Unilever USA filed the petition in August 2003, along with published human clinical trials on vitamin D and estimates of dietary intake of vitamin D from natural sources and current and proposed uses.
Vitamin D occurs naturally in foods including dairy products, eggs, fish, meat fats and organ meats and mushrooms, and is also produced by the body with exposure to ultraviolet light.
It is important for human health since it enhances the absorption of calcium and phosphate from the small intestine, thereby maintaining blood serum concentrations. Deficiency can lead to bone disorders, such as rickets in children and osteomalacia in adults.
When taken in too high doses, however, it can also be dangerous, causing elevated blood plasma calcium levels through excessive absorption of calcium from the intestine and resorption from bone.
The tolerable upper intake level for the vitamin, as established by the Institute of Medicine in 1996, are 2000 IU (international units) per day for adults and children over the age of one year, and 1,000 IU per day for infants.
Recommended intake is 200 international units per day (IU/d) for young adults, 400 IU/d for those aged 51 to 70 years, and 600 IU/d for those over age 70.
However recent evidence has suggested that the population is more likely to suffer from a lack of vitamin D than an excess.
In a presentation to the American Academy of Dermatology Association in May, Columbia University's Dr Vincent DeLeo warned that some sectors of the population, particularly older adults and darker-skinned people, may not glean the vitamin D they need from incidental exposure or diet. He recommended supplementation, rather than trying to boost intake through increased sun exposure, which increases the risk of skin cancer.
Also this year a study presented at a meeting of the American Association of Clinical Endocrinologists suggested that more than half of osteoporosis sufferers do not consume sufficient quantities of vitamin D, an oversight that could make them more vulnerable to falls and fractures.
Unilever's petition specifically flagged the potential use of vitamin D3 in "meal replacement bars, other-type bars, and soy-protein based meal replacement beverages that are represented for special dietary use in reducing or maintaining body weight".
Based on the evidence presented, Unilever said that vitamin D3 was safe for use in bars up to 100 IU per 40 g product, and in soy-protein based meal replacement beverages up to 140 IU per 240 ml product.
After reviewing the material, the FDA concluded "there is a reasonable certainty that no harm will result from the use of vitamin D3 as a nutrient supplement in meal replacement bars… Thus, vitamin D3 is safe for its proposed use."
This decision means that the administration will go ahead and amend section 172.380 Vitamin D3 (21 CFR 172.380) of the food additives regulations to allow for the new use.
Vitamin D, including vitamin D3, is affirmed GRAS for use in infant formula, margarine and other foods with certain limitations: up to 350 international units (IU) per 100 grams in breakfast cereals; 90 IU per 100 grams in grain and pasta products; 42IU per 100 grams in milk; and 89 IU per 100 grams in milk products.
Any use outside the scope of the limitations (including the food categories) requires either food additive regulation or an amendment of the section that sets out the limitations.
Until now, vitamin D3 was only approved for use as a nutrient supplement in calcium fortified fruit juice and fruit juice drinks.
At the time of publication Unilever had given no indication of concrete plans to introduce meal replacement bar and beverage products containing vitamin D3.