Merck offering nature-identical folate in new markets

The product, Metafolin, has been available in the US since 2002 through specialty players like Nature Made, Metagenics and Source Naturals.

Safety approvals from the European Food Safety Authority (EFSA) in October last year​, and last month from the Joint FAO/WHO Expert Committee on Food Additives (JECFA), look set to open up new markets for the patented ingredient.

The folate, the calcium salt of L-5-methyltetrahydrofolic acid or, for short, L-methylfolate, has a number of advantages over folic acid, sold in volumes of double-digit metric tons to food and supplement makers each year.

However it is, not surprisingly given some ten years of investment in the production process, significantly more expensive than folic acid - so much so, that many in the industry will find it prohibitive.

Yet despite the major price difference, the firm is confident of gaining a "5-10 per cent share"​ of the overall folic acid market in coming years, according to Merck Eprova​ product manager Roger Weibel.

This belief comes from the product's significant advantages over folic acid, now considered a commodity.

"It is like the different between a Volkswagen and a Rolls Royce,"​ suggests Weibel.

Starting with folic acid, the company uses a chemical process to complete the steps that the body normally performs on folic acid so that it can be metabolized.

"Metafolin is the same compound that is commonly available in foods. The body does not have to convert it, as it does with the pro-vitamin folic acid, so it is active straight away,"​ explained Weibel.

"We did a comparison study with folic acid, where we used a crossover design so that the products were tested on the same people. Metafolin was about 50 per cent more bioavailable,"​ he told NutraIngredients.com.

Metafolin is also more homogenously available compared with folic acid.

"All of those tested responded in a similar way to Metafolin whereas folic acid's bioavailability varied more,"​ added Weibel.

He added that there is increasing concern in the US about the levels of unmetabolised folic acid remaining in the blood plasma after consumption of folic acid-fortified products. Folate that is directly usable by the body is less likely to build up.

While the product could therefore have clear advantages for foods too, Eprova remains focused on the supplement market, although it has self-affirmed GRAS for the US market and approval from the JECFA for the ingredient's use in foods for special dietary uses and other foods.

Use of folic acid in supplement form is growing, by a few per cent, in Europe, and somewhat faster in Asia. But there is still low awareness of the requirements for the nutrient by many segments of the population, and many people do not reach their recommended daily allowance (RDA), according to Merck Eprova, which claims to be the largest producer of specialty folates for supplements and pharmaceutical applications.

Weibel believes that a dossier for a racemic form of the substance, 5-methyl-tetra hydrofolate, which was submitted to the UK's Food Standards Agency for addition to the new EU supplement directive's positive list clears Metafolin for use in the UK too. The one-page dossier was submitted by the National Association of Health Stores.

Some other European markets have also adopted the UK's list of dossiers that gives ingredients derogation from the directive.

The positive evaluation by JECFA should help secure further approvals in other countries around the world. JECFA, an expert scientific committee of the Food and Agriculture Organization and the World Health Organization, also advises national governments and the Codex Alimentarius Commission.

It remains to be seen however whether supplement makers can persuade consumers that the clear benefits of a nature-identical folate over folic acid are worth its premium price.