Quality has always been a top priority at TMR. Throughout the years, TMR has been vigilant in improving our manufacturing processes. 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 GMP certification 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.
ConcenTrace® Trace Mineral Drops has been affirmed 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. GRAS status allows for food and beverage manufacturers to add ConcenTrace® to their products to help fortify, improve flavor, and upgrade label nutritional claims with confidence in its safety as an ingredient.
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).
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.
Bisphenol A (BPA) is a phthalate chemical, and a building block for polycarbonate, a rigid, clear plastic commonly used for baby bottles, reusable water bottles, and other applications. Researchers have linked the hormone-mimicking chemical to a host of issues, including behavioral and developmental effects in children. TMR cares about your health and has never used bottles containing BPA. We only use bottles that are made from PET (polyethylene terephthalate, recycle code #1) and HDPE (high-density polyethylene, recycle code #2). Click here to view the official statement from our bottle supplier.
ConcenTrace®, Utah Sea Minerals, Ionic Magnesium, and Mega-Mag are all certified Kosher by the Rabbinical Council of California (RCC). According to the RCC's website, "the word kosher is a Hebrew word that means fit or proper. It refers to food that meets the requirements of Jewish Dietary Law. The body of laws governing such requirements is called Kashrut or Kashrus. The product adhering to these guidelines is called Kosher. Jewish dietary laws originate in the Written and Oral Torah (the Bible) and are further expounded upon by the Rabbis of the Mishnaic and Talmudic era. Two factors play fundamental roles in determining the kosher status of a product:
a. The source of the ingredients
b. The status of the production equipment.
"A common misconception is that kosher reflects the conferring of a blessing on food by a Rabbi. There is no truth to this whatsoever. Although Jewish ritual does require the recitation of a blessing prior to the consumption of food, there is no blessing which can make the food itself kosher or un-kosher."
To view the certificates for each product, click the name of the product from the following list: ConcenTrace®, Utah Sea Minerals, Ionic Magnesium, Mega-Mag. For more information on Kosher certfication or the RCC, visit www.rccvaad.org.
According to the IFANCA's website, Halal is an Arabic word meaning "lawful" or "permitted". Halal is the dietary standard of Muslims. Halal prohibits the consumption of the following: swine/pork and its by-products, animals improperly slaughtered or dead before slaughtering, animals killed in the name of anyone other than ALLAH (God), alcohol and intoxicants, carnivorous animals, birds of prey, land animals without external ears, blood and blood by-products, and foods contaminated with any of the previously mentioned products.
TruLabel is a dietary supplement label registration and random-testing program of the Natural Products Association (NPA). One of the main reasons why this program was designed was to give consumers and retailers a high level of confidence that products sold by NPA member companies are accurately labeled.
As a member of the NPA, we are required to register all of our labels through the TruLabel department. Products are periodically and randomly selected for third-party laboratory analysis to confirm the label. This analysis verifies that the contents of the label matches the contents of what is in the product. For more information on the TruLabel Program, click here.