Purity & Quality
Lab Tested & Purity Verified - What Does it all Mean?
"Produced in a GMP certified facility"
"Third Party Lab Tested"
You have probably seen one or more of the above statements but what do they REALLY mean? FDA approval is like the Good Housekeeping Seal of Approval, only much more so. But as reassuring as they may seem, the words "FDA approved" or "FDA registered" don't mean that much because FDA certification of a product is never a guarantee of safety or effectiveness.
All products that make health-related claims need some kind of clearance by the FDA. Cosmetics don't unless they claim to treat specific problems such as dandruff or acne. The FDA holds different products to different standards. The only products the FDA actually "approves" are drugs and serious high-tech medical devices such as implantable defibrillators.
It also important to note the FDA doesn't regulate vitamins, herbs or other dietary supplements. If a company claims that a supplement is "FDA approved", you should doubt that altogether.
The FDA doesn't test supplements
This is why companies aren't allowed to claim their vitamins or herbs can treat or prevent any specific disease. But prescription drugs are different. They have to go through a rigorous testing process to convince the agency that the product has some benefits that outweigh the risks. Over-the-counter drugs such as cough syrups and pain relievers are also monitored by the FDA although the testing process isn't as rigorous, especially if the product is considered likely to be safe.
How we test our ingredients and finished products
The first step in our Quality Control begins with our raw materials suppliers. We buy ingredients from all over the world. Whether the suppliers are known to us for years or they are new, we survey them regularly and audit their internal quality control procedures. Unlike many other companies, we do not simply rely on a supplier's Certificates of Analysis (COA) because they are very easy to forge.
When raw materials reach our facility, they are immediately quarantined. Our Quality Control staff then begins the process of checking each ingredient against our purchase specifications. Is the quantity shipped correct? Is there visible damage to the shipping containers? Does the accompanying paperwork match the purchase order specifications? After we confirm the inbound shipments are correct on paper, numerous samples from each shipment are then taken to our fully staffed in house testing laboratory where the samples are tested for identify and purity.
Our primary testing method is by Fourier transform infrared spectroscopy (FTIR). Fourier transform infrared spectroscopy (FTIR) is an incredibly versatile materials analysis technique used in helping identify organic and some inorganic materials. FTIR analysis measures the infrared region of the electromagnetic radiation spectrum, which has a longer wavelength and a lower frequency than visible light, and is measurable in a sample when submitted to infrared radiation (IR). The basic theory at work is that the bonds between different elements absorb light at different frequencies.
The light is measured using an infrared spectrometer which produces the output of an infrared spectrum. The IR spectrum is a graph of infrared light absorbance by the substance on the vertical axis and the frequency (wavelength) on the horizontal axis.
Unknown materials are identified by searching the spectrum against a database of reference spectra. Materials can be quantified using the FTIR materials characterization technique as long as a standard curve of known concentrations of the component of interest can be created.
FTIR can be used to identify unknown materials, additives within polymers, surface contamination on a material and more. The results of the tests can pinpoint a sample's molecular composition and structure.
A device called an interferometer is used to identify samples by producing an optical signal with all the IR frequencies encoded into it. The signal can be measured quickly.
Then the signal is decoded by applying a mathematical technique known as Fourier transformation. This computer-generated process then produces a mapping of the spectral information. The resulting graph is the spectrum which is then searched against reference libraries for identification.
FTIR can be used on solid, liquid and gaseous samples. Usually the amount of material required for a viable analysis is very small and most analyses can be done relatively quickly with little sample preparation.
Interpreting the X-Axis: The Infrared Spectrum
The x-axis or horizontal axis represents the infrared spectrum, which plots the intensity of infrared spectra. The peaks, which are also called absorbance bands, correspond with the various vibrations of the sample's atoms when it's exposed to the infrared region of the electromagnetic spectrum. For mid-range IR, the wave number on the infrared spectrum is plotted between 4,000 to 400 cm-1.
Interpreting the Y-Axis: Absorbance or Frequency
The y-axis or vertical axis represents the amount of infrared light absorbed or transmitted by the material being analyzed.
The Absorbance Bands
Typically, absorbance bands are grouped within two types: Group frequencies and fingerprint frequencies. Group frequencies are characteristic of small groups of atoms or functional groups such as CH, OH, and C=O. These types of bands are typically seen above 1,500cm-1 in the infrared spectrum and they're usually unique to a specific functional group, making them a reliable means of identifying functional groups in a molecule.
As for fingerprint frequencies, these are highly characteristic of the molecule as a whole; they tell what is going on within the molecule. These types of absorbances are typically seen below 1500cm-1 in the infrared spectrum; however, some functional groups will absorb in this region as well. As a result, this region of the spectrum is less reliable for identification, but the absence of a band is often more indicative than the presence of a band in this region.
Release from Quarantine
Once the test results confirm identity and purity, the materials are released for production. But our testing doesn't stop there. Throughout the production process, samples are taken at critical points and checked again. Finally, the finished product is checked before it is placed into inventory and ready for shipment. We further track each lot number against our sales database to ensure we know where our products go. Retention samples of raw materials, in process materials and finished goods are kept for a minimum of two years.