...................................................................................................................................................
ADA REPORTS
Position of The American Dietetic Association:
Vitamin and mineral supplementation
esearch on the relationship between diet and disease has
R increased scientific interest in determining what nutrient
intakes optimize health, and whether these intakes can be
adequately provided by diet. Epidemiologic studies suggesting
that high fruit and vegetable consumption reduces cancer risk,
together with scientific hypotheses about molecular and tissue
damage from biological oxidation mechanisms, have increased
interest in antioxidant nutrients and the possible benefits of
supplemental beta carotene, vitamin C, and vitamin E (1).
Concerns about osteoporosis and research indicating a posi-
tive association between calcium intake and bone mass have
led a scientific panel to recommend daily quantities of calcium
that greatly exceed typical intakes (2). Research showing that
supplementation with folic acid for several weeks before and
after conception decreases the incidence of neural tube de-
fects has sparked debate on whether all women of child-
bearing age should take a multivitamin supplement (3).
Concurrent with such scientific discussions, there has been
intense public interest in dietary supplements. According to
government surveys, 4 of 10 Americans regularly used dietary
supplements in the early to mid-1980s (4). A 1993 Newsweek
poll found that 7 of 10 Americans used supplements at least
occasionally (June 7, 1993:46-51). Approximately 3,400 dif-
ferent vitamin and mineral supplement products (5) are on the
market and account for $4 billion annually in gross sales
(Time. November 1, 1993:73-74).
This intense scientific, popular, and regulatory interest
provides a dynamic climate for The American Dietetic
Association’s (ADA) position on the role of foods and dietary
supplements in promoting health.
POSITION STATEMENT
It is the position of The American Dietetic Association that
the best nutritional strategy for promoting optimal health
and reducing the risk of chronic disease is to obtain
adequate nutrients from a wide variety of foods. Vitamin
and mineral supplementation is appropriate when well-
accepted, peer-reviewed, scientific evidence shows safety
and effectiveness.
GOOD NUTRITION DEPENDS ON A GOOD DIET
Research on the relationship between diet and disease has
indicated the importance of macronutrients and micronutri-
ents, and has documented the need to avoid dietary excesses
and to ensure adequate nutrient consumption. Concerns about
dietary excesses, speculation about the potential benefits of
macronutrients that are not easily supplemented, and incom-
plete identification of the myriad food components that may
reduce disease risk all underscore the fact that nutrition
cannot be optimized simply through manipulation of the food
supply or supplementation.
Much remains unknown about the biologically active com-
ponents of food. For example, recent research has identified
numerous compounds in plant and animal foods that are not
essential nutrients, but have antioxidant properties and show
anticarcinogenic activity in animals (6). Plant foods contain
many compounds, including natural pesticides to ward off
plant predators, that have anticarcinogenic properties in small
amounts found in food but may not be safe or effective in larger
amounts (7). Given our incomplete knowledge, eating a wide
variety of foods and avoiding chemical excesses or imbalances
are the best ways to obtain adequate amounts of beneficial food
constituents. The Dietary Guidelines for Americans (8) and the
Food Guide Pyramid (9) emphasize liberal use of grain prod-
ucts, vegetables, and fruits; moderate use of meats and dairy
products; and sparing use of fats and sweeteners. Good nutri-
tion primarily depends on appropriate food choices, and con-
suming a wide variety of foods in moderate amounts reduces
the risk of both inadequate and excessive intakes.
RECOMMENDED NUTRIENT INTAKES
In establishing a recommended intake for a nutrient, the
criteria should be scientific evidence of the nutrient’s effective-
ness and safety in supporting optimal biological performance,
reducing disease risk, and preventing nutrient deficiencies.
Such criteria do not assume that the recommended amounts
can be met from dietary sources. At the same time, long-term
nutrient consumption at levels beyond those found in usual
diets cannot be assumed to be safe just because lower levels are
present in the diet or because adverse effects have not been
discerned in random public self-supplementation. Sound sci-
entific evidence is essential before advising the public to
change dietary and nutrient patterns.
Recommended Dietary Allowances (RDAs) (10) have been
established through scientific agreement on the basis of evalu-
ation of experimental evidence by the Food and Nutrition
Board of the National Academy of Sciences. The Food and
Nutrition Board has indicated that the concept of reduction of
chronic disease risk should be considered in the formulation of
future RDAs (11).
NUTRIENT SUPPLEMENTATION IN
THE UNITED STATES
Although nutrient supplements should not be used as a substi-
tute for healthful eating, there is little evidence to suggest that
supplement users consume fewer nutrients from food than
those who do not use supplements. National surveys con-
ducted in the 1980s indicated that supplement users had
higher intakes of nutrients from foods (12-14) and ate more
fruits and vegetables than those not taking supplements (14,15).
Supplement use was most common in the western United
States and among whites, women, older persons, those with
higher personal incomes, those with more education (4,16,17),
nonsmokers (especially former smokers) (17), and those who
did not drink alcohol heavily (17). Supplement use was more
common among persons who believe diet affects disease (17).
JOURNAL OF THE AMERICAN DIETETIC ASSOCIATION / 73
...................................................................................................................................................
ADA REPORTS
Is there evidence to suggest benefits of self-supplementa-
tion? A 13-year follow-up of 10,758 participants in the first
National Health and Nutrition Examination Survey found that
cancer mortality and overall mortality were similar in regular
users and in nonusers of supplements (12). Using the same
data set, Enstrom et al (18) reported that men (but not
women) with high dietary vitamin C intakes who used vitamin
C supplements had reduced overall mortality compared with
those who had a high dietary intake of vitamin C and did not
take vitamin C supplements or those who had a low dietary
intake of vitamin C and did or did not take vitamin C supple-
ments. These reports exemplify the limitations of survey data,
which can yield different conclusions from different analyses
of the same data set. Limitations of these particular studies
include the inability to separate the effects of different supple-
ments (supplement users commonly supplemented themselves
with more than one nutrient); the inability to separate effects
of supplements from effects of different diets (eg, users also
had greater nutrient intakes and consumed more fruits and
vegetables); and the inability to quantify nutrient intake be-
cause of the variability and limited accuracy of 24-hour recalls
and the lack of quantitative data on supplement use. Thus,
associations between health and supplement use derived from
surveys must be interpreted with caution, and may be most
useful in suggesting the need for controlled research trials.
In two large studies of self-supplementation in the United
States, vitamin E supplements were associated with a reduced
coronary disease risk in 39,910 male health professionals (19)
and 87,245 female nurses (20) monitored for 4 and 8 years,
respectively, after dietary questionnaires were completed.
Overall mortality did not differ according to use of vitamin E
supplements (19,20) or multivitamin supplements (19,20).
The researchers concluded that recommendations to the pub-
lic about vitamin E supplementation should await results of
randomized, controlled clinical trials.
NEED FOR STRONG SCIENTIFIC EVIDENCE BASED
ON CONTROLLED CLINICAL TRIALS
Recent research on beta carotene and cancer has emphasized
that results of epidemiologic studies associating disease risk
with food consumption should not be extrapolated to isolated
food constituents without additional controlled investigation
of the specific constituents. Numerous epidemiologic studies
associating a high consumption of fruits and vegetables with
reduced incidence of cancer, especially lung and colorectal
cancer, have led to FDA’s acceptance of related health claims
for food labels of fruits and vegetables, but not for labels of
antioxidant vitamins (21). Epidemiologic studies do not estab-
lish cause and effect because they do not control for other diet
and lifestyle variables that may be characteristic of persons
who eat plenty of fruits and vegetables. Likewise, retrospective
studies of associations between cancer incidence and dietary
or blood beta carotene levels cannot control for other compo-
nents of high-carotene fruits and vegetables.
Cause-and-effect relationships can be tested most conclu-
sively with prospective, randomized, double-blind, placebo-
controlled supplementation trials. Such trials control for con-
founding variables by randomly assigning the supplement to
participants who are otherwise identically treated and evalu-
ated. Generally, it is easier to control experiments with supple-
ments than with dietary changes because the treatment can be
easily blinded from participants and investigators and requires
fewer and simpler behavioral changes. Several such trials are
prospectively investigating whether beta-carotene supplements
will reduce cancer incidence. One of the earliest completed
trials found no beneficial effects, and an unexpected higher
74 / JANUARY 1996 VOLUME 96 NUMBER 1
incidence of lung cancer and of total mortality with use of beta-
carotene supplements in male Finnish smokers (22). The
Finnish study found that the highest initial concentrations of
beta carotene in blood were associated with reduced incidence
of lung cancer, whereas supplementation with beta carotene
was not (22). This is consistent with the possibility that the
blood level of beta carotene may only be an inactive marker of
the consumption of fruits and vegetables, which may contain
other active substances that reduce cancer risk.
Rarely can a single study stand alone as scientific verification
of a hypothesis. The results may be a statistically rare chance
occurrence, results may not be representative of results in
other populations, or beneficial effects may require longer
studies or more sensitive testing. Since the Finnish study (22),
another randomized, placebo-controlled study has indicated
that supplementation with beta carotene has no effect on
incidence of colorectal adenoma (23). Combined supplemen-
tation with modest amounts of beta carotene, vitamin E, and
selenium (but not with combinations of retinol and zinc,
riboflavin and niacin, or vitamin C and molybdenum) was
associated with reduced cancer mortality in Linxian, China, an
area with very high rates of esophageal cancer and low nutrient
intakes (24). Because of the low baseline nutritional status of
this Chinese population, the results may reflect the benefits of
correcting marginal nutritional deficiencies; thus, the finding
may not be applicable to populations eating a Western diet.
Additional controlled supplementation trials will help resolve
whether antioxidant nutrients such as beta carotene, vitamin
C, and vitamin E can prevent or reduce incidence of cancer and
heart disease as has been suggested by epidemiologic studies.
Prospective clinical trials can also increase knowledge of the
safety of supplements. The Finnish study (22) raised safety
concerns about α-tocopherol supplements, which were associ-
ated with fewer cases of ischemic stroke and more cases of
hemorrhagic stroke, with no significant difference in overall
mortality. Such a finding is consistent with research suggesting
that high doses of vitamin E decrease platelet thromboxane
production and exacerbate vitamin K deficiency (25). The
possibility is also raised that, by decreasing blood coagulation,
α-tocopherol could prove beneficial for some people and det-
rimental for others. Randomized, controlled trials to evaluate
the effect of dietary supplementation on chronic disease risk
will also increase knowledge about supplement safety in rela-
tion to long-term health.
CIRCUMSTANCES FOR WHICH
SUPPLEMENTATION IS INDICATED
When dietary selection is limited, nutrient supplementation
can be useful for meeting the RDAs. Examples include supple-
mental vitamin B-12 for strict vegans who eliminate all animal
products from the diet; folic acid for women of child-bearing
age who consume limited amounts of fruits, leafy vegetables,
and legumes; vitamin D for those with limited milk intake and
sunlight exposure; calcium for those with lactose intolerance
or allergies to dairy products; and a multivitamin and mineral
supplement for those following severely restricted weight-loss
diets. Therapeutic nutrient supplementation is, of course,
indicated to treat or prevent nutrient deficiency in a variety of
specific clinical situations related to increased nutrient re-
quirements; reduced nutrient consumption, absorption, or
utilization; or increased nutrient excretion.
Iron supplementation during pregnancy is routinely prac-
ticed in the United States. Recently, two expert committees
called for more research concerning whether iron supplemen-
tation should occur routinely or only on the basis of individual
iron status assessment (26,27). A Food and Nutrition Board
...................................................................................................................................................
committee recommended further study into the possibility of
adverse outcomes at very low or high hemoglobin levels, but
concluded that the practice of routine iron supplementation
should not be changed without further research (26). Another
Food and Nutrition Board committee has made specific recom-
mendations for supplementation with iron, zinc, copper, cal-
cium, vitamin B-6, folate, vitamin C, and vitamin D for pregnant
women who do not consume an adequate diet or who are in
high-risk categories, such as women carrying more than one
fetus, heavy smokers, or alcohol or drug abusers (28).
The determination of calcium intakes that reduce the risk of
osteoporosis is an active area of research. An NIH expert
scientific panel has recently recommended calcium intakes,
preferably from dietary sources, that are generally higher than
the current RDAs (2). Both the NIH recommendations and the
RDAs exceed the 600 mg average daily intakes of adult women
(29). Although one randomized clinical trial of supplementa-
tion with 500 mg calcium indicated that bone mass increased
only in persons with initial calcium intakes less than 400 mg
daily (30), another found that bone mass increased with
consumption of 1,000 mg supplemental calcium independent
of initial intakes (31). Fracture rate was reduced in a random-
ized clinical trial of calcium and vitamin D supplementation
(32), as well as in another trial using vitamin D alone (33).
Additional research is needed using fracture incidence as
criterion and distinguishing between the benefits of calcium
and vitamin D. Genetic markers, such as a variant of the gene
for the vitamin D receptor that is associated with reduced bone
mineral density (34), are likely to help in the future identifica-
tion of persons who have greater nutrient requirements. High
intakes of calcium are not without risk; for example, high
intakes inhibit iron absorption (35). At present, individualized
dietary assessment and counseling can help identify those who
are able to obtain recommended levels of calcium and vitamin
D from dietary (and sunlight) sources and those who may
benefit from fortified foods or supplements.
Concerns about general nutrient intake, particularly of more
nutritionally vulnerable population groups (eg, young chil-
dren, women of child-bearing age, pregnant or lactating women,
tobacco users, and the elderly), have stimulated scientific
discussion about whether to advocate the use of modest doses
of general multivitamin-mineral supplements to help meet
RDAs (3). As already indicated, and as emphasized by the Food
and Nutrition Board (10), it is both practicable and desirable to
meet the RDAs by consuming a variety of foods. This is the best
way to ensure a balance of nutrients and consumption of
appropriate amounts of healthful food components for which
no RDA is established. Although there is little scientific evi-
dence of harm from use of low-dose multivitamin-mineral
supplements, it is possible that even modest amounts of mul-
tivitamin and mineral supplements may contribute to exces-
sive intakes or imbalances. For instance, the additional iron
commonly found in multivitamin and mineral supplements is
unlikely to benefit adult men or postmenopausal women, who
are at low risk of iron deficiency. On the other hand, supple-
mental iron is more likely to cause harm in these groups: a
substantial portion of the population is heterozygous for
hemochromatosis, there is a possible increased risk of cardio-
vascular disease or cancer with high iron stores, and there are
possible adverse competitive interactions with other minerals
such as copper and zinc. Low-dose multivitamin-mineral supple-
ments are more likely to benefit those with limited dietary
intakes and will probably provide minimal advantage to per-
sons who eat a variety of foods according to dietary guidelines.
Such low-dose supplements improved indexes of immune
function and reduced illness from infection in a double-blind,
placebo-controlled investigation of 96 free-living elderly Cana-
dian men and women (36). Similar supplements had no benefit
in a double-blind, placebo-controlled study of muscle weak-
ness and physical frailty in 100 very elderly nursing home
residents (37). More research in this area should be encour-
aged. Meanwhile, recommendations to use low-dose multivita-
min and mineral supplements should depend on individualized
dietary assessment.
FOOD FORTIFICATION MAY MORE EFFECTIVELY
ADDRESS SOME POPULATION PROBLEMS
When scientific evidence indicates benefits of increased nutri-
ent intake beyond what is commonly consumed by a population
group, and there is no risk of unsafe intakes for others, food
fortification may be more effective than supplementation. For
example, investigations that included randomized controlled
trials of folic acid supplementation (38,39) led the US Public
Health Service to recommend that all women of child-bearing
age consume 400 µg folic acid daily to reduce incidence of spina
bifida and other neural tube defects (40). FDA authorized use
of health claims for food labels about the relationship between
folic acid and neural tube defects and proposed folic acid
fortification of cereal and grain products (41).
But what is the best way to ensure adequate folic acid intake
in women of child-bearing age before conception and in the
earliest weeks of pregnancy? Folate intakes of 400 µg daily can
be met by consuming diets rich in fruits, vegetables, and
legumes; by folic acid supplementation; and/or by food fortifi-
cation. It is preferable to consume 400 µg folate from dietary
sources because this will likely improve dietary intakes in other
ways. However, national surveys indicate that the average
daily folate intake of US women is approximately 230 µg/1,957
kcal (42,43). (This may underestimate actual intakes because
of underreporting of food intake and inadequacies in food
composition data. Also, folate from foods may not be com-
pletely bioavailable [44].) Both the dietary and supplementa-
tion approaches to this problem would likely be inadequate for
some segments of the population because both rely on per-
sonal behavioral change. This is an instance when nutrient
fortification of appropriate target foods can more comprehen-
sively increase the nutrient intake of the population than can
reliance on nutrient supplements.
TOXICITIES, ADVERSE NUTRIENT INTERACTIONS,
AND SAFETY
Nutrient imbalances and toxicities are less likely to occur when
nutrients are derived from foods. Although vitamin A toxicity
has occurred from eating the livers of carnivorous animals or
large fish (45), most nutrient toxicities occur through supple-
mentation. Estimated toxic doses for daily oral consumption of
vitamins and minerals by adults (46, p 518) are as low as 5 times
the recommended intake for selenium, and as high as 25 to 50
times or more the recommended intakes for folic acid and
vitamins C and E. Although median amounts of nutrients taken
by supplement users in a 1980 national survey were less than
3 to 5 times the recommended intakes, 5% took doses exceed-
ing 25 times the recommended intakes for thiamin; riboflavin;
and vitamins B-6, B-12, C, and E (16). The toxicities of high
doses of nutrients such as vitamins A, B-6, and D; niacin; iron;
and selenium are well established (46). Iron supplements
intended for other household members are the most common
cause of pediatric poisoning deaths in the United States (26).
Large doses of vitamin A may be teratogenic (10). Because
of this risk, the Food and Nutrition Board recommends avoid-
ing supplementation with preformed vitamin A during the first
trimester of pregnancy unless there is specific evidence of
JOURNAL OF THE AMERICAN DIETETIC ASSOCIATION / 75
...................................................................................................................................................
ADA REPORTS
vitamin A deficiency (28). A study of 22,748 pregnant women
found that women taking more than 10,000 IU preformed
vitamin A had a greater risk of giving birth to babies with cranial
neural crest defects (47). Such a risk in early pregnancy raises
a need for caution about general vitamin and mineral supple-
ment use by women of child-bearing age.
Besides problems with direct toxicity of some individual
nutrients, nutrient supplementation can cause problems re-
lated to nutrient imbalances or adverse interactions with medi-
cal care. Many problems associated with high doses of a single
nutrient may reflect interactions that result in a relative defi-
ciency for another nutrient. As already indicated, high doses of
vitamin E can interfere with vitamin K action and enhance the
effect of coumarin anticoagulant drugs (25). High amounts of
calcium inhibit absorption of iron (35) and possibly other trace
elements (10). Folic acid can mask hematologic signs of vita-
min B-12 deficiency, which, if untreated, can result in irrevers-
ible neurologic damage. Folic acid can also interact adversely
with anticonvulsant medications (10). Zinc supplementation
can reduce copper status, impair immune responses, and
decrease high-density lipoprotein cholesterol levels (10).
In 1989 to 1990, supplements of the amino acid L-tryptophan
were associated with an US outbreak of more than 1,500 cases
of a newly described disorder, eosinophilia-myalgia syndrome,
which resulted in 38 deaths. Although these deaths were
probably caused by contamination in the chemical manufac-
turing process rather than by the toxicity of L-tryptophan (48),
they represent a tragic consequence of taking supplements
that have little scientific justification of benefit.
THE DIETARY SUPPLEMENT HEALTH AND
EDUCATION ACT OF 1994
Although there is sincere scientific and public interest in the
potential benefit of dietary supplementation, supplements
have frequently been associated with unfounded or misleading
health claims. The Dietary Supplement Health and Education
Act of 1994 (49) placed the burden of proof of unsafe or
adulterated products or of false or misleading labeling on the
FDA rather than on the manufacturer. Unfortunately, the act
allowed different regulations for health claims related to di-
etary supplements than for those related to foods, in contrast
with recommendations in a previous ADA position (50). The
act prohibited label claims related to the diagnosis, treatment,
or prevention of disease, but allowed claims if
a statement claims a benefit related to a classical nutrient defi-
ciency disease and discloses the prevalence of such disease in the
United States, describes the role or a nutrient or dietary ingredient
intended to affect the structure or function in humans, character-
izes the documented mechanism by which a nutrient or dietary
ingredient acts to maintain such structure or function, or describes
general well-being from consumption of a nutrient or dietary
ingredient (49).
Such claims must be backed by the manufacturer’s substantia-
tion that they are truthful and not misleading, and must be
accompanied by the following: “This statement has not been
evaluated by the Food and Drug Administration. This product
is not intended to diagnose, treat, cure, or prevent any disease”
(49). Concerns about the appropriate labeling of dietary supple-
ments will be further addressed by a new Commission on
Dietary Supplement Labels.
According to the Dietary Supplement Health and Education
Act, dietary supplements must have the identity and strength
represented on the label and meet appropriate specifications
for quality (including tablet or capsule disintegration), purity,
and composition. Voluntary standards for quality, purity, dis-
integration, and dissolution are in the US Pharmacopeia (51).
76 / JANUARY 1996 VOLUME 96 NUMBER 1
RECOMMENDATIONS AND APPLICATION
Eating a wide variety of foods is the best way to obtain essential
nutrients. The ADA recognizes the sincere interest of supple-
ment users in promoting good health and their desire to freely
choose their own supplement regimens. For those who choose
to use supplements, low levels of nutrients that do not exceed
the RDA are recommended. This is consistent with recommen-
dations of the American Medical Association (52), the Food
and Nutrition Board (10,46), and ADA’s previous joint state-
ment with the American Institute of Nutrition, the American
Society for Clinical Nutrition, and the National Council Against
Health Fraud (53).
ADA supports and encourages regular revisions and refine-
ment of the RDAs as new research expands nutrition knowl-
edge. Reducing chronic disease risk should be part of the
rationale for recommended intakes. ADA also encourages
private and public support of research into food and nutrient
intakes to support optimal health, including the role of dietary
supplements in achieving this goal.
ROLE AND RESPONSIBILITIES OF
DIETETICS PRACTITIONERS
In accordance with the medical philosophy “first do no harm,”
recommendations to take dietary supplements should be based
on well-accepted scientific evidence. Recommendations for
use of nutrient supplements by individuals should come from
physicians or registered dietitians applying current scientific
knowledge after individual dietary and nutrition assessment.
Registered dietitians should evaluate clients’ dietary supple-
mentation practices, and provide counseling to prevent exces-
sive intakes or adverse interactions with medical treatment.
Health professionals should report harmful effects of dietary
supplements to FDA’s Adverse Reaction Monitoring System.
Public education efforts should focus on the importance of
eating a varied diet following scientifically based dietary guide-
lines. Dietetics professionals are uniquely qualified to educate
and counsel people to improve dietary selections and food
preparation for the promotion of good health.
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■ ADA Position adopted by the House of Delegates on October
29, 1995. This position is in effect until December 31, 1999. The
American Dietetic Association authorizes republication of this
position, in its entirety, provided full and proper credit is
given. Requests to use portions of the position must be di-
rected to ADA Headquarters at 800/877-1600, ext 4896.
■ Recognition is given to the following for their contributions:
Author:
Janet R. Hunt, PhD, RD
Reviewers:
Mary Carey, PhD, RD; Dietitians in General Clinical Practice
dietetic practice group; Janet L. Gregor, PhD; Robert A. Jacob,
PhD; Oncology Nutrition dietetic practice group; Sports, Car-
diovascular and Wellness Nutritionists dietetic practice group
(Susan Kleiner, PhD, RD; Debra Krummel, PhD, RD); Phyllis
Stumbo, PhD, RD
JOURNAL OF THE AMERICAN DIETETIC ASSOCIATION / 77