September 15, 2023. Joshua Fitch, Editor
FDA warns parents, caregivers about illegally sold infant formula | Image Credit: © iQoncept - stock.adobe.com.
The LittleOak Company is issuing a voluntary recall for two infant formula products following the FDA's determination that they were illicitly sold in the United States.
The FDA has issued a warning to parents and caregivers regarding the voluntary recall of infant formula by the LittleOak Company, as these products were found to be illegally sold in the United States, according to a press release on Thursday, September 14, 2023.
The affected products, namely LittleOak Natural Goat Milk Infant Formula and LittleOak Natural Goat Milk Follow-on Formula, are being recalled after being sold in the United States without the submission of a premarket notification to the FDA. Parents and caregivers are strongly advised against feeding infants with LittleOak Infant Formula. The FDA emphasizes that premarket notifications for new infant formula are essential for demonstrating safety and nutritional adequacy by providing key information on ingredients, nutritional content, and manufacturing before long-term availability in the US market. The introduction of new infant formula without proper FDA notification is strictly prohibited.
It is crucial for parents and caregivers to be aware that these products, sold online via the company’s website, have not undergone evaluation to ensure compliance with nutritional and food safety standards. Furthermore, the preparation instructions on the product labels do not align with commonly used measurements on infant formula bottles in the United States, posing potential challenges for caregivers attempting to achieve the required concentration. Failure to mix the formula appropriately could result in inadequate nutrition for the infant. The FDA strongly discourages the use of alternative measurements, such as spoons or measuring cups, as these could introduce microbial contaminants to the formula.
Following communication with the FDA, the company voluntarily recalled the affected formulas on September 9, 2023. Sales and distribution of the recalled infant formulas in the United States have been halted until all necessary requirements are met.
Photo courtesy of FDA
In 2022, the FDA deferred the LittleOak Company's request for enforcement discretion to temporarily sell infant formula in the United States. This decision was based on concerns related to product label preparation instructions and unanswered questions regarding two ingredients that had not been evaluated by the FDA for their safety in infant formula use. Ultimately, the FDA did not grant enforcement discretion to the LittleOak Company.
There have been no reported illnesses or complaints associated with LittleOak products according to the FDA. Individuals seeking alternative goat milk infant formulas in the United States can refer to currently available formulas under the FDA's enforcement discretion policy.Reference:
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
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