FDA Okays Bitter Blocker GRAS Status
Linguagen Corp., a taste technology company, announced it has received a letter from the U.S. Food and Drug Administration (FDA) indicating the agency does not have any questions regarding the GRAS (generally recognized as safe) status of its bitter blocker adenosine monophosphate (AMP).
GRAS status may be based either on a history of safe use in food prior to 1958 or on scientific procedures, which require the same quantity and quality of evidence as would be required to obtain a food additive regulation. These standards have been developed by the FDA to assure consumers they are purchasing and consuming a safe product for themselves and their families.
AMP is a natural compound which may be used in food and beverage products and in oral pharmaceuticals to help block the bitter taste that often is found in these products. In 2003, a patent exclusively licensed by Linguagen was issued for these uses, and AMP was declared GRAS when a panel of three independent scientific experts reviewed the compound. After receiving the GRAS determination, Linguagen voluntarily submitted the AMP safety package to the FDA for review.
"Receiving acknowledgement from the FDA on our GRAS status is an important milestone for Linguagen, which reiterates what we've always known -- AMP is a safe compound that will be useful in making better tasting, more healthy products for the marketplace," said Shawn M. Marcell, COO, Linguagen. "As more and more food and beverage manufacturers continue to seek ways to improve the taste of their products without adding excess salt or sugar, we're confident our GRAS status will help make their decision even easier."
For a substance to be added to food products, it is normally subject to FDA approval; however, certain ingredients may be allowed on the market if they are determined to be GRAS by a panel of qualified experts. For such products, the FDA established a procedure whereby any person may voluntarily notify the FDA of a determination that a particular use of a substance is GRAS.
Linguagen identifies and commercializes natural compounds that allow pharmaceutical, food and beverage companies to enhance their product offerings by improving the taste of their ingredients.