FDA Alerts Parents and Caregivers to Concerns Regarding LittleOak Infant Formula
Audience
- Parents and caregivers of infants who consume infant formula
Products
- LittleOak Natural Goat Milk Infant Formula
- LittleOak Natural Goat Milk Follow-on Formula
The products were sold online through the company’s webpage.
Purpose
The U.S. Food and Drug Administration (FDA) is alerting parents and caregivers about LittleOak infant formulas that are currently being voluntarily recalled by the company. The products have been sold in the U.S. illegally because the company has not submitted to the FDA the required premarket notification. Premarket 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, among other things, before the product is available long-term on the U.S. market. It is prohibited to introduce into U.S. commerce a new infant formula without submitting a premarket notification to the FDA.
Summary of Problem and Scope
The FDA determined that LittleOak Infant Formula was sold in the U.S. without complying with the FDA’s infant formula regulations. Because the firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Additionally, preparation instructions on the label of the containers do not align with measurements commonly displayed on infant formula bottles in the U.S. These directions may pose challenges to caregivers, impeding their ability to properly mix the formula at the appropriate concentration. Errors in mixing the infant formula could lead to diluting the formula and failing to supply the infant with adequate nutrition, which may slow or delay growth; or over-concentrating the formula, which could lead to dehydration, electrolyte imbalance, and kidney issues. The FDA does not recommend that caregivers use other ways to measure infant formula (such as measuring cups or spoons), which could introduce microbial contaminants to the product.
Further Information for Consumers
The FDA advises parents and caregivers not to feed LittleOak Infant Formula to infants under their care. Parents and caregivers of infants who have purchased these products should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. For example, the formulas contain some ingredients that have not yet been evaluated by FDA to determine if they are safe to use in infant formula. Further, they should be aware that the preparation instructions on the label of the containers do not align with measurements commonly displayed on infant formula bottles in the U.S. These directions may pose challenges to caregivers, impeding their ability to properly mix the formula at the appropriate concentration. Errors in mixing the infant formula could lead to diluting the formula and failing to supply the infant with adequate nutrition, which may slow or delay growth; or over-concentrating the formula, which could lead to dehydration, electrolyte imbalance, and kidney issues. The FDA does not recommend that caregivers use other ways to measure infant formula (such as measuring cups or spoons), which could introduce microbial contaminants, such as Cronobacter sakazakii, to the product.
If parents and caregivers are looking for an alternative goat milk infant formula for sale in the U.S., there are goat milk infant formulas that are currently being marketed under the FDA’s enforcement discretion policy.
At this time, the agency is not aware of any associated illnesses or complaints related to the LittleOak products.
To report a complaint or adverse event (illness or serious allergic reaction), you can:
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Background
Little Oak infant formula was sold without the submission of a required premarket notification to the FDA and, therefore, has not been evaluated to determine whether the product meets U.S. food safety and nutritional standards. The FDA has communicated to the firm that they have not met the requirements for selling infant formula in the U.S., and on September 9, 2023, the firm agreed to voluntarily recall the affected products and cease sale and distribution of infant formula to the U.S. until the firm has met the requirements to do so.
Previously, in 2022, the LittleOak Company requested enforcement discretion to be able to sell infant formula in the U.S. temporarily. The FDA deferred consideration of their request because of concerns regarding the preparation instructions on the product labels, among other reasons. In addition, the FDA had questions about two ingredients in their infant formulas that have not yet been evaluated by FDA to determine if they are safe to use in infant formula. The FDA did not believe these issues could be resolved quickly to help meet the need during the infant formula shortage, and ultimately did not issue a letter of enforcement discretion to the LittleOak Company.