Under the law, FDA may approve the use of a food additive only after conducting a scientific safety review of the information provided in the petition to ensure that use of ingredients added to foods are safe for the general population. In this case, the FDA evaluated the projected human dietary exposure to vitamin D from foods and dietary supplements, safety data, and other relevant information and found these uses of vitamin D to be safe.
Vitamin D is a fat-soluble vitamin that is essential for human health. It comes in many forms; the two major forms being vitamin D2 and vitamin D3. Vitamin D without a subscript represents either vitamin D2 or vitamin D3 or both. The major function of vitamin D is to help with the absorption of calcium and phosphorus in the small intestine. Vitamin D deficiency can lead to abnormalities in bone metabolism, such as rickets in children or osteomalacia in adults. Excess intake of vitamin D can also be harmful, elevating calcium levels in the blood (hypercalcemia).
The approval, which amends existing food additive regulations, will allow manufacturers to voluntarily add up to 84 IU/100g of vitamin D3 to milk, 84 IU/100g of vitamin D2 to plant-based beverages intended as milk alternatives, and 89 IU/100g of vitamin D2 to plant-based yogurt alternatives.
As of July 18, 2016, manufacturers may begin using the new amount of vitamin D.