ConcenTrace®, Trace Minerals Research’s (TMR) concentrated complex of over 72 ionic trace minerals from the Great Salt Lake, has been self-affirmed as Generally Recognized as Safe (GRAS) for use in food and beverages. According to FDA regulations, the process involved an intensive review by an independent panel of experts, qualified by training and experience to evaluate the safety of food ingredients.
To affirm ConcenTrace’s GRAS status, TMR sought out an expert panel from AIBMR Life Sciences Inc. (Puyallup, WA) because of its experience, knowledge and expertise with GRAS self-affirmations. The expert panel included physicians and two PhD toxicologists with 83 years combined experience in toxicology, who also worked as division heads for the Food and Drug Administration (FDA).
ConcenTrace® is an all natural complex of ionic trace minerals that has been harvested from the Great Salt Lake in Utah, USA and is concentrated by a proprietary solar evaporation process. TMR adds ConcenTrace® to its products because it believes that the majority of the population doesn’t get an adequate daily intake of trace minerals that is necessary for optimum health and wellness. 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 of Trace Minerals Research. “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 over 72 ionic trace minerals can now do so with that same confidence.”
When an ingredient or substance is determined to be 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 the 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.
About AIBMR Life Sciences, Inc.—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.
About TMR—Trace Minerals Research (www.traceminerals.com) is the ionic mineral supplement brand you’ve known and trusted for over 35 years. TMR is the exclusive provider of ConcenTrace® Trace Mineral Drops, an ionic, solar evaporated, GRAS-affirmed and food-grade essential trace mineral complex that is harvested from the Great Salt Lake for food, beverage and dietary supplement use. ConcenTrace® is also the number one selling trace mineral in the natural products industry. TMR uses these naturally balanced, naturally occurring minerals as the basis for all products in its branded product line. Extensive research supports the need to keep minerals in proper balance throughout the body in order to achieve optimal health. Trace Minerals Research is focused solely on servicing the natural products industry and the company’s complete line of superior quality nutritional supplements is backed by a “Feel the Difference or Your Money Back” guarantee. In addition, TMR is Good Manufacturing Practices (cGMP) certified by the Natural Products Association™ (NPA) (www.naturalproductsassoc.org) under the new Food and Drug Administration’s final cGMP rule [21 CFR 111] for dietary supplements and has been GMP certified since 2004.