What's in the Bottle? An Introduction to Dietary
Supplements
Introduction
Dietary supplements are a topic of great public
interest. Whether you are in a store, using the Internet, or
talking to people you know, you may hear about supplements and
claims of benefits for health. How do you find out whether
"what's in the bottle" is safe to take and whether science has
proven that the product does what it claims? This fact sheet
provides some answers.
1. What are dietary supplements?
Dietary supplements (also called nutritional
supplements, or supplements for short) were defined in a
law passed by Congress in 1994 (see the box below).
Contain a "dietary ingredient" intended
to supplement the diet. Examples of dietary
ingredients include vitamins, minerals,
herbs* (as single
herbs or mixtures), other
botanicals,
amino acids, and
dietary substances such as
enzymes and
glandulars.
Come in different forms, such as
tablets, capsules, softgels, gelcaps,
liquids, and powders.
Are not represented for use as a
conventional food or as a sole item of a
meal or the diet.
Are labeled as being a dietary
supplement.
Dietary supplements are sold in grocery, health food,
drug, and discount stores, as well as through mail-order
catalogs, TV programs, the Internet, and direct sales.
People take supplements for many reasons. A
scientific study on this topic was published in 2002.3
In it, over 2,500 Americans reported on supplements they
used (given the categories of vitamins/minerals and
herbal products/natural supplements) and for what
reasons. Their responses are summarized in the table
below.
3. Is using supplements considered conventional
medicine or complementary and alternative medicine
(CAM)?
Some uses of dietary supplements have become part of
conventional medicine (see box below).
For example, scientists have found that the vitamin
folic acid prevents certain birth defects, and a regimen
of vitamins and zinc can slow the progression of the eye
disease age-related macular degeneration.
On the other hand, some supplements are considered to
be complementary and alternative medicine (CAM)--either
the supplement itself or one or more of its uses. An
example of a CAM supplement would be an herbal
formula that claims to relieve arthritis pain, but has
not been proven to do so through scientific studies. An
example of a CAM use of a supplement would be
taking 1,000 milligrams of vitamin C per day to prevent
or treat a cold, as the use of large amounts of vitamin
C for these purposes has not been proven.
Conventional Medicine
Conventional medicine is medicine as
practiced by holders of M.D. (medical doctor) or
D.O. (doctor of osteopathy) degrees and by their
allied health professionals, such as nurses,
physical therapists, and dietitians. Other terms
for conventional medicine include allopathy;
Western, mainstream, orthodox, and regular
medicine; and biomedicine.
Complementary and
Alternative Medicine (CAM)
Health care practices and products that are
not presently considered to be part of
conventional medicine are called CAM.
Complementary medicine is used together
with conventional medicine. Alternative
medicine is used in place of conventional
medicine. There is scientific evidence for the
effectiveness of some CAM treatments. But for
most, there are key questions yet to be answered
through well-designed scientific studies, such
as whether they are safe and work for the
diseases or conditions for which they are used.
The National Center for Complementary and
Alternative Medicine (NCCAM), part of the
National Institutes of Health (NIH), is the
Federal Government's lead agency for scientific
research on CAM.
4. How can I get science-based information on a
supplement?
There are several ways to get information on
supplements that is based on the results of rigorous
scientific testing, rather than on
testimonials and other
unscientific information.
Ask your health care provider. Even if your
provider does not happen to know about a particular
supplement, he can access the latest medical
guidance about its uses and risks.
Dietitians and pharmacists also have helpful
information.
You can find out yourself whether there are any
scientific research findings on the CAM supplement
you are interested in. NCCAM and other Federal
agencies have free publications, clearinghouses, and
databases with this information.
5. If I am interested in using a supplement as
CAM, how can I do so most safely?
Here are some points to keep in mind:
It is important to talk to your health care
provider (or providers, if you have more than one)
about the supplement. This is for your safety and a
complete treatment plan. It is especially
important to talk to your provider if you:
Are thinking about replacing your regular
medical care with one or more supplements.
Are taking any medications (whether
prescription or over-the-counter). Some
supplements have been found to interact with
medications (see box below).
Have a chronic medical condition.
Are planning to have surgery. Certain
supplements may increase the risk of bleeding or
affect anesthetics and painkillers.
Are pregnant or nursing a baby.
Are thinking about giving a child a
supplement. Many products being marketed for
children have not been tested for their safety
and effectiveness in children.
Do not take a higher dose of a supplement than
what is listed on the label, unless your health care
provider advises you to do so.
If you experience any side effects that concern
you, stop taking the supplement, and contact your
provider. You can also report your experience to the
U.S. Food and Drug Administration's (FDA) MedWatch
program, which tracks consumer safety reports on
supplements.
If you are considering or using herbal
supplements, there are some special safety issues to
consider. See the NCCAM fact sheet "Herbal
Supplements: Consider Safety, Too."
Supplements and Drugs Can
Interact
For example:
St. John's wort can increase the effects
of prescription drugs used to treat
depression. It
can also interfere with drugs used to treat
HIV infection, to treat cancer, for birth
control, or to prevent the body from
rejecting transplanted organs.
Ginseng can increase the stimulant
effects of caffeine (as in coffee, tea, and
cola). It can also lower blood sugar levels,
creating the possibility of problems when
used with diabetes drugs.
Ginkgo, taken with anticoagulant or
antiplatelet drugs, can increase the risk of
bleeding. It is also possible that ginkgo
might interact with certain psychiatric
drugs and with certain drugs that affect
blood sugar levels.
6. I see the word "natural" on a lot of supplement
labels. Does "natural" always mean "safe"?
There are many supplements, as well as many
prescription drugs, that come from natural sources and
are both useful and safe. However, "natural" does not
always mean "safe" or "without harmful effects." For
example, consider mushrooms that grow in the wild--some
are safe to eat, while others are poisonous.
The FDA issues warnings about supplements that pose
risks to consumers, including those used for CAM
therapies. A sample list is in the box below. The FDA
found these products of concern because they:
Could damage health--in some cases severely.
Were contaminated--with other unlabeled herbs,
pesticides, heavy metals, or
prescription drugs.
Interacted dangerously with prescription drugs.
Examples of Supplements
That Have Carried FDA Cautions About Safety
Ephedra
GHB (gamma hydroxybutyric acid), GBL
(gamma butyrolactone), and BD
(1,4-butanediol)
Kava
Some "dieter's teas"
L-tryptophan
Certain products, marketed for
sexual enhancement and claimed to be
"natural" versions of the drug Viagra,®
which were found to contain an unlabeled
drug (sildenafil or tadalafil).
PC SPES and SPES
Aristolochic acid
Comfrey
St. John's wort
7. Does the Federal Government
regulate supplements?
Yes, the Federal Government regulates supplements
through the FDA. Currently, the FDA regulates
supplements as foods rather than drugs. In general, the
laws about putting foods (including supplements) on the
market and keeping them on the market are less strict
than the laws for drugs. Specifically:
Research studies in people to prove a
supplement's safety are not required before
the supplement is marketed, unlike for drugs.
The manufacturer does not have to prove that the
supplement is effective, unlike for drugs.
The manufacturer can say that the product
addresses a nutrient deficiency, supports health, or
reduces the risk of developing a health problem, if
that is true. If the manufacturer does make a claim,
it must be followed by the statement "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."
The manufacturer does not have to prove
supplement quality. Specifically:
The FDA does not analyze the content of
dietary supplements.
At this time, supplement manufacturers must
meet the requirements of the FDA's Good
Manufacturing Practices (GMPs) for foods. GMPs
describe conditions under which products must be
prepared, packed, and stored. Food GMPs do not
always cover all issues of supplement quality.
Some manufacturers voluntarily follow the FDA's
GMPs for drugs, which are stricter.
Some manufacturers use the term
"standardized" to describe efforts to make their
products consistent. However, U.S. law does not
define standardization. Therefore, the use of
this term (or similar terms such as "verified"
or "certified") does not guarantee product
quality or consistency.
If the FDA finds a supplement to be unsafe once
it is on the market, only then can it take action
against the manufacturer and/or distributor, such as
by issuing a warning or requiring the product to be
removed from the marketplace.
In March 2003, the FDA published new proposed
guidelines for supplements that would require
manufacturers to avoid contaminating their products with
other herbs, pesticides, heavy metals, or prescription
drugs. The guidelines would also require supplement
labels to be accurate. These new guidelines could take
effect as early as 2004.
The Federal Government also regulates supplement
advertising, through the Federal Trade Commission. It
requires that all information about supplements be
truthful and not mislead consumers.
What's in the Bottle Does
Not Always Match What's on the Label
A supplement might:
Not contain the correct
ingredient (plant species). For example, one
study that analyzed 59 preparations of
echinacea found that about half did not
contain the species listed on the label.
Contain higher or lower amounts of the
active ingredient. For example, an NCCAM-funded
study of ginseng products found that most
contained less than half the amount of
ginseng listed on their labels.
Be contaminated
8. Is NCCAM supporting research on supplements?
Yes, NCCAM is funding most of the nation's current
research aimed at increasing scientific knowledge about
supplements--including whether they work; if so, how
they work; and how purer and more standardized products
could be developed. Among the substances that
researchers are studying are:
Yeast-fermented rice, to see if it can lower
cholesterol levels in the blood
Soy, to see if it slows the growth of tumors
Ginger and turmeric, to see if they can reduce
inflammation associated with arthritis and asthma
Chromium, to better understand its biological
effects and impact upon insulin in the body,
possibly offering new pathways to treating type 2
diabetes
Green tea, to find out if it can prevent heart
disease
NCCAM is also sponsoring or cosponsoring
clinical trials on
supplements, including:
Glucosamine hydrochloride and chondroitin
sulfate, to find out if they relieve knee pain from
osteoarthritis
Black cohosh, to see if it reduces hot flashes
and other symptoms of menopause
Echinacea, to see if it shortens the length or
lessens the severity of colds in children
Garlic, to find out if it can lower moderately
high cholesterol levels
Ginkgo biloba, to determine whether it
prevents or delays decline in cognitive (thinking)
function in people aged 85 or older
Ginger, to confirm whether it eases nausea and
vomiting after cancer chemotherapy
For More Information
NCCAM Clearinghouse
Toll-free in the U.S.: 1-888-644-6226
International: 301-519-3153
TTY (for deaf or hard-of-hearing callers):
1-866-464-3615
The FDA monitors--and regulates for safety--foods,
medicines, medical devices, cosmetics, and
radiation-emitting consumer products.
Center for Food Safety and Applied
Nutrition (CFSAN)
Web site:
www.cfsan.fda.gov
Toll-free in the U.S.: 1-888-723-3366
CFSAN oversees the safety and labeling of
supplements, foods, and cosmetics. Publications
include "Tips for the Savvy Supplement User:
Making Informed Decisions and Evaluating
Information."
NCCAM has provided this
material for your information. It is not
intended to substitute for the medical expertise
and advice of your primary health care provider.
We encourage you to discuss any decisions about
treatment or care with your health care
provider. The mention of any product, service,
or therapy in this information is not an
endorsement by NCCAM.
Health Disclaimer: The content on this site is for
reference purposes and is not intended to substitute for advice given by
a specialist or other licensed health-care professional. Actual product
packaging & materials may contain more and/or different information than
that shown on this website.
Chronic fatigue syndrome, or CFS, is a complex disorder characterized by
weakness and a profound fatigue that is not improved by bed rest. The
illness can be worsened by physical or mental activity. People with CFS
most often function at a much lower level of activity than they were
able to before the illness began. In addition to these features,
patients report various nonspecific symptoms, including weakness, muscle
pain, impaired memory and/or mental concentration, insomnia, and fatigue
lasting more than 24 hours after exertion.
In some cases, CFS can persist for years. The cause of CFS has not been
identified and no specific diagnostic tests are available. Moreover,
since many illnesses have extreme fatigue as a symptom, care must be
taken to rule out other known and often treatable conditions before a
diagnosis of CFS is made.
Definition of CFS
There has been much debate about how best to define CFS. In general, in
order to receive a diagnosis of chronic fatigue syndrome, a patient must
satisfy two criteria:
1.
Have
severe chronic fatigue of six months or longer, with other known medical
conditions ruled out by clinical diagnosis, and
2.
Have
four or more of the following symptoms at the same time: significant
trouble with short-term memory or concentration, sore throat, tender
lymph nodes, muscle pain, pain in several joints without swelling or
redness, headaches of a new type, pattern or severity, unrefreshing
sleep, and malaise (symptoms such as discomfort, weakness, or nausea)
lasting more than 24 hours after activity.
The symptoms must have continued or recurred during six or more months
of illness in a row and must not have started before the fatigue.
Other Commonly Observed Symptoms in CFS
In addition to the primary defining symptoms of CFS, a number of other
symptoms have been reported by some CFS patients. The frequencies of
occurrence of these symptoms vary from 20% to 50% among CFS patients.
They include abdominal pain, alcohol intolerance, bloating, chest pain,
chronic cough, diarrhea, dizziness, dry eyes or mouth, earaches,
irregular heartbeat, jaw pain, morning stiffness, nausea, night sweats,
psychological problems (depression, irritability, anxiety, panic
attacks), shortness of breath, skin sensations, tingling sensations, and
weight loss.
Clinical Course of CFS
It is vital to understand the clinical course of CFS. This knowledge is
required to simplify communication between physicians and patients, to
evaluate possible new treatments, and to address insurance and
disability issues. The clinical course of CFS varies considerably among
persons who have the disorder; the actual percentage of patients who
recover is unknown, and even the definition of what should be considered
recovery is subject to debate.
Some patients recover to the point that they can resume work and other
activities, but continue to experience various or periodic CFS symptoms.
Some patients recover completely with time, and some grow progressively
worse. CFS often follows a cyclical course, alternating between periods
of illness and relative well being. Recovery is defined by the patient
and may not reflect complete symptom-free recovery. The Centers for
Disease Control and Prevention (CDC) continues to monitor patients
enrolled in a four-city surveillance study conducted by the CDC from
1989 to 1993.
About 50% of those patients reported "recovery," and most recovered
within the first 5 years after the illness began. No characteristics
were identified that made one patient more likely to recover than
another. At the start of the illness, the most commonly reported CFS
symptoms were sore throat, fever, muscle pain, and muscle weakness. As
the illness progressed, muscle pain and forgetfulness increased and the
reporting of depression decreased.
Other Conditions Can Cause Fatigue
There are many clinically defined, frequently treatable illnesses that
can result in fatigue. These include hypothyroidism, sleep apnea and
narcolepsy, major depressive disorders, chronic mononucleosis, bipolar
affective disorders, schizophrenia, eating disorders, cancer, autoimmune
disease, most hormonal disorders, subacute infections, obesity, alcohol
or substance abuse, and reactions to prescribed medications. Diagnosis
of any of these conditions would rule out a diagnosis of CFS, unless
this other condition has already been treated and no longer explains the
fatigue and other symptoms.
Similar Medical Conditions
In addition to illnesses that cause fatigue, a number of other
conditions have been described that have a group of symptoms to CFS.
Although these illnesses might have a primary symptom other than
fatigue, chronic fatigue is commonly associated with all of them. These
include fibromyalgia syndrome, myalgic encephalomyelitis, neurasthenia,
multiple chemical sensitivities, and chronic mononucleosis.
Treatment of Chronic Fatigue Syndrome
A variety of therapeutic approaches have been described as helping
patients with chronic fatigue syndrome. Since no cause for CFS has been
identified, treatment programs are directed at relief of symptoms, with
the goal of the patient regaining some level the function and well-being
they had before becoming ill.
Decisions about treatment for CFS or any chronically fatiguing illness
should only be made with the help of a health care provider. Currently,
most health care providers with experience in treating persons with CFS
use some combination of:
Physical
activities: light exercise, stretching, or yoga; or therapies such
as massage or acupuncture
Education:
learning how to adjust activities and behaviors that could make the
illness worse
Medications:
Pharmacologic therapy is directed toward the relief of specific
symptoms experienced by the individual patient. The usual treatment
strategy is to begin with very low doses and to gradually increase
dosage as necessary and as tolerated. These might include drugs to
ease pain, reduce fatigue, relieve depression, improve sleep, and
treat anxiety.
Although many experimental drugs and treatments have been promoted for
improvement of CFS symptoms, in fact none have been proven to be
effective. Some are useless and others can be dangerous. They should be
avoided until research has validated their claims.
In addition, a variety of dietary supplements and herbal preparations
are claimed to have potential benefits for CFS patients. With few
exceptions, the effectiveness of these remedies for treating CFS has not
been evaluated in controlled trials. Contrary to common belief, the
"natural" origin of a product does not ensure safety. Dietary
supplements and herbal preparations can have potentially serious side
effects and some can interfere or interact with prescription
medications. CFS patients should seek the advice of their health care
provider before using any unprescribed remedy.
Researchers continue to work on the complex issues of chronic fatigue
syndrome and its treatment, with the hope of one day finding out how it
is caused and how to treat or even cure this complicated and difficult
illness.