Folate form gains FDA NDI approval

By Shane Starling

- Last updated on GMT

Italian supplier Gnosis Bioresearch has won New Dietary Ingredient (NDI) approval from the Food and Drug Administration for a synthetic folate salt form.

The ingredient, called Quatrefolic, is used to tackle stability and solubility issues that can occur with some forms of calcium salts.

Gnosis marketing manager Lorena Carboni said the NDI notification adds to GRAS status the ingredient already enjoys for use in the US food supply.

The company’s offering is a form of 5-methylfolate calcium salt which it derives from vegetarian-sourced glucosamine.

“Irrespective of whether ingested food contains natural or synthetically-derived folates, these are metabolized to 5-methyltetrahydrofolate, which is considered the biologically active form of the B-vitamin folic acid,”​ the company said.

Folate – typically found in leafy vegetables, sprouts, fruits, yeast and dairy products – is unstable and susceptible to oxidation.

Bioavailability can decrease 70 per cent in three days in leafy vegetables if they are stored at room temperature, increasing to 95 per cent if cooked in water.

“Irrespective of whether ingested food contains natural or synthetically-derived folates, these are metabolized to 5-methyltetrahydrofolate, which is considered the biologically active form of the B-vitamin folic acid,”​ Carboni said.

Deficit of folate represents one of the most common nutritional deficiencies and may occur when dietary intake is inadequate, when an increased need is not matched by an increased intake (particular physiological conditions as pregnancy, lactation, children growing), when altered absorption/excretion (or losses) than usual are present and when metabolism or drugs assumption interfere with the ability of the body to use folate.

Folate is most commonly linked with reducing the incidence of neural tube defects.

Another calcium alternative - calcium sulphate – has won Food and Agriculture Organization/World Health Organization Joint Expert Committee on Food Additives (JECFA) approval as a food additive.

It recommended a daily intake (RDI) of 2500mg that did not specify between various calcium forms.

A rat study found no difference in calcium bioavailability from different sources.
Human studies showed calcium sulphate bioavailability from mineral waters is comparable to milk and that sulphate anion does not affect the urinary excretion of calcium.

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