GRAS status will boost benfotiamine, XSTO says

Let’s start first with benfotiamine and how it’s different from regular old B1.  Benfotiamine is a fat soluable form of the otherwise water soluable vitamin.  The body does make small amounts of benfotiamine from regualar B1, Murray said, but BenfoPure is a synthetically manufactured ingredient.

The altered, fat-soluable form of the ingredient is key to its activity.

“It makes it significantly more bioavailable,” ​Murray, XSTO's vice president of business development, told NutraIngredients-USA.  While the body does manufacture its own small amounts of benfotiamine from the base vitamin, taking massive doses of garden-variety B1 isn’t the answer because the body can only absorb the water-soluable form at a certain rate, with overages simply excreted. If a consumer were dedicated enough to take intermediate doses of B1 throughout the day they might be able to achieve a similar level of benfotiamine in their system as with direct supplementation, but it’s an unlikely scenario, Murray said.

Healthy glucose metabolism​

So what’s benfotiamine good for?  The ingredient has science results relating to its effect in supporting healthy glucose metabolism, and helps to blunt the insulin-spiking and cell-damaging effects of high sugar consumption.  In addition, the ingredient has been shown to support healthy circulation in capillaries, especially in the extremities where diabetes can wreak some of its most gruesome damage.

“When we consume too much sugar and there is too much sugar in the cell and it interferes with the protein recycling. Cells constantly recycle and rebuild protein molecules When they can no longer be recycled the cell attaches a sugar molecule and tosses them out.”​

Excess amounts of sugar throws a wrench into the works, Murray said.

“When we have not enough protein being recycled, the cell dies,”​ he said.

Murray said  this makes the ingredient a natural for a population exhibiting increasing high rates of prediabetes, and becoming increasingly aware of the health threat.  According to data from Supermarket News​ quoted by XSTO, 51% of shoppers are looking for products with “reduced low or no sugar” attributes.

ODI or NDI?​

The ingredient has been on the market since 1993 in Germany, Murray said.  So that should bring it in under the DSHEA grandfather date deadline, right?

Not so fast, Murray said.  In the opinion of XSTO Solutions, the alternation of the base form thiamine to change it into benfotiamine is enough to fall under the ‘chemical alteration’ definition of DSHEA, making it in effect a New Dietary Ingredient.  It was for this reason that Hamari Chemicals of Japan, the ingredient’s manufacturer, decided to hire a US consultant to help assemble a self-affirmed GRAS dossier for BenfoPure.

Ingredients that have GRAS status do not need to file a NDI notification, even if they might technically qualify as New Dietary Ingredients.  Murray said the plan is take that GRAS status to the gold standard level.

“What we hope to do is to submit our GRAS file to FDA and get a no objection letter,”​ he said.

Even with its GRAS status, the biggest market for the ingredient is in supplements, Murray said.  Going the GRAS route was a way to avoid the uncertainties that currently swirl around the NDI filing process.

Regulatory limbo was a drawback​

And having a solid regulatory footing will be a big differentiator for the ingredient and could help expand the overall market, Murray said.

“We took it through the GRAS process because we thought it really needs to stand on its own identity,”​ Murray said.

“We’ve got several companies coming to us saying they really wanted to handle this product but they were either nervous or put off by the regulatory position. We’ve had several other companies that say they are willing to pay up from their current Chinese sources to have a product with a  regulatory status,”​ he said.