The company noted that an independent panel of scientific experts recently met in Washington, DC and determined that SunActive Fe is safe and is GRAS for its intended use as a nutrient supplement/fortifier in foods with no limitations other than those set forth in the FDA's fortification policy for iron.
SunActive Fe is a "micronized super-dispersible iron without iron flavor or color-changing potential", according to the company, adding that its product is stable against heat, salt, pH, and oxidation, gentle on the stomach, does not promote constipation, and provides good absorption and bioavailability.
Reporting in the British Journal of Nutrition earlier this year, researchers at the Institute of Food Science and Nutrition in Zurich found SunActive Fe to exhibit equal bioavailability to ferrous sulfate in adult women when incorporated into either a wheat cereal or a low fat yogurt drink.
SunActive Fe is intended for use as an iron fortification ingredient in foods and beverages without producing bad tastes or colors.
Researchers are increasingly highlighting the importance of iron. A study earlier this year, for example, by the University of Michigan found that teenagers who suffered iron deficiency as infants were likely to score lower on cognitive and motor tests, even if that iron deficiency was identified and treated in infancy.
Iron deficiency with anaemia affects about 25 percent of infants worldwide and twice as many have iron deficiency without anaemia. Many poor and minority children in the developed countries are also affected.
Researchers at the University of Michigan gathered data on Costa Rican children who were diagnosed with severe, chronic iron deficiency when they were 12-23 months old and were treated with iron supplements.
The team then examined 191 children in working- to middle-class families at five years, 11-14 years and again at 15-17, and found the iron-deficient babies grew up to lag their peers in both motor and mental measures.
Children who had good iron status as babies showed better motor skills than those who had been iron deficient, said Betsy Lozoff, director of the Center for Human Growth and Development at the University of Michigan, presenting the findings at the Pediatric Academic Societies' annual meeting.
During development, iron performs a variety of important roles. Iron is required to build myelin, which covers nerves and helps them share signals more efficiently, for example. Iron is also needed for brain chemicals, such as the neurotransmitter dopamine, which sends signals within the brain. Iron deficiency also differentially affects the hippocampus, which is involved in certain types of memory and other important processes.
Babies typically get their iron from the mother during pregnancy and from mother's milk, but their rapid growth demands even more iron after the first four to six months. Other foods infants often eat, such as soft cereals, cow's milk and fruits, are poor sources of iron. In the United States, fortifying baby formula and cereals with iron has helped a great deal, but these have not been adopted internationally, and iron deficiency remains more common elsewhere.
It has been estimated that 10 to 12 percent of US women and 40 to 80 percent of women in developing countries are iron deficient but not anemic, yet most are unaware of their condition. High risk groups include women who are physically active, dieting or vegetarians.