DIETARY SUPPLEMENT TASKFORCE

Background and Overview

Representatives of trade organizations expressed a need for validated analytical methods for botanicals and dietary supplements to AOAC INTERNATIONAL in August 2000. According to the Dietary Supplement Health and Education Act of 1994, dietary supplements are considered foods and, therefore, fall under the scope of AOAC INTERNATIONAL. AOAC agreed to organize an ad hoc meeting at the AOAC INTERNATIONAL Annual Meeting in September 2000 to determine the extent to which analytical methods were needed for dietary supplements. At the end of the meeting, the ad hoc group concluded that the dietary supplement industry and regulatory agencies need rigorously validated analytical methods for botanicals and other dietary supplement products to protect the public safety and to regain consumer confidence in the quality of these products. The organizations involved include:

AOAC formed a Dietary Supplement Task Group (DSTG) on botanicals and dietary supplements. This Task Group represented all major stakeholders involved in the botanicals and dietary supplement industry. In addition, the Task Group provided critical connections within industry and technical information to ensure successful completion of the project.

Financial Champion

In September 2001, the dietary supplement community found a champion to financially support its work through AOAC INTERNATIONAL. A contract was initiated between AOAC and the National Institutes of Health (NIH), Office of Dietary Supplements (ODS), and the U.S. Food and Drug Association (FDA) / Center for Food Safety and Applied Nutrition (CFSAN). The contract specifies two ephedra methods with separate protocols each for dietary supplements and biologicals, and then another method for aristolochic acid be validated through the AOAC INTERNATIONAL Official MethodsSM process, using specified HPLC and/or MS detection techniques, and specified numbers of test materials/matrices to ensure broad applicability of the methods.

In a large five-year modification issued in September 2002, AOAC INTERNATIONAL was also contracted to initiate at least two (2) new pre-collaborative studies during the first year; and to complete the write-ups for at least five (5) Single Lab Validated (if the validation efforts are successful) during the first two (2) years. AOAC was contracted to complete the write-ups for at least twenty (20) Single Lab Validated (if the validation efforts are successful) during the first five (5) years.

Objectives

One major objective of this contract is to provide the CFSAN, FDA and the ODS, and NIH with accurate, reliable, practical, validated and published AOAC Official Methods for selected dietary supplements.

The effort to produce fully validated methods for dietary supplement ingredients involves four steps:

1. Accessing methods
2. Picking the most appropriate method for a multi-laboratory collaborative study
3. The conduct of the collaborative study
4. Evaluation of the results of the collaborative study.

Expert Review Panels (ERPs) with members from industry, academia and government review the methods and select one (or more) for validation in a "full" collaborative study. To assist the AOAC Senior Scientific Administrator (SSA) of these review panels, a "core group" of experts was organized. The purpose of this core group is to advise the SSA on:

1. Having sufficient methods to justify empanelling an ERP
2. Ensuring that the "right" methods been collected or identifying gaps in methodology; and 3) serve as advisors to the ERP.
3. A second major objective is to foster AOAC's administrative support of its general validation program.
4. A third major objective is to generate, consolidate, and make scientifically validated (reliable) information more readily available to the FDA, NIH, other governmental agencies as well as consumers, industry and other major stakeholders (trade associations, academia, and international organizations).
5. A fourth major objective is to adapt (as a model) an evaluation mechanism functionally equivalent to the so-called "NIH expert peer review committee," to be used by AOAC to more efficiently evaluate pertinent data and documents that are critical to the validation efforts overall.
6. A fifth major objective is to organize and offer appropriate training to (future) analysts and associated stakeholders that enhances the probability that a given protocol can be in-house validated to the technical and practical standards necessary to fulfill the criteria established by AOAC.

Dietary Supplements Task Group

The AOAC Dietary Supplements Task Group (DSTG) is comprised of 21 experts from the dietary supplements community (see the DSTF Roster). The Group was established by AOAC INTERNATIONAL in late 2000 to identify and review analytical methods that currently exist for a number of dietary supplements, as well as to conduct literature review of top ingredients, and to identify funding resources for dietary supplements methods validation.

Recognizing the value of this expert group, it became part of the NIH-FDA contract activities to offer technical support and advice to AOAC. A key function of the Task Group is to remain involved in AOAC dietary supplement activities as specified in the project/contract and thereby maximize the probabilities that the major objectives can be accomplished.

The DSTG meets on a regular basis, the most recent on April 8, 2003 in Gaithersburg, MD. Although the DSTG is a sizeable group of 21, many other meeting attendees representing the dietary supplements industry and regulators also attend the meetings realizing the importance of AOAC's dietary supplement initiative.

Important activities stemming from the most recent meeting include:

1. The approval of the new priority ingredient list, which now includes Echinacea, Green Tea, Garlic, Goldenseal, Vitex, and Skullcap
2. The formation of the second Ingredient Ranking Subtask Group (IRS)
3. The formation and implementation of two of the Expert Review Panels
4. The ongoing work on analyte and sample determination, as well as sample procurement; and (5) open and informative discussions regarding the seven dietary supplement ingredients selected (determination of analytes, samples, best techniques, etc.). The DSTG will meet again on September 12th, at the AOAC INTERNATIONAL Annual Meeting. See the draft minutes of the April 8, 2003 DSTG Meeting.

Pool of Experts

One of the requirements of AOAC's contract with the U.S. Food and Drug Administration requires the formation of an expert review committee as a method evaluation mechanism. In the implementation of this requirement, the AOAC has:

1. Selected from staff a Senior Scientific Administrator (SSA), Dr. Albert Pohland, to coordinate and oversee the operation of the Pool of Experts and the Expert Review Panels (ERPs)
2. Developed a draft description of how the panels will be formed and operate
3. Distributed to its membership, the DSTG and to the Methods Committee on Dietary Supplements, a call for volunteers to serve as members of a Pool of Experts from which individuals are to be selected by the SSA to serve on the panels when needed.

The Pool of Experts serves as a resource that collectively has the knowledge and experience to advise AOAC in the successful implementation of the project. Therefore, AOAC asks potential applicants to provide evidence of:

1. Demonstrated experience in the conduct of collaborative studies
2. Experience in single lab validation of methods
3. Detailed knowledge of the dietary supplements industry, and of the ingredients selected
4. Educational background, particularly in the fields of pharmacognosy, organic, analytical, natural products chemistry, or statistics
5. A record of publications.

As a result of this call for volunteers to join the Pool of Experts, AOAC now has a list of some 65 volunteers. Participation by additional volunteers in this Pool is encouraged and welcomed. Contact Dr. Al Pohland, Senior Scientific Advisor, with a copy to Jennifer Diatz.

Expert Review Panels

The principal purpose of the ERP is to select the method(s) that should be considered for "full" collaborative study. This selection would be based upon the combined judgment of the Panel that the method has been sufficiently studied to: (a) meet the acceptance criteria for single laboratory validation; (b) meet the needs of the user community; and (c) be successful in a "full" collaborative study.

A description of the Policies and Procedures for Expert Review Panels governing the operation of the panels was approved by the DSTG on January 10, 2003. The purpose of these guidelines is to ensure that the decisions made with respect to all aspects of the method validation process are clearly understood and that every effort is made to avoid any real or perceived conflicts of interest. For this reason, all potential members of the Pool of Experts were asked to provide a curriculum vitae. These CVs are on file in the AOAC office, both electronically and in hard copy.

One of the most important factors to be considered by the ERP in selection of the best method is applicability to the "matrices of interest." A great deal of effort, therefore, was focused on determining exactly what samples would be used in a collaborative study. A Sub-Group on Samples was convened by the DSTG to assist in this effort. At the same time, AOAC collected information on the types of products commercially available. <br />

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