By The Food and Drug Administration (FDA) has issued a warning to Abbott Laboratories and Infinant Health for illegally selling probiotic products that have not been approved for use in preterm infants. In a statement released on Thursday, the FDA informed healthcare providers about the potential risks associated with these products, which contain live bacteria or yeast.
It is crucial to highlight that the FDA has pointed out the dangers these products pose to preterm infants, citing one reported infant death this year due to the use of a probiotic product in a hospital setting to prevent necrotizing enterocolitis.
The FDA emphasized that no probiotic product has been approved as a drug or biological product for use in infants of any age. As a result, the regulatory body has reached out to Abbott and Infinant regarding specific products.
In a letter sent on Tuesday, the FDA addressed Abbott concerning its Similac Probiotic Tri-Blend. Abbott has agreed to discontinue sales of this product and collaborate with the FDA on further corrective actions.
Additionally, the FDA has issued a warning to Infinant regarding its probiotic product, Evivo with MCT Oil, which was being sold to treat or prevent disease in preterm infants. Following the FDA’s advisory, Infinant voluntarily recalled the product, and it is no longer available in the United States.
These actions demonstrate the FDA’s commitment to ensuring the safety and well-being of preterm infants by holding companies accountable for selling unapproved probiotic products.
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