NIH State-of-the-Science Conference Statement on

Multivitamin/Mineral Supplements
and Chronic Disease Prevention

NIH Consensus and State-of-the-Science Statements

Volume 23, Number 2
May 15–17, 2006

NATIONAL INSTITUTES OF HEALTH

Office of the Director
About the NIH Consensus Development Program
National Institutes of Health (NIH) consensus and state-of-the-science
statements are prepared by independent panels of health professionals
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during a 2-day public session, 3) questions and statements from
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the public session, and 4) closed deliberations by the panel during
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statement of the NIH or the federal government.
The statement reflects the panel’s assessment of medical knowledge
available at the time the statement was written. Thus, it provides
a “snapshot in time” of the state of knowledge on the conference
topic. When reading the statement, keep in mind that new knowledge
is inevitably accumulating through medical research, and that the
information provided is not a substitute for professional medical
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Reference Information
For making bibliographic reference to this statement, it is
recommended that the following format be used, with or without
source abbreviations, but without authorship attribution:
NIH State-of-the-Science Conference Statement on
Multivitamin/Mineral Supplements and Chronic Disease Prevention.
Ann Intern Med. 2006; 145:364–371.

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NIH State-of-the-Science Conference Statement on
Multivitamin/Mineral Supplements
and Chronic Disease Prevention

NIH Consensus and State-of-the-Science Statements

Volume 23, Number 2
May 15–17, 2006

NATIONAL INSTITUTES OF HEALTH

Office of the Director

i
 Disclosure Statement
All of the panelists who participated in this conference
and contributed to the writing of this statement were
identified as having no financial or scientific conflict
of interest, and all signed forms attesting to this fact.
Unlike the expert speakers who present scientific data
at the conference, the individuals invited to participate
on NIH Consensus and State-of-the-Science panels are
reviewed prior to selection to assure that they are not
proponents of an advocacy position with regard to the
topic and are not identified with research that could
be used to answer the conference questions.
For more information about conference procedures,
please see http://consensus.nih.gov/aboutcdp.htm.

Archived Conference Webcast

The NIH State-of-the-Science Conference on
Multivitamin/Mineral Supplements for Chronic Disease
Prevention was webcast live May 15–17, 2006. The
webcast is archived and available for viewing free of
charge at http://consensus.nih.gov/previousstatements.htm.

ii
Abstract
Objective
To provide health care providers, patients, and the
general public with a responsible assessment of
currently available data on multivitamin/mineral
supplements and chronic disease prevention.

Participants
A non-DHHS, non-advocate 13-member panel included
experts in the fields of food science and human nutrition,
biostatistics, biochemistry, toxicology, geriatric medicine,
family medicine, pediatrics and pediatric endocrinology,
cancer prevention, epidemiology, disease prevention and
health promotion, and consumer protection. In addition,
19 experts from pertinent fields presented data to the
panel and conference audience.

Evidence
Presentations by experts and a systematic review of
the literature prepared by The Johns Hopkins University
Evidence-based Practice Center, through the Agency
for Healthcare Research and Quality. Scientific evidence
was given precedence over anecdotal experience.

Conference Process
The panel drafted its statement based on scientific
evidence presented in open forum and on published
scientific literature. The draft statement was presented
on the final day of the conference and circulated to the
audience for comment. The panel released a revised
statement later that day at http://consensus.nih.gov.
This statement is an independent report of the panel
and is not a policy statement of the NIH or the
Federal Government.

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 Conclusions
Use of multivitamins/minerals (MVMs) has grown rapidly
over the past several decades, and dietary supplements
are now used by more than half of the adult population
in the United States. In general, MVMs are used by
individuals who practice healthier lifestyles, thus making
observational studies of the overall relationship between
MVM use and general health outcomes difficult to interpret.
Despite the widespread use of MVMs, we still have
insufficient knowledge about the actual amount of
total nutrients that Americans consume from diet and
supplements. This is at least in part due to the fortification
of foods with these nutrients, which adds to the effects
of MVMs or single-vitamin or single-mineral supplements.
Historically, fortification of foods has led to the remediation
of vitamin and mineral deficits, but the cumulative effects
of supplementation and fortification have also raised
safety concerns about exceeding upper levels. Thus,
there is a national need to improve the methods of
obtaining accurate and current data on the public’s total
intake of these nutrients in foods and dietary supplements.
In systematically evaluating the effectiveness and safety
of MVMs in relation to chronic disease prevention,
we found few rigorous studies on which to base clear
conclusions and recommendations. Most of the studies
we examined do not provide strong evidence for
beneficial health-related effects of supplements taken
singly, in pairs, or in combinations of three or more.
Within some studies or subgroups of the study
populations, there is encouraging evidence of health
benefits, such as increased bone mineral density and
decreased fractures in postmenopausal women who
use calcium and vitamin D supplements. However,
several other studies also provide disturbing evidence
of risk, such as increased lung cancer risk with
β-carotene use among smokers.

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The current level of public assurance of the safety
and quality of MVMs is inadequate, given the fact that
manufacturers of these products are not required to
report adverse events and the FDA has no regulatory
authority to require labeling changes or to help inform
the public of these issues and concerns. It is important
that the FDA’s purview over these products be authorized
and implemented.
Finally, the present evidence is insufficient to recommend
either for or against the use of MVMs by the American
public to prevent chronic disease. The resolution of
this important issue will require advances in research
and improved communication and collaboration
among scientists, health care providers, patients,
the pharmaceutical and supplement industries, and
the public.

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 Introduction
At least half of American adults take a dietary supplement,
the majority of which are multivitamin/multimineral (MVM)
supplements. As more and more Americans seek
strategies for maintaining good health and preventing
disease, and as the marketplace offers an increasing
number of products to fulfill that desire, it is important
that consumers have the best possible information to
make their choices. Assessing the available scientific
evidence on the benefits of MVM supplement use for
chronic disease prevention, identifying the gaps in the
evidence, and recommending an appropriate research
agenda to meet the shortfalls are subjects considered
in this report.
The word vitamine was coined in 1912, as an abbreviated
term meant to capture the notion of important factors in
the diet, or “vital amines.” This was preceded more than
150 years earlier by British navy physician James Lind’s
discovery—in the first recorded controlled trial—that citrus
juice, a good source of what was found two centuries
later to be vitamin C, could prevent scurvy in sailors.
In 1913, the first vitamin was isolated: thiamin, the
deficiency of which caused beriberi. Thirteen vitamins
and 15 essential minerals have now been identified as
important to human nutrition.
Large-scale fortification of diets began in the United
States with the addition of iodine to table salt in 1924
to prevent goiter, followed by the addition of vitamin
D to milk in 1933 to prevent rickets and the addition
of thiamin, riboflavin, niacin, and iron to flour in 1941.
Multivitamin/multimineral products providing more than
vitamins A and D became available in pharmacies and
grocery stores in the mid-1930s. In the early 1940s,
the first MVM tablet was introduced.
Although clinical deficiency of vitamins or minerals, other
than iron, is now uncommon in the United States, growth
in supplement use has accelerated rapidly with marketing
spurred by claims—some based on scientific studies—
that chronic conditions could be prevented or treated

4
by supplement use. Annual sales of supplements
to Americans are now reported at about $23 billion,
a substantial share of which is spent on vitamins
and minerals.
With such widespread use of MVM, increasing public
and medical confusion over apparently contradictory
results from studies, and reports of possible adverse
effects from overuse in certain circumstances, the
Office of Dietary Supplements and the Office of Medical
Applications of Research of the NIH convened a State-
of-the-Science Conference on Multivitamin/Mineral
Supplements and Chronic Disease Prevention, held on
May 15–17, 2006, in Bethesda, Maryland. The goal of
the conference was to assess the evidence available on
MVM use and outcomes for chronic disease prevention
in the generally healthy population of adults and to make
recommendations for future research. The conference
focused on vitamins and minerals and did not deal with
botanicals, hormones, or other supplements. It also
did not address the treatment of vitamin or mineral
deficiencies. Except for considerations of safety, the
conference also did not review issues of primary
relevance to pregnant women or children.
Specifically, the conference explored the following
key questions:
• What are the current patterns and prevalence
of the public’s use of MVM supplements?
• What is known about the dietary nutrient intake
of MVM users versus nonusers?
• What is the efficacy of single vitamin/mineral
supplement use in chronic disease prevention?
• What is the efficacy of MVM in chronic disease
prevention in the general population of adults?
• What is known about the safety of MVM for the
generally healthy population?
• What are the major knowledge gaps and research
opportunities regarding MVM use?

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 During the first two days of the conference, experts
presented information on each of the key questions.
After weighing the scientific evidence, including the
data presented by the speakers and a formal evidence
report commissioned through the Agency for Healthcare
Research and Quality (AHRQ), an independent panel
prepared and presented a draft of this state-of-the-
science statement addressing the conference questions.
The evidence report prepared for the conference is
available at www.ahrq.gov/clinic/tp/multivittp.htm.
For the purpose of this statement, the term MVM refers
to any supplement containing three or more vitamins
and minerals but no herbs, hormones, or drugs, with
each component at a dose less than the tolerable upper
level determined by the Food and Nutrition Board—
the maximum daily intake likely to pose no risk for
adverse health effects. Our review also included studies
of the relationship of single-nutrient supplements and
two-nutrient supplements to certain disease outcomes.
The term primary prevention refers to preventing the
development of disease in a person who does not
have the disease in question. The chronic conditions
assessed include cancer; age-related sensory loss; and
cardiovascular, endocrine, neurologic, musculoskeletal,
gastroenterologic, renal, and pulmonary diseases.
A word is warranted about the nature of the evidence
base considered by the panel. The range of vitamins
and minerals of possible interest was so broad that
the conference planning committee chose to focus
the evidence report on nutrients for which the potential
for impact had been most strongly suggested and on
conditions for which supplements were thought to
have the most potential influence.
The planning committee also limited the scope of
the evidence report to consideration of randomized,
controlled trials (RCTs), which are generally considered
the gold standard for evidence-based decision making.
These are studies in which participants are allocated
by chance alone to receive or not receive one of two
or more clinical interventions. For example, while folate
6
supplementation was initially shown to decrease the
risk for neural tube defects in animal studies, outcome
data in nonhuman models were not considered sufficient
evidence on which to base policy recommendations.
At the next level of evidence, observational studies in
humans suggested efficacy of folate supplementation
to prevent such defects. However, these were criticized
because they were not randomized and were potentially
subject to bias. Not until these findings were confirmed
by RCTs in humans was public policy implemented,
including fortification of cereal grains with folate.
An observational study is one in which the exposure or
treatment of interest is not assigned to the participant by
the investigator. Such studies suggested that β-carotene
intake might protect against the development of
some types of cancer. However, RCTs of β-carotene
supplementation not only showed no benefit, they also
found an increased risk for lung cancer in persons who
smoked cigarettes or who were exposed to asbestos.
These examples illustrate both the risk of relying only
on observational studies and the advantage of
RCTs in identifying both benefits and risks of MVM
supplementation.
Limiting the focus of our statement to RCTs has some
inherent limitations, given the potential of other types
of studies to provide important insights. Observational
studies, for example, are particularly useful for generating
hypotheses, defining adverse effects, and documenting
long-term treatment consequences. They are often
essential precursors to the well-conducted RCTs
important for policy formation.
Our principal recommendations focus on the compelling
research activities that must be supported to better inform
the decisions that millions of Americans are making each
day to use or not to use MVM supplements to prevent
chronic disease. At the same time, mindful of the constraints
of the available evidence base, we have also taken care
not to make premature recommendations about whether
generally healthy Americans should or should not take
MVM supplements. Because of the need for more
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 reliable information on MVMs, we have made strong
recommendations for research and for increased
U.S. Food and Drug Administration (FDA) oversight
of the MVM industry.

1. What are the current patterns and

prevalence of the public’s use of
MVM supplements?
More than half of American adults take dietary
supplements in the belief that they will make them
feel better, give them greater energy, improve their
health, and prevent and treat disease. The use of
supplements has been steadily increasing, and growth
appears likely to continue. Currently, users spend more
than $23 billion per year on supplements, and among
this supplement-using population, MVM is the major
category of supplements, used by about one third of
Americans. Uncertainty remains in estimating prevalence
of use because of problems defining these products;
increasing complexity in the formulation of supplements,
including more non-MVM components and specialized
formulas; and varying frequency of use.
It appears that use is higher among women and
among the children of women who use supplements;
in elderly persons; among people with more education,
higher income, healthier lifestyles and diets, and lower
body mass indices; and among residents of the western
United States. Individuals with chronic illnesses or who
are seeking to prevent recurrence of a serious disease
(for example, cancer) also tend to be more frequent
users. Many dietary supplement users perceive their
health as better. Conversely, MVM use is lower among
smokers and certain ethnic and racial groups, such
as African American persons, Hispanic persons, and
Native Americans, while certain Asian ethnic groups
appear to have higher MVM use. Ironically, populations
at highest risk for nutritional inadequacy who might
benefit the most from MVM are the least likely to
use such products.

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2. What is known about the dietary
nutrient intake of MVM users
versus nonusers?
According to several studies, MVM supplement users
(for example, adults, infants, toddlers age 12 to 24
months, adolescents, and elderly persons) also tend
to have higher micronutrient intakes from their diet than
nonusers. Consequently, MVM users have an increased
intake but are also more likely to exceed the upper level.
The trend to “fortify” certain foods not required by law to
be fortified with vitamins and minerals makes calculation
of total intake more difficult. A recent industry report
estimates that, in 2005, 65 percent of Americans used
such fortified foods or beverages, worth $36 billion,
and that these sales are increasing rapidly.
The measurement of dietary vitamin/mineral intake and
intake from supplements is uncertain, which undermines
our ability to accurately assess the distribution of vitamin/
mineral intake in the population, as well as our ability to
use observational studies to detect effects of vitamin/
mineral intake on chronic disease. In part, these
uncertainties stem from individuals’ difficulty in identifying
correctly what supplements they are actually taking
and their frequency of consumption (for example,
many products look alike but are very different in their
composition). Moreover, the lack of databases of MVM
composition limits the ability to translate supplement intake
into amounts of various vitamins and minerals actually
consumed. There are thousands of product labels, vast
differences in the amounts of vitamins/minerals delivered
by various products, and major variability within even
the same product over time and across batches.
These methodologic difficulties should be resolved by
two actions. The quality of self-report data of MVM use
should be improved to enhance accuracy and specificity
of reported MVM intake, and new databases that detail
the exact composition of MVM supplements need to be
built and updated on a continuous basis.

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 3. What is the efficacy of single vitamin/
mineral supplement use in chronic
disease prevention?
Few high-quality clinical trials have been conducted
to determine whether single-use or paired vitamins/
minerals prevent chronic diseases, and even fewer
are generalizable to the U.S. population. In addition,
much of the evidence derives from post hoc analyses
for outcomes not originally chosen as study end points.
These studies are reviewed in the evidence report.

Findings by Vitamin/Mineral
β-Carotene
Two large trials (1, 2) designed to test lung cancer
prevention with β-carotene found a surprising increase in
lung cancer incidence and deaths in smokers and male
asbestos workers. There was no effect in preventing
a number of other types of cancer, including gastric,
pancreatic, breast, bladder, colorectal, and prostate
cancer as well as leukemia, mesothelioma, and lymphoma.
The overall mortality rate was elevated in women, but not
men, treated with β-carotene throughout the intervention
and postintervention period. A third large trial (3), in healthy
American men, found no effect of β-carotene on cancer
except an increased risk for thyroid and bladder cancer.
Two other β-carotene trials (4, 5) to prevent nonmelanoma
skin cancer found no effect on subsequent skin cancer
incidence. A large study of healthy American women also
found no effect of β-carotene on cancer incidence (6).
Four of these β-carotene trials (2, 3, 5, 7) also evaluated
cardiovascular disease (CVD) and found no benefits. In
healthy women, there was a suggestion of increased
stroke risk in one study (6) and an increased risk for CVD
in women smokers in the Carotene and Retinol Efficacy
Trial (CARET) (8).

Vitamin A
No trials were found for vitamin A supplementation alone.
When vitamin A was paired with β-carotene in one trial
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(2), lung cancer and CVD deaths were increased. When
vitamin A was combined with zinc in another trial, there
was no impact on esophageal or gastric cardia cancer,
although noncardia stomach cancer decreased (9).

Vitamin E
Four trials tested vitamin E. One large study of healthy
women, the Women’s Health Study (WHS), recorded
decreased cardiovascular deaths, although there was no
effect on incidence of CVD events (10). Another trial found
a decreased risk for prostate cancer (and a suggestion
of decreased colorectal cancer risk) in male smokers, as
well as a decreased risk for angina and thrombotic stroke
(7, 11–14). No other effects were found on other types
of cancer. There was a trend toward increased bleeding,
subarachnoid hemorrhage, and hemorrhagic stroke
among male smokers in this study (7), but in the WHS,
no increase in hemorrhagic stroke was seen among
women (10). Another trial (15) yielded inconclusive
results for main cardiovascular end points because of
small numbers and because the trial was stopped
prematurely. Two trials examined development of age-
related cataract (16) and lens opacity (14), respectively,
and reported no effect of vitamin E supplementation.

Vitamin B2 and Niacin

One large Chinese trial of vitamin B2 and niacin found
a decreased risk for nuclear cataracts (17). No effects
were found on cortical cataracts, mortality rates, stroke,
upper gastrointestinal dysplasia, or cancer.

Vitamin B6
Two small, short-duration studies of vitamin B6 to prevent
cognitive decline in elderly men and women showed no
effects (18).

Folic Acid with or without Vitamin B12

Multiple studies have shown the effectiveness of folic
acid use by women of childbearing age to prevent neural
11
 tube defects in offspring. Four small, short-duration
studies of folic acid, with or without vitamin B12, to prevent
cognitive decline in older adults found no effects (19).

Selenium
Three trials tested selenium supplementation to prevent
cancer. In two Chinese trials, selenium decreased liver
cancer incidence in patients at high risk because of
either a family history of liver cancer or hepatitis B
exposure status (20). The reports of these trials, however,
lack many important details. The third selenium trial was
conducted in men and women who had a history of
skin cancer (21). It found no decrease in skin cancer but
reported reductions in total deaths from cancer and in
the incidence of lung, prostate, and colorectal cancer
(outcomes the study was not designed to investigate).

Calcium and Vitamin D

Multiple studies demonstrate that calcium increases
bone mineral density in postmenopausal women but by
itself does not decrease fracture risk. Vitamin D alone
does not increase bone mineral density or decrease
fracture risk, but it does work in combination with calcium
to decrease the risk for hip and nonvertebral fractures
in postmenopausal women. Vitamin D and calcium
may increase the risk for kidney stones. The single trial
that tested the effect of calcium supplementation and
vitamin D on colorectal cancer risk found no effect,
but the doses may have been inappropriately low (22).

Summary
Few trials of individual or paired vitamins and minerals
for the prevention of chronic disease produced beneficial
effects. We found no evidence to recommend β-carotene
supplements for the general population and strong
evidence to recommend that smokers avoid β-carotene
supplementation. In combination, calcium and vitamin
D have a beneficial effect on bone mineral density and
fracture risk in postmenopausal women. On the basis

12
of single studies and analysis of secondary outcomes,
there is a suggestion that selenium may reduce risk for
prostate, lung, and colorectal cancer; that vitamin E may
decrease cardiovascular deaths in women and prostate
cancer incidence in male smokers; and that vitamin A
paired with zinc may decrease the risk for noncardia
stomach cancer in rural China. Trials of niacin; folate; and
vitamins B2, B6, and B12 produced no positive effect on
chronic disease occurrence in the general population.

4. What is the efficacy of MVM in chronic

disease prevention in the general
population of adults?
Five RCTs conducted in the United States, the United
Kingdom, China, and France studied the efficacy of MVM
supplements in the primary prevention of cancer and CVD
and in delaying the development or progression of cataract
and age-related macular degeneration (9, 23–27). The five
studies used combinations of three to seven vitamins,
minerals, or both in one or more intervention arms.
We noted some limitations in these studies. In the Chinese
study, while the body mass index of study participants
was within the normal range, there were indications of
inadequate intake of some micronutrients, thus limiting
the generalizability of this study’s findings to the U.S.
population (9). Three of these studies addressed eye
disease, and all were performed in patients who had
existing eye disease and were seen in ophthalmology
clinics (25–27). One of these studies had only 71 patients
and included several supplements other than vitamins
and minerals in the intervention (27). A binational study of
cataracts had different entry criteria in each country (25).

Findings by Disease
Cancer
Both trials that examined cancer end points found a
reduction in cancer incidence, mortality, or both. In
China, overall cancer incidence and mortality rates were

13
 significantly reduced, as were incidence and mortality
rates for the two leading types of cancer, esophageal and
gastric, in an arm of the study that included vitamin E,
β-carotene, and selenium (9). The decrease in esophageal
cancer emerged as a statistically significant finding only
after many years of follow-up. Another arm of the study,
on zinc and vitamin A, was associated with a reduction in
noncardia gastric cancer, although other gastric cancer
and esophageal cancer were not reduced. In France, an
intervention consisting of vitamin E, selenium, vitamin C,
β-carotene, and zinc was associated with a reduction in
overall cancer incidence in men only, but no individual
cancer was clearly reduced (23). Overall mortality rates in
men were also lower in the intervention group. No effect
was seen in women. In China, younger persons in the
intervention group had a lower incidence of esophageal
cancer, but older persons had a higher incidence
associated with treatment. Among men in the French
study with normal prostate-specific antigen levels, the
intervention was associated with a lower incidence
of prostate cancer, but prostate cancer incidence was
higher among men with high prostate-specific antigen
levels at baseline (24).

CVD
None of the reviewed studies showed any benefits or
harm related to CVD resulting from MVM use in the
studied populations.

Cataract
Mixed results emerged from studies in which cataract
progression was the targeted outcome. Only modest
and inconsistent effects were found in the two studies
that reported any benefit (25, 26).

Age-Related Macular Degeneration

One study showed less progression of intermediate-
stage age-related macular degeneration in persons
receiving vitamins C and E, β-carotene, and zinc (26).

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Summary
The uncertainty resulting from these trials suggests that
multivitamin trials are unlikely to lead to generalizable
knowledge. They cannot distinguish between the effects of
individual components; they are likely to be contaminated
by MVM use in the placebo group; they have a weaker
biological basis than single-vitamin or single-mineral
studies; they require very large sample sizes; and they will
become outdated from a public health perspective because
of the changing composition of commonly used MVMs.
There is evidence from one well-designed trial to
consider use of antioxidants and zinc in adults with
intermediate-stage age-related macular degeneration.
Some suggestive evidence points to possible benefit
of selenium, vitamin E, or both in cancer prevention,
especially in men.However, studies have also identified
subgroups of the population whose cancer risk might
increase with such supplementation. Trials currently
in progress (for example, the Selenium and Vitamin E
Cancer Prevention Trial [SELECT] and the Physicians’
Health Study II) should help determine the actual benefits
and harms of such supplementation.

5. What is known about the safety of MVM

for the generally healthy population?
Most people assume that the ingredients in MVM
supplements are safe. There is evidence, however, that
certain ingredients in MVM supplements can produce
adverse effects, including reports from RCTs that noted
excess lung cancer occurring in asbestos workers and
smokers consuming β-carotene. In addition, esophageal
cancer excess was found with long-term follow-up of
older Chinese patients treated with selenium, β-carotene,
and vitamin E supplements (9). There was also evidence
for gender difference in patterns of lung cancer and CVD
risk related to β-carotene. In another study, patients
with elevated prostate-specific antigen levels at baseline
who were receiving an MVM intervention had higher
incidence of prostate cancer (24).

15
 Vitamin D and calcium may increase the risk for kidney
stones for certain people. These data raise safety
questions both in general and in special populations.
Although these studies are not definitive, they do suggest
possible safety concerns that should be monitored for
primary components of multivitamins.
The RCTs and observational studies on vitamin and
mineral supplements have provided little information
on the safety of single-vitamin, single-mineral, or MVM
dietary supplements. Safety assessments were often
limited to adverse reports from patients who dropped
out of trials. The RCTs did not include assessments of
well-known potential adverse end points. Issues that
have not been adequately addressed include but are
not limited to reproducibility of the MVM manufacturing
process, characterization of the vitamin mix, demonstration
of the absence of contaminants, stability, and interactions
with other nutrients or drugs.
There is potential for adverse effects in individuals
consuming dietary supplements that are above the upper
level. This can occur not only in individuals consuming
high-potency single-nutrient supplements but also in
individuals who consume a healthy diet rich in fortified
foods in combination with MVM supplements. Furthermore,
by law, the listing of ingredient amounts on nutrient
supplement labels is the minimum content; thus,
higher intakes are probable. Data from prospective
studies have shown that individuals taking MVM dietary
supplements improved their nutritional adequacy with
respect to several nutrients but also increased the
proportion of their intakes above the upper level for
several of the supplemented nutrients. With the strong
trends of increasing MVM and other dietary supplement
consumption, and the increasing fortification of the U.S.
diet, we are concerned that a growing proportion of
the population may be consuming levels considerably
above the upper level, thus increasing the possibility
of adverse effects.

16
The FDA has insufficient resources and legislative
authority to require specific safety data from dietary
supplement manufacturers or distributors before or after
their products are made available to the public. This
lack of regulation exists despite the reality that many of
the ingredients of MVMs would be subject to premarket
approval if they were marketed as food additives and that
in some cases the ingredients possess biological activities
similar, if not identical, to those found in medications.
The 1994 Dietary Supplement Health and Education
Act (DSHEA) assumed that history of use of a given
supplement was evidence for safety, thus grandfathering
in all supplements on the market before the legislation.
However, use of nutrients in foods and supplements in
the United States is changing, and we are concerned that
public safety cannot be assured. Adverse events from
MVMs appear with some frequency in both the reports of
the American Association of Poison Control Centers and
the FDA’s MedWatch system.
We found the primary recommendation of the 2005
Institute of Medicine committee report on dietary
supplements compelling: “[T]he regulatory mechanisms
for monitoring the safety of dietary supplements, as
currently defined by DSHEA, [should] be revised. The
constraints imposed on FDA with regard to ensuring the
absence of unreasonable risk associated with the use of
dietary supplements make it difficult for the health of the
American public to be adequately protected.” The FDA
should have the authority to better inform consumers
and health professionals regarding the existence of
upper levels as well as the possible risks of exceeding
those levels; develop a formal, mandatory adverse event
reporting system for dietary supplements; and mandate
provision of a MedWatch toll-free telephone number
or Web site on product labels to facilitate reporting of
adverse events. Furthermore, we recommend that health
care professionals, consumers, and manufacturers use
the FDA MedWatch adverse event reporting system to
report adverse events associated with the use of dietary
supplements. Finally, we recommend that Congress revise
and update the law to reflect current knowledge.

17
 6. What are the major knowledge
gaps and research opportunities
regarding MVM use?
This review of the state of the science has identified
important gaps in knowledge about the relationship
between MVM use and chronic disease prevention in
generally healthy adults. These deficiencies are attributable
to shortcomings in data quality and a paucity of rigorously
designed and conducted studies, especially RCTs.
Hence, this report emphasizes the need and rationale
for rigorous, state-of-the-art, methodologically and
technologically forward-looking research to bridge these
gaps. We strongly recommend the following actions.
• Elicit more accurate information from individuals to
improve the quality of self-reported data on MVM use.
Capitalize on new electronic technologies, design and
employ improved questionnaires, and develop new
dietary and MVM recall methods, all to enhance
accuracy and specificity of reported MVM intake.
• Build new MVM databases that detail the exact composition
of supplements, update them on a continuous basis,
and assure their constant availability to the research
community. A national database, such as that developed
and maintained by the U.S. Department of Agriculture
for food composition, will be a major improvement for
determining potential impact, benefits, and harms of MVM.
• Determine the most effective means to translate
scientific information and improve communication
about dietary supplements among consumers, health
care providers, industry, scientists, and policymakers.
• Develop a strategy to support the study of possible
interactions of MVMs with nutrients or prescribed
and over-the-counter medications.
• Study populations that reflect the diversity of the
United States ethnically, economically, and by age
and sex. Focus on population segments previously
underrepresented and also on individuals at increased
risk for chronic disease.
18
• Capitalize on the rapidly progressing state of biomedical
science to develop and apply techniques for assessing
the basic biological mechanisms by which supplements
may modify disease risks, for example, nutritional
genomics, molecular imaging, and systems biology
network approaches. The resulting knowledge may
identify important new biomarkers, early in the
disease process, that may inform observational
studies and RCTs.
• Design and conduct rigorous RCTs of the impact of
individual supplements (or paired supplements, when
biologically plausible) to test their efficacy and safety
in prevention of chronic disease, using well-validated
measures. Select the vitamins and minerals to be
studied on the basis of their biological plausibility
and outcomes of appropriate observational and pilot
studies. Include in trials the most modern and validated
biomarkers of exposure, bioavailability intermediary
metabolism, and early disease. When possible,
incorporate relevant genetic polymorphisms and other
indices of individual physiologic characteristics into
trial design. Randomized, controlled trials should
employ such cost-effective and innovative methods
as fractional factorial designs, which will permit the
simultaneous evolution of multiple single supplements
and their low-order interactions. Assure sufficient trial
duration of both observational studies and RCTs during
intervention and follow-up to determine important
outcomes that may inform public policy decisions.

Conclusions
Use of MVMs has grown rapidly over the past several
decades, and dietary supplements are now used by
more than half of the adult population in the United
States. In general, MVMs are used by individuals who
practice healthier lifestyles, thus making observational
studies of the overall relationship between MVM use and
general health outcomes difficult to interpret. Despite
the widespread use of MVMs, we still have insufficient
knowledge about the actual amount of total nutrients

19
 that Americans consume from diet and supplements.
This is at least in part due to the fortification of foods
with these nutrients, which adds to the effects of
MVMs or single-vitamin or single-mineral supplements.
Historically, fortification of foods has led to the
remediation of vitamin and mineral deficits, but the
cumulative effects of supplementation and fortification
have also raised safety concerns about exceeding upper
levels. Thus, there is a national need to improve the
methods of obtaining accurate and current data on
the public’s total intake of these nutrients in foods
and dietary supplements.
In systematically evaluating the effectiveness and safety
of MVMs in relation to chronic disease prevention, we
found few rigorous studies on which to base clear
conclusions and recommendations. Most of the studies
we examined do not provide strong evidence for
beneficial health-related effects of supplements taken
singly, in pairs, or in combinations of three or more. Within
some studies or subgroups of the study populations,
there is encouraging evidence of health benefits, such as
increased bone mineral density and decreased fractures
in postmenopausal women who use calcium and vitamin
D supplements. However, several other studies also
provide disturbing evidence of risk, such as increased
lung cancer risk with β-carotene use among smokers.
The current level of public assurance of the safety
and quality of MVMs is inadequate, given the fact that
manufacturers of these products are not required to
report adverse events and the FDA has no regulatory
authority to require labeling changes or to help inform the
public of these issues and concerns. It is important that
the FDA’s purview over these products be authorized
and implemented.
Finally, the present evidence is insufficient to recommend
either for or against the use of MVMs by the American
public to prevent chronic disease. The resolution of this
important issue will require advances in research and
improved communication and collaboration among

20
scientists, health care providers, patients, the
pharmaceutical and supplement industries, and
the public.

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23
 State-of-the-Science Panel
J. Michael McGinnis, M.D., M.P.P. William R. Hazzard, M.D.
Panel and Conference Professor
Chairperson Department of Medicine
Senior Scholar Division of Gerontology and
Institute of Medicine Geriatric Medicine
The National Academies University of Washington
Washington, DC Chief, Geriatrics and
Extended Care
Diane F. Birt, Ph.D. VA Puget Sound Health
Distinguished Professor Care System
Department of Food Science Seattle, Washington
and Human Nutrition
Director, Center for Douglas B. Kamerow, M.D., M.P.H.
Research on Botanical U.S. Editor, BMJ
Dietary Supplements Professor of Clinical
College of Agriculture and Family Medicine,
College of Human Sciences Georgetown University
Iowa State University Chief Scientist, Health,
Ames, Iowa Social, and Economics
Research
Patsy M. Brannon, Ph.D., R.D. RTI International
Professor Washington, DC
Division of Nutritional Sciences
Cornell University Bernard Levin, M.D.
Ithaca, New York Professor of Medicine
Vice President for
Raymond J. Carroll, Ph.D. Cancer Prevention and
Distinguished Professor Population Sciences
of Statistics University of Texas M.D.
Professor of Nutrition Anderson Cancer Center
and Toxicology Houston, Texas
Department of Statistics
Texas A&M University James M. Ntambi, Ph.D.
College Station, Texas Steenbock Professor
Departments of Biochemistry
Robert D. Gibbons, Ph.D. and Nutritional Sciences
Director University of Wisconsin–Madison
Center for Health Statistics Madison, Wisconsin
Professor of Biostatistics
and Psychiatry
University of Illinois at Chicago
Chicago, Illinois

24
Nigel Paneth, M.D., M.P.H. Audrey F. Saftlas, Ph.D., M.P.H.
Professor of Epidemiology Professor
Pediatrics and Human Department of Epidemiology
Development The University of Iowa
College of Human Medicine College of Public Health
Michigan State University Iowa City, Iowa
East Lansing, Michigan
William Vaughan
Douglas Rogers, M.D. Senior Policy Analyst
Head, Section of Pediatric and Consumer’s Union
Adolescent Endocrinology Washington, DC
The Cleveland Clinic
Cleveland, Ohio

Speakers
Anthony J. Alberg, Ph.D., M.P.H. Benjamin Caballero, M.D., Ph.D.
Associate Professor Professor
Blatt Ness Endowed Chair Center for Human Nutrition
in Oncology Johns Hopkins Bloomberg
Department of Biostatistics, School of Public Health
Bioinformatics, and Baltimore, Maryland
Epidemiology
Hollings Cancer Center Allen Dobson, Ph.D.
Medical University of Senior Vice President
South Carolina The Lewin Group
Charleston, South Carolina Falls Church, Virginia

Bruce N. Ames, Ph.D. Peter Greenwald, M.D., Dr.P.H.

Professor of the Director, Division of
Graduate School Cancer Prevention
University of California, Berkeley National Cancer Institute
Senior Scientist National Institutes of Health
Nutrition and Bethesda, Maryland
Metabolism Center
Children’s Hospital Robert P. Heaney, M.D.
Oakland Research Institute John A. Creighton
Oakland, California University Professor
Professor of Medicine
Diane Benford, Ph.D. Department of Medicine
Chemical Safety Division Creighton University
Food Standards Agency Omaha, Nebraska
London, United Kingdom

25
 Han-Yao Huang, Ph.D., M.P.H. Johanna M. Seddon, M.D., Sc.M.
Assistant Professor Director, Epidemiology Unit
Department of Epidemiology Department of Ophthalmology
Johns Hopkins Bloomberg Massachusetts Eye and
School of Public Health Ear Infirmary
Sidney Kimmel Comprehensive Boston, Massachusetts
Cancer Center
Johns Hopkins A. Elizabeth Sloan, Ph.D.
School of Medicine Editor/Columnist
Baltimore, Maryland Food Technology
Functional Foods &
Suzanne Murphy, Ph.D., R.D. Nutraceuticals and Flavor
Research Professor & The Menu Magazines
Cancer Research Center Escondido, California
of Hawaii
University of Hawaii Meir J. Stampfer, M.D., Dr.P.H.
Honolulu, Hawaii Professor of Epidemiology
and Nutrition
Roy M. Pitkin, M.D. Chair, Department of
Professor Emeritus Epidemiology
University of California, Departments of Epidemiology
Los Angeles and Nutrition
La Quinta, California Harvard School of Public Health
Professor of Medicine
Ross L. Prentice, Ph.D. Harvard Medical School
Biostatistician Boston, Massachusetts
Division of Public
Health Sciences Maret Traber, Ph.D.
Fred Hutchinson Cancer Professor
Research Center Linus Pauling Institute
Seattle, Washington Oregon State University
Corvallis, Oregon
Cheryl L. Rock, Ph.D., R.D.
Professor Jason J.Y. Woo, M.D., M.P.H., FACOG
Family and Preventive Medicine Team Leader for the
Cancer Prevention and Clinical Group
Control Program Division of Dietary
University of California, Supplement Programs
San Diego Office of Nutritional Products,
La Jolla, California Labeling, and Dietary
Supplements
Irwin H. Rosenberg, M.D. Center for Food Safety &
Senior Scientist and Applied Nutrition
University Professor U.S. Food and Drug
Jean Mayer U.S. Department of Administration
Agriculture Human Nutrition College Park, Maryland
Research Center on Aging
Tufts University Elizabeth Yetley, Ph.D.
Boston, Massachusetts Office of Dietary Supplements
Office of the Director
National Institutes of Health
Bethesda, Maryland

26
Planning Committee
Johanna Dwyer, D.Sc., R.D. Elsa A. Bray
Planning Committee Senior Advisor for the Consensus
Co-Chairperson Development Program
Senior Nutrition Scientist Office of Medical Applications
Office of Dietary Supplements of Research
Office of the Director Office of the Director
National Institutes of Health National Institutes of Health
Bethesda, Maryland Bethesda, Maryland

Paul M. Coates, Ph.D. Emily Chew, M.D.

Planning Committee Deputy Director
Co-Chairperson Division of Epidemiology
Director and Clinical Research
Office of Dietary Supplements National Eye Institute
Office of the Director National Institutes of Health
National Institutes of Health Bethesda, Maryland
Bethesda, Maryland
Gerald Combs, Jr., Ph.D.
Mayada Akil, M.D. Center Director
Office of Science Policy Grand Forks Human Nutrition
and Program Planning Research Center
National Institute of U.S. Department of Agriculture
Mental Health Grand Forks, North Dakota
National Institutes of Health
Bethesda, Maryland Margaret Coopey, R.N., M.G.A.,
M.P.S.
David Atkins, M.D., M.P.H. Health Policy Analyst
Chief Medical Officer Center for Practice and
Center for Outcomes Technology Assessment
and Evidence Agency for Healthcare
Agency for Healthcare Research and Quality
Research and Quality U.S. Department of Health
U.S. Department of Health and Human Services
and Human Services Rockville, Maryland
Rockville, Maryland
Cindy D. Davis, Ph.D.
Barbara A. Bowman Nutritional Science Research
Associate Director for Science Group
National Center for Chronic National Cancer Institute
Disease Prevention and National Institutes of Health
Health Promotion Bethesda, Maryland
Chronic Disease Prevention
Centers for Disease Control
and Prevention
Atlanta, Georgia

27
 James Everhart, M.D., M.P.H. Barnett S. Kramer, M.D., M.P.H.
Chief Director
Epidemiology and Clinical Office of Medical Applications
Trials Branch of Research
Division of Digestive Diseases Office of the Director
and Nutrition National Institutes of Health
National Institute of Bethesda, Maryland
Diabetes and Digestive
and Kidney Diseases Molly Kretsch, Ph.D.
National Institutes of Health National Program Leader
Bethesda, Maryland for Human Nutrition
Agriculture Research Service
Judith A. Finkelstein, Ph.D. U.S. Department of Agriculture
Health Scientist Administrator Beltsville, Maryland
Neuroscience and
Neuropsychology of Catherine Loria, Ph.D.
Aging Program Epidemiologist
National Institute on Aging National Heart, Lung,
National Institutes of Health and Blood Institute
Bethesda, Maryland National Institutes of Health
Bethesda, Maryland
Gilman D. Grave, M.D.
Chief Kelli K. Marciel, M.A.
Endocrinology, Nutrition, Communications Director
and Growth Branch Office of Medical Applications
National Institute of of Research
Child Health and Office of the Director
Human Development National Institutes of Health
National Institutes of Health Bethesda, Maryland
Bethesda, Maryland
J. Michael McGinnis, M.D., M.P.P.
Laura Kettel Khan, Ph.D. Panel and Conference
Deputy Chief Chairperson
Chronic Disease Nutrition Counselor to the President
Division of Nutrition The Robert Wood
and Physical Activity Johnson Foundation
Centers for Disease Washington, DC
Control and Prevention
Atlanta, Georgia Joan A. McGowan, Ph.D.
Chief
Marguerite A. Klein Musculoskeletal
National Center for Diseases Branch
Complementary and National Institute of Arthritis
Alternative Medicine and Musculoskeletal
National Institutes of Health and Skin Diseases
Bethesda, Maryland National Institutes of Health
Bethesda, Maryland

28
Linda D. Meyers, Ph.D. Susan Rossi, Ph.D., M.P.H.
Director Deputy Director
Food and Nutrition Board Office of Medical
Institute of Medicine Applications of Research
The National Academies Office of the Director
Washington, DC National Institutes of Health
Bethesda, Maryland
Lata S. Nerurkar, Ph.D.
Senior Advisor for John Paul SanGiovanni, Sc.D.
the Consensus Staff Scientist
Development Program Division of Epidemiology
Office of Medical Applications and Clinical Research
of Research National Eye Institute
Office of the Director National Institutes of Health
National Institutes of Health Bethesda, Maryland
Bethesda, Maryland
Paul A. Sheehy, Ph.D.
Malden C. Nesheim, Ph.D. National Institute of Neurological
Professor of Nutritional Disorders and Stroke
Sciences Emeritus National Institutes of Health
Provost Emeritus Bethesda, Maryland
Division of Nutritional Sciences
College of Human Ecology Pamela Starke-Reed, Ph.D.
Cornell University Deputy Director
Ithaca, New York Division of Nutrition
Research Coordination
Lester Packer, Ph.D. National Institutes of Health
Professor Bethesda, Maryland
Adjunct Faculty
Department of Amy F. Subar, Ph.D., M.P.H., R.D.
Molecular Pharmacology Research Nutritionist
and Toxicology National Cancer Institute
University of Southern National Institutes of Health
California School Bethesda, Maryland
of Pharmacy
Los Angeles, California Anne Thurn, Ph.D.
Director
Irwin H. Rosenberg, M.D. Evidence-Based Review Program
Senior Scientist and University Office of Dietary Supplements
Professor National Institutes of Health
Jean Mayer U.S. Department Bethesda, Maryland
of Agriculture Human
Nutrition Research Center Paula R. Trumbo, Ph.D.
on Aging Supervisory Nutritionist
Tufts University Division of Nutrition
Boston, Massachusetts Programs and Labeling
U.S. Food and Drug
Administration
College Park, Maryland

29
 Conference Sponsors
Office of Dietary Supplements Office of Medical Applications
Paul M. Coates, Ph.D. of Research
Director Barnett S. Kramer, M.D., M.P.H.
Director

Conference Cosponsors
National Cancer Institute National Institute of Arthritis
Andrew C. von Eschenbach, M.D. and Musculoskeletal and
Director Skin Diseases
Stephen I. Katz, M.D., Ph.D.
National Center for Director
Complementary and
Alternative Medicine National Institute of Child Health
Stephen E. Straus, M.D. and Human Development
Director Duane Alexander, M.D.
Director
National Eye Institute
Paul A. Sieving, M.D., Ph.D. National Institute of Diabetes and
Director Digestive and Kidney Diseases
Griffin P. Rodgers, M.D., M.A.C.P.
National Institute on Aging Acting Director
Richard J. Hodes, M.D.
Director

Conference Partners
Centers for Disease Control U.S. Department of Agriculture
and Prevention Mike Johanns, J.D.
Julie Louise Gerberding, Secretary
M.D., M.P.H.
Director

U.S. Food and Drug Administration

Andrew C. von Eschenbach, M.D.
Acting Commissioner

30