ConcenTrace® GRAS for Foods, Beverages

OGDEN, UtahConcenTrace® was self-affirmed GRAS (generally recognized as safe) for use in food and beverages following an intensive review by an independent panel of experts per FDA regulations. The concentrated complex of more than 72 ionic trace minerals from the Great Salt Lake offered by Trace Minerals Research (TMR) was examined by an expert panel from AIBMR Life Sciences Inc., Puyallup, WA, that included physicians and two toxicologists who have worked as division heads for FDA.

ConcenTrace® is concentrated by a proprietary solar evaporation process, and, when added to the diet, can help increase the trace minerals necessary for optimum health and wellness, according to TMR. Achieving GRAS status for ConcenTrace® will allow TMR to further its reach into the functional food and beverage sectors.

Achieving GRAS status for ConcenTrace® is major step for our company," said Scott Perkes, managing partner, TMR. Now that ConcenTrace® is GRAS, not only can current and potential consumers of ConcenTrace® be even more confident in its safety as a dietary supplement, but food and beverage companies who are looking to fortify their products with a water-soluble complex of more than 72 ionic trace minerals can now do so with that same confidence."

When an ingredient or substance is determined GRAS, it requires sensible confidence in the minds of scientists that it is not harmful when used as it is intended. The process of achieving the GRAS determination requires a comprehensive review and a consensus of safety by a panel of experts who are qualified by training and expertise to evaluate the safety of the ingredient. Classifying an ingredient as GRAS is a program by FDA and is regulated under sections 201 and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), with additional regulations in 21 CFR 170.3 and 21 CFR 170.30.

AIBMR Life Sciences is a dedicated full-service natural products and functional food and beverage consulting company, specializing in GRAS self-affirmations, nutraceutical research, regulatory compliance, safety testing (toxicological studies), medical writing and product development. AIBMR Life Sciences was founded in 1978, and works with companies in the United States and throughout the world.