The final rule, published today in the Federal Register, follows a petition filed in 2007 by US food group Dean Foods. To access the rule, click here.
The amendment to the food additive regulations in part 172 (21 CFR part 172) Food Additives Permitted for Direct Addition to Food for Human Consumption allows for the addition of crystalline vitamin D2 – and not the resin from the vitamin – to soy beverages, soy beverage products, soy-based butter substitute spreads, soy-based cheese substitutes, and soy-based cheese substitute products.
The major function of vitamin D in the human body is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine.
However, although the vitamin is essential in humans, experts have noted that about one billion people are estimated to be vitamin D deficient, even more so since very few foods are fortified with the vitamin.
Vitamin D deficiency may precipitate or exacerbate osteopenia, osteoporosis, muscle weakness, fractures, common cancers, autoimmune diseases, infectious diseases and cardiovascular diseases. There is also some evidence that the vitamin may reduce the incidence of several types of cancer and type 1 diabetes.
Currently, the US Institute of Medicine (IOM) recommends that children and adults up to age 50 should consume 200 International Units (IU) of vitamin D per day – equivalent to 5μg. Adults aged between 51 and 70 should have an intake of 400 IU (10 μg), and adults aged 71 and over should consume 600 IU (15 μg).
In its petition, Dean Foods had requested that vitamin D2 be permitted for addition as a nutrient supplement at the following maximum levels:
· 50 IU per 100g of soy beverages
· 89 IU per 100g of soy beverage products, 330 IU per 100g of soy-based butter substitute spreads
· 270 IU per 100g of soy-based cheese substitutes and soy-based cheese substitute products
Because high levels of vitamin D can be toxic, IOM has set a tolerable upper intake level (UL) of 1,000 IU per day for infants, and 2,000 IU for children and adults.
In its petition, Dean Foods submitted dietary intake estimates from current and proposed uses and from naturally-occurring sources of vitamin D, and compared these to IOM’s tolerable upper intake levels.
After reviewing the data, FDA concluded that “there is a reasonable certainty that no harm will result from the use of vitamin D2 as a nutrient supplement” in the soy products in question.
Vitamin D is currently affirmed as generally recognized as safe (GRAS) for use in foods under 21 CFR 184.1950. The vitamin can be used in:
· infant formula and margarine (vitamin D2)
· calcium-fortified fruit juices and fruit juice drinks (vitamin D3)
· meal replacement bars and other bars (vitamin D3)
· soy protein-based meal replacement beverages positioned for maintaining body weight (vitamin D3)
· cheese and cheese products (vitamin D3)
The GRAS status covers both the crystalline and resin vitamin D2 and vitamin D3. However, the new rule (section 172.379) allowing for the addition of the vitamin to soy foods relates only to crystalline vitamin D2.