Quality Control

Since 1979, Allergy Research Group® has used only the purest raw materials available, and has implemented strict quality control procedures in every stage of production, including inspection of raw materials, manufacturing, packaging, and storing. Allergy Research Group® is licensed by the State of Utah Department of Agriculture and Food, Certificate of Registration for Food Establishment number 190455 and US FDA registration number 19516500330.

GMP Standards

Our products are manufactured under FDA regulations at 21 CFR part 111 and comply with Dietary Supplement current Good Manufacturing Practices (cGMP). The GMP standards are applied to a wide variety of procedures associated with the manufacturing of dietary supplements, including receiving, testing, and approval of raw materials, production, and process controls, laboratory testing of labeled and packaged finished product, distribution control and accountability, and shelf life expiration testing to ensure freshness and potency.

For many years we have used the same manufacturers to produce our powder formulas, capsules, tablets, softgels, gels, and liquid products to ensure consistency. All of our certified manufacturers meet or exceed cGMP requirements established by the FDA, as well as state and local regulations. In our facility in South Salt Lake City, Utah, our highly trained staff bottle, label, and ship our finished products. Our newly installed automatic bottling line has multiple built-in quality checks, such as weight verification and metal detection, to ensure all finished packaged products have the pre-determined physical count and are contaminant-free.

Independent Third Party Laboratories

In addition to our in-house quality control department, we use certified independent analytical laboratories to test raw materials as well as finished products. All of our certified laboratories meet or exceed cGMP requirements. These labs include, but not limited to: Advanced Labs, Alkemist Labs, Aemtek, Avanti Polar Lipids, Covance, Chemical Solutions Ltd, ChromaDex, Craft Technologies, Eurofins, MicroQuality Labs, Venture Labs, etc. Our products are assayed for identity, purity and potency, and are confirmed to contain pre-determined amounts of the contents listed on every label. Microbial, pesticides/herbicides, aflatoxins, residual solvents, and heavy metals analysis are also conducted on all applicable products.

Procedures of Analysis

We utilize a number of advanced methods of analysis, including high performance liquid chromatography (HPLC), IR and UV-VIS spectroscopy, capillary electrophoresis (CE), inductively coupled plasma-mass spectrometry (ICP-MS), atomic absorption (AA), thin layer chromatography (TLC), Fourier transform infrared spectroscopy (FTIR), DNA analysis, GMO-Testing, major food allergen testing, and radiation contamination testing along with biochemistry and wet chemistry techniques.

Unsurpassed Ingredient Quality

Allergy Research Group uses only the purest and highest quality raw materials available. For example, we use only Nattokinase NSK-SD®, the first nattokinase introduced into the US market, which has established standardization and quality levels for all other nattokinase. Our S-Acetyl Glutathione is a novel oral glutathione formulation, and our Glandular products are derived from government-inspected, range-fed animals, raised in New Zealand and Australia under the strictest government regulations. Our Tocomin SupraBio Tocotrienol products are 100% non-GMO, non-soy, Kosher certified, and Halal certified, from a pure palm mixed tocotrienol complex, with a natural ratio of alpha, beta, gamma, and delta-tocotrienols, obtained using sustainable agriculture from a founding member of the Roundtable on Sustainable Palm Oil (RSPO).

Allergens and Allergen Testing

We take great care in how we qualify both our raw material suppliers and our contract manufacturers (CMOs).

We perform on-site audits to evaluate cGMP adherence of our CMOs on a regular schedule. Those that handle various potential allergens in their facilities get top priority and more frequent audits.

All our suppliers much be certified ‘good manufacturing processors’ (cGMP). We maintain and update audit certifications from third party reviewers, proving their commitment to cGMPs. We require our suppliers to complete a questionnaire, which covers the many aspects of their supply chain and processing, including the presence or absence of all the allergens we list. When we are informed of changes to the manufacturing flow process for a supplier, we re-evaluate their supplier questionnaire.

We do select finished product testing for allergens that may be present due to a known processing aid ingredient, or information about known allergens that may be present in the facility in question. We also do select finished product testing of possible allergens from the official FDA allergen list as well our own, including corn and yeast.

If we make specific claims on our product label for the absence of a particular allergen, i.e. if the label states No Gluten and Non-Dairy, then we test for gluten and dairy.

At least once a year, we test final products for possible suspected allergens, which are allergens from any known processing aid ingredient, and/or transparent information from the supplier that they also handle certain known allergens in their facility. These include any relevant allergens from the list of major allergens as outlined by FDA. We also perform corn and/or yeast testing as needed, as these allergens may be intolerable to some individuals.

We use accredited third party ISO laboratories to perform enzyme-linked immunosorbent assays (ELISA) and to interpret the result as allergen-free if it is below the recommend guideline’s lowest reportable limit.

We also review all technical data packets for an ingredient, including manufacturing flow chart, MSDS, certificate of analysis (COA), allergen/GMO/gluten statements, and others. For some highly refined material that the supplier excludes as an allergen, we will not indicate it as an allergen. As an example, properly produced vitamin E (d-alpha tocopherol) is defined as ‘highly refined’. Starting with soybeans, soy oil is extracted and refined, leaving behind all detectible protein content (proteins are typically the offending allergen components). Then the oil is further refined and purified to make vitamin E. For these reasons, the regulations do not require vitamin E to list ‘soy’ as the source, since the chance of a soy allergen being present is negligible.

For most formulas, the main Quality Control documents are available on our website on the relevant product page. Our Quality Control Department offers full transparency of our allergen testing, as requested for a specific product.

Also see:
Hypoallergenic
GMO Policy
CA Prop 65