U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
December 15, 2000


Letter to Stakeholders
Regarding Contract on Dietary Supplement Safety Issues

Letter
Contract Scope of Work


Dear Dietary Supplement Stakeholder:

We would like to inform you about a contract the Food and Drug Administration recently entered into with the Institute of Medicine (IOM) of The National Academies. This contract, in the amount of $1 million and entitled "Framework for Evaluating the Role of Dietary Supplements in Health," has been let in order to provide an appropriate protocol for the agency to use in reviewing the safety of dietary supplements. The contract covers the time period September 30, 2000 through September 29, 2002.

In the agency’s view, the development of such a protocol is not only critical to the responsible and timely implementation of the Dietary Supplement Health and Education Act, but is an activity that should be an open process driven by a well-grounded scientific rationale. The contract requires that the IOM constitute a committee that will (1) develop a proposed framework for categorizing and prioritizing dietary supplement ingredients based on safety issues, (2) describe a process for developing a review system with specifications for evaluating the safety and role in health of dietary supplement ingredients, and (3) develop at least six prototypes as examples of using the proposed framework. The framework will include a methodology to review the available peer-reviewed literature with regard to the role of dietary supplement ingredients in health, taking into consideration methods other expert bodies have used to categorize and review issues related to safety and possible roles in health of dietary supplements and their ingredients. Additionally, the IOM may solicit other funding sources to support this effort.

The process by which committee members are determined and meetings are held are prescribed by The National Academies, and described on their web site (http://www.nationalacademies.org). The IOM has recently forwarded a request to many organizations and individuals seeking nominations for members of this committee. Current plans call for the IOM to hold a public meeting to solicit specific comments and input about aspects that need to be considered in developing the framework after the committee is finalized and oriented to its charge. Although review of nominations has begun, additional candidates may be nominated through the end of the year by forwarding their names to Allison Yates, Director of the Food and Nutrition Board, Institute of Medicine, The National Academies, 2101 Constitution Ave., NW, Washington, DC 20418. Once the committee is named, additional information about the charge to the committee and its first meeting will be on the Current Projects section of the National Academies web site.

It is expected that a proposed framework will be developed during the first year of the project and released for comment and review by The National Academies prior to its finalization by the end of the second year. When the proposed framework is released by The National Academies next year, we will also put it on the FDA web site for your review and comment.

We hope this information is helpful to you. Within the next few days, a description of the contract will be posted on the FDA web site (www.fda.gov).

Sincerely yours,


Christine J. Lewis, Ph.D.
Director
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition


Contract Scope of Work

CONTRACT: FRAMEWORK FOR EVALUATING THE ROLE OF DIETARY SUPPLEMENTS IN HEALTH

Period of Performance:
September 30, 2000 – September 29, 2001

TIN 53-019-6932 DUNS 04-196-4057

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C-1 Scope of Work (In Contract Schedule)

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work as described below:

Purpose

Given the increasing role of dietary supplement products in the U.S. marketplace, a comprehensive and authoritative review of the state-of-the-art knowledge base on the available safety data on the broad range of ingredients used in dietary supplement products in the U.S. marketplace is urgently needed.

Background

FDA has primary regulatory responsibility for ensuring the safety of the U.S. food supply, including the safety of ingredients used in dietary supplements marketed under food jurisdictions of the Food, Drug and Cosmetic Act. Unlike conventional foods, FDA has limited experience and expertise with dietary supplement ingredients. Moreover, there are thousands of ingredients that can and are being used in dietary supplements. Many of these have history of use as traditional medicines, but lack a similar history of use in food products such as dietary supplements. Currently marketed dietary supplement uses often differ from traditional uses. Both their history of use based on purported "biological activity" and deviations in use from traditional applications give rise to the need for evaluating safety in the context of current uses.

This lack of history of use as food products makes it difficult for FDA to effectively monitor both safety of marketed ingredients and the potential for claimed uses to cause harm. Manufacturers and retailers, health professionals and researchers, and consumers experience difficulty in translating the available scientific evidence for medicinal uses to the food context. Additionally, this lack of food history often results in the imposition of international trade barriers against U.S. products.

Other authoritative bodies have published reviews of the use of dietary supplement ingredients for drug applications (e.g., Commission E in Germany). These monographs focus primarily on efficacy issues. Safety is generally only evaluated in the context of their traditional medicinal uses. Similar monograph reviews for the safety of these ingredients when marketed as foods have not been systematically conducted.

Scope of Work

The contractor shall work closely with FDA/CFSAN throughout the period of this contract.

The focus shall be on the use of ingredients in dietary supplements regulated under food provisions of the law, not as drugs or therapeutic agents.

The contractor shall develop a framework that includes criteria for how review of dietary supplements and ingredients should be prioritized with regard to safety issues.

The contractor shall describe a process for developing a monograph system with specifications for evaluating the safety of dietary supplement ingredients and shall develop at least six prototype monographs as examples.

The contractor shall solicit public input on the proposed framework and relative to their plans for monograph development.

The contractor shall consider the relevance/lack of relevance of the way in which other expert bodies have categorized and reviewed supplement safety issues.

The description of the framework and criteria for categorizing the safety of dietary supplement ingredients shall contain sufficient information to describe the rationale used.

The prototype monographs shall contain information to document the science base and rationale for the conclusions and recommendations contained in these documents.

The framework shall outline approaches to be used to conduct the review of available research regarding the role of each dietary supplement or ingredient in maintaining health and decreasing risk of disease.

The project shall be conducted in several phases:

Phase I:

The contractor shall identify a framework for categorizing and/or classifying ingredients based on safety concerns.

Across and within the categories, the contractor shall give criteria for how ingredient reviews should be prioritized.

The contractor shall publish its proposed framework and rationale for this framework and shall also solicit public comment on these.

Phase II:

The contractor shall develop prototype monographs for at least six of the most critical risk categories. The prototype monographs shall consist of, but are not limited to: (a) a description of the ingredient under review, (b) a critical evaluation of the state-of-the-art science relative to the adverse effects of the ingredient, (c) a review of the research on its role in maintaining health and decreasing risk of disease, (d) identification of research needed to further characterize its adverse effects and role in health, and (e) conclusions as to what is known and unresolved issues about the safe use conditions for this ingredient when included as part of a dietary supplement.

The contractor shall publish a final report for the proposed framework and rationale.



This document was issued on December 15, 2000.
For more recent information on Dietary Supplements
See http://www.cfsan.fda.gov/~dms/supplmnt.html



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