Ingredients supplier Kyowa Hakko said it has completed the GRAS self-affirmation of its energy boosting dipeptide ingredient Sustamine, opening up the market for its use in foods and beverages.
Sustamine, an L-Alanyl-L-Glutamine ingredient derived from the L-Alanine and L-Glutamine amino acids, is marketed as a “high-tech” amino acid that promotes muscle rehydration and recovery, and can be used as a source for energy refueling.
In order to qualify for GRAS (generally recognized as safe) status in the US, an ingredient needs to be examined by a group of experts and determined as safe for human consumption when added into foods. Companies may either self-affirm their ingredients as GRAS once this process has been completed, or they can request the FDA to evaluate the documentation provided for additional backing. If FDA has no objection, a company can market its ingredient as being FDA-notified GRAS, which tends to be better accepted by industry.
Kyowa did not respond to calls for comment in time for publication on whether it would be seeking an FDA letter of non objection on Sustamine’s GRAS status.
Sustamine is produced through a patented fermentation technology, that can directly connect two amino acids without requiring a chemical modification during the process, the manufacturer says.
This ensures that the product can be formed directly from glucose as opposed to having to manufacture from two separate amino acids.
The ingredient is supplied in powder form, which is water soluble into a clear solution, said Kyowa.
"Sustamine can be used in a powder or solid applications, but is best suited for use in liquids," a spokeperson said in July.
They explained that as an L-Alanyl-L-Glutamine, Sustamine offers a more stable higher yield product when grown in liquid or gel-based cell culture media compared to regular L-Glutamine, which breaks down easily. The group suggests that the product can offer a number of benefits for food, beverage and healthcare manufacturers.
"The product can be used as a stable form of the amino acid L-Glutamine in ready-to-drink formulations and will assist with hydration and electrolyte replacement- critical for sports specific formulations," the spokesperson said.