Testing Protocol

Functional Brands Supplements Are Tested Using State-of-the-Art Technologies

We test our raw materials and finished products far beyond FDA requirements. Our process uses highly equipped, state-of-the-art independent laboratories that have been selected carefully based on their excellent reputations for nutraceutical testing. We use many laboratories for the specialized services they offer because no individual lab could run all the assays that are required. Only the most advanced and accepted methods and procedures for our protocol are employed. The laboratory equipment used is the most advanced state-of-the-art equipment available, including mass spectrometers for heavy metal and pesticide testing contaminants with exacting precision up to parts per trillion.

Raw Material Identity

Raw material identity is verified using Near Infrared (NIP) Spectroscopy. This equipment uses a material’s absorbance characteristics in the NIR visibility spectrum to construct an absorbance graph typical of that particular material.

Heavy Metal Analysis

Heavy metal analyses of raw materials and finished products are performed by state-of-the-art ICP-Mass Spectrometer (ICP-MS) equipment that offers microanalysis of heavy metal contamination. Results can be obtained in parts per billion on all materials and even parts per trillion under certain conditions. This type of equipment is the only accepted and required type of laboratory equipment for complying with California’s Proposition 65 heavy metal specifications. Sample preparation for the ICP-MS is performed using advanced technology microwave digestion.

Allergy Testing

The allergy testing of Functional Brands Supplements products is done by way of enzyme-linked immunosorbent assay (ELISA) methodology, which is sensitive down to specific parts per million depending on the allergen. Casein, gluten, soy, sesame, and peanut allergens are continually monitored in all of Kirkman’s products.

Pesticide Testing

Functional Brands Supplements monitors all raw materials for hundreds of potentially harmful pesticides. We know of no other supplement company that tests to this degree. Many supplement companies monitor plant and herbal type products for pesticides because they are the most likely products to be contaminated with pesticides, but nutritional supplement raw materials come from manufacturing facilities all over the world, and pesticide contamination could easily occur with any type of material.

Pesticide residues fall into two categories: non-volatile and volatile.  To monitor all types of potential pesticide contamination, therefore, requires two distinct types of laboratory equipment. The non-volatile pesticides are detected and measured with liquid chromatography (LC). Non-volatile pesticides are tested on state-of-the-art LC triple quadrupole spectrometer (LC-MS) equipment. By using the new triple quadrupole technology, a tenfold increase in sensitivity is realized compared to older single quad technology. LC-MS is also used to test for non-volatile chemicals, vitamins and other compounds for dietary and food supplements.

The assay measurements of volatile pesticides and other volatile chemicals and contaminants require different technology. Kirkman uses state-of-the-art custom gas chromatograph (GC) equipment for this purpose, equipped with a pesticide GC-MS analyzer. This is the most advanced technology available for the analysis of volatile pesticide compounds.

Label Claim Verifications and Stability Testing

Label claim verifications and ongoing stability studies of Functional Brands Supplements products are performed using Food and Drug Administration (FDA), United States Pharmacopeia (USP), Food Chemical Codex, or equivalent Association of Analytical Chemists (AAC) methodology. In the case of contaminants regulated separately by the State of California under Proposition 65, Kirkman follows California’s recommended testing procedures, which usually are even more stringent than that of the FDA or USP.

Microbiological Testing (Bacteria, Yeast, Mold)

We also monitor raw materials and finished products for the presence of microbiological contamination, yeast, and mold growth. Stringent limits are in place to monitor aerobic bacterial plate counts, yeast and mold counts, and the continuous absence of problematic bacteria including E. coli, Salmonella, Staphylococcus aureus, and Listeria. Testing methods utilized for this microbiological testing are derived from the FEDA’s Bacteriological Analytical Manual, the USP or the AOAC.

Functional Brands Supplements’ Quality Assurance

Functional Brands Supplements has a Quality Assurance department that is entirely devoted to ensuring that the laboratories we use are well qualified; use the most current and best testing procedures; and test with the most up-to-date equipment for effective, accurate results.