SunActive® Iron Achieves 'Unlimited' GRAS Status for Foods and Beverages

December 07, 2004, Minneapolis – Taiyo announced today that its iron fortification ingredient SunActive® Fe has achieved self-affirmed GRAS (Generally Recognized As Safe) status. 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/fortificant in foods with no limitations other than those set forth in the Food and Drug Administration’s Fortification Policy for Iron.

The importance of iron in human nutrition continues to be amplified, especially in the context of this mineral’s role in the absence of iron deficiency anemia. Several clinical studies have shown iron supplementation of females with non-anemic iron insufficiency to produce substantive improvements in fatigue, mood, and cognitive function.

One of the potential downsides of iron fortification in foods and beverages is the development of organoleptic changes, as seen with the water soluble iron fortificant, ferrous sulfate. SunActive Fe is a micronized super-dispersible iron without iron flavor or color-changing potential. It exhibits superior stability against heat, salt, pH, and oxidation, is gentle on the stomach, does not promote constipation, and provides superior 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.

Although the components of SunActive Fe, a patented ingredient comprised of ferric pyrophosphate and emulsifiers, were already considered GRAS by the FDA, Taiyo chose to take the extra step and affirm the safety of SunActive as a stand alone ingredient. “The unanimous approval of SunActive, without limitations, further adds to the comfort of fortifying products with iron for our customers”, stated Scott Smith, Vice President of Taiyo. “We foresee a renewed interest in iron fortification for women’s health platforms in food, beverage, and confection delivery systems.”

SunActive Fe is intended for use as an iron fortification ingredient in foods and beverages without producing bad tastes or colors. SunActive Fe is the recipient of numerous international awards, recognizing it for its advanced research and ingredient applications, including the Most Innovative Food Ingredient Award at Food Ingredients Europe (FIE) and the NutrAward for Best New Product at Nutracon 2003.


Taiyo International is the North American sales office for Taiyo Kagaku Japan, a leading manufacturer of functional ingredients for the food, beverage and dietary supplement industries. Taiyo focuses on the development of innovative ingredients, derived from natural sources, to further develop the body’s ability to protect and manage one’s health.

Scott Smith
[email protected]

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