FDA Amends Food Additive Regulations to Expand Permitted Uses of Vitamin D in Food

Contributor: Rachel Rosenberg

As of July 16, 2016, FDA’s amendment to expand the safe uses of vitamin D2 and D3 as nutrient supplements in food for human consumption became effective. This amendment stems from a food additive petition (FAP 3A4801) filed by Dean Foods Company and WhiteWave Foods Company. Vitamin D2 may now be used in edible plant-based food products intended for use as milk alternatives and yogurt alternatives, while vitamin D3 may now be used in milk at levels higher than previously permitted.

Dean Foods/ WhiteWave requested the following amendments:

1. In edible plant-based beverages intended for use as milk alternatives, levels of vitamin D2 as a nutrient supplement are not to exceed 84 International Units (IU) per 100 grams (g).
2. In edible plant-based yogurt alternatives, levels of vitamin D2 are not to exceed 89 IU per 100 g.
3. The proposed use of 84 IU vitamin D2 per 100 g in edible plant- based beverages would replace the then allowable maximum use of 50 IU per 100 g in soy beverages.
4. The “soy beverages” category would be eliminated to create a new category of food that may be supplemented with vitamin D2.
5. In milk, vitamin D3 would be permitted as a nutrient supplement at levels higher than those then permitted.

To support their petition, Dean Foods/WhiteWave submitted dietary exposure estimates and dietary sources of vitamin D, all of which were in line with the FDA’s food additive regulations and their GRAS affirmation regulation. Based on this information, as well as a number of publications regarding human clinical studies on vitamin D, they had determined that vitamin D’s proposed uses are safe.

Vitamin D is essential for human health. Its main purpose is to enhance the absorption of calcium and phosphorus in the small intestine, which ensures a healthy level of those minerals in blood serum concentrations. Vitamin D deficiency can lead to calcium and bone abnormalities, which are more commonly seen as rickets (children) and osteomalacia (adults). However, an excessive intake of vitamin D may cause hypercalcemia in the blood plasma. To ensure that this does not occur, FDA has specified that vitamin D may only be used in food within GRAS limitations, including the category of food, functional use of the ingredient and the level of use.

Vitamin D (affirmed as GRAS) has been widely used in infant formula and margarine. More specifically, vitamin D3 has been approved as a nutrient supplement for use in fruit juices, meal replacement and other types of bars, soy beverages used for maintaining or reducing body weight and certain cheese/cheese products. Vitamin D2 is approved for use as a nutrient supplement in soy beverages and soy-based butter & cheese substitutes. It is also approved as a food additive in a leavening agent commonly found in yeast-leavened baked goods, baking mixes and yeast-leavened baked snack foods.

In order to ensure the safety of vitamin D, certain data and information were taken into account: projected human dietary exposure to the additive, the additive’s toxicological data, and other relevant information available (e.g. published articles). The documents that FDA considered and relied upon in reaching its decision to approve the petition will be made publicly available.