As required by law, Prolacta Bioscience is registered as a food manufacturer with FDA and the Department of Homeland Security. The US FDA Center for Food Safety and Applied Nutrition has determined that Prolacta’s added-mineral products are to be regulated as infant formulas. As such, Prolacta Bioscience is required to be in compliance with Federal regulations governing the production and labeling of such items as covered by statute in 21 CFR 100-169, and, in particular, parts 105-107 dealing with infant foods.
Additionally, the states of California and New York define and regulate human milk as a tissue which requires State specific tissue bank licenses. These regulations are specific to the proper collection, handling and distribution of human tissues, particularly human breast milk. Prolacta Bioscience maintains a current tissue banking license from both of these states and have had multiple site visits from the FDA and CA DHS with no written observations issued.
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