CEDAR KNOLLS, N.J. — Emisphere Technologies on May 1 said it has been informed by an independent panel of expert scientists that the company’s carrier for its intended application to be combined with nutrients and added to food and dietary supplements has been provisionally designated as 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, the company said. The GRAS status will establish the carrier as exempt from pre-market approval, the company said.
Michael V. Novinski, president and chief executive officer, predicted that the first product to incorporate this technology will be an oral vitamin B12 product.
The company said the final step before achieving final 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 that the company was in active discussions with food manufacturing companies as well as supplement makers about potential applications.
Vitamin B12 has been an initial focus because so many Americans have absorption problems, Mr. Hart said.
"There are 30 million to 40 million vitamin B12 injections each year," Mr. Hart said.
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," he 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.
Mr. Hart said Emisphere believes its SNAC technology will have application for other vitamins and nutrients. Emisphere said the technology "makes it possible to deliver a therapeutic molecule orally without altering its chemical form or biological integrity." In pharmaceuticals, the company has been working for several years on applying the technology to compounds such as insulin and heparin.