Nutrient carrier gains self-affirmed GRAS approval

by Jeff Gelski
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Emisphere Technologies, Cedar Knolls, N.J., said an independent panel of expert scientists provisionally designated that the company’s carrier for its intended application to be combined with nutrients and added to food and dietary supplements is Generally Recognized as Safe (GRAS).

Emisphere said following a "comprehensive evaluation of research and toxicology data," its SNAC (sodium amino caprylate) carrier was determined to be safe at a dosage up to 250 mgs per day. Using the technology enhances the dietary availability of nutrients, according to the company. The GRAS status will establish the carrier as exempt from pre-market approval, accordng to the company.

Michael V. Novinski, president and chief executive officer, predicted the first product to incorporate the technology will be an oral vitamin B12 product.

The company said the final step before achieving GRAS status for the SNAC technology will be publication, scheduled for this summer, of peer-reviewed papers about the technology in the International Journal of Toxicology.

Nicholas J. Hart, vice-president of strategy and development at Emisphere, told Food Business News the company was in active discussions with food manufacturing companies and supplement makers about potential applications.

Many individuals are unable to absorb vitamin B12 in supplements or in food.

"Breakfast cereal may be fortified with vitamin B12, but for people with absorption problems, eating a truckload of corn flakes will not give them adequate intake," Mr. Hart said.

Often manifested as pernicious anemia, a deficiency of vitamin B12 may lead to neurological problems beginning with tingling hands and feet and then cognitive problems. Untreated, the deficiency may be debilitating.

Several sub-groups are particularly prone to B12 deficiency, including the elderly, individuals with celiac or Crohn’s disease, patients on H2 blockers and those who have had gastric bypass surgery.

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