LittleOak will recall its baby formula products after they were “illegally” sold in the United States, the Food and Drug Administration announced Thursday. Photo courtesy of FDA
Sept. 15 (UPI) -- LittleOak will recall its baby formula products after they were "illegally" sold in the United States, the Food and Drug Administration announced Thursday.
The company, based in New Zealand, sells goat milk-based infant formulas that have been sold in the United States through the company's website, the FDA said in its announcement.
"The products have been sold in the U.S. illegally because the company has not submitted to the FDA the required premarket notification," the regulators said.
"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."
LittleOak said in a statement on its website that parents in the United States began purchasing the company's formulas during an infant formula shortage after two babies died from bacterial infections after consuming U.S.-made Similac.
"As a result of this overwhelming support, we began the process to secure FDA approval for our LittleOak infant formula range," the company said.
"Sadly, while our application is still in process, the FDA has requested us to stop selling our infant formula products to U.S. families through our global online channel while we complete the pre-market approval, which primarily focuses on creating U.S. FDA-compliant labeling."
The company said it will focus its efforts to obtain FDA approval "as quickly as we can" to ensure the products can be sold again in the United States.
"It leaves us in an absolutely heartbreaking position where we have no choice but to immediately stop providing U.S. families with LittleOak formula -- a formula that we know many of you have come to rely on," the company said.
LittleOak stressed that the recall does not pertain to a quality or safety issue but one of compliance. In its statement, the FDA said the preparation instructions on the label of the containers do not align with measurements commonly displayed on infant formula bottles in the U.S.
Parents and caregivers following these directions could improperly mix the infant formula, which could lead to diluting the formula and failing to supply the infant with adequate nutrition or over-concentrating the formula. This could cause dehydration, electrolyte imbalance and kidney issues.
"LittleOak has been nourishing children for years and feeds millions of infants and babies across the globe every day, and will continue to do so," the company said.
"LittleOak is proudly manufactured in New Zealand, which has the highest production and quality standards anywhere in the world, including the U.S."
Still, LittleOak said the company plans to soon begin manufacturing FDA-compliant milk for toddlers in the United States which will be available for U.S. families "in the coming months."