Two infant formula products are being voluntarily recalled by the LittleOak Company after the FDA deemed they were illegally sold in the United States.
The FDA is alerting parents and caregivers about infant formula that the manufacturer is voluntarily recalling after US products were sold illegally, the federal agency announced in a Thursday, September 14, 2023, press release.
LittleOak natural Goat Milk Infant Formula and LittleOak Natural Goat Milk Follow-on Formula are being voluntarily recalled after they were sold in the United States submission of a premarket notification to the FDA. Parents and caregivers are advised not to feed LittleOak Infant Formula to infants. These notifications for new infant formula are “intended to demonstrate the safety and nutritional adequacy of the formula by providing the FDA the opportunity to review key information about ingredients in the product, key nutritional information, and manufacturing information… before the product is available long-term on the US market.” Introducing a new infant formula into the United States commerce without a premarket notification to the FDA is prohibited.
The agency highlights that parents and caregivers should be aware that the products, which were sold online via the company’s website, have not been evaluated to determine if they meet nutritional and food safety standards. On the label of the containers, preparation instructions do not align with measurements commonly displayed on infant formula bottles in the Untied States, potentially causing issues for caregivers and their ability to mix the formula at the required concentration. Failure to mix formulas to the appropriate concentration could lead to the dilution of the formula, potentially failing to supply the infant with adequate nutrition. The FDA does not recommend using alternative measurements for infant formula such as spoons or measuring cups, items that could introduce microbial contaminants to the formula.
On September 9, 2023, the company agreed to voluntarily recalled affected formulas, after communication with the FDA. Sales and distribution of the affected infant formulas have ceased sale in the United States until requirements are met.
The LittleOak Company’s request for enforcement discretion to be able to sell infant formula in the United States temporarily was deferred by the FDA in 2022, because of concerns surrounding product label preparation instructions, “among other reasons,” the FDA stated. The agency also had questions regarding 2 ingredients in the formulas that have “not yet been evaluated by the FDA to determine if they are safe to use in infant formula.” Ultimately, the FDA did not issue a letter of enforcement discretion to the LittleOak Company.
The FDA is not aware of illnesses or complaints associated with LittleOak products. For those looking for an alternative goat milk infant formula in the United States, click here to review current formulas marketed under the FDA’s enforcement discretion policy.
FDA alerts parents and caregivers to concerns regarding LittleOak infant formula. FDA. Press release. September 14, 2023. Accessed September 15, 2023. https://www.fda.gov/food/alerts-advisories-safety-information/fda-alerts-parents-and-caregivers-concerns-regarding-littleoak-infant-formula?utm_medium=email&utm_source=govdelivery