FDA Alerts Parents and Caregivers to Concerns Regarding LittleOak Infant Formula

 

LittleOak Natural Goat Milk Infant Formula & LittleOak Natural Goat Milk Follow-on Formula  

The U.S. Food and Drug Administration (FDA) has issued an alert to parents and caregivers regarding concerns about LittleOak infant formulas. The products in question include LittleOak Natural Goat Milk Infant Formula and LittleOak Natural Goat Milk Follow-on Formula (pictured above).

These products were primarily sold online through the company’s official webpage.

Recall and Reason

The FDA has informed that LittleOak infant formulas are currently undergoing a voluntary recall by the company. 

The reason for this recall is that these products have been sold in the U.S. without the necessary premarket notification submission to the FDA. 

Such notifications are crucial as they provide the FDA with an opportunity to review essential details about the product's ingredients, nutritional information, and manufacturing processes before they are made available long-term in the U.S. market.

Problem and Scope

The FDA has determined that the LittleOak Infant Formula was sold in the U.S. without adhering to the FDA’s infant formula regulations. Due to the absence of the required premarket notification, these products have not been evaluated to ensure they meet U.S. food safety and nutritional standards. 

Additionally, the preparation instructions on the product labels do not match the measurements commonly found on infant formula bottles in the U.S. This discrepancy can lead to potential errors in formula preparation, which might result in undernutrition or over-concentration of the formula, causing health issues like dehydration, electrolyte imbalance, and kidney problems.

Advice to Consumers

The FDA strongly advises parents and caregivers not to feed LittleOak Infant Formula to infants. The products have not been evaluated for U.S. food safety and nutritional standards. 

The preparation instructions on the containers might confuse caregivers, leading to potential errors in formula mixing. Such errors can have adverse effects on the infant's health, including dehydration and kidney issues. 

The FDA also discourages the use of alternative measuring methods, like cups or spoons, as they could introduce microbial contaminants to the formula.

Background

The LittleOak infant formula was sold without submitting the necessary premarket notification to the FDA. As a result, it has not been evaluated for U.S. food safety and nutritional standards. 

On September 9, 2023, the company agreed to voluntarily recall the affected products and halt the sale and distribution of infant formula to the U.S. until they meet the required standards. 

2022 Background 

In 2022, the LittleOak Company had sought permission to temporarily sell infant formula in the U.S., but the FDA deferred their request due to concerns about the product labels and certain ingredients.

Reporting Issues

If anyone has complaints or adverse events related to the LittleOak products, they can report directly to the FDA through various channels, including calling an FDA Consumer Complaint Coordinator or completing an electronic or paper Voluntary MedWatch form.

For more detailed information, you can visit the official FDA website

My thoughts

It is quite stunning that any formula company would sell a product that had not been approved. Typically formula companies follow the basic nutritional guidelines and are routinely given approval to sell their products. It would be very interesting to see what the issues flagged were for this.

But, more importantly, I am thrilled to see that this recall is also because of the lack of basic standard preparation labelling, which can allow for contamination of the product. After all that we know about formula being contaminated or how improper labelling can cause health issues with babies, how is this still happening?

Jacqui

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