Vitamin D is a fat-soluble vitamin that is essential for human health. It comes in many forms. The two major forms are 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). Vitamin D is a food additive added to food as an optional ingredient.
Under the law, the 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.
In July 2016, FDA approved an increase to the amount of vitamin D that may be added as an optional ingredient to milk, and approved the addition of vitamin D to beverages made from edible plants intended as milk alternatives, such as beverages made from soy, almond, and coconut, and edible plant-based yogurt alternatives. Vitamin D was already authorized for use in soy beverages, but today’s approval increases the authorized amount for such beverages that are intended as milk alternatives.
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.
Manufacturers may begin using the new amounts on July 18, 2016. See the Federal Register Notice for more information.