Iron deficiency has a devastating impact on millions of people around the world. The major problem has been to find a supplement that not only works well but also avoids metallic taste. Chelates—part of the company’s Functional Chemicals’ business—believes it’s found the answer.
The productin question is iron EDTA, explains Chelates technical manager for Asia Pacific Carel Wreesmann,which Chelates has been producing since the 1970s for the agricultural market as an antidote to iron deficiency in plants.But it may also bea possible solution to iron deficiency anemia, the most widespread nutritional deficiency in the world.
UNICEF estimates that iron deficiency affects half of the developing world’s infants, undermines the health of 500 million women of reproductive age and leads to more than 60,000 childbirth deaths a year. It also causes a range of other problems in millions of people, such as impaired cognitive development in children, to exhausting fatigue, maternal mortality and low productivity in the workplace.
Traditionally, one of the most effective ways to combat any deficiency has been to add supplements to staple foods, something that has been done in Western countries for the last half a century. However, fortifying foods with iron has been a particular challenge as the compounds most readily absorbed in food cause an organolectic effect, the result being an unpleasant metallic taste, color changes, or even worse, accelerated rancidity.
“Iron EDTA seems to be an exception to that rule. There are no problems with taste and it is well absorbed in the human body," explains Wreesmann, who has been working on iron EDTA for Chelates for the last seven years. "Many large-scale population trials have proven the efficacy of iron EDTA in reducing iron deficiency anemia.”
After much legwork by International Life Sciences Institute (ILSI)—an American-based scientific association dedicated to improving health and nutrition worldwide, especially in developing countries—the World Health Organization (WHO) declared iron EDTA safe in 1999.
BU Chelates—which mainly produces industrial cleaners for institutions such as hospitals—came into the iron EDTA picture when it was approached by ILSI in 2000.
“We already had iron EDTA-based syrup on the market in France, called Ferrostrane®, which had been available in the UK since 1965, but had never become popular,” says Wreesmann. “But as a world leader in the agricultural market, we knew it was a simple step up to develop food grade iron EDTA. The molecule is the same as the agricultural version but minus certain contaminants.”
Chelates is also able to provide increasingly critical food suppliers with HACCP (Hazard Analysis Critical Control Points) certification—a relatively new food safety system to ensure undue contaminations are eliminated. The only thing missing was the name—Ferrazone®—which came from Chelates’ sales manager in India, one of the businesses’ biggest potential markets because of huge problems with iron deficiency in that country.
The next step was to put Ferrazone to the test in the field. Working together with the Dutch University of Wageningen and a major food producer, a trial was set up and is now in progress in Kenya involving around 510 children between the ages of three and eight from three different schools. All of the children are now receiving porridge made from Ferrazone-fortified maize.
The food company and the Kenyan Health Ministry are responsible for the day-to-day running of the trial, while Chelates’ remit was to provide the expertise on mixing iron EDTA into corn flour. Blood samples will be taken from the schoolchildren and stored in a refrigerator and will then be shipped to Wageningen University for analysis when the trial ends in December. Chelates also have another successful pilot running at a hospital in Mumbai, India, which, according to Wreesmann, has been a major success.
In November, Ferrazone obtained expert panel approval—the so-called GRAS (Generally Regarded As Safe) certification—which gives Chelates the green light to gain formal FDA approval and start seeking registration in countries such as Kenya, which look to the FDA to take a lead.
“The FDA GRAS is important as a stepping stone to registration in countries like Kenya,” explains Wreesmann. “It’s good to be able to state that the product you are using in Kenya has been declared safe for use in the U.S. because what’s good for the U.S is good for them.”
A little orphan
What is particularly pleasing to Wreesmann, who is based in Arnhem, the Netherlands, is that Ferrazone has a good chance of success, despite the fact that it has been tagged an “orphan” drug.
“Ferrazone is what the Americans call an “orphan” drug because it is off patent and orphan drugs are not popular in business,” he explains. “You need to do all the registrations, files, dossiers and trials, but without the assurance and protection of a patent.”
But while most producers shy away from taking a commitment because of the costs involved, he believes the project has a lot going for it.
“Our micronutrients business has shown that it’s possible to have good business without patent protection. And this is an area with huge potential. A person can benefit from 40 milligrams of iron EDTA a day to be healthy.
“China and India—which both have huge problems with iron deficiency—have a total population of more than two billion. In fact, China is already fortifying soy sauce with iron EDTA, which shows that it is cost effective. The government there is actually rolling out iron EDTA across the whole country because it’s such a huge public health issue.
“Iron deficiency is a problem of immense magnitude,” continues Wreesmann. “Two billion people around the world are iron deficient. But it’s not just the developing world, ten percent of women in Europe have it too.
“The World Bank has calculated that the cognitive damage done to children is severely hampering GDP growth in some countries, which in turn contributes further to the cycle of undernourishment. But, as BU Salt demonstrated with iodized salt, something can be done and that’s a project which is still winning Akzo Nobel plaudits around the world.”