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Interview with Loretta Zapp
President, Industrial Labs and Founder, 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 do you see as the central purpose of the INA Methods Validation Program?


Our methods establish consistency in testing, which is really our goal. If five different labs get a different result from the same sample -- or if a manufacturer gets different results from different labs, it calls the entire testing process into question. By peer-validating analytical methods, we ensure that manufacturer can rely on specific methods of testing. Valid tests are tools to aid in production of safe and correctly labeled products. If a label says a substance has a 24% ginkoside level, we want to be able to verify that with certainty.
DSQI: How well is INA doing in fulfilling this need?

INA is enjoying some success, because we are accomplishing what we set out to do. We had hoped to have methods peer-validated for 6 botanical by the end of our first year and it looks like that will happen. Many of our sponsors are competitors who have chosen to put aside their competitive swords and came together in a cooperative effort for the good of the industry. There are no special privileges or exclusive rights. Everything we develop goes out to the general public. Anyone who wants one of the validated methods can simply ask for it.

The fact that these companies stepped up to the plate and paid for this effort I believe, is a testimonial to the credibility and good intentions of these companies. We currently have funding for two years. At the end of year one, we will come together again and look at how to keep going.

DSQI: Who do you see as the users of the INA MVP?
Zapp: Test laboratories, suppliers of raw materials and ingredients, distributors, manufacturers, retailers, and of course anyone doing studies: the press and clinical researchers. As a test lab, we do a lot of quality control for manufacturers and suppliers, and increasingly for retailers as well. We've been getting samples from all levels of retailers, from large chains to small stores. Although INA MVP produces validated methods for ingredients, many of these methods will apply with little additional validation work to final products.
DSQI: Are other labs involved in INA?
Zapp: Yes. About 35 labs around the globe. We solicit labs they solicit us and we qualify and pay them to do the validation work. Other labs definitely cooperate in this effort; it's not just manufacturers who are involved. It seems like every week another lab wants to be involved as word is getting out. The response has been really positive from both industry and academia, and as I've mentioned from labs in other countries as well.
DSQI: Do you expect MVP to be adopted industry-wide?

We're not asking people to adopt MVP as an industry-wide standard. If a manufacturer has a method that works for them, they can compare our method to their in-house method. Hopefully, the two tests results will agree. If not, they probably need to look a little harder at the methods. Sometimes steps in an extraction or processing protocol might interfere with a method's performance -- We may discover something that INA needs to know about the performance of its method.

Botanical chemistry is challenging and we always welcome information related to improving the robustness of our methods. In taking a method through the validation process, we try to utilize a very broad array of extracts in order to be sure we address the most common denominators. However, someone may have a unique extraction process which prevents the INA method from working on their particular product. The best solution is to have an open dialogue. It's important to make our methods available to the public so people can try them and we can learn from those who use them. Botanical methods validation is still new in the United States.

One of the negative events that is occurring in our industry is the media hype surrounding what are described as sub-potent products. Perpetuating the "buyer beware" sentiment. If the press continues its investigative reporting, it is in everyone's best interest that the test methods used in a study are validated.

DSQI: What do you see as INA's biggest challenges and accomplishments?
Zapp: The fact is that we've taken the first step. A lot of work still needs to be done. Right now, the Methods Validation Program addresses only raw materials and extracts, not final products. Final products method validation is be much more complicated, but does need to be addressed. There is so much variety in final product formulations. Manufacturers use different procedures to create extracts -- and to create the wide range of final forms: tablets, capsules, gelcaps, liquids, tinctures, etc. To cover all these matrices is a laborious task. This program is a first step and a worthy beginning.
DSQI: Where do you expect to go with MVP?
Zapp: Our goal is to establish methods that are included in the peer-verified methods book of the AOAC (Association of Official Analytical Chemists). We additionally will submit methods to the US Pharmacopoeia.
DSQI: Might this lead to more government regulation of the manufacturing process?
Zapp: Not necessarily. Companies that make product should already be implementing testing in their process. This program is designed to aid in good manufacturing by providing consistency in testing tools. Dr. Jim Tanner with the FDA sits on our advisory board. We believe that there is mutual benefit gained from this relationship. Involvement in our program allows FDA to learn as we continue to ourselves, the analytical challenges faced by herbal supplement makers. FDA has limited resources for method development and validation. This program helps fill some gaps and attempts to keep the industry and the agency on the same page.
DSQI: Is it possible for a company to have a valid method that is different from the MVP's method?
Zapp: Yes, it is possible. In that case, the company should be able to show they have a method that works and not be held to our method.
DSQI: Supposing that the FDA adopted INA's methods once accepted by the AOAC. Does it follow that a manufacturer might have to change its manufacturing process to pass the AOAC method even if its own method was valid?
Zapp: I don't see the FDA making an issue of this. In the dietary supplement industry, the technology is evolving so rapidly. There's a lot of science to be learned about how to quantify and qualify these botanicals products. It would not make sense for the FDA to be cut and dried or to say "You must use method X!" -- especially for final products. Companies should always verify that methods work on their product forms.
DSQI: Is the INA planning an MVP label or certification process?
Zapp: Not at this point.
DSQI: Any other plans in store for INA?
Zapp: Our goal is to provide tools that support production of high-quality botanicals. The industry has a strong need for self-regulation, and we're looking to provide resources for a self-regulation process. Right now, we're in the discussion stages of figuring out where our analytical expertise fits in best, in providing these tools for industry.

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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