child in their sole liquid form.
"Among the requirements for infant formulas, the FDA specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients. In addition, any ingredient used in infant formula must be safe and suitable for such use," according to the FDA.
A report published by the American Academy of Pediatrics (AAP) last year found that "follow-on formulas," those typically aimed at children 12 to 36 months of age, are not necessary for the majority of children.
Researchers from AAP's Committee on Nutrition said that in most cases fortified cow milk is better after reviewing the growing array of toddler formulas and concluded that the majority of these products were promoted using misleading marketing tactics.
"Compared with unfortified cow milk, some children who consumed OIYCFs (older infant-young child formulas) have demonstrated improved vitamin D and E intakes. 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," the report said.
A spokesperson for Abbott, one of the largest producers of formulas in the United States, said at the time that there may be other circumstances in which toddler formulas are necessary or useful.
"National health studies indicate that U.S. toddlers have nutritional gaps in their diet often related to picky eating. When they don't do well transitioning to table foods, or won't drink milk, our toddler drinks contain many of the complementary nutrients, such as vitamins and minerals, that they may be missing in their diet. Toddler drinks may be an option to help fill nutrient gaps for these children 12 to 36 months of age. Abbott does not recommend or indicate its toddler drinks for infants under 12 months of age," a company spokesperson said in a statement.
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