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Interview with Mark Lange
Science Director, Institute for Nutraceutical Advancement (INA)
March 20, 1999

On March 20, 1999, we spoke with Mark Lange, INA's Science Director, and Loretta Zapp, President of Industrial Labs and the driving force behind formation of both the Institute for Nutraceutical Advancement and the MVP. Read the context for this interview.

DSQI:

What issues have you encountered in developing validation methods?
Lange:

Probably our most significant discovery is how difficult it can be to develop a uniform testing procedure. Even when an in-house method seems to be very good and is backed with a lot of validation data by the lab or manufacturer that developed it, some of these methods don't always perform as well as you'd expect when you apply them to many different types of samples and have them done by many different labs. Overcoming these difficulties requires the kind of open communication and sharing of information and ideas that we've established here at INA.

Robust lab testing is the cornerstone to having quality products. Having good testing procedures is essential for operating a facility under GMPs. So we are achieving our goals, despite the problems we have encountered in the validation process. The more problems we uncover, the more it tells me we're doing the right thing, and that it's time to tackle this giant problem. Ultimately the consumer will win.

The industry is concerned that consumers may lose confidence in dietary supplements for lack of consistent results when products are tested. The industry is responding. MVP is a giant step forward. Competing companies are sitting down and working together for the good of the consumer.

DSQI: What specific progress has INA made in developing methods since its inception last year?
Lange:

Basically, we have taken test procedures for various standard marker compounds and used them to test both plant material and extracts -- running each test through a very rigorous protocol to see if the method is performing accurately and precisely no matter which lab conducts the test. Using such a method, the test will always work and provide valid and consistent results from lab to lab and manufacturer to manufacturer.

Methods for gingko and ginseng are now published on INA's web site. Methods for echinacea, kava, and St. John's wort are currently under development -- and saw palmetto is next on our agenda.

DSQI: What has been your biggest challenge?
Lange:

The wide variety of different products based on the same botanical.

Sometimes different species are used or may be present in different ratios or blends. For example, American, Siberian, and Korean ginseng are distinctly different species -- as are echinacea augustifolia and echinacea purpurea. Also, various products might contain different parts of the plant -- flower, leaf, root, stem -- again in differing ratios. Extraction techniques also vary greatly.

So for any particular botanical, there can be as many as ten quite different kinds of products. Creating a single validation process for all of them becomes extremely complicated. It's like saying, "Here's a recipe for a cake needs that needs to work in every brand of oven and at altitudes ranging from Mt. Everest to Death Valley." All these different parameters must be addressed in order to get good results no matter which product is tested or who performs the test.

DSQI: Is it possible that manufacturers would change their formulas in order to ensure they pass these validated test methods?
Lange:

That's a very insightful question. We haven't run into this yet but it's in the back of everyone's mind.

We're now validating a new procedure for St. John's wort. The industry's currently accepted procedure is DAC91 or 86 -- a spectrophotometric procedure. You dissolve the sample into a solvent that you place into a spectrometer, an instrument that measures absorption of light at a specific wavelength -- and then run calculations of the hypericin level.

Our INA group decided to use the HPLC method instead which may yield different results from the industry's spectrophotometric standard. It's too early to tell. It would be great to develop a better test method that produces the same results as the previous method. We always strive for this.

INA members are now wondering if their levels will turn out to be different than when tested using HPLC. It is possible that the MVP methods we develop could ultimately impact manufacturer steps for extracts. Not yet, fortunately.

DSQI: What is INA's biggest accomplishment?
Lange:

Getting the MVP program up and running. When we first started, everyone said it won't happen -- that you can't get thirty competitors to sit around and agree about anything. We happily proved them all wrong. Of the thirty initial sponsors, none have dropped out yet. It's a very stable group.

We have very enjoyable intellectually challenging meetings where we discuss the hard issues and politics around any decision -- and we come to agreement. We listen to everyone's opinion. After every MVP meeting, I'm really proud of everybody. We're all working together to solve this critical issue of test procedures.

INA Developing Standardized Tests of Botanical Products

Botanical products have complex chemical structures -- and different manufacturers use different formulas and procedures for creating different products. Many useful methods have been developed by manufacturers and independent test labs to analyze and ensure the quality of these botanicals. But these methods vary among manufacturers and among test labs. Given such an array, is it even possible to create standardized test procedures that are equally valid for every product that contains a particular plant?

The Institute for Nutraceutical Advancement (INA) believes it is both possible and necessary. Organized by Industrial Laboratories, Inc., INA is a consortium joined by thirty manufacturers and suppliers of herbal products to develop standard methods for analyzing dietary supplements. By establishing standard test methods, it is hoped that producers and labs can obtain consistent, accurate results.

In early 1998, INA launched their Methods Validation Program (MVP): "an international project designed to select, validate and publish scientific methods for use in analyzing raw botanical materials."

The INA is broadly represented by a number of organizations in an advisory capacity, including the American Herbal Products Association (AHPA), The National Nutritional Foods Association (NNFA), the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), the Association of Official Analytical Chemists (AOAC), the Council for Responsible Nutrition (CRN), the U.S. Food and Drug Administration (FDA), and the Herb Research Foundation (HRF).

To date, the INA has published test methods for three raw materials: Kavalactones in Piper Methysticum, Flavonol Glycosides in Ginkgo Biloba, and Ginsenosides in Panax Ginseng and American Ginseng.

On March 20, 1999, we spoke with Mark Lange, INA's Science Director, and Loretta Zapp, President of Industrial Labs and the driving force behind formation of both the Institute for Nutraceutical Advancement and the MVP.end-of-story

 

   
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