In 2004, TMR became Good Manufacturing Practices (GMP) Certified by the Natural Products Association™ (NPA) and was one of the first 50 companies to achieve such a certification. See our GMP Certificate here.
The NPA was the first organization to offer a third-party GMP certification program specific to the manufacturing of dietary supplements and dietary ingredients. These GMP standards represented the industry's best practices and served as the basis of the NPA GMP Certification Program as well as establishing a higher level of control than was currently required by the FDA.
In June 2007, the FDA published the final GMP regulation specific to dietary supplements (21 CFR 111). In order to keep the NPA GMP Certification program relevant and reflect the highest level of industry good manufacturing practices, the NPA GMP Standard was revised to include all of the FDA GMP requirements of 21 CFR 111 and certain requirements from the 2000 version of the NPA GMP standard that exceed requirements of the FDA GMPs, or reflect best industry practices that are necessary for the evaluation of compliance to the NPA GMP standard.
Since June 2007, we have diligently worked to become compliant with all requirements from the FDA's final GMP regulation. In October 2010, after endless hours of preparation, Trace Minerals Research received its updated under the FDA’s final dietary supplement regulations (21 CFR 111).
GMP certification shows our customers, retailers and international buyers that we are committed to producing safe products of the highest quality. We are constantly looking for new technologies and research that help us improve our manufacturing processes and our products are tested by a third-party laboratory to ensure quality and safety.
Quality has always been a top priority at Trace Minerals. Throughout the years, Trace Minerals has been vigilant in improving our manufacturing processes. We believe that the best processes help make the best and healthiest products. That’s the main reason why we strictly control the quality of our products and why we have achieved numerous certifications for you to be sure you’re getting only the best.
Trace Minerals is committed to the highest standard of quality, including identity, purity, strength, and composition, which is why we were one of the first 50 companies to become Good Manufacturing Practices (cGMP) certified by the Natural Products Association in 2004 when the certification was first introduced. Today, Trace Minerals is cGMP certified under the new Food and Drug Administration’s final cGMP rule [21 CFR 111] for dietary supplements by the National Brand Certification Program by UL Registrar LLC . UL has been a premier global independent safety science company for 120 years and recently partnered with the Natural Products Association (NPA) to certify that dietary supplement makers are following federal guidelines and regulations that are an essential part of the government’s oversight of the industry. The UL Certification Program not only meets the current FDA rule [21 CFR 111] for GMP’s, but it exceeds the rule with other specific requirements as outlined by the Revised NPA’s cGMP Standard for Dietary Supplements. UL is the third-party auditor who conducts annual audits of Trace Mineral's manufacturing facilities to ensure that all elements of the manufacturing process are reviewed to provide reasonable assurance that processes are sufficiently controlled so that products meet their established specification. UL’s auditors are trained in the NPA GMP standard, as they will administer the certification program, the audit function, and the final decision on whether our products meet the standard to achieve compliance.
Trace Minerals is America’s #1 selling trace mineral brand! As the #1 trace mineral leader, we source mineral and trace mineral complexes from all over the world, including ionic minerals from Utah’s inland sea, colloidal minerals, plant derived minerals from humic shale, and fulvic acid. In addition, as demand may require, through a proprietary process, we can make ionic trace minerals that matches the quality and purity that we harvest from Utah’s inland sea. The source on the north shores of the Utah’s inland sea is located at a highly secluded and secure site that is surrounded by thousands of acres of private property that is only accessible by passing through locked gates. The pristine location allows us to pump the lake water into our ponds with the lowest impact possible on the environment.
Because of the unique design of our ponds and the fact that our proprietary processes have become more efficient and technologically advanced, the process of harvesting minerals and concentrating them at the perfect time is a four-month process that requires attention and precision. In fact, our accelerated solar evaporation process allows us to use less lake water to yield the same amount of high quality minerals. We do it in such a short time because our proprietary evaporation process was developed and designed by our own David Butts, certified chemical engineer and one of the world’s foremost experts in the field of solar evaporation technology on the GSL and throughout the world. Mr. Butts was the founder of solar evaporation technology on the GSL and has over 40 years of experience in the design, operation, and extraction of minerals and salts from lakes, oceans, and underground deposits like the GSL. Click here to read the official letter from Mr. Butts on his overview of Trace Mineral’s solar evaporation facility.
To ensure the highest quality and concentration, at our harvesting facility we test over 13 potential extraction points within our State-approved water rights area and approved right-of-entry from the state and determine from those tests the best site to harvest the particular batch we are seeking. Once the solar evaporation ponds are filled, Mr. Butts and our quality control staff test the water several times a week during the evaporation process to continue to ensure its quality. In addition to EPA testing, the extraction site and evaporation ponds also meet all standards and guidelines for heavy metals by the Codex Alimentarius Commission (Codex) and the United States Pharmacopeia (USP). Once the concentrated water reaches our cGMP facility, our quality control staff—which includes Mr. Butts—tests the product again with all of the same series of tests as before as well as additional tests to ensure we are meeting our cGMP and GRAS standards for quality and safety. Then we have the product sent to a third-party laboratory to verify our findings, which is part of our standards as a cGMP facility. We invest great deal of time and money in the testing process so we are confident we are providing you with the highest quality solar-evaporated and food-grade ionic trace mineral supplement from the GSL. ConcenTrace® Trace Mineral Drops is GRAS-Affirmed, Kosher certified, Halal certified, and vegan certified. In addition, ConcenTrace® and all of our product labels are randomly tested and verified to meet label claims by the Natural Products Association’s TruLabel® Program. Make sure you look for the blue bottle and the Trace Minerals Research logo so you know you’re getting America’s #1 selling trace mineral, the most awarded and certified trace mineral supplement on the market!