Which of the following is a key feature of oral Vitamin K in relationship to FDA approval?

Oral Vitamin K is not currently FDA approved for use in newborns, which is a critical feature regarding its regulatory status. Although Vitamin K is vital for newborns to prevent bleeding disorders like Vitamin K deficiency bleeding (VKDB), the FDA has not granted approval specifically for the oral administration of Vitamin K to all newborns.

While healthcare practitioners commonly recommend Vitamin K injections at birth to ensure adequate levels for infants, the oral formulation does not carry the same approval status, indicating that the FDA has not officially evaluated or sanctioned it for this specific use. This distinction is significant in understanding the regulatory landscape of neonatal care and the use of Vitamin K supplementation for newborns.

In practice, even though doctors often advise Vitamin K for infants either orally or via injection, it is particularly important to distinguish that the injection form is the one typically utilized and endorsed within established guidelines.