Thorne Research - the Only Nutriceutical Company in the United States with World-wide Pharmaceutical Certification

For 21 years Thorne Research, Inc., has manufactured the highest quality, hypoallergenic dietary supplements available. At the forefront of product quality and manufacture, Thorne has, for many years, operated under comprehensive Good Manufacturing Practices guidelines (GMPs) developed by utilizing pharmaceutical industry models and the exceedingly stringent GMP model developed by the Australian Therapeutic Goods Administration (TGA). For 21 years, practitioners have reinforced the conclusion that they achieve superior results with Thorne products, and that sensitive patients tolerate Thorne products when other companies' products are not tolerated.

Fact 1. Unlike laboratories which, for example, test blood for practitioners and are required to operate under the Congressionally-mandated Clinical Laboratory Improvement Amendments (CLIA) (go to: http://www.fda.gov/cdrh/CLIA/ ), there are no "FDA approved" laboratories for the dietary supplement industry. For an interesting perspective go to Testing ...1, 2, 3 ...Testing. Click Here to View PDF.

Fact 2. A widely held misconception among practitioners is that a company can obtain accurate analyses of raw materials and/or finished product from "independent" laboratories. Indeed, there are many high-quality laboratories that have developed various methods for analysis of ingredients. For example, a USP procedure is very accurate if USP has a published method, but only for the individual substance or a final individual ingredient dosage form. The USP does not have methods, however, for such things as a combination of ingredients, or even individual analytical methods for many substances. To fill this analytical vacuum, the existing laboratories have developed methods that can be replicated by others and will stand up to scrutiny when challenged. The Association of Analytical Communities (AOAC), the premier analytical body, has three method-validation programs: the AOAC Official Methods Program, the Peer-Verified Methods Program, and the Performance Tested Methods Program. Even the AOAC is calling for validated methods for dietary supplements. CLICK HERE FOR PDF. The truth is many laboratories utilize unsubstantiated methods and/or run on outdated equipment with inaccurate methodologies. Many report results of analysis for ingredient combinations that are impossible to accurately analyze for.

For the practitioner, the companies who now use marketing literature to extol the virtues of their "quality control" are not answering a number of important questions.

Without a doubt, the first question practitioners should answer for themselves is: WHOM DO YOU TRUST? For example, at what point in time did the company who is asking you to trust them actually start manufacturing their own products? Thorne has always manufactured its own products since Day One, 21 years ago. For a number of years, several companies that model themselves after Thorne initially utilized jobbers to make their products, although they now enthusiastically proclaim they have their own manufacturing facility and GMPs. Thorne has always been the innovator, not just an eager imitator jumping on the bandwagon.

A second question deserving an answer is whether a company has an in-house quality control laboratory. The following example illustrates the superiority of an in-house laboratory: The Thorne GMPs require, as do pharmaceutical GMPs, the in-process testing of a product as it is being manufactured. While it is certainly commendable when a company tests its finished product, what do they do to ensure the product is of uniform quality and purity throughout the entire manufacturing process? This entails not only having the necessary internal quality control processes (via both GMPs and SOPs), but also having an in-house quality control laboratory. No pharmaceutical manufacturer can operate a manufacturing plant without an in-house quality control laboratory. At Thorne, six full-time laboratory personnel operate our state-of-the-art-laboratory. Thorne's in-house laboratory equipment, costing in excess of a half-million dollars, includes the following:

• Inductively Coupled Plasma Spectrometer (ICP)
• High Pressure Liquid Chromatograph (HPLC) with series 200 Diode Array Detector and series 200 Fluorescence Detector
• Gas Chromatograph/Mass Spectrometer (GCMS) with Flame Fluorescence Detector and Electron Capture Detector
• Near Infrared Spectrophotometer

VIEW PHOTOGRAPHS OF THORNE RESEARCH LAB

Q: If a manufacturer does not have an in-house quality control laboratory, how can it validate the analysis of an "independent" outside laboratory?

A: It can't.

Some companies send finished product to outside laboratories for independent testing, readily accepting the laboratory's cheapest testing method available; for example, accepting Flame Atomic Absorption Spectrophotometer testing (FAAS) for trace mineral analysis, even though FAAS is now recognized as being inaccurate and outdated. Other problems entail using improper testing methods.

The third question to ask, assuming the company has an in-house laboratory, is how comprehensive their quality control GMPs actually are. Although the GMPs proposed by industry trade groups are a good starting point, they very clearly do not address all the issues that are imperative for superior quality control.

Fact: Many companies now resort to the deceptive marketing ploy of professing that, "we independently test each and every raw material" and/or "we independently test each and every finished product." In reality, most companies do not have an in-house quality control laboratory to ensure their in-process manufacturing actually meets acceptable standards, let alone the ability to confirm the quality and accuracy of whatever independent laboratory they may be utilizing. As noted in the AOAC call for methods above, there are necessary quality requirements to consider a method as being acceptable. For example, many laboratories only calibrate their equipment once-a-week, many times utilizing outdated or poorly stored standards. For an interesting perspective, request from a laboratory the estimated cost to analyze a compound, then make a follow-up request explaining that the test procedure used must be validated and be able to stand up in court. Suddenly the initial cost estimate will go up two- or three-fold, since most laboratories do not utilize validated methods.