S C I E N T I F I C

S T A T U S

S U M M A R Y

Dietary Supplements:

Nutritional and
Legal Considerations

This Scientific Status

Summary addresses
the role of dietary

A PUBLICATION OF
THE INSTITUTE OF FOOD TECHNOLOGISTS
EXPERT PANEL ON FOOD SAFETY AND NUTRITION

supplement products
in normal health

he omnivorous diet of humans can

provide the diverse blend of nutrients

needed for growth, maintenance, and overall

health. For some people, however, food alone
may not supply adequate amounts of required
nutrients. Nutritional needs change with aging,

Historical Overview

pregnancy, and lactation and may be altered by

Until the mid-1990s, the most common dietary supplements were multivitamin/mineral
formulations containing varying percentages of
the Recommended Dietary Allowances (RDAs)
for those nutrients. Publicity surrounding claims
made by Nobel-laureate Linus Pauling in the
1970s, that megadosesof at least 10 times the
RDA of ascorbic acid could prevent or cure the
common cold, flu, and cancer (Herbert and Barrett, 1981), may have stimulated public interest in
the use of vitamin supplements to enhance health.
Although few of the claims made for supplements in popular books during the 1970s and
1980s were supported by rigorous scientific research, the mainstream scientific community
gradually became intrigued by the potential
health benefits of dietary supplements. This interest was fueled in part by studies demonstrating
that nutrient antioxidants, including vitamins C
and E and b-carotene, have a role in protecting
cells from oxidative free radical damage. Furthermore, epidemiological studies suggested that a
diet rich in fruits and vegetables and abundant in
antioxidants, nutrients, and other substances, reduced the risk of coronary heart disease and certain cancers.
By the mid 1990s, antioxidant became a
household word and antioxidant-fortified supplements and foods appeared on the market. Moreover, as some Americans increasingly became disenchanted with rising health care costs and the

acute and chronic diseases or other medical

MARY ELLEN
CAMIRE AND
MARK A. KANTOR
Author Camire is Associate Professor, Dept. of Food Science and
Human Nutrition, University of
Maine, 5736 Holmes Hall, Orono,
ME 04469-5736; author Kantor
is Associate Professor and Extension Specialist, Dept. of Nutrition
and Food Science, University of
Maryland, 3304 Marie Mount Hall,
College Park, MD 20742-7521

VOL. 53, NO. 7 JULY 1999

foodsand the role of these products in normal

health. The use of dietary supplements for persons
diagnosed with cancer, heart disease, HIV, and other chronic illnesses will not be extensively discussed, as these uses would likely fall under drug
regulations.

conditions.
During the twentieth century, progress has
been made in elucidating the biochemical structures and physiological roles of vitamins and other nutrients. Today, many nutrients can be produced abundantly and inexpensively through laboratory synthesis, microbial fermentation, or other processes. Thus, nutritional imbalances or other special needs for vitamins and minerals, if
properly recognized, can be treated with oral dietary supplements or with nutrient solutions administered through other routes if medically warranted.
Once confined mainly to health food stores
and pharmacies, dietary supplements now are
found in a much broader variety than before in
supermarkets and national discount chain stores
and are sold though mail order catalogues, television, and the Internet. Although some supplements such as prenatal vitamin/mineral blends require a prescription, most do not and are readily
available over-the-counter.
Because dietary supplements are regulated as a
special category of foods rather than drugs in the
United States, the Institute of Food Technologists is
well positioned to address this topic. This Scientific
Status Summary specifically addresses dietary supplementsnot medical foods nor functional

FOODTECHNOLOGY 87

S C I E N T I F I C

Dietary
Supplements
C O N T I N U E D
perceived impersonal nature of conventional Western medicine, there was a
dramatic rise in the popularity of various complementary and alternative
practices, including Chinese herbal medicine, Ayurvedic medicine (an Indian holistic medical system incorporating foods
and herbs), acupuncture, and homeopathy (Angell and Kassirer, 1998; Eisenberg
et al., 1998). During the early 1990s, the
U.S. Food and Drug Administration
(FDA) attempted to increase regulation
of herbal products and other dietary
supplements (Gilhooley, 1997), creating
concern among both consumers and
supplement manufacturers.

Regulatory And Safety Issues

A major change in how supplements
are regulated occurred when Congress
passed the Dietary Supplement Health
and Education Act (DSHEA) of 1994
(Public Law 103-417), which amended
the 1958 Food Additive Amendments to
the Federal Food Drug and Cosmetic
Act. DSHEA defines a dietary supplement as a product, other than tobacco,
intended to supplement the diet that
contains at least one or more of the following ingredients: a vitamin, a mineral,
an herb or other botanical, an amino
acid, or a dietary substance for use to
supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, or extract or combination of any of the previously mentioned ingredients.
Under the new and broader definition, dietary supplements often contain
ingredients not recognized as traditional
nutrients. Categories of dietary supplements and examples of materials within
each category are listed in Table 1. Prior
to DSHEA, the FDA could have challenged the use of non-nutrient ingredients as unapproved food additives.
DSHEA created the Office of Dietary
Supplements (ODS) within the National
Institutes of Health to promote and coordinate scientific studies of dietary supplements in relation to health. DSHEA
also mandated the formation of the
Commission on Dietary Supplement Labels, an independent panel of experts
that was appointed to study and make
88

FOODTECHNOLOGY

S T A T U S

S U M M A R Y

Examples of Dietary Ingredients Defined as Dietary Supplements

by the Dietary Supplement Health and Education Act of 1994 1

Table 1

Category

Examples

Vitamin

Vitamins A, D, E, C, B 6, B12, thiamin, riboflavin, niacin, folate, biotin,

pantothenic acid

Mineral

Calcium, iron, zinc, magnesium, manganese, selenium, copper,

chromium, iodine

Herb or other botanical

Garlic, gingko, chamomile, dandelion, milk thistle, capsicum,

valerian, yohimbe, guarana

Amino acid

Lysine, tryptophan, cysteine, isoleucine, methionine, valine

A dietary supplement
used to supplement
the diet by increasing
the total dietary intake

Fish oil, blue-green algae, bee pollen, bone meal, melatonin

Concentrates, metabolites,
constituents, or combinations
of any ingredient above

Allicin (from garlic), gingko ginsenosides, bilberry extract,

chamomile tea

U.S. Public Law 103-417

recommendations about regulating and

evaluating label claims and other statements for dietary supplements.
Supplements vs. drugs and food additives. How does a dietary supplement
differ from a drug, and how does a dietary ingredient in a supplement differ
from a food additive in a conventional
food? A drug is a product used to diagnose, cure, mitigate, treat, or prevent diseases, whereas a dietary supplement is
meant to supplement the diet by increasing the total dietary intake of a substance. A food additive is any substance
that is either intentionally added (direct
additive) to food to improve its shelf-life,
texture, nutrition, or other aspect of
quality, or that unintentionally contaminates (indirect additive) food, such as
packaging materials or machine residues.
Dietary ingredients in supplements are
exempt from the food additive regulations applicable to conventional foods.
The pre-market approval process for
direct food additives and drugs is lengthy
and expensive, requiring that manufacturers rigorously test the products safety
and effectiveness and requiring that this
evidence is reviewed by FDA before new
products are introduced into the marketplace. Drugs also must be tested for
efficacy, which is the desired measure of
a products effect on a disease condition.
Efficacy must be proven through adequate and well-controlled investigations,
including human trials, demonstrating
that the drug will have the effect claimed
on its labeling. Under DSHEA, however,
dietary supplement ingredients may be
sold without undergoing a formal FDAapproval process. Although the supplement manufacturer is not required to

provide rigorous scientific evidence of

safety or efficacy, the manufacturer
should be able to provide information to
support any labeling claims.
Safety of ingredients. DSHEA allows
manufacturers to use ingredients in dietary supplements that have been present
in the food supply or that have been
marketed as dietary supplement ingredients prior to 1994. A company wishing
to market a new dietary supplement ingredient (i.e., an ingredient not marketed
prior to October 15, 1994) must submit
to FDA a notification including information showing that the ingredient will
reasonably be expected to be safe. This
means that the substance does not
present a significant or unreasonable
risk of illness or injury to most individuals under the typical conditions of use
(FDA, 1997a). This notification must be
submitted 75 days prior to the expected
marketing date. FDA approval, however,
is not required before the product is
marketed. Although a manufacturer is
responsible for ensuring that its dietary
supplement products are safe, FDA bears
the burden of showing that a supplement is unsafe or mislabeled before it
can restrict or ban the products use.
Thus, it is FDAs role to address safety
problems that arise in the population
from the use of dietary supplements.
Hazardous product reports in the
marketplace. Since passage of DSHEA,
FDA has identified several problems and
manufacturers have conducted recalls to
remove potentially dangerous products
from the market. State and local governments may set more stringent laws and
regulations for the sale of dietary supplements and can prevent the sale of potenJULY 1999 VOL. 53, NO. 7

S C I E N T I F I C
tially harmful products within their jurisdictions. For example, in the aftermath of
a number of deaths attributed to supplements containing the herb ephedra (Ephedra sinica Stapf, FDA, 1997b), Florida, Texas and Ohio moved to limit sales of ephedra and its extracts.
Since 1993, a system has been in place
to report to FDA problems related to dietary supplements, infant formulas, and
medical foods. Report sources include
FDAs Medwatch program for healthcare
providers (1-800-FDA-1088), FDA field
offices (telephone blue pages), health
agencies, consumers, and health professionals. The FDA Special Nutritionals Adverse Event Monitoring System (SN/
AEMS) maintains a searchable database
available on the Internet (<http://vm.
cfsan.fda.gov/~dms/aems.html>) where
reports can be searched by several categories: product, ingredient, manufacturer, or
adverse event as reported. However, because these reports are volunteered, they
may not always be accurate.

Classification and Labeling

Dietary supplements are classified as
food products, but DSHEA stipulates that
such products must be labeled as dietary
supplements and be sold in the form of
pills, capsules, tablets, gelcaps, liquids,
powders, or other forms, and not be represented for use as conventional foods. Supplements also cannot be marketed as the
only item in a meal or diet.
As of March 1999, dietary supplement
packages must bear a Supplement Facts
panel, similar to the Nutrition Facts panel
mandated for food labels by the Nutrition
Labeling and Education Act (NLEA) of
1990. The purpose of this labeling is to provide information about nutrients and other
dietary ingredients. Figure 1 shows a typical
supplement facts panel (Kurtzweil, 1998).
The label must list all dietary ingredients
and the Daily Values (DV) of the amounts
contained in a serving. If no DV has been
established for a dietary ingredient, this
must be indicated.
If a blend of ingredients is proprietary,
the total quantity of ingredients per serving must be stated rather than the amount
of each individual ingredient in the blend.
If an ingredient is an herbal product, the
part of the plant (such as the root or leaf)
from which the ingredient is derived must
be identified. The common name of the
botanical as listed in Herbs of Commerce
(American Herbal Products Association,
Silver Spring, Md.) may be used; if a botanical is not listed in the book, the Latin
VOL. 53, NO. 7 JULY 1999

S T A T U S

Statement of
Identity

Net quantity of
contents

Structurefunction claim
Directions
Supplement
Facts panel

S U M M A R Y

Anatomy of the
New Requirements
for Dietary
Supplement Labels
(Effective March 1999)

GINSENG
A DIETARY SUPPLEMENT

60 CAPSULES

When you need to perform your best, take ginseng.

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.
DIRECTIONS FOR USE: Take one capsule daily.

Supplement Facts
Serving Size 1 Capsule
Amount Per Capsule

Other
ingredients
in descending
order of
predominance
and by
common name
or proprietary
blend.

Oriental Ginseng, powdered (root)

250 mcg*

*Daily Value not established.

Other ingredients: Gelatin, water, and glycerine.
ABC Company
Anywhere, MD 00001

Name and place of business of manufacturer,

packer or distributor. This is the address to
write for more product information.

Fig.1Dietary Supplement Label Format From Kurtzweil (1998)

binomial name (e.g., Echinacea augustifolia DC) must be used. The following
information also must appear on the
label: statement of identity, which identifies the contents of the product; net
quantity of contents; ingredient list (in
descending order by weight); and the
name and address of the manufacturer,
packer, or distributor (FDA, 1997c).
Health claims vs. nutritional support claims. Health claims are specifically defined under NLEA as statements that characterize the relationship
between a food substance and a specific
disease or health-related condition, and
which are based on significant scientific
agreement. Health claims on dietary
supplement labels must meet the same
criteria established under NLEA for
conventional food products (Commission on Dietary Supplement Labels,
1997). FDA-authorized health claims

include relationships between calcium

and osteoporosis, folate and neural tube
birth defects, soluble fiber and coronary
heart disease, and sugar alcohols and
dental caries. Other health claims are approved only for foods but not supplements (Commission on Dietary Supplement Labels, 1997; Storlie et al., 1998).
DSHEA permits four types of structure/function claims, formerly referred to
as nutritional support statements, to appear on supplement labels (Table 2).
Structure/function claims can be distinguished from the more rigorous health
claims in that they are not permitted to
state or imply a link between a supplement and the treatment, diagnosis, cure
or prevention of a disease. DSHEA requires manufacturers of a dietary supplement bearing a structure/function label
claim to notify FDA of the claim no later
than 30 days after first marketing the

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Dietary
Supplements
C O N T I N U E D
product (FDA, 1997d) and to substantiate
that the claim is truthful and not misleading. Structure/function claims must be
accompanied by the following disclaimer:
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.
In November 1998, the Federal Trade
Commission (FTC, 1998) issued for the
industry an advertising guide on dietary
supplements that clarified truthful claims
with respect to advertising. The guide
states that dietary supplement manufacturers must back up explicit claims and
implied benefits made for their products
and that: FDA has primary responsibility
for claims on product labeling, including
packaging, inserts, and other promotional
materials distributed at the point of sale.
The FTC has primary responsibility for
claims in advertising, including print and
broadcast ads, infomercials, catalogs, and
similar direct marketing materials. Marketing on the Internet is subject to regulation in the same fashion as promotions
through any other media.
The functions, benefits, and safety of
dietary supplements are discussed below,
by supplement category.

Vitamins
Functions. Vitamins are essential organic compounds that perform numerous and diverse metabolic functions, often serving as enzymatic cofactors. With
some exceptions, vitamins or their precursors must be obtained from food or
supplements. The main exceptions are
vitamin D, a hormone-like vitamin that
can be synthesized in the skin upon exposure to sunlight and other forms of ul-

S T A T U S

traviolet radiation, and therefore is not

absolutely required in the diet, and vitamin K which can be synthesized by intestinal microflora. Some vitamins have
multiple chemical forms or isomers that
vary in biological activity. For example,
four forms of tocopherol occur in food,
with a-tocopherol having the greatest vitamin E activity. Numerous carotenoids
occur in nature and in food, but only a
handful have vitamin A activity. Some
carotenoids, such as lycopene, do not
possess vitamin A activity but, nonetheless, have important health benefits.
The popular literature has emphasized that natural vitamins are superior to
synthetic ones, even though the active ingredient is often chemically identical in
both forms. However, added folic acid in
dietary supplements or fortified foods is
better absorbed than naturally occurring
folate in foods. Pregnant women administered synthetic folic acid (pteroylglutamic
acid) had higher serum folate levels than
women given the natural conjugated form
of the vitamin (Neuhouser et al., 1998).
Benefits. The mechanisms by which
vitamins prevent illnesses are not well
understood, and the amounts needed to
lower risks for certain disease conditions
may be higher than the current recommended levels for preventing nutritional
deficiencies. For example, the Institute of
Medicine (IOM, 1998a) recommends
that to prevent neural tube birth defects,
women of child-bearing age should consume 400 g of folic acid per day (but
not more than 1,000 g/day) from fortified foods and/or dietary supplements in
addition to folate obtained from a varied
diet. Ascorbic acid intakes of 80-200 mg
daily (8 - 20 times the amounts needed
to prevent scurvy) may be necessary to
enhance certain physiological functions
and minimize specific disease risks (Weber et al., 1996).
Certain vitamins act as antioxidants,
protecting cells from free radical-induced
damage. The minerals selenium and man-

Table 2 Permissible Statements of Nutritional Support for Dietary

Supplements1
A benefit related to a classical nutrient deficiency, including a statement of the prevalence of such
deficiencies in the United States
A description of the role of a nutrient or dietary ingredient intended to affect the structure or function in
humans
A documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or
function
General well-being from consumption of a nutrient or dietary ingredient
1

Dietary Supplement Health and Education Act of 1994 (Public Law 103-417)

90

FOODTECHNOLOGY

S U M M A R Y
ganese, required constituents of glutathione peroxidase and superoxide dismutase, respectively, also may serve as antioxidants. Products labeled high in antioxidants or having similar content claims
must contain at least 20% of the Reference Daily Intake (RDI) of ascorbic acid,
a-tocopherol, or b-carotene, per reference amount customarily consumed
(FDA, 1997e). However, the actual
amounts of antioxidants that confer protection are not known and probably vary
among individuals, since persons exposed
to increased oxidative stress may have elevated antioxidant requirements (Block,
1992; Halliwell, 1997). Moreover, ascorbic acid, a-tocopherol and b-carotene interact and complement each other. Similarly, polyphenolic compounds also protect these vitamins by supporting their
antioxidant functions (Jacob, 1995).
Safety. Foods typically contain safe
levels of vitamins, but dietary supplements that contain high levels of vitamins could be hazardous. Therefore, in
formulating supplements, manufacturers
should keep the per serving amounts
well below levels known to result in adverse effects. The Institute of Medicine
(IOM)/Food and Nutrition Board (FNB)
is establishing tolerable upper intake levels (UL) for nutrients (IOM, 1998a, b).
The UL is the maximum level of daily
nutrient intake that is unlikely to pose
adverse health risks to almost all of the
individuals in the group for whom it is
designed. Although excess water-soluble
vitamins are usually excreted in urine,
thus minimizing toxicity, adverse symptoms from consuming high doses of water-soluble nutrient supplements have
been reported, including diarrhea from
vitamin C (Levine et al., 1995) and peripheral neuropathy from vitamin B6
(Snodgrass, 1992).
The RDA for niacin, a vitamin that is
also used as a drug to lower blood cholesterol levels, is 16 mg for adult men (IOM,
1998a), a level that maintains normal metabolism and prevents the deficiency disease pellagra. The UL for niacin is 35 mg/
day (IOM, 1998a). The pharmacological
dose to reduce serum lipids is close to 3 g
of nicotinic acid per day, an amount virtually impossible to obtain from food.
Physicians who prescribe nicotinic acid
must carefully monitor a patients response and adjust the dose accordingly, to
minimize unpleasant and potentially hazardous side effects such as skin flushing,
pruritis, hyperglycemia, duodenal ulcers,
and liver toxicities.
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S T A T U S

Table 3 Potential Adverse Effects of Dietary Supplements

Dietary Supplements

Potential Adverse Effects1

Omega-3 fatty acids

(fish and flaxseed oils)

Increased need for vitamin E to counteract free

radicals and lipid oxidation

Ascorbic acid

Excessive iron absorption leading to

hemachromatosis

b-carotene

Cancer

Folic acid

Masking of vitamin B12 deficiency, possibly causing

nervous system damage

Iron

Fatalities in small children; inhibited absorption of

other minerals; hemachromatosis

Arnica/wolfs bane (Arnica montana L.),

bee pollen, chamomile (Matricaria recutita L.,
Chamaemelum nobile L.), psyllium, chitosan

Allergic response, including dermatitis and hives

Cascara sagrada (Rhamnus purshiana DC),

castor oil (Ricinus communis L.), senna
(Cassia senna L. ), other cathartics

Diarrhea and dehydration

Chaparral (Larrea tridentata (DC) cov.), comfrey Liver damage

(Symphytum sp.), pau darco (Tabebuia sp.).
Blue-green algae

Gastrointestinal disturbances, especially vomiting

and diarrhea

From FDA Special Nutritionals Adverse Event Monitoring System; Albanes et al. (1996)

Fat-soluble vitamins are more readily

stored in the body than water-soluble
ones, and therefore have the potential to
be more dangerous. Vitamins E and K
are considered relatively non-toxic; acute
or chronic over-consumption of vitamins A and D, however, is hazardous. Vitamin A can cause spontaneous abortions and birth defects, especially at levels above 20,000 IU/day (NRC, 1989). A
high vitamin D intake can cause hypercalcemia, leading to the deposition of
calcium in soft tissues and serious damage to the heart and kidneys. Other potential adverse effects of vitamins are
shown in Table 3. Vitamins and other dietary supplements also may interact with
prescription medications (Table 4), although relatively little is known about
such interactions.

Minerals
Functions. There are at least 21 essential mineral elements, inorganic compounds that are involved in such metabolic processes as muscle contraction,
transmission of nerve impulses, maintenance of water and acid-base balance,
and catalysis of numerous other biological reactions. Iron is an essential constituent of hemoglobin. Copper, magnesium, and zinc are co-factors for a variety of enzymes. As previously mentioned, manganese and selenium can
function as antioxidants and contribute
to endothelial integrity.
Calcium and phosphorus are major
VOL. 53, NO. 7 JULY 1999

components of bone. A dietary deficiency of calcium is associated with osteoporosis. For many individuals, calcium supplementation may be a more realistic option for obtaining the adult Adequate Intake (AI) of 1,000-1,200 mg
calcium/day than relying upon calciumrich foods. Calcium supplements reduced bone turnover during weight loss
(Ricci et al., 1998) and maintained calcium absorption and bone density in winter when sunlight exposure, necessary for
vitamin D activation, is diminished
(Storm et al., 1998). Although calcium
supplementation helps prevent loss of
bone density, its effect is weaker than
treatment with estrogen, calcitonin, or

S U M M A R Y
bisphosphonates, a reflection of the
complex etiology of osteoporosis (Riggs
et al., 1998).
Trivalent chromium is a cofactor for
insulin and thus plays an important role
in glucose metabolism, although there
are no convincing data suggesting that
chromium supplements are useful for
preventing or treating diabetes. In recent
years, chromium picolinate has been
promoted in the popular literature as an
aid for losing weight and increasing
strength and lean tissue, but there is no
convincing evidence to support these
claims. Although chromium picolinate
supplements in conjunction with an exercise program reduced total cholesterol,
LDL-cholesterol, and insulin levels in a
group of young adult males compared to
exercise alone, the subjects in this study
showed no differences in strength or lean
body mass (Boyd et al., 1998), and supplementation alone was not evaluated.
Safety. It is unlikely for one to consume toxic levels of minerals just from
food, although selenium toxicity has
been reported in China and other areas
where high concentrations of selenium
exist in soil and accumulate in plants.
The human intestine has limited capacity to absorb mineral cations, thus the excessive consumption of one mineral can
lead to impaired absorption of others.
For example, a high iron intake inhibits
the absorption of zinc, while an excessive
intake of zinc hinders copper absorption.
Iron deficiency anemia remains a
global public health problem typically
associated with poverty and is more
common in women and children. However, iron also acts as a pro-oxidant inducing free radical damage, and an ex-

Table 4 Potential Drug-Dietary Supplement Interactions

Drugs

Dietary Supplements

Potential Adverse Effects

Thiazide diuretics

Bearberry or uva ursi

(Arctostaphylos uva-ursi L.),
senna (Cassia senna L.)

Hypokalemia, dehydration

Laxatives

Cascara, dietary fiber

Diarrhea, dehydration, abdominal distress,

nutrient malabsorption

Anticonvulsants

Folic acid

Impaired levels of anticonvulsive

Anticoagulants

Vitamins E and K, feverfew

Excessive bleeding
(Tanacetum parthenium L.),
garlic (Allium sativum L.),
ginger (Zingiber officinale
Roscoe), gingko (Gingko biloba L.)

Methotrexate
(anticancer agent)

Folate

Tumor growth

Monoamine oxidase
inhibitors

Ephedra (Ephedra sinica Stapf.)

Liver damage, high blood pressure

Adapted from Lamy (1994), Leung and Foster (1996)

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Dietary
Supplements
C O N T I N U E D
cessive iron intake may promote lipid
oxidation, damaging mitochondria and
DNA. Furthermore, a substantial proportion of the population has genetic
traits for hemachromatosis and tends to
accumulate toxic levels of iron in the liver (Bothwell, 1995; Lynch, 1995). Cellbased theories on how iron overload
promotes hepatic, cardiac, and pancreatic disease have been reviewed by Britton
et al. (1994). Opposition to widespread
iron fortification of foods to prevent
anemia in women and children may reduce the number of iron fortified products available, creating a need for these
sensitive populations to rely on supplements. Men and post-menopausal women have lower iron needs and thus do not
require iron supplementation in most
cases. FDA requires child-resistant closures on prenatal iron supplements to
prevent accidental poisoning of young
children, for whom the lethal dose is
about 3 g (NRC, 1989).
Commercial calcium supplements,
notably dolomite and bonemeal, may be
contaminated with lead at levels exceeding FDA tolerable daily intake limits
(Bourgoin et al., 1993). However, mineral, as well as most vitamin supplements
are generally manufactured according to
United States Pharmacopeia (USP)
guidelines prohibiting such contamination. The USP is a nongovernmental,
voluntary organization that establishes
guidelines for vitamin and mineral supplement strength, purity, and quality.

Amino Acids

S T A T U S

ergy source, and high intakes may be injurious to persons with impaired kidney
function. The excessive consumption of
protein or amino acids may lower calcium stores by increasing the excretion of
urinary calcium, which is needed to
buffer the excreted protein waste. Although there is no clear association between high protein intake and the risk
for osteoporosis, susceptible individuals
should refrain from consuming a highprotein diet or taking amino acid supplements (NRC, 1989).
Supplements of L-tryptophan, a precursor of the brain neurotransmitter serotonin, became popular as a natural
sleep aid in the late 1980s. However, a
large 1989 epidemic of eosinophilia-myalgia syndrome (EMS), a rare and sometimes fatal systemic illness characterized
by elevations of certain white blood cells
and severe muscle pain, was associated
with the use of tryptophan supplements.
Therefore, FDA requested that manufacturers recall supplements containing
synthetic tryptophan (Glickstein et al.,
1990; Kamb et al., 1992). It is not clear if
the adverse effects were due to the amino
acid, a contaminant, or to their interaction. A contaminating dimer of tryptophan was found in supplements produced by one manufacturer that supplied most of the tryptophan used in the
United States, so most of the EMS cases
were related to this source. However, this
contaminant may not be the sole cause
of EMS (Roufs, 1992). Furthermore, cases of EMS possibly related to mixtures of
amino acids have been reported since the
original outbreak, which involved supplements containing only L-tryptophan.
The finding in 1998 of impurities in
some dietary supplement products containing 5-hydroxy-L-tryptophan, which
is synthesized from L-tryptophan in the
body, suggests that continued caution
may be warranted with the use of tryptophan supplements (FDA, 1998).

Functions. A balanced diet provides

the nine essential amino acids that humans cannot synthesize; hence, protein
deficiency is rare in the United States. AlBotanicals
though solutions of free amino acids
Functions. This category of dietary
may be appropriate for total parenteral
supplements is controversial because
nutrition of critically ill patients, there is
many botanical supplement ingredients
no evidence that amino acid suppleare not derived from plants normally
Pathogen
toxin for
Food
ments are beneficial Temperature
for healthy persons.Time toused
food, and safety and efficacy ofC
F
formation (h)
Safety. Unlike vitamins and minerals,
ten have not been established with ranthere are no Dietary Reference Intakes
domized, placebo-controlled clinical ex(DRIs), dietary reference values for the
periments. Plant products and their exintake of nutrients and food compotracts are sources of traditional nutrients
nents by Americans and Canadians, for
as well as biologically-active non-nutrient
amino acids. Excess amino acids must be
phytochemicals. For example, the large
deaminated before being used as an enfamily of phenolic compounds, which in92

FOODTECHNOLOGY

S U M M A R Y
cludes anthocyanins and other flavonoids,
function as antioxidants and thus may
protect cells from free radical damage.
The concentration and distribution
of phytochemicals in medicinal vascular
plants varies in the roots, stems, leaves,
flowers, and fruits, and also fluctuates
during the growth cycle or season. Moreover, plants or related species similar in
appearance may have vastly different
chemical compositions. For example, the
composition of ginseng grown in Korea
(Panax ginseng C.A. Mey) is different
from that of the native American plant
(Panax quinquefolius L.). This may create
difficulties in formulating botanical supplements with consistent ingredients and
potencies and presents challenges for inexperienced plant collectors.
Conventional medical journals have
begun to publish more controlled clinical studies using botanicals. A review of
18 randomized controlled trials concluded that saw palmetto (Serenoa repens
[Bartr.] Small) extracts improve male
urological symptoms with less likelihood
of adverse events compared with the prescription drug finasteride, but the authors cautioned that long-term effectiveness against benign prostatic hyperplasia
had not been documented (Wilt et al.,
1998). Although Chinese herbal medicine improved the symptoms of patients
with irritable bowel syndrome compared
with those given placebos, only those patients who had received individualized
herb therapy maintained improvement
14 weeks after cessation of therapy (Bensoussan et al., 1998). A special article, reviewing 12 popular herbs, was published
in the Archives of Family Medicine to increase physician awareness of the history,
safety and efficacy of these products
(OHara et al., 1998).
The five most popular botanicals in
the United States are listed in Table 5.
These materials are sold singly and in
combination with other dietary supplement ingredients. These herbs are also
added to some products such as juices
and water. Tyler (1993) considers these
particular botanicals to be safe and effective in healthy individuals.
Safety. Many botanical supplements
are consumed with no adverse effects, yet
some products with known hazards are
present in the marketplace (Tables 3 and
4). The most serious problems have resulted from ingesting the herb ephedra (Ephedra sp.), also known as ma huang. Ephedrine and related alkaloids in this product
are potent central nervous system stimuJULY 1999 VOL. 53, NO. 7

S C I E N T I F I C

S T A T U S

clude phytoestrogens and other compounds that mimic mammalian hormones. Melatonin supplements, that contain the synthetic form of a hormone produced by the brains pineal gland, have
been promoted to aid sleep, counter jet
lag, and slow aging, but there are concerns
about potential side effects (Grafias,
1996).
Dehydroepiandrosterone (DHEA) is
an anabolic steroid that is promoted for
enhancing physical strength and immunity, which diminish during aging. The
International Olympic Committee considers DHEA an illegal steroid and has
banned its use. A recent analysis of sixteen commercial DHEA products revealed that only half the products contained the actual amount of DHEA stated on the product label, with actual levels varying between 0-150% of the label
content (Parasrampuria et al., 1998). A
variety of adverse side effects has been
associated with DHEA and reported to
the FDA SN/AEMS. Another steroidal
hormone, androstenedione, became
popular in 1998 amid publicity that it
was used by baseball slugger Mark McGwire (Schrof, 1998). However, a recent
study indicated that oral supplements of
androstenedione did not enhance muscle
strength in men and was associated with
adverse effects including a reduction of
serum HDL-cholesterol and an elevation
of serum estradiol levels (King et al.,
1999).
Oral creatine supplementation is popular among athletes, but many studies
have failed to show an ergogenic benefit.
Furthermore, numerous side effects including renal abnormalities have been reported for creatine (Pritchard and Kaira,
1998), and there is growing concern
about potential longterm adverse effects
on various organ systems (Juhn, 1999).

lants. Dietary supplements containing

ephedra are promoted for increasing energy and aiding in weight loss, but may be
accompanied by such adverse effects as
anxiety, heart attack, stroke, and seizures,
sometimes resulting in death. A number of
deaths caused by cardiac arrest have been
attributed to ephedra. FDA has proposed
to limit the ephedrine alkaloid content in
supplements to 8 mg per serving, with a
limit of 3 servings/day, and to prohibit the
incorporation of other stimulants such as
caffeine or yohimbine (an alkaloid in Pausinystalia yohimba Pierre) that can augment
the effects of alkaloids (FDA, 1997b).
Herbal teas are popular among consumers trying to avoid caffeine, but
herbal tea supplements may contain
guarana (Paullinia cupana H.B.K.), mat
(Ilex paraguariensis St. Hil.), or cola nut
(Cola nitida Schott & Endl.), ingredients
that are rich sources of caffeine. Since
caffeine disclosure is not required for dietary supplements, consumers who take
certain herbal supplements may inadvertantly be exposed to undesirable or high
levels of caffeine. Commercial herbal tea
products may also contain potentially
dangerous compounds such as hepatotoxic pyrrolizidine alkaloids and various
tannins, allergens, and psychoactive
compounds (Manteiga et al., 1997).

Other Dietary Supplement

Products
Hormones are not typically considered to be part of the diet, yet hormonal
products represent an important segment
of the dietary supplement market. Hormone supplements are promoted for
maintaining or restoring physiological
levels of hormones that decline with aging. Some preparations contain meat animal by-products such as ovaries, uteri,
and testes. Plant-derived ingredients in-

Table 5 Most Popular Herbs in the U. S. and Their Purported Benefits

Herb

1997 Sales
($million)

Common name

Latin name

Echinacea - alone
or in blends with
goldenseal

Echinacea purpurea L. and

other Echinacea species,
Hydrastis canadensis L.

260

Enhance immunity

Gingko

Gingko biloba L.

250

Improve circulation, particularly

to the brain

Ginseng

Panax ginseng C.A. Mey (Asian)

Panax quinquefolius L. (American)

230

Increase energy, resistance to

stress (adaptogenic)

Garlic

Allium sativum L.

210

Reduce atherosclerosis and high

blood pressure

St. Johns wort

Hypericum perforatum L.

200

Relieve mild depression

From Anonymous (1998)

VOL. 53, NO. 7 JULY 1999

Purported Benefit/Action

S U M M A R Y
Recently, FDA issued warnings for
products chemically related to g-butyrolactone (GBL) and g-hydroxybutyric acid
(GHB), which are marketed as sleep aids.
GBL and GHB have been associated with
at least three deaths and more than 100 adverse reactions, including coma and
breathing difficulty (FDA, 1999). Some of
the products contain 1,4 butanediol, which
is converted to GHB when ingested.

Occurrence of Nutritional
Deficiencies in the United States
Classical nutritional deficiency diseases, caused by inadequate intakes of
specific vitamins and minerals, are rare
in the United States today. Scurvy, caused
by a vitamin C deficiency, now occurs
mainly in infants who are exclusively fed
cows milk or among elderly individuals
habitually consuming severely restricted
diets. Beriberi, caused by a thiamin deficiency, is seen mostly in alcoholics who
have an increased requirement and often
an inadequate intake of thiamin. Rickets
declined after milk began to be routinely
fortified with vitamin D about sixty
years ago, replacing cod liver oil as the
chief source of this vitamin for children.
Although seldom seen today, rickets may
occur if the conversion of vitamin D to
its biologically active form is impaired
due to kidney failure or other diseases.
Similarly, pellagra, which was a widespread problem in the southern United
States during the early part of the twentieth century, has virtually disappeared as
both niacin and tryptophanwhich can
be converted to niacinare prevalent in
the American diet.
Public health measures such as the
fortification of breads and cereals with
iron and some B vitamins, the widespread use of iodized salt, and the fortification of milk with vitamin D have
markedly reduced the incidence of deficiency diseases that were once common.
Furthermore, the year-round availability
of fruits and vegetables, and the diversity
and affordability of the food supply in
general, have helped eliminate nutrient
deficiencies. Today, nutrition-related diseases in the United States are typically
chronic in nature and are more likely associated with an excessive intake of fats,
sweets, and calories from all sources,
rather than from dietary inadequacies.
Certain segments of the population,
however, are susceptible to nutritional
deficiencies because of elevated requirements arising from medical or environmental conditions or inborn errors of

FOODTECHNOLOGY 93

S C I E N T I F I C

Dietary
Supplements
C O N T I N U E D
metabolism (NRC, 1989). For example, a
thiamin deficiency may exist in renal patients undergoing chronic dialysis or in
patients on long term intravenous feeding. Smokers may require more vitamin
C than nonsmokers to counteract the increased metabolic turnover of the vitamin associated with smoking. A vitamin
E deficiency is sometimes seen in premature, low birth weight babies, or in individuals with abnormal fat absorption.
Persons with other malabsorption conditions such as atrophic gastritis, or
those suffering from cancer or other serious illnesses, also may have increased requirements for certain nutrients. A dietary deficiency of vitamin B12 is rare,
even among vegans, and more than 95%
of vitamin B12 deficiencies in the United
States are due to inadequate absorption
of this nutrient.
It is more common for Americans to
report consuming dietary intakes that fall
below the RDA for certain nutrients than
to exhibit overt deficiency symptoms. According to the U.S. Department of Agricultures (USDA) 1994-96 Continuing Survey
of Food Intakes by Individuals (CSFII), the
nutrients most likely to be consumed below RDA levels were iron, calcium, zinc,
and magnesium, and women were more
likely than men to fall short of the recommendations. For example, females 12-19
years of age had the lowest calcium intake
of any age/sex group, meeting only 64% of
the RDA for calcium, while women greater
than 20 years of age consumed 77% of the
RDA. On the other hand, men 20-69 years
of age consumed at least 99% of the RDA
for calcium.
Failure to meet the RDA intakes does
not necessarily mean that an individual
is not meeting nutrient requirements,
since RDAs represent population averages with margins of safety that account
for presumed variability in requirements
among individuals. Also, dietary intake
data do not correlate precisely with disease risk. For example, although about
10 million Americans have osteoporosis,
it is not possible to attribute the disease
solely to a lack of dietary calcium, since
genetic predisposition, gender, estrogen,
vitamin D intake, and lifestyle factors
such as amount of physical activity and
94

FOODTECHNOLOGY

S T A T U S

exposure to sunlight also are risk factors

(NIH, 1998).
When are nutrient supplements warranted for the general population? Many
health professionals advise the routine
use of calcium and/or vitamin D supplements to help prevent osteoporosis, especially for high-risk or elderly individuals. Iron is routinely given during pregnancy, and folic acid is recommended for
all women of child-bearing age. Recent
studies suggest that dietary supplements
of folic acid, vitamin B6, and vitamin B12
may have broad public health benefits, as
these nutrients are associated with lowering blood homocysteine levels, which
may reduce the risk of coronary heart
disease (Welch and Loscalzo, 1998).
There is concern among some professionals that the American population is
consuming an imbalance of polyunsaturated fatty acids, with the ratio of omega-6 to omega-3 fatty acids being larger
than optimal. Since few commonly consumed foods are good sources of omega3 fatty acids, supplements may be more
widely recommended in the future.
Using relative risk estimates, Bendich
et. al. (1997) estimated that almost $20
billion in hospital expenses might be
avoided if women of child-bearing age
took folic acid and multivitamins with
zinc daily, and if older adults consumed
vitamin E supplements daily. The Council for Responsible Nutrition (Washington, D.C.), a dietary supplement trade
association, recently summarized the
benefits of supplement use for protecting
against diseases or conditions such as osteoporosis, heart disease, some birth defects, infectious disease in the elderly,
cataracts and macular degeneration, and
some cancers and reducing health care
costs (Dickinson, 1998).

Supplement Use
Data from nutritional surveys. National nutrition surveys have focused on
the use of traditional vitamin and mineral supplements. About 25% of 11,643
adults who took part in the 1992 National Health Interview Survey took supplements every day (Slesinski et al., 1996).
Individuals taking vitamins had significantly lower fat diets, with more fiber
and vitamins (calcium for women), suggesting that supplement users have generally healthy lifestyles. Users of dietary
supplements tend to be female, collegeeducated, and have incomes over
$50,000 (Eisenberg et al., 1998). In one
survey, elderly Georgia residents who

S U M M A R Y
used dietary supplements were more
likely to be physically active, and to have
more arthritis or stomach problems than
their non-user neighbors (Houston et al.,
1997). Calcium, vitamin E, and vitamin
C were the most popular supplements
used within this group, and the researchers concluded that supplement use was
part of a cluster of health behaviors
practiced by this group.
Of more than 2,000 Americans questioned in a recent telephone survey of alternative medical practices, 12.1% reported using herbal products and 5.5% reported using megavitamins (Eisenberg et
al.,1998). Herbs were identified as one of
the most commonly used treatments for
allergies, insomnia, and digestive disorders; vitamins were used for high blood
pressure, but other uses were not explored
in the study. These products were not fully reimbursable by insurance companies.
Concurrent use of herbal products and/or
high doses of vitamins was reported by almost 1/5 of the 44% of persons taking
prescription medications.
In February 1999, National Public
Radio, Kaiser Family Foundation, and
Harvard University Kennedy School of
Government conducted a telephone survey of 1200 American adults, of whom
412 reported using supplements regularly or sometimes. Although 55% of the
individuals surveyed were very or somewhat familiar with supplements other
than vitamins or minerals, only 33% reported using these products regularly or
sometimes (Table 6). Supplement users
were more likely to believe that taking
supplements is beneficial and that these
products are safe. Regular supplement
users were not different from non-users
in their attitudes about government regulation of dietary supplements.
Dietary supplement industry sales
data. Consumers spent an estimated $6.5
billion in 1996, double the expenditures
in 1990-91 (Kurtzweil, 1998). The U.S.
dietary supplement market was $12.8
billion in 1997, with sales projected to
continue to increase, especially through
Internet marketing (Anonymous, 1998).
Vitamins still dominate the U.S. dietary
supplement market, accounting for nearly half the sales in 1997 (Figure 2), followed by herbs and botanicals. These
sales figures do not include over-thecounter medications that provide calcium or other minerals.

Conclusion
Although nearly half of the adults in
JULY 1999 VOL. 53, NO. 7

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S T A T U S

Table 6 1999 National Public Radio, Kaiser Family Foundation, Harvard Kennedy

School of Government Survey on Americans and Dietary Supplements1

Familiarity with herbal products, amino acids,
over-the-counter hormone pills and others

Percent of
persons surveyed

Very familiar

16%

Somewhat familiar

39

Not too familiar

22

Not at all familiar

22

Dont know/refused to answer

How often do you use these kinds of supplements?

Percent of
persons surveyed

Regularly

18

Sometimes

15

Hardly ever

16

Never

50

Dont know/refused to answer

N = 1200. The survey was conducted by telephone in February, 1999. From NPR (1999)

the United States regularly consume dietary supplements, relatively little data
exist on the physiological effects of many
available products. Future nutrition surveys must carefully document the extent

Vitamins 40.7%
Other 13.0%
rition
s nut
Sport
9.3%

Minerals 9.3%

Herbs 27.8%

Fig. 21997 U.S. Nutrition Industry

Dietary Supplement Product Categories.
Adapted from Anonymous (1998)

of supplement use, which will be a challenge given the large number of products
now available. Because the nature of dietary supplements available in the marketplace is diverse, it is difficult to provide general recommendations regarding
use. Fortunately, the growing popularity
of dietary supplements should spur additional, much-needed research on optimal dosages, interactions with drugs and
food components, and the relationships
between supplements on health maintenance and chronic disease prevention in
persons of different genders and ages.
The creation of the International
Bibliographic Information on Dietary
Supplements (IBIDS) database (<http://
VOL. 53, NO. 7 JULY 1999

odp.od.nih.gov/ods/databases/ibids.
html>), a joint project of the ODS and
the USDA Food and Nutrition Information Center, early in 1999 should provide
scientists and the public with easier access to publications on supplements. A
forthcoming report on the value of vitamin and mineral supplements for improving the nutritional status of low income Americans is expected to be issued
late in 1999 by the USDA and the Life
Sciences Research Office of the American
Society for Nutritional Sciences (Bethesda, Md.).
The passage of DSHEA has created
an economic and regulatory environment favorable to the expanded marketing, sales, and distribution of dietary
supplements. Opportunities for consumers to purchase dietary supplements in a
free market economy are vastly increased, but expectations remain that
government agencies provide protection
from unsafe or mislabeled products. One
of the future challenges with respect to
dietary supplements will be to reconcile
these apparently opposing forces. Furthermore, better education of consumers
would aid their critical evaluation of advertising and label claims and enable
them to reach informed decisions regarding which, if any, dietary supplements to take.

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Expert Panel on Food Safety and Nutrition in Food Technology. Scientific Status Summaries, which
are not necessarily written by the Expert Panel, are rigorously peer-reviewed by the Expert Panel
as well as by individuals outside the panel who have specific expertise in the subject. IFTs Expert
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timely production of Scientific Status Summaries, comprises academicians representing expertise in one or more areas of food science/technology and nutrition.
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JULY 1999 VOL. 53, NO. 7