Merging Quality Science

with Supplement Research

A Strategic Plan for the Office of Dietary Supplements

Office of Dietary Supplements

Office of the Director

National Institutes of Health
ii

A Strategic Plan for the Office of Dietary Supplements

Contents (click on a topic)

Preface................................................................................................ iv

Background........................................................................................... 1

Introduction.................................................................................. 1

Brief History................................................................................. 2

Why a Strategic Plan?...................................................................... 3

Development of the Strategic Plan....................................................... 4

Overview.............................................................................................. 5

Foundation............................................................................................. 6

Congressional Mandates.................................................................... 6

Operating Definition of Dietary Supplements............................................ 7

Mission Statement........................................................................... 9

Scientific Goals and Objectives..................................................................... 9

Goal 1: Evaluate the role of dietary supplements in the

prevention of disease and reduction of risk factors

associated with disease...................................................... 10

Goal 2: Evaluate the role of dietary supplements in physical

and mental health and in performance..................................... 11

Goal 3: Explore the biochemical and cellular effects of

dietary supplements on biological systems and

their physiological impact across the life cycle......................... 11

Goal 4: Improve scientific methodology as related to the

study of dietary supplements................................................. 12

Goal 5: Inform and educate scientists, health care

providers, and the public about the benefits

and risks of dietary supplements.......................................... 13

Methods.............................................................................................. 14

Operating Principles....................................................................... 14

Criteria....................................................................................... 14

Types of Activities........................................................................ 15

Emerging Science......................................................................... 20

Plan Evaluation Process................................................................... 20

Conclusion........................................................................................... 20

Acknowledgments.................................................................................. 22

References............................................................................................. 23
iii

Appendixes........................................................................................... 26

A. Strategic Planning Participants........................................................ 27

B. Excerpt from the Dietary Supplement Health

and Education Act of 1994............................................................. 36

C. Reference Sources for ODS Definitions

and Terminology........................................................................ 37

D. ODS Incorporation of DHHS Customer Service Plan ............................. 39
iv

PREFACE

As the Director of the Office of Dietary Supplements (ODS) at the National

Institutes of Health (NIH), I am pleased to present the first strategic plan for this new

office. The plan outlines the ODS research goals and objectives and serves as a guide for

activities and resource needs for the office for the next three to five years.

The strategic plan was developed through collective input from over 120

scientists and professionals from academia, government, industry, public interest, and

professional groups. The final plan reflects more than 700 comments, suggestions, and

concerns, from these strategic plan participants which have been carefully analyzed and

incorporated through reviews of earlier drafts. I would like to acknowledge these

individuals who volunteered their time and participated in this planning process (see

Appendix A). It is their shared vision with ODS that is reflected in this document. I am

also grateful to the ODS team for their diligence and commitment to creating an

exceptional plan for the office. The ODS is mandated to foster the broadening of the

science base in dietary supplement research. Another important ODS responsibility is

collecting these results and disseminating them in a meaningful manner. These dual roles

of promoting research and disseminating research results are reflected in this strategic

plan.

This plan is not meant to be a static document, but one that will evolve and grow.

Please do not hesitate to contact the ODS with comments and suggestions regarding the

plan or office activities, through the contact addresses below. Also be sure to visit the

ODS Internet web page, http://dietary-supplements.info.nih.gov.

Bernadette M. Marriott, Ph.D.

Director, Office of Dietary Supplements

July 1998

National Institutes of Health

9000 Rockville Pike

Bldg. 31, Room 1B25

Bethesda, MD 20892

Tel: (301) 435-2920

Fax: (301) 480-1845

E-mail: ods@nih.gov

Web site: http://dietary-supplements.info.nih.gov
1

BACKGROUND

Introduction

In the United States, dietary supplements have been defined by the Dietary

Supplement Health and Education Act

(DSHEA) [Public Law 103-417, Section

3.(a), October 1994] to include

a product (other than tobacco) intended to supplement the diet that

bears or contains one or more of the

following dietary ingredients: (A) a

vitamin; (B) a mineral; (C) an herb or

other botanical; (D) an amino acid;

(E) a dietary substance for use by man

to supplement the diet by increasing

the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient

described in clause (A), (B), (C), (D),

or (E).

Scientific inquiry linking dietary

supplements to a healthier life can be

viewed as a relatively new area of research.

In the early part of the twentieth century,

nutrition sciences and dietary recommendations focused on the identification and

treatment of nutritional deficiency diseases.

Although Americans have long been consuming vitamin and mineral supplements, it

is only within the last two decades that a direct relationship between diet and health

(and, therefore, the potential beneficial role

for nutrient supplements beyond the minimum amounts required to avoid deficiency)

has become apparent. The possible roles for

food ingredients, dietary supplements and

other natural product derivatives to promote

health and reduce the risk of disease have

also become recognized. The publication of

The Surgeon General’s Report on Nutrition

and Health (DHHS, 1988) and the Diet and

Health report (NRC, 1989a) highlighted the

the diet-health relationship and led to a

paradigm shift: nutrition professionals began

to recognize the potential value of supplements to reduce disease risk. Since the publication of these reports, scientific research

that characterizes the potential roles of individual nutrients and food ingredients as dietary supplements has grown dramatically.

Important government studies, such

as the National Health and Nutrition Examination Survey (NHANES), the Baltimore

Longitudinal Study on Aging, and other

large-scale studies have included information on the use of dietary supplements.

These studies provide important scientific

information on the links between disease

and dietary parameters and also serve as key

monitors of change in healthful behaviors

and health trends.

In contrast to the large scientific literature on individual nutrients as supplements, there is a much smaller database of

scientific information on botanical ingredients. Considerable research on the effects of

botanical ingredients has been conducted in

Europe and Asia where plant products have

a long tradition of use. However, the overwhelming majority of nonnutrient dietary

supplements has not received in-depth scientific scrutiny. It is important, therefore, to

conduct scientific research to determine the

benefits and risks of promising botanical ingredients and to interpret available scientific

information for the public.

As with any scientific research involving human health, a series of research

steps will lead to a solid scientific base from

which public health policy advice can be

generated. New hypotheses are often generated from epidemiological studies of supplement exposures and specific health out-
2

comes, or basic research, such as the characterization of an active compound from a

plant. Testing for biological activity, or experimental intervention studies with laboratory animals, is often a second step. Results

from these types of studies, when coupled

with clinical observations, often lead to

health-related hypotheses and indicate research areas worth pursuing with clinical

trials. Structured observational studies and

small, direct intervention studies also may

provide additional evidence. Large-scale

clinical trials of safety and efficacy are characterized by diverse study populations and

highly monitored protocols. This latter type

of study or combinations of the various

study types can form the basis for recommending health policy changes.

Careful research is costly. While the

cost of basic biological research, animal

studies, and small-scale epidemiological

studies may range from less than one hundred to several hundred thousand dollars, the

cost of large-scale, randomized clinical trials

of efficacy and safety of a compound tested

against disease endpoints may typically

range into millions of dollars for a single

study. The ensuring value to the health of

the public can be great.

Dietary supplements do not have the

advantages of potential market exclusivity

that stimulates corporate research investment with prescription drugs. As a result,

the dietary supplement industry has not yet

invested heavily in research. The federal

government alone cannot move dietary supplement research forward. A combined effort of good scientific research supported by

government and industry is needed to clearly

identify how and when supplements can be

beneficial. The Report of the Commission on

Dietary Supplement Labels (CDSL, 1997)

highlighted the need for governmentacademic-industry partnership in dietary

supplement research. Professionals from

these three groups participated in the development of the ODS Strategic Plan. It is

hoped that this plan will lay the groundwork

for a three to five year governmentacademic-industry partnership in research.

Brief History

Public Law 103-417, the DSHEA,

amended the Federal Food, Drug, and Cosmetic Act “to establish standards with respect to dietary supplements.” This law

authorized the establishment of the Office of

Dietary Supplements (ODS) at the National

Institutes of Health (NIH). The DSHEA

designated tasks for the office and its director that were deemed necessary by Congress

to improve knowledge about dietary supplements. The ODS was established within

the Office of the Director, NIH, under the

supervision of the Associate Director for

Disease Prevention, William R. Harlan, M.D.

(Figure 1).

In November 1995, Harold E. Varmus, M.D., Director of NIH, appointed

Bernadette M. Marriott, Ph.D. as the Director of ODS. She came to NIH from the Food

and Nutrition Board, Institute of Medicine,

National Academy of Sciences, Washington,

D.C., where she was Deputy Director,

responsible for planning and managing the

research evaluation of national and international food and nutrition activities.

Since assuming the position of director, Dr. Marriott has promoted dialogue

among scientists and academicians, government, and industry regarding dietary supplements and encouraged these groups to

participate in the strategic planning process
3

FIGURE 1 Organization of the Office of the Director, NIH, showing the location of the Office

of Dietary Supplements, summer 1998.

for the ODS. In addition, Dr. Marriott has

been meeting with each NIH Institute and

Center (IC) Director to introduce the purpose and activities of the ODS as well as

identify common areas of scientific interest.

The initial costs of the ODS for 1995 were

funded through the NIH Director’s Discretionary Fund. Since fiscal year (FY) 1996,

the operating and program funds for the

ODS have been a line item in the budget of

the NIH Office of the Director.

In its first two years, the ODS has

addressed its congressional mandates and

begun to fulfill the purposes and duties defined in the DSHEA. A separate status report, Report of the First Years of the Office

of Dietary Supplements, 1995–1998, will be

published that provides an overview of these

activities and accomplishments.

Why a Strategic Plan?

Establishing a new government office can be both exciting and overwhelming.

From the inception, numerous decisions regarding both the operation and the activities

of the office must be made. Many decisions

will affect the future direction and success

of the office. In order for the office to move

forward systematically, it is necessary to

have a coherent plan with well-defined

short- and long-term goals that can be

evaluated, reviewed, and improved. One of

the first activities undertaken by the ODS

was the development of a strategic plan.

This plan will serve as the framework for

decision making for the next three to five

years.

The ODS Strategic Plan will not be

static. It will be evaluated regularly in order

to assess the effectiveness of the strategies

and methods used to achieve the office purpose and goals. This process will also allow

for adjustments in response to unforeseen

Office of Alternative Medicine Office of Dietary Supplements Office of Disease Prevention Office of Rare Disease Research Office of Medical Applications of Research

Associate Director for Disease Prevention

William R. Harlan, M.D.

National Institutes of Health

Deputy Director

Ruth L. Kirschstein, M.D.

National Institutes of Health

Director

Harold E. Varmus, M.D.
4

changes in scientific or public health needs

and opportunities.

DSHEA also authorized the establishment of a Presidential Commission on

Dietary Supplement Labels (Public Law

103-417, Section 12). This commission was

given the task to

...conduct a study on, and provide recommendations for, the regulation of label claims, and statements for

dietary supplements, including the use

of literature in connection with the

sale of dietary supplements and procedures for the evaluation of such

claims.

The resulting commission report (CDSL,

1997) included the findings and specific

guidance and recommendations to federal

agencies and industry. As part of its factfinding, the Commission reviewed the activities of the ODS and made the following

recommendations:

• ODS should strive to be an effective focal point for research on and understanding of the health effects of dietary

supplements.

• ODS should place greater emphasis on

its assigned role of advising other government agencies on a broad range of issues relating to dietary supplements.

By developing this strategic plan the ODS

has laid out a blueprint for its future that directly addresses these recommendations.

Development of the Strategic Plan

In its first year, a principal goal of

the ODS was to inform the biomedical and

professional communities about the new office. To accomplish this goal, the ODS Director attended numerous national meetings

and gave more than 35 presentations describing the new office. Each presentation

included a request that individuals from academia, industry, government, and the public

participate in the development of a strategic

plan for the ODS.

Through this process, professional

groups were identified that represented the

major scientific and public interests in the

field of dietary supplements. These groups

were then formally contacted and asked to

recommend individuals who were knowledgeable about the scientific and public issues related to dietary supplements. The

recommended individuals were formally invited to participate as ad hoc advisers to the

ODS. Over 98 per cent of those contacted

accepted the invitation.

Seven strategic planning meetings

were held from September 1996 through

February 1997. The meetings involved over

120 scientists and professionals from academia, industry, government, and public interest groups (see Appendix A for a list of

participants). The first three meetings, each

attended by a different set of specialists, focused on the definition and scope of dietary

supplements, and the setting of scientific

priorities. The next three meetings involved

different ad hoc advisers and built on the

first phase to develop a mission statement,

further define scientific priorities, and identify specific activities for the ODS.

The collective input from these

groups was used to develop a preliminary

draft of the ODS Strategic Plan. At the seventh meeting, the ODS convened representatives from the NIH ICs and other interested federal agencies to review and critique

the preliminary draft. Comments on the

preliminary draft, coupled with comments

and suggestions from the earlier sessions led
5

to a final draft of the ODS Strategic Plan.

This draft was sent to all 129 participants for

their review and comments. Over 700 comments, concerns, and suggestions were received, carefully reviewed by the ODS staff,

and incorporated into the final ODS Strategic Plan.

OVERVIEW

The ODS Strategic Plan comprises

three major components: Foundation, Scientific Goals and Objectives, and Methods.

Each component is summarized below and

developed more fully in subsequent pages.

Foundation

Three areas lay the groundwork for

the ODS Strategic Plan:

1. The Congressional Mandates were set

forth by the 103d Congress. This section

presents the congressional mandates within

the context of the ODS in general, the Department of Health and Human Services

(DHHS), and the NIH.

2. The term Dietary Supplements was defined by the DSHEA, and the activities of

the ODS will be guided by this definition.

An Operating Definition of Dietary Supplements has been developed by ODS to

provide further clarification, categories, and

examples that scientists and administrators

can readily interpret. This operating definition was proposed and refined through the

strategic planning process.

3. The ODS Mission Statement succinctly

states the purpose and mandates of the ODS.

Scientific Goals and Objectives

The ODS has identified five equally

weighted scientific goals and specific objectives:

Goal 1: Evaluate the role of dietary supplements in the prevention of disease and reduction of risk factors associated with disease.

Goal 2: Evaluate the role of dietary supplements in physical and mental health and in

performance.

Goal 3: Explore the biochemical and cellular effects of dietary supplements on biological systems and their physiological impact across the life cycle.

Goal 4: Improve scientific methodology as

related to the study of dietary supplements.

Goal 5: Inform and educate scientists, health

care providers, and the public about the

benefits and risks of dietary supplements.

Collectively, these goals will guide

the ODS toward fulfillment of its mission.

Methods

The ODS has identified five general

methods that it will use to move its objectives forward.

1. Operating Principles describes the underlying approaches of all the ODS activities.
6

2. Criteria defines what the ODS will use

to evaluate competing scientific priorities.

3. Types of Activities outlines the approaches ODS will use to accomplish its

goals, for example, through research support, research dissemination, and education.

4. Emerging Science describes how the

ODS will identify and promote new or developing scientific topics of merit.

5. Plan Evaluation Process outlines ways

in which the ODS will continually review its

progress toward meeting its goals and objectives.

FOUNDATION

Congressional Mandates

The DSHEA created the ODS and specifies the general scientific functions and duties for

the office and also a number of distinct tasks for the office and its director. The complete provisions from the DSHEA that are applicable to the ODS are included in Appendix B. These mandates are interpreted here in terms of their applicability to ODS in general, within the DHHS, and

within NIH.

ODS GENERAL MANDATES

The DSHEA [Public Law 103-417,

Section 13.(a)] included two overarching

mandates for the ODS that govern its general activities:

• “...explore more fully the potential role

of dietary supplements as a significant part

of the efforts of the United States to improve

health care;...”

• “...promote scientific study of the benefits of dietary supplements in maintaining

health and preventing chronic disease and

other health-related conditions.”

ODS MANDATES WITHIN THE DHHS

The Department of Health and Human Services (DHHS) is the principal unit

with the federal government responsible for

protecting and promoting health. As such,

the DHHS has a leadership role in helping

all Americans develop and maintain healthy,

productive, and independent lives. The

ODS also has a dual mandate to provide science support related to dietary supplements

within the DHHS:

• “...compile a database of scientific research on dietary supplements and individual nutrients;...”

• “...serve as the principal advisor to the

Secretary and to the Assistant Secretary for

Health and provide advice to the Director of

the National Institutes of Health, the Director of the Centers for Disease Control and

Prevention, and the Commissioner of Food

and Drugs on issues relating to dietary supplements... .”
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ODS MANDATES AT NIH

In addition to these general mandates, ODS has specific mandates within

NIH. As the major funding agency of biomedical research in the United States, NIH

has a leadership role in setting the agenda

for scientific research and establishing policy on how and by whom research is conducted (NIH, 1997). The DSHEA gave the

ODS a threefold mandate within NIH:

• “...conduct and coordinate scientific research within the National Institutes of

Health relating to dietary supplements and

the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism;

...”

• “...collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign

sources or the Office of Alternative Medicine; ...”

• “...coordinate funding relating to dietary

supplements for the National Institutes of

Health.”

Operating Definition of Dietary Supplements

The term dietary supplements is defined in the DSHEA as:

“ a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following

dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary

substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E)...is not represented for use as a conventional food or as a sole item of a meal or the diet; and is labeled as a dietary supplement.” [Public Law 103-417, Section 3.(a)]

Meetings with NIH Institute Directors and individuals from other agencies indicated that the definition stated in DSHEA

required clarification so that scientists and

administrators could readily interpret

whether compounds of interest to them

would fall within the ODS mandate.

Further, the DSHEA definition encompassed such a wide array of compounds

that some type of categorization was required to promote science in a systematic

fashion. The ODS therefore enlisted the assistance of participants in the strategic planning meetings to develop an operating definition and broad categories within which to

group dietary supplements to help focus

ODS activities.

ODS Approach to Dietary Supplements

The ODS accordingly has determined that its research focus will be on the

types and quantities of ingredients that may

be contained in commercially marketed

dietary supplements and their role in maintenance and promotion of health. Thus there

are two basic assumptions that govern ODS

activities: compounds that are under consideration 1) currently have an intended use as

dietary supplements or ingredients in dietary
8

supplements; and 2) compounds or ingredients therefore must meet the method of delivery and other statutory definitions for

dietary supplements described in DSHEA.

Ingredients or chemical constituents derived

from items that may be termed “functional

foods”1

, or some compounds that may be

termed “nutraceuticals”2

, may also be dietary supplements if they fall within the

statutory definitions of DSHEA. The ODS

considers solutions that are used to provide

total parenteral or full enteral nutrition (by

tube feeding) to be outside the scope of the

office. However, research on the health effects of specific supplement ingredients that

may be added experimentally to these solutions may be considered within the scientific

scope of the ODS depending upon the ingredient and study design.

Therefore, the ODS will identify and

foster research on the health benefits and

risks of substances based on the merit of the

underlying scientific evidence regardless of

how they might be currently incorporated

into the different categories of commercial

products or their regulatory status in the

commercial marketplace. This approach allows the ODS flexibility to address the scientific questions relevant to the role of specific substances in promoting health without

being unnecessarily constrained by the nuances that bear on whether a substance may

be lawfully used in a dietary supplement, or

whether specific information on the label/labeling causes a product to be marketed

under regulatory frameworks other than as a

dietary supplement.

 

1

 Functional Food - any modified food or food ingredient that may provide a health benefit beyond the

traditional nutrients it contains (Thomas and Earl,

1994).

2

 Nutraceutical - any substance that may be considered a food or part of a food and provides medical or

health benefits, including the prevention and treatment of disease (DeFelice, 1993).

Operating Definition

Following DSHEA, a Dietary Supplement is viewed by the ODS as any substance that is consumed in addition to the

regular diet - that is, in addition to meals,

snacks, and beverages - and follows the

methods of delivery clauses outlined in the

Act. Food items, in any physical form (such

as a liquid or a powder intended to be added

to a liquid, etc.) that are intended to be a sole

source of nutrition, meal replacements, or

conventional foods are not dietary supplements as defined in DSHEA, and thus are

outside of the scope of ODS.

Categories of Dietary Supplement Ingredients

Dietary supplements may contain

one or more ingredients whose health benefits and risks are of interest singly and in

combination. To simplify the ODS management of information and activities pertaining to the broad and heterogeneous

spectrum of ingredients that are included in

dietary supplements, it will group dietary

supplement ingredients into three categories:

Botanicals, Nutrients, and Other Dietary

Substances. The reference sources used by

the ODS for definitions and terminology for

each category are described in Appendix C.

Botanical Ingredients include all

plant-derived materials whether fresh, preserved, or dried full plants, plant parts, plant

species mixtures, plant extracts, and compounds found in such materials. Thus, items

that are commonly termed “herbs” or

“herbal products”, regardless of whether

they meet the dictionary definition of herb3

or that are comprised of parts, extracts, or

preparations of woody plants will be included as botanical ingredients.

 

3

 Herb- a flowering plant whose stem above ground

does not become woody.
9

Nutrient Ingredients include all essential and non-essential nutrients and other

food constituents, that are typically described in standard nutrition reference texts

or that fall within the review parameters of

the Food and Nutrition Board, National

Academy of Sciences in consideration of

Dietary Reference Intakes (DRIs). Thus, this

category would include substances recognized as essential nutrients (i.e., iron, vitamin C, essential amino acids, etc.) and substances not generally recognized as being

essential but that have or may have a dietary

or nutrient role in humans.

Other Dietary Substances comprises

a broad and diverse group of substances that

are neither of plant origin nor alone could be

viewed as “nutrients” within the commonsense meaning of the term. For example,

such substances could include animal or

plant metabolites or constituents, microorganisms and certain of their constituents,

etc. The substances subject to inclusion in

this category are limited by the statutory

definition of “dietary supplement” in the

DSHEA (i.e., not an approved or investigational drug, not a conventional food or meal

replacement, and intended to be used to supplement the diet, etc.).

Mission Statement

The mission of ODS is to strengthen knowledge and understanding of dietary supplements

by evaluating scientific information, stimulating and supporting research, disseminating

research results, and educating the public to foster an enhanced quality of life and health

for the U.S. population.

SCIENTIFIC GOALS AND OBJECTIVES

A major purpose set forth for the

ODS by Congress is to increase scientific

research on dietary supplements. However,

the broad array of dietary supplements

makes it impossible to promote research in

all available areas simultaneously. It is necessary, therefore, to focus on specific goals

and on objectives that will support and accomplish these goals. As a unit within NIH,

ODS will promote and support clinically

relevant, basic research, including animal

studies, as well as clinical studies of efficacy

and safety (NIH, 1997). Therefore, basic

research that is likely to advance particular

areas of science related to dietary supplement use and health will be an important aspect of ODS activities.

A DHHS wide mandate for the ODS

is to “serve as the principal advisor ...relating to dietary supplements” [Public Law

103-417, Section 13. (a)]. Through addressing the following goals and objectives the

ODS will further develop a scientific base

from which to provide information and advice.

During the strategic planning process, numerous approaches to goal setting

were developed, revised, discarded, reinvented, and recommended. As a result, the

ODS has identified five equally weighted
10

scientific goals that form the cornerstone of

its programs. Each goal addresses a pivotal

role for the ODS. The objectives listed with

each goal represent specific scientific areas

that were identified by the OSD staff and ad

hoc advisers as scientific priorities for the

next three to five years. In the objectives,

basic and clinical research related to the

same field of study may be addressed in one

or more goals, or not at all depending on the

research gaps identified in the strategic

planning process. These goals and objectives

were selected for their relevance to dietary

supplements and the likelihood that they

would produce successful outcomes.

These goals and objectives will

guide the ODS when preparing future budgets and determining ODS activities on an

annual basis.

Goal 1: Evaluate the role of dietary supplements in the prevention of disease and

reduction of risk factors associated with disease.

Over 100 million Americans regularly use dietary supplements (Aartes, 1997).

Many supplement users report that they take

dietary supplements to reduce the risk of

disease or generally to promote health

(Brevoort, 1998). Disease prevention research includes the identification of risk

factors and interventions that prevent the occurrence of disease (or its progression, if

detectable but asymptomatic). In a broader

sense, it also includes analysis of the etiology and mechanisms of disease that may

contribute basic knowledge applicable to

future preventive interventions (Harlan,

1998). As a unit within the NIH, the ODS

must promote and support basic research

that is likely to advance particular areas of

science that may be relevant to clinical

studies of efficacy and safety and specific

health problems. To address Goal 1, the

ODS sets the following objectives:

• Advance the understanding of the specific impact of nutrient and botanical supplements or their ingredients on immunocompetence particularly related to

HIV/AIDS and infectious agents.

*Specific areas of scientific priority included in the

DSHEA legislation.

• Stimulate research on the potential roles

of dietary supplements in reducing the risk

and control of cancer*, particularly cancer

of the breast, ovary, and prostate*.

• Evaluate the role of specific supplements

in reducing the symptoms or pathology of

coronary heart disease* and diabetes.

• Identify those dietary supplements that

reduce the symptoms of, and possibly retard

the progression of arthritis, including osteoarthritis.

• Introduce a cross-disciplinary initiative

to study the interactions among diet, supplements, and physical activity in bone

health and reducing the risk and progression

of osteoporosis*.

• Develop strategies to evaluate the role of

individual and multiple supplements to reduce the risk and progression of ocular disease, particularly cataracts* and macular degeneration.

• Foster the inclusion of research on the

role of dietary supplements in federal initiatives to address the etiology, reduction, and

health outcomes of obesity in the U.S.

population.
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• Examine whether dietary supplement use

may influence the progression of oral diseases.

Goal 2: Evaluate the role of dietary supplements in physical and mental health

and in performance.

In 1996, the U.S. Surgeon General

issued a report recommending that Americans increase their physical activity (DHHS,

1996). In response to the Senate Appropriations Committee of the U.S. Congress, the

Institute of Medicine, National Academy of

Sciences prepared a report that detailed recommendations for mental health research

(IOM, 1994). In keeping with these reports

and the congressional mandate, ODS seeks

to promote research on the scientific benefits

and risks of dietary supplements in maintaining health and performance. The following are objectives to address Goal 2:

• Encourage research efforts to evaluate

the relationships among dietary supplements

and physical health and performance that

includes the full range of age and population

groups, hydration status, temperature regulation, environmental stress, and physical

activity.

• Advance research on the role of dietary

supplements in altering body composition

and weight control.

• Advance research on the role of dietary

supplements for increasing muscle strength,

endurance, conditioning, and anaerobic

power.

• Initiate research to identify and characterize the unique nutrient and caloric needs

of persons with disabilities and elucidate

potential roles for dietary supplements.

• Encourage research to determine the

beneficial and detrimental effects of dietary

supplements on mood, fatigue, stress, and

psychological well-being.

• Promote further study of dietary supplements that have been demonstrated scientifically to enhance cognitive performance.

Goal 3: Explore the biochemical and cellular effects of dietary supplements on

biological systems and their physiological impact across the life cycle.

The use of dietary supplements may

influence biological systems or the physiological challenges to these systems during

human development. One function of the

ODS is to define areas of research focus and

foster exploration of the biologic variables

related to acute and chronic use of dietary

supplements. The following objectives have

been identified to carry out this goal:

• Investigate how dietary supplements

may moderate specific processes of aging.

• Explore how the assimilation of dietary

supplements varies with age-related physiologic changes.
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• Advance the understanding of how dietary supplements may influence reproductive systems, birth defects*, and fetal development.

• Characterize the relationships among

dietary supplements and basic cognitive

processes, including attention, learning, and

memory.

• Evaluate the role of individual supplements and supplement ingredients in the

underlying pathophysiology of metabolic,

endocrine, and gastrointestinal disorders,

particularly those associated with drug

abuse.

• Identify the changes in basic metabolic

and physiologic processes that may occur

with physical disabilities and potential roles

for dietary supplements.

Goal 4: Improve scientific methodology as related to the study of dietary

supplements.

Dietary supplement research is conducted across many scientific disciplines

and supported by a wide array of methods.

Key to enhancing progress in the field is the

integration of research that accommodates

the variety of supplements, supplement delivery systems, sites and mechanisms of action, and groups of individuals who take

supplements. Scientific advancement with a

particular supplement may hinge, therefore,

on the development or refinement of appropriate and/or novel instrumentation or methods. To meet this goal, the ODS proposes

the following objectives:

• Promote the identification and characterization of bioactive compounds in dietary

supplements by delineating their mode

of absorption, distribution, metabolism,

mechanism of action, and excretion.

*Specific areas of scientific priority included

in the DSHEA legislation.

• Evaluate and develop animal and clinical

methods for determining the efficacy and

safety of dietary supplements.

• Develop new and validate existing epidemiological/survey methods for assessing

dietary supplement usage.

• Promote the collection of reliable and

valid data on dietary supplement usage.

• Promote academic-government-industry

partnerships to advance dietary supplement

research and technology transfer.

• Develop model systems to predict and

characterize the potential for adverse effects

resulting from interactions among dietary

supplements and nutrients, other supplements, and drugs.

• Identify and facilitate the development

of new methods for characterizing supplements and their active components.

• Establish guidelines to delineate the

combination of experimental methods necessary to demonstrate high confidence levels

for efficacy and safety of dietary supplement

use.
13

Goal 5: Inform and educate scientists, health care providers, and the public

about the benefits and risks of dietary supplements.

The ODS Director was mandated by

Congress [Public Law 103-417, Section

13.(a)] to serve in an advisory capacity to

the DHHS regarding “(A) dietary intake

regulations; (B) the safety of dietary supplements, (C) claims characterizing the relationship between (i) dietary supplements;

and (ii) (I) prevention of disease or other

health-related conditions; and (II) maintenance of health; and (D) scientific issues

arising in connection with the labeling and

composition of dietary supplements”. The

Report of the Commission on Dietary Supplement Labels, (CDSL, 1997) recommends

that the ODS place greater emphasis on this

advisory role. The ODS has included this

mandate as a specific objective for achieving

goal 5.

Since the ODS began in November

1995, the office has received over 1,200

calls or requests from the public for personal

health care information about dietary supplements. An almost equal number of calls

have been logged in the ODS from scientists

and health care professionals. To assist these

groups, the ODS will promote and support

the development of scientifically valid information and educational materials on dietary supplements and individual nutrients

through the objectives that follow:

• Serve as a key resource and adviser for

policy makers about dietary supplements.*

*Specific areas of scientific priority included

in the DSHEA legislation.

• Develop and maintain a publicly accessible database of published, peer-reviewed,

scientific literature on dietary supplements.*

• Develop and maintain a publicly accessible database of federally funded scientific

research on dietary supplements.*

• Stimulate dialogue about dietary supplements among government agencies, academia, public advocacy groups, and industry.

• Facilitate the integration of scientific information on dietary supplements within

standard and continuing education programs

for health care providers.

• Promote training of scientific investigators in dietary supplements research, as well

as effective communication of research results.

• Encourage the regular inclusion of dietary supplement intake information as part

of a patient’s medical history.

• Conduct a survey to assess the need for a

public information system on dietary supplements.

• Evaluate and effectively communicate to

the public the results of recent scientific research.
14

METHODS

Operating Principles

The ODS has identified a number

of operating principles that will guide its

activities. The fundamental theme behind these principles is sound scientific

methodology. ODS supports the highest

quality science with regard to conducting research and communicating research findings to the public. A focus on

efficacy and safety in any intervention

study must be considered to ensure this

high-quality science. While some goals

and objectives may specifically mention

safety, the ODS will approach all research from the perspective that benefits

and risks must be addressed where possible. The ODS will interpret the scientific research on dietary supplements and

present a balanced view of scientific

evidence to the public. To maximize

public access and keep costs as low as

possible, the ODS will use its Internet

World Wide Web site to disseminate information. As directed by Executive

Order 12862 (see Appendix D), the ODS

will be open to new concepts of customer service orientation in order to provide quality service to the public. In addition, the ODS will visibly and actively

communicate and receive commentary

on its research plans, accomplishments,

and activities through a variety of forums. The ODS will also strive to coordinate with other agencies, institutes, or

the private sector in all areas of dietary

supplement research in order to avoid

duplication of efforts and potential waste

of government resources. (NIH, 1997)

Within NIH, ODS will work with its

Dietary Supplements Liaison Panel (see

Types of Activities section) to promote

and coordinate activities. Finally, the

ODS will focus its activities on the mission and goals set forth in this strategic

plan.

Criteria

The ODS will not have the resources to financially support all of the

dietary supplements research submitted

for consideration. The ODS therefore

has established the following evaluation

criteria to facilitate decision making

among competing scientific priorities:

• Relevance to the Mission of the ODS

The ODS is committed to implementing its goals and objectives.

ODS-supported research must delineate

a clear link between dietary supplements

and health. Similar to the ICs, the ODS

is responsive to the areas of research

emphasis that are identified by the NIH

Director (NIH, 1997).

• Expand experimental possibilities,

or develop emerging or innovative research strategies and methods.

As experimental possibilities expand, the ODS will strive to develop innovative research strategies and methods. Priority research strategies will:

prevent disease where other treatment
15

modalities fail, complement existing

preventive strategies, present and/or develop a needed novel methodology or

approach, provide a biomarker for disease, have a high biological plausibility,

and/or have the possibility of multiple

positive health impacts. Innovative research methods will open new directions

in basic research, allow specific key research questions to be addressed, and

move research forward toward clinical

applications.

• Fund research of the highest quality.

The ODS will adhere to the values of the NIH, which are based on the

highest quality science. High-quality

science must provide enough methodological detail to be validated or refuted,

have an appropriate experimental design,

and consider the quantity and quality of

prior studies. The ODS will promote

and fund research that is based on these

premises.

• Demonstrate a relationship to important public health need(s).

The ODS recognizes its responsibility in supporting dietary supplements

research that addresses an important

public health need. As a funding source,

the ODS must consider the relevance of

research to important problems in health

and the potential for reducing health care

costs.

• Offer potential for partnership or

collaborative efforts with other institutions and organizations.

The ODS acknowledges the importance of maximizing the use of funds

by avoiding duplication of ongoing research strategies. As a member of the

NIH community, the ODS strives for

potential partnerships and/or collaborative efforts with the ICs, other agencies,

and members of the private sector that

may reduce duplication. The ODS also

recognizes the importance of DHHStargeted subpopulations (DHHS, 1997)

that are underrepresented in research efforts. The ODS will emphasize these

populations in all of its activities.

Types of Activities

The ODS has identified five scientific goals and the strategic objectives

needed to accomplish them. The activities ODS will initiate to move this

agenda forward are described below.

These activities focus on research promotion, support, dissemination, and coordination, as well as advisory activities,

education, and partnering programs. The

complete description of ODS’ accomplishments to date will be published

separately in the forthcoming status report, Report of the First Years of the

Office of Dietary Supplements,

1995–1998.

Research Promotion and Support

Grants, Contracts, and Awards

As an office within the Office of

the Director at NIH, the ODS does not

have the authority to directly fund investigator-initiated research grant appli-
16

cations. Instead, the ODS may support

research by partnering with ICs at the

NIH or with another federal agency to

co-fund research grants or initiate Program Announcements (PAs), Requests

for Applications (RFAs), and Requests

for Proposals (RFPs). Those last

mechanisms stimulate research in specific key areas. NIH uses groups of outside experts through workshops, conferences and symposia to gather opinions

on the gaps in science that may be identified for research support through PAs,

RFAs, and RFPs.

A specific example of an intraagency agreement that is being used by

the ODS is the Research Enhancement

Awards Program (REAP). Through

REAP, grant applications are received

and reviewed by the ICs following the

standard NIH extramural research grant

process. Highly meritorious applications that fall outside an IC’s funding

resources and are within the research

interests of the ODS can be nominated

by NIH ICs to receive partial or full

funding from ODS. This innovative and

successful program was originally designed by the NIH Office of Research

on Women’s Health. The ODS has recently co-funded a total of 13 research

studies with the National Institute on

Alcohol Abuse and Alcoholism, the

National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Cancer Institute, the National Institute of Child Health and Human Development, the National Institute of

Deafness and Other Communication

Disorders, the National Institute of

Dental Research, the National Institute

of Diabetes and Digestive and Kidney

Diseases, the National Eye Institute, and

the National Institute of Neurological

Disorders and Stroke.

Contracts are a mechanism that

the ODS may use to conduct research,

such as the Public Information Center

Needs Assessment Survey that was initiated by the ODS and is being conducted

in collaboration with the Food and Nutrition Information Center (FNIC), U.S.

Department of Agriculture (USDA).

This study is evaluating the need for a

Dietary Supplements Information Center for the public, and it capitalizes on

the extensive experience of the FNIC

staff in responding to public questions

and developing information centers for

other issues.

The ODS also supports projects

jointly with other government agencies

such as the Centers for Disease Control

and Prevention (CDC), the Food and

Drug Administration (FDA), and the

Department of Defense (DoD). An example is the joint federal contract with

the National Academy of Sciences for

the Food and Nutrition Board study on

the Dietary Reference Intakes (DRIs) for

Thiamin, Riboflavin, Niacin, Vitamin B6,

Folate, Vitamin B12, Pantothenic Acid,

Biotin, and Choline (IOM, 1998).

Periodically, funds are also provided for individual awards of merit to

new or promising investigators, scientists, or staff who further the mission of

the office. Travel awards are also provided to defray the cost of scientist’s

attendance at conferences co-sponsored

by the ODS. Various mechanisms including intra/interagency agreements,

are used to implement these awards.

Centers for Dietary Supplement

Research

The ODS believes that there is a

need to identify/create Centers for Dietary Supplement Research to effectively

promote dietary supplement research.
17

By a “research center” the ODS is following the standard NIH definition of a

“center” which means a group of collaborating scientists who have demonstrated/can demonstrate their expertise

and capabilities in conducting research

on a specific topic. The ODS therefore

seeks to collaborate with the NIH ICs,

other government agencies, and industry

to jointly develop and fund eight research centers that will focus on the efficacy and safety of dietary supplements. Four of these centers will each

focus on one of the ODS’ major goal

areas. Four other centers will each focus on botanical supplements research,

including basic scientific issues of botanical supplement characterization and

quality. These centers will be developed

following standard NIH competitive

centers mechanisms and, where possible, build on the infrastructure of existing government-funded research centers

to reduce overhead costs and maximize

money directed toward research. It is

expected that some or all of these centers will be linked as consortia in order

to share resources and avoid duplication. The ODS will actively facilitate

this consortium concept.

Conferences, Workshops, and

Symposia

To stimulate research, the ODS

plans, organizes, and supports small

conferences, workshops, and symposia

on scientific topics related to dietary

supplements. The ODS can initiate such

activities alone, but more often will

work in conjunction with NIH ICs, other

government agencies, and professional

organizations. The specific goals and

outcomes of these convening activities

vary with the scientific topic.

Occasionally, the ODS will

sponsor large conferences or workshops to provide an overview of a scientific area and bring together scientists

and professionals from different disciplines to identify gaps in research and

directions for future joint endeavors. For

example, the ODS held a major two-day

workshop, “The Role of Dietary Supplements for Physically Active People”

in conjunction with the American Society for Nutritional Sciences and the

American Society for Clinical Nutrition.

Co-sponsored by 11 NIH ICs, this

workshop presented a state-of-the-art

scientific review of dietary supplements

that may enhance the health of people

who actively engage in regular exercise.

More typically, the ODS sponsors or co-sponsors small workshops to

assist in defining research gaps in a specific scientific area of dietary supplement research. In 1996–1997, for example, the ODS co-sponsored two workshops that were initiated by the National

Institute on Aging: “Melatonin and

Sleep” and “Melatonin and Aging”. The

ODS is co-sponsoring 15 conferences or

workshops in 1998 that were initiated

by various NIH ICs in response to a request from the ODS.

Research Dissemination

Databases

To fulfill the congressional directives to collect and compile databases of federally funded research and

peer-reviewed scientific literature on

dietary supplements, the ODS is developing two databases that will be accessible to the public through the ODS Internet home page. CARDS (Computer

Access to Research on Dietary Supplements) will be a database of existing and
18

ongoing dietary supplement research

currently supported by federal agencies.

The database will start with FY95-

funded extramural and intramural research activities of the NIH. CARDS

will include the funded research activities of other federal agencies when the

data are available. IBIDS (International

Bibliographic Information on Dietary

Supplements) is a database of published

international scientific literature on dietary supplements. IBIDS is being developed and maintained by the FNIC

under contract with the ODS. The

IBIDS database is a compilation of dietary supplement bibliographic citations

from 11 medical and scientific databases. The search engine is userfriendly to encourage both researchers

and the general public to identify scientific literature on dietary supplements

quickly and easily.

Internet Home Page

The ODS has completed an Internet home page to disseminate information to scientists and the public.

This web site provides information

about the ODS, including its origins,

mandates, databases, publications, current Program Announcements and Requests for Proposals sponsored by various ICs at the NIH, as well as other activities, programs, and scientific resources.

Publications

The ODS publishes scholarly

reviews about dietary supplements in

peer-reviewed scientific journals. In addition, information pages that are derived from the reviews will be prepared

for the public that interpret the literature

findings in a more applied sense.

The ODS also plans to publish

proceedings from some of the major

workshops it sponsors, such as the recent “The Role of Dietary Supplements

for Physically Active People,” which

will be published as a supplement to the

American Journal of Clinical Nutrition.

A formal bibliography was prepared

for that workshop in conjunction with

the National Library of Medicine. This

bibliography, like all other ODS publications, is available through the ODS

Internet web site.

Advisory Activities

The ODS is mandated to serve

as principal adviser to the Secretary and

Assistant Secretary for Health, as well

as advise the NIH Director, the CDC

Director, and the Commissioner of Food

and Drugs about issues related to dietary

supplements. The ODS also advises

Congress on these matters by answering

inquiries, writing reports, delivering

presentations, and participating in interagency committee activities on a

regular basis.

Research Coordination

To coordinate research and

funding on dietary supplements at the

NIH, the ODS has established a Dietary

Supplements Liaison Panel, which

consists of members appointed by the

directors of the ICs at the NIH. This

group meets periodically to identify

fruitful areas for joint research and to

coordinate those research efforts. The

liaison group is currently developing a

mechanism for trans-NIH research coordination on dietary supplements.

The ODS also serves as a member of the NIH Nutrition Research

Coordinating Committee (NCC),
19

which is managed through the NIH Division of Nutrition Research Coordination, National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK).

The NCC coordinates all nutrition research at NIH and provides a regular

forum for dialogue between ICs about

scientific issues related to nutrition, diet,

and health. In addition, the NCC staff

provides a link to the DHHS interagency Nutrition Policy Board, which

coordinates nutrition research among

the public health agencies and the Interagency Committee on Human Nutrition

Research (a subcommittee of the Committee on Health, Safety and Food of the

National Science and Technology

Council in the Office of the President).

Education

Historically, exposure to nutrition research and training has been limited in medical schools, as documented

by several National Academy of Science

reports (NRC, 1983, 1994, 1995).

Therefore, to improve medical student

education about the benefits and risks of

dietary supplements in health care, the

ODS is collaborating with the developers of a CD-ROM educational program that has been successfully introduced into medical school curricula.

The ODS intends to support a dietary

supplement module for this series.

The ODS is also initiating a series of small-scale, focused sessions for

scientists and professionals to promote

the submission of high-caliber proposals

for botanical supplements research.

These training sessions will be held regionally as part of national professional

meetings.

Partnering Programs

As part of the NIH, the ODS can

accept donations and bequests to support the mission of the office. Donations

are handled in a gift fund account that

is separate from the appropriation that

NIH receives from Congress. These

funds support research, in general and

therefore cannot be earmarked for specific projects or investigations. Gift

funds may be specified for use in particular broad categories of dietary supplement research, such as vitamin, mineral, or botanical supplement research.

The Small Business Innovation

Research (SBIR) program is a threephase research and development federal

government set-aside program that supports innovative research that has potential for commercialization and that is

conducted by a small business. The

SBIR is therefore oriented toward developing a research-based "product" that

moves toward commercialization

through the grant process. NIH has a

substantial set-aside for the SBIR program.

The Small Business Technology Transfer Research (STTR) program encourages technology transfer

through cooperative research between

small business concerns and nonprofit

research institutions. The ODS encourages corporate groups and academic institutions to form partnerships and apply

for STTR grants related to dietary supplements and the technology needed to

understand the mechanism of action of

dietary supplement components.

The role of the ODS in the SBIR

and STTR programs, in general, will be

to facilitate and coordinate such partnerships with the NIH ICs. ODS envisions

that the SBIR and STTR programs may

have an important role in advancing a

number of the objectives listed under

Goal 4.
20

Emerging Science

The ODS has outlined an ambitious scientific agenda. However, despite

carefully laid plans, unpredictable advances in science can create opportunities that were not anticipated. The ODS

will therefore, reserve funds that will be

used annually to conduct one activity

that responds to an emerging science issue, or “hot topic,” in dietary supplements research or education that may lie

outside the objectives in the strategic

plan. The ODS will avail itself of the

opinions of outside experts, as needed, to

identify emerging science topics and

recommend appropriate activities. This

approach will help the ODS identify unanticipated links between supplements

and health.

Plan Evaluation Process

Preparing a strategic plan that

covers a three to five year span is an important step. However, if there are no

interim evaluations it is unlikely that the

plan will be successful. Therefore, if the

plan’s goals and objectives need to be

adjusted because of a shift in scientific

priorities, the strategic plan will be reevaluated. In addition, progress toward

the goals and objectives of the strategic

plan will be reviewed annually by the

ODS staff, ODS ad hoc advisers and the

NIH Dietary Supplements Liaison Panel.

The ODS also will prepare periodic

status reports of its activities.

The ODS will maintain dialogue

with other interested federal agencies

and offices and dietary supplement interest groups. Through this dialogue,

ODS will continue to welcome comments and suggestions regarding the

strategic plan.

CONCLUSION

The ODS Strategic Plan sets the

future course of scientific activities for

the ODS during the next three to five

years. It will guide the office toward the

systematic fulfillment of its Congressionally mandated purpose to advance

the scientific study of dietary supplements for disease prevention and health

maintenance.

Five key scientific goals and specific objectives to realize these goals

have been established with the participation of more than 120 scientists, professionals, and government representatives. Every effort was made to focus on

the scientific and public health issues

that are most relevant to the field of dietary supplements and which have a high

probability of success. Specific areas in

which it was felt that the ODS is able to

make unique contributions were also

identified and these will be a priority.

Through the systematic execution and dynamic evaluation of this plan,
21

the ODS will merge the highest quality

science into the field of dietary supplements by evaluating the scientific information, as well as providing the stimulus, training and support for research.

The ODS is also committed to the dissemination of research results for the

education of the public and scientific

communities in order to foster an enhanced quality of life and health for the

U.S. population.

In FY 1998, the ODS has initiated and is proceeding with its goals and

objectives. The office will continue to

work with advisers from many disciplines to develop its programs. In addition, the office is committed to enhancing cross-institute coordination within

the NIH and providing a customer service approach in all its endeavors. The

ODS welcomes comments and suggestions on all aspects of this strategic plan.
22

ACKNOWLEDGMENTS

From its inception, ODS, NIH, has benefited from the thoughtful help and suggestions of many people. The ODS is indebted to the 77 scientists and professionals who

served as ad hoc advisers on the strategic plan, and the 52 members of the government

forum who volunteered their time to help develop and review this plan (see Appendix A).

The ODS is grateful to the professional nutrition societies, the botanical and natural

products associations, and their professional communities for their interest and willingness to participate in this and other activities of the ODS.

The ODS appreciates the positive interactions, assistance, and suggestions in all

aspects of its work from the members and staff of the Nutrition Coordinating Committee,

(NCC), Division of Nutrition Research Coordination (DNRC), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and NCC’s director, Van S. Hubbard. The ODS works closely in all its endeavors with the Office of Alternative Medicine (OAM) and appreciates the helpful insight and collaborative approach of the OAM

staff, particularly its Director, Wayne B. Jonas, and Deputy Director, Geoffrey P. Cheung. The ODS could not have worked so rapidly with its databases without the contributions of Jim Krebs-Smith, Carole I. Hudgings (NINR), Eric Manheimer (ODS student

intern, 1996−1997), Rebecca I. Erickson (ODS 1996–1997), and staff of the Office of

Extramural Research (OER).

The ODS also appreciates the support of colleagues from other offices that work

under the Associate Director for Disease Prevention in the difficult steps involved in

starting a new office. William H. Hall (Office of the Medical Applications of Research;

OMAR) was instrumental in the success of the first ODS workshop, “Dietary Supplement

for Physically Active People”, as well as helping with all aspects of ODS communications. Susanne Strickland (Health Promotion Program Manager) initially provided much

useful background information and has continued to keep the ODS staff informed about

any and all dietary supplement issues that come to her attention. The other ODP office

directors, John H. Ferguson (OMAR) and Stephen C. Groft (Office of Rare Disease,

ORD) have provided invaluable assistance to ODS.

Finally, the activities that led to this plan could not have been accomplished without the dedication of many individuals who have worked with the ODS in temporary or

contractual positions over the last three years as part of the ODS “team”: Donna F. Allen,

Marcia L. Ancker, Rebecca B. Costello, Pamela M. Dressell, Rebecca I. Erickson, Judith

Grumstrup-Scott, Jeanette M. Hosseini, Terri J. Krakower, and Ellen Nayeri. We are also

thankful for the participation of Judy H. Pruden (Executive Potential Program trainee for

the Centers for Disease Control and Prevention) and Meredith A. Robbins (student intern,

1998).

The ODS is particularly indebted to William R. Harlan, Associate Director of

NIH for Disease Prevention, for his thoughtful guidance on all endeavors undertaken by

the ODS. Any activities that can be viewed as successful should be attributed to his support and belief that a new office can break new ground. Dr. Harlan also gave this office

the latitude to use creative approaches to build a framework and develop this strategic

plan.
23

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26

APPENDIXES
27

APPENDIX A

Strategic Planning Participants

Office of Dietary Supplements (ODS)

National Institutes of Health

Richard A. Allison, Ph.D.

Executive Officer

American Society for Nutrition Sciences

Bethesda, Maryland

Pamela A. Anderson, Ph.D., R.D.

Section Head Medical Nutrition R&D

Ross Products Division, Abbott Labs

Columbus, Ohio

Judith M. Ashley, M.S.P.H., Ph.D, R.D.

Associate Director for Nutrition Education

and Research

University of Nevada

Reno, Nevada

E. Wayne Askew, Ph.D.

Professor and Director

Division of Foods and Nutrition

University of Utah

Salt Lake City, Utah

Lynn B. Bailey, Ph.D., R.D.

Professor

Department of Food Science

and Human Nutrition

University of Florida-Gainesville, FSHN

Gainesville, Florida

Marilyn L. Barrett, Ph.D.

Director of Research and Development

Pharmacognosy Consulting Services

Redwood City, California

I. Scott Bass, Esq.

Adjunct Professor Georgetown University

Graduate School of Public Policy

Sidley and Austin

Washington, District of Columbia

Ms. Anne R. Bavier

Deputy Director

Office of the Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Dan Benardot, Ph.D., R.D., L.D.

Associate Professor of Nutrition and Dietetics

Associate Director of Research

Center for Sports Medicine and Sports Sciences

Georgia State University

Department of Nutrition and Dietetics

Atlanta, Georgia

Adrianne Bendich, Ph.D.

Associate Director of New Products Research

SmithKline Beecham

Consumer Health Care

Parsippany, New Jersey

Ms. Bobbie P. Bennett

Special Assistant for Scientific Information

Office of the Director

Office of Communications

National Institutes of Health

Bethesda, Maryland

Mark A. Bieber, Ph.D.

Nutrition Research Associate

Best Foods

Somerst, New Jersey

Bruce R. Bistrian, M.D., Ph.D.

Professor of Medicine

Harvard Medical School

Chief, Division of Clinical Nutrition

Beth Israel Deaconess Medical Center

Boston, Massachusetts
28

ODS Strategic Planning Participants (Cont’d)

David R. Black, Ph.D., M.P.H., C.H.E.S.

Professor of Health Promotion, Foods and

Nutrition and Health Sciences

Purdue University

West Lafayette, Indiana

George L. Blackburn, M.D., Ph.D.

Associate Professor of Surgery

Harvard Medical School

Beth Israel Deaconess Medical Center

Boston, Massachusetts

Jeffrey B. Blumberg, Ph.D.

Professor

Tufts University

Boston, Massachusetts

Mark Blumenthal

Executive Director

American Botanical Council

Austin, Texas

Peggy R. Borum, Ph.D.

Professor of Human Nutrition

Department of Food Science

and Human Nutrition

University of Florida

Gainesville, Florida

Phyllis E. Bowen, Ph.D., R.D.

Associate Professor

Department of Human Nutrition and Dietetics

University of Chicago

Chicago, Illinois

Barbara Bowman, Ph.D.

Chief, Chronic Disease Prevention Branch

Centers for Disease Control and Prevention

Atlanta, Georgia

Patsy M. Brannon, Ph.D., R.D.

Chair and Professor

Department of Nutrition and Food Science

University of Maryland

College Park, Maryland

Ronette R. Briefel, Dr. P.H., R.D.

Nutrition Policy Advisor,

Senior Research Epidemiologist

National Center for Health Statistics

Hyattsville, Maryland

Donald J. Brown, N.D.

Director, Natural Product Research Consultants

Faculty, Bastyr University

Seattle, Washington

Timothy E. Byers, M.D., M.P.H.

Professor, Preventive Medicine and Biometrics

University of Colorado

Health Sciences Center

Denver, Colorado

Benjamin H. Caballero, M.D., Ph.D.

Director, Division of Human Nutrition

Professor of International Health

Johns Hopkins University

Baltimore, Maryland

C. Elizabeth Castro, Ph.D.

Nutrition Advisor

Office of Disease Prevention

and Health Promotion

Department of Health and Human Services

Washington, District of Columbia

Shirley C. Chen, Ph.D.

Principle Scientist, Nutrition

Lipton Foods

Baltimore, Maryland

Carolyn Clifford, Ph.D.

Chief, Diet and Cancer Branch

National Cancer Institute

National Institutes of Health

Bethesda, Maryland

Paul M. Coates, Ph.D.

Deputy Director

Division Nutrition Research Coordination

National Institute of Diabetes and Digestive

and Kidney Diseases

National Institutes of Health

Bethesda, Maryland
29

ODS Strategic Planning Participants (Cont’d)

Jerry Cott, Ph.D.

Chief, Pharmacologic Treatment Research

Program

Division of Clinical and Treatment Research

National Institute of Mental Health

National Institutes of Health

Rockville, Maryland

Robert J. Cousins, Ph.D.

Boston Family Professor of Nutrition

Director, Center for Nutritional Sciences

Food Science and Human Nutrition Department

University of Florida

Gainesville, Florida

Edward M. Croom, Jr., Ph.D.

Coordinator, Phytomedicine Project

University of Mississippi

National Center for the Development

of Natural Products

University, Mississippi

Stephen L. DeFelice, M.D.

Chairman

The Foundation for Innovation in Medicine

Cranford, New Jersey

Robert A. Defilipps, Ph.D.

Museum Specialist

Department of Botany

The Smithsonian Institution

Washington, District of Columbia

Hector F. Deluca, Ph.D.

Steenbock Research Professor and Chairman

Department of Biochemistry

University of Wisconsin

Madison, Wisconsin

V. Annette Dickinson, Ph.D.

Director, Scientific and Regulatory Affairs

Council for Responsible Nutrition

Washington, District of Columbia

Joseph S. Drage, M.D.

Training and Special Programs Officer

National Institute of Neurological

Disorders and Stroke

National Institutes of Health

Bethesda, Maryland

James A. Duke, Ph.D.

Herbal Vineyard

Fulton, Maryland

Johanna T. Dwyer, D.Sc.

Professor of Medicine and Community Health

Tufts University Schools of Medicine

and Nutrition

Francis Stern Nutrition Center Box 783

New England Medical Center

Boston, Massachusetts

John W. Erdman, Jr., Ph.D.

Division of Nutritional Sciences

University of Illinois

Urbana, Illinois

Nancy D. Ernst, M.S. R.D.

Nutrition Coordinator

National Heart, Lung, and Blood Institute

National Institutes of Health

Rockville, Maryland

Fran Ertl, Ph.D.

Vice President Technical

Botanicals International

Long Beach, California

Norman R. Farnsworth, Ph.D.

Professor of Pharmacognosy

University of Illinois at Chicago

College of Pharmacy

Chicago, Illinois

John H. Ferguson, M.D.

Director

Office of Medical Applications of Research

Office of the Director

National Institutes of Health

Bethesda, Maryland
30

ODS Strategic Planning Participants (Cont’d)

John D. Fernstrom, Ph.D.

Profesor of Psychiatry, Pharmacology

and Neuroscience

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania

Loretta P. Finnegan, M.D.

Director, Women’s Health Initiative

Office of the Director

National Institutes of Health

Bethesda, Maryland

Kenneth D. Fisher, Ph.D.

Senior Nutrition Consultant

Office of Disease Prevention

and Health Promotion

Department of Health and Human Services

Washington, District of Columbia

Ms. Denise Ford, M.S. R.D.

Chief, Clinical Nutrition Research

Nutrition Department

Clinical Center

National Institutes of Health

Bethesda, Maryland

Gail C. Frank, Dr.P.H., C.H.E.S., R.D.

Professor of Nutrition

California State University at Long Beach

Adjunct Professor of Medicine and Pediatrics

University of California at Irvine

California State University

Long Beach, California

Jeanne Freeland-Graves, Ph.D., R.D.

Bess Heflin Centennial Professor and Chairman

Department of Human Ecology

University of Texas at Austin

Austin, Texas

LTC. Karl E. Friedl, Ph.D.

U.S. Army Medical Research and Materiel

Command

Fort Detrick, Maryland

Victor I. Fulgoni, III, Ph.D.

Vice President, Nutrition

Kellogg Company

Battle Creek, Michigan

Paul Gaist, Ph.D., M.P.H.

Office of AIDS Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Ann Marie Gebhart, Ph.D.

Executive Officer

The American Society for

Clinical Nutrition, Inc.

Bethesda, Maryland

M. Eric Gershwin, M.D.

Professor of Medicine and

Chief of Clinical Immunology

University of California

Davis, California

Dorothy W. Gietzen, Ph.D.

Professor

VM Anatomy Physiology and Cell Biology

University of California

Davis, California

Walter H. Glinsmann, M.D.

Adjunct Professor

Georgetown School of Public Policy

Washington, District of Columbia

Gilman D. Grave, M.D.

Chief

Endocrinology Nutrition and Growth Branch

National Institute of Child Health

and Human Development

National Institutes of Health

Rockville, Maryland

Stephen C. Groft, Pharm.D.

Director, Office of Rare Diseases

Office of the Director

National Institutes of Health

Bethesda, Maryland
31

ODS Strategic Planning Participants (Cont’d)

Kenneth A. Gruber, Ph.D.

Health Scientist Administrator

National Institute on Deafness and

Other Communication Disorders

National Institutes of Health

Rockville, Maryland

Barbara C. Hansen, Ph.D.

Professor of Physiology

Director, Obesity and Diabetes

Research Center

University of Maryland School of Medicine

Baltimore, Maryland

William R. Harlan, M.D.

Associate Director for Disease Prevention

Office of the Director

National Institutes of Health

Bethesda, Maryland

Joanne M. Holden, M.S.

Research Leader

Agricultural Research Service

United States Department of Agriculture

Riverdale, Maryland

Van S. Hubbard, M.D., Ph.D.

Director, Division Nutrition Research

Coordination

National Institute of Diabetes and Digestive

and Kidney Disease

National Institutes of Health

Bethesda, Maryland

Carole Hudgings, Ph.D.

Program Officer

Office of the Director

Office of Alternative Medicine

National Institutes of Health

Bethesda, Maryland

Janet R. Hunt, Ph.D., R.D.

Research Nutritionist

Grand Forks Human Nutrition Research Center

United States Department of Agriculture/ ARS

Grand Forks, North Dakota

Richard D. Irwin, Ph.D.

Research Chemist Environmental Toxicology

Program

National Institute of Environmental Health

Sciences

National Institutes of Health

Research Triangle Park, North Carolina

Loren D. Israelsen

Executive Director

Utah Natural Products Alliance

Salt Lake City, Utah

John T. Kalberer, Jr., Ph.D. (retired)

Coordinator for Disease Prevention

Office of the Director

Office of Disease Prevention

National Institutes of Health

Bethesda, Maryland

Mitchell Kanter, Ph.D.

Principal Scientist

Director, Clinical Nutrition Research

Quaker Oats Company

Barrington, Illinois

Jag H. Khalsa, Ph.D.

Health Scientist Administrator

Center on AIDS and

Other Medical Consequences

National Institute on Drug Abuse

National Institutes of Health

Rockville, Maryland

Sooja K. Kim, Ph.D., R.D.

Chief, Nutritional and Metabolic Sciences IRG

Acting Chief, Endocrinology and Reproductive

Sciences IRG

Center for Scientific Review

National Institutes of Health

Bethesda, Maryland
32

ODS Strategic Planning Participants (Cont’d)

Carol Kramer-LeBlanc, Ph.D.

Staff Director for Nutrition Policy and Analysis

Center for Nutrition Policy and Promotion

United States Department of Agriculture

Washington, District of Columbia

Donna Krasnewich, M.D., Ph.D.

Senior Staff Fellow

National Human Genome Research Institute

National Institutes of Health

Bethesda, Maryland

William E.M. Lands, Ph.D.

Director, Division of Basic Research

National Institute on Alcohol Abuse

and Alcoholism

National Institutes of Health

Rockville, Maryland

Floyd E. Leaders, Ph.D.

President

The Leaders Group, Inc.

Rockville, Maryland

Mark Lino, Ph.D.

Economist

Center for Nutrition Policy and Promotion

United States Department of Agriculture

Washington, District of Columbia

Michael K. May, Ph.D.

Director, GI Transport and Absorption, Nutrient

Metabolism Programs

National Institute of Diabetes and Digestive

and Kidney Disease

National Institutes of Health

Bethesda, Maryland

Robert S. McCaleb

President

Herb Research Foundation

Boulder, Colorado

Joan A. McGowan, Ph.D.

Director, Musculoskeletal Diseases Branch

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

National Institutes of Health

Bethesda, Maryland

Michael McGuffin

President

American Herbal Products Association

Los Angeles, California

Kevin S. McGuiness, Esq.

Partner

McGuiness and Holch

Washington, District of Columbia

Walter Mertz, M.D.

Rockville, Maryland

Mohsen Meydani, DVM, Ph.D.

Professor

USDA HNRC on Aging

Tufts University

Boston, Massachusetts

Linda D. Meyers, Ph.D.

Acting Director for Science and Nutrition

Office of Disease Prevention

and Health Promotion

Department of Health and Human Services

Washington, District of Columbia

Suzette J. Middleton, Ph.D.

Scientist in Olestra Regulatory

and Clinical Developments

Procter and Gamble

Winton Hill Technical Center

Cincinatti, Ohio

Gary A. Miller, Ph.D.

Vice President, Science and Technology

The RiceX Company

El Dorado-Hills, California

John A. Milner, Ph.D.

Professor and Head

Nutrition Department

The Pennsylvania State University

University Park, Pennsylvania
33

ODS Strategic Planning Participants (Cont’d)

Barbara J. Moore, Ph.D.

President and CEO

Shape Up America!

Bethesda, Maryland

Robert J. Moore, Ph.D.

Senior Regulatory Scientist

Office of Special Nutritionals

Food and Drug Administration

Washington, District of Columbia

Timothy H. Moran, Ph.D.

President, Society for the Study

of Ingestive Behavior

Department of Psychiatry

and Behavioral Sciences

Johns Hopkins Medical Institutions

Baltimore, Maryland

Mary C. Mulry, Ph.D.

President

Foodwise, Inc.

Boulder, Colorado

Forrest H. Nielsen, Ph.D.

Center Director

Grand Forks Human Nutrition Research Center

United States Department of Agriculture/ARS

Grand Forks, North Dakota

Godfrey P. Oakley, Jr., M.D., S.S.P.M

Director, National Center for

Environmental Health

Centers for Disease Control and Prevention

Atlanta, Georgia

Samuel W. Page, Ph.D.

Scientific Director, Joint Institute

for Food Safety and Applied Nutrition

Food and Drug Administration

Washington, District of Columbia

E. Ann Pendergast, M.P.H, R.D

Chief Nutritionist

Department of Health and Human Services

HRSA/MCHB

Rockville, Maryland

Mary Frances Picciano, Ph.D.

Professor, Nutrition Department

Pennsylvania State University

University Park, Pennsylvania

Susan M. Pilch, Ph.D.

Team Leader, Division of Science

and Applied Technology

Food and Drug Administration

Washington, District of Columbia

Vivian W. Pinn, M.D.

Associate Director

Office of the Director

Office of Research on Women’s Health

National Institutes of Health

Bethesda, Maryland

Marshall Plaut, M.D.

Chief of the Allergic Mechanisms Section

National Institute of Allergy

and Infectious Diseases

National Institutes of Health

Bethesda, Maryland

Donna V. Porter, Ph.D. R.D.

Specialist in Life Sciences

Library of Congress

Washington, District of Columbia

Peter C. Preusch, Ph.D.

Program Director

National Institute of General Medical Sciences

National Institutes of Health

Bethesda, Maryland

Mary Ann Richardson, Ph.D.

Chief, Movement Disorders Program

Nathan Kline Institute

Orangeburg, New York

Anita Ring

Program Analyst

Office of AIDS Research

Office of the Director

National Institutes of Health

Bethesda, Maryland
34

ODS Strategic Planning Participants (Cont’d)

Cheryl L. Rock, Ph.D., R.D.

Associate Professor

Department of Family and Preventive Medicine

Cancer Prevention and Control

University of California at San Diego

La Jolla, California

Lois A. Salzman, Ph.D.

Special Assistant for Research

National Institute of Dental Research

National Institutes of Health

Bethesda, Maryland

Dennis A. Savaiano, Ph.D.

Dean, School of Consumer and Family Sciences

Purdue University

West Lafayette, Indiana

Alexander G. Schauss, Ph.D.

Director, Life Sciences Division

American Institute for Biosocial Research, Inc.

Tacoma, Washington

David D. Schnakenberg, Ph.D.

Executive Officer

American Society for Clinical Nutrition

Bethesda, Maryland

Charles R. Sherman, Ph.D.

Deputy Director

Office of Medical Applications of Research

Office of the Director

National Institutes of Health

Bethesda, Maryland

Denise Sofka, M.P.H., R.D.

Nutrition Consultant

Department of Health and Human Services

HRSA/MCHB

Rockville, Maryland

Alfred Sommer, M.D., M.H.S.

Dean, School of Hygiene and Public Health

Johns Hopkins University

Baltimore, Maryland

Bonnie Spring, Ph.D.

Professor of Psychology

FUHS Chicago Medical School

Chicago, Illinois

V. Srini Srinivasan, Ph.D.

Senior Scientist

U.S. Pharmacopeia

Rockville, Maryland

Sachiko T. St. Jeor, Ph.D., R.D.

Professor and Director

Nutrition Education and Research Program

University of Nevada School of Medicine

Reno, Nevada

Meir Stampfer, M.D., Dr.P.H.

Professor of Epidemiology and Nutrition

Harvard School of Public Health

Boston, Massachusetts

Pamela Starke-Reed, Ph.D.

Health Scientist Administrator

Biology of Aging Program

National Institute on Aging

National Institutes of Health

Bethesda, Maryland

Judith S. Stern, Sc.D., R.D.

Professor of Nutrition and Internal Medicine

Department of Nutrition

University of California

Davis, California

Phyllis J. Stumbo, Ph.D.

Head Research Dietitian

Clinical Research Center

University of Iowa

Iowa City, Iowa

John W. Suttie, Ph.D.

Professor, Department of Biochemistry

Professor and Chair

Department of Nutrition Sciences

University of Wisconsin

Madison, Wisconsin
35

ODS Strategic Planning Participants (Cont’d)

John P. Troup, Ph.D.

Vice President, Scientific Affairs

General Nutrition Centers

Pittsburgh, Pennsylvania

Varro E. Tyler, Ph.D., Sc.D.

Distinguished Professor Emeritus

Department of Medical Chemistry

and Pharmacognosy

Purdue University

West Lafayette, Indiana

Barbara A. Underwood, Ph.D.

Chemist

National Eye Institute

National Institutes of Health

Bethesda, Maryland

Roy T. Upton

Herbalist

American Herbal Pharmacopoeia

Santa Cruz, California

Martina Vogel-Taylor, M.T.

Program Analyst

Office of the Director

Office of Disease Prevention

National Institutes of Health

Bethesda, Maryland

Nancy S. Wellman, Ph.D., R.D., F.A.D.A.

Director, National Policy and Resource Center

on Nutrition and Aging

Florida International University

Miami, Florida

Gary M. Williams, M.D.

Director , Naylor Dana Institute

American Health Foundation

Valhalla, New York

Elizabeth A. Yetley, Ph.D.

Director, Office of Special Nutritionals

Food and Drug Administration

Washington, District of Columbia

Anthony L. Young, Esq.

General Counsel

American Herbal Products Association

Piper & Marbury

Washington, District of Columbia

Irina V. Zhdnanova, M.D., Ph.D.

Research Scientist

Massachusetts Institute of Technology

Cambridge, Massachusetts
36

APPENDIX B

Excerpt from the Dietary Supplement Health

and Education Act of 1994

The Dietary Supplement Health and Education Act (DSHEA) [Public Law 103-

417, Section 13.(a)]) set out the following functions and duties for the Office of Dietary

Supplements (ODS) as authorized at the National Institutes of Health:

“SEC. 485C. DIETARY SUPPLEMENTS.

“(a) ESTABLISHMENT.-The Secretary shall establish an Office of Dietary Supplements

within the National Institutes of Health.

“(b) PURPOSE.-The purposes of the Office are--

“(1) to explore more fully the potential role of dietary supplements as a significant

part of the efforts of the United States to improve health care; and

 “(2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions.

 “(c) DUTIES.-The Director of the Office of Dietary Supplements shall—

“(1) conduct and coordinate scientific research within the National Institutes of

Health relating to dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects,

osteoporosis, cataracts, or prostatism;

“(2) collect and compile the results of scientific research relating to dietary

supplements, including scientific data from foreign sources or the Office of Alternative

Medicine;

“(3) serve as the principal advisor to the Secretary and to the Assistant Secretary

for Health and provide advice to the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food

and Drugs on issues relating to dietary supplements including--

 “(A) dietary intake regulations;

 “(B) the safety of dietary supplements;

 “(C) claims characterizing the relationship between--

“(i) dietary supplements; and

“(ii) (I) prevention of disease or other health-related conditions;

and

“(II) maintenance of health; and

 “(D) scientific issues arising in connection with the labeling and composition of dietary supplements;

“(4) compile a database of scientific research on dietary supplements and individual nutrients; and

“(5) coordinate funding relating to dietary supplements for the National Institutes

of Health.”
37

APPENDIX C

Reference Sources for Definitions and Terminology

Through its advisory groups, the ODS obtained recommendations for other scientific publications that could serve as the basic reference materials for the three categories

of dietary supplement ingredients: botanicals, nutrients, and other dietary substances.

For botanical ingredients, the ODS will follow the International Rules of Botanical Nomenclature and include proper botanical authorities after taxa names. The Plant

Book ( Mabberley, 1997) and Flora of North America (Flora of North America Committee, 1993) will be standard references used by the ODS to assist with taxonomic clarification. An additional reference source will be Herbs of Commerce (Foster, 1992). This

report, undertaken by the American Herbal Products Association, is a compilation of

common plant names representing botanical ingredients that are available commercially

for ingestion in one form or another in the United States. The common names were keyed

to one Latin binomial by a consensus panel. In areas where taxonomy is unclear, the ODS

will contact botanical experts for their opinion. Additional reference sources that will be

used by the ODS for botanical supplements are: Sturtevant’s Edible Plants of the World

(Hedrick, 1972), Dictionary of Plants Containing Secondary Metabolites (Glasby, 1991),

The Database of Biologically Active Phytochemicals and Their Activities (Duke, 1992),

Encyclopedia of Common Natural Ingredients Used in Food, Drugs and Cosmetics (Leung and Foster, 1996), and A Dictionary of Natural Products: Terms in the Field of

Pharmacognosy Relating to Natural Medicinal and Pharmaceutical Materials, and the

Plants, Animals, and Minerals From Which They Are Derived (Hocking, 1997).

A single reference could not be identified as compendium for the nutrient

supplements category. The ODS thus will use the Recommended Dietary Allowances,

tenth edition (NRC, 1989b) as its primary reference for traditional nutrients and incorporate the new Dietary Reference Intake volumes as they become available. The ODS is

creating a selected library of nutrition reference books to use for this category. Additional primary references for nutrient supplements are: Diet and Health (NRC, 1989a),

Nutritional Biochemistry (Brody, 1994), The Concise Encyclopedia of Foods and Nutrition (Ensminger et al., 1995), Present Knowledge in Nutrition, seventh edition (Zeigler
38

and Filer, 1996), the Food Chemicals Codex, fourth edition (IOM, 1996), and the Food

Chemicals Codex First Supplement to the fourth edition (IOM, 1997).

Reference resources are limited for the third supplement category, other dietary

substances. Many of the books listed above will provide basic information on these other

supplements, and the ODS will also use relevant government reports and compendiums.

The ODS welcomes recommendations for additional acquisitions that can serve as basic

references for supplement nomenclature, structure, and properties.
39

APPENDIX D

INCORPORATION OF CUSTOMER SERVICE PLAN

Executive Order 12862

Just prior to establishment of the Office of Dietary Supplements (ODS), and as

part of the administration’s reinventing government initiative, President Clinton issued

Executive Order 12862, “Setting Customer Service Standards.” In it, the President called

for a revolution within the federal government to change the way it does business and to

become customer driven. The goal was to achieve standards of quality within government and customer service for the American people equal to the best in the business environment. Each agency was to develop, publish, and make readily available to the public

its own customer service plan with specific standards of performance.

DHHS Customer Service Plan

In response to the Executive Order, Donna E. Shalala,, Secretary of the Department of Health and Human Services (DHHS), established a plan that integrated new

customer service goals into the agency’s mission. The DHHS goal was “to protect and

promote the health, social, and economic well-being of all Americans in a way that

proves the highest quality service.”

Two of the DHHS goals are particularly relevant to the ODS:

1. to promote the public health through knowledge and education, and

2. to invite partners to collaborate in program and policy development.

ODS Customer Service Plan

The ODS has embraced the DHHS customer service philosophy and incorporated

it into its own operating plan. As a new office, the ODS does not have to change to a

customer-oriented approach, it can simply develop customer service standards as it builds

and expands the office.
40

Throughout DHHS, advisory panels and focus groups are working to enhance information exchange and strengthen partnerships. Similarly, the ODS has demonstrated

its commitment to the DHHS customer service philosophy by convening the series of

seven ad hoc advisory meetings that led to this strategic plan. The ODS plans to develop

and maintain such partnerships and continue the dialogue; these activities are critical to

the success of the office and to ODS meeting its mandates, goals and objectives.
NIH Publication No. 98-4356

September 1998