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Bioactives American brings first GRAS-affirmed salacia oblonga extract to market

By Hank Schultz , 10-Feb-2014
Last updated on 10-Feb-2014 at 17:46 GMT

Bioactives American Corporation has brought to market what the company calls the first GRAS version of a salacia oblonga ingredient for blood sugar management.

The ingredient, branded as Salsulin, is an extract of the herb that has a long history of use in Ayurvedic medicine as a treatment for diabetes and obesity.  A 2007 study conducted by Abbott Labs and Radiant Research found that use of the herb blunts blood sugar spikes and insulin response after a meal.  That study supported similar results from a 2005 study.

Enzyme inhibition

Mohamed Rafi, CEO of Bioactives American Corporation, based in Highlands Park, NJ, said the company’s water extract of the root of the vine that is native to India and Sri Lanka works to inhibit the absorption of carbohydrates after a meal, an analogous method of action to some of the pharmaceuticals prescribed for diabetes patients.

“The root extract inhibits the enzyme glucosidase,” Rafi told NutraIngredients-USA. “The extract binds to the enzyme molecules and they can’t convert starch into glucose as well.  It has been well documented,” he said.

The use of the extract shares one potential side effect with those drugs, Rafi said, and that is a tendency among some users toward intestinal gas.  Those unabsorbed carbohydrates end up getting fermented in the GI tract, leading to the effect, he said.

Rafi said the ingredient could show great potential in addressing the needs of consumers who are in a pre diabetic state.  As matters stand, there is less support for those patients than for patients with full-blown type 2 diabetes, who have crossed the diagnostic threshold that calls for a drug prescription.  Salsulin could provide a safe, gentle alternative that could help keep some of those patients out of the blood sugar red zone, he said.

Growing opportunity

And the opportunity is a big one, and growing, Rafi said. According to research cited by Bioactives American, 22 million people were living with some type of diabetes in 2012, up from 17.5 million in 2007. New research from the American Diabetes Association states that the total cost of diabetes was $245 billion in 2013, a 41% increase from $174 billion spent in 2007.

But something of a pall hangs over the sector, with FDA having stated in a recently released draft guidance on medical foods that diabetes is a condition for which a medical food cannot be formulated, and that type 2 diabetes is a condition that in the agency’s estimation can be handled primarily by diet modification, which begs the question as to what a nutraceutical ingredient can claim in terms of promoting healthy blood glucose levels.

The initial press release for the launch of Salsulin said “Bioactives American’s Salsulin can be used as a Medical Food at a dose of 480 mg/60 kg body weight/day.”  Rafi said in light of the input he received from the expert panel that worked on the company’s GRAS self affirmation and other expert advice, he’s confident in that statement.  And in addition to that usage, the ingredient is suitable for supplements and as a food additive, Rafi said.

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