|
What you need to know first
If you are thinking about using dietary supplements such as
vitamins, herbs, or any product made from plants (botanicals) as part
of your cancer treatment, you will want to know more before you decide
what you want to do. This information is offered to help you learn more
about dietary supplements so you can make a more informed decision
about using them safely.
Risks and side effects
Like drugs, dietary supplements have risks and side effects.
They can usually be used safely within certain dosage guidelines. But,
unlike drugs, dietary supplements are mostly self-prescribed, with
little or no input from informed medical sources like doctors, nurses,
or pharmacists. There is a lot of wrong information out there. Even for
those who are well informed, it can be hard to find reliable
information about the safe use and potential risks of dietary
supplements.
As part of its function to monitor supplement safety, the U.S.
Food and Drug Administration (FDA) gathers reports of illness, injury,
or reactions from supplements. But before December 2007, supplement
makers were not required to report serious harmful effects to the FDA,
so most of these events were not reported. This means there is a large
gap in reports, but this should improve in the future.
Looking to other sources of information, exposures to
supplements (such as vitamins and herbs or botanicals) accounted for
nearly 26,000 calls to U.S. poison control centers in 2007 alone. Of
these calls, there were more than 600 moderate to severe outcomes, and
1 death. More than 1,500 of these cases were described as "adverse
reactions," and more than 3,000 were treated in health care facilities.
Since most people who suffer unexpected side effects, illnesses, or
drug interactions from dietary supplements do not call a poison control
center, this is likely to be a very low estimate of actual events.
Used properly, certain dietary supplements may reduce the risk
of some diseases, relieve or reduce discomfort caused by certain drugs
or conditions, or simply make you feel better (improve your quality of
life). But taking dietary supplements can be risky, especially for
people who are getting cancer treatment.
Special problems for people getting cancer
treatment
There are several ways that supplements can cause problems for
people during cancer treatment. For example, some dietary supplements
can cause skin sensitivity and severe reactions when taken during
radiation treatment. Patients who are having radiation treatments
should talk to their doctors before taking any supplement. And,
patients receiving chemotherapy may be at higher risk for drug
interactions if they take dietary supplements. Cancer experts often
recommend that these patients avoid dietary supplements altogether
until their cancer treatment is over. But if you decide to take
supplements anyway, be sure to let your doctor know exactly what you
are taking.
Dietary supplement advertising and promotion
Keep in mind that a great deal of what you hear or read about
dietary supplements is based on anecdotal
evidence -- that is, evidence based on people's (even doctors')
personal experiences or opinions rather than objective, controlled
scientific studies.
Be skeptical of sources that make grand claims based on a few
people's testimonials or vague references to "scientific proof." The
rule "if it sounds too good to be true, it probably is" usually applies
to such claims. Remember also that the makers and sellers of
supplements have a financial interest in promoting their products. Look
for evidence or research on the supplement from objective, third-party
sources. See our information Complementary and Alternative
Methods for Cancer Management to learn more. You
can read it on our Web site or call us for a copy.
Talking with your doctor
Regardless of your treatment, it is always safest to talk with
your doctor about the amount of each supplement you plan to take before
you start. If you have been taking supplements and want to continue to
do so, it is important that your doctor know this, too.
Many doctors are just starting to learn about the uses, risks,
and potential benefits of dietary supplements. In some cases, this can
cause problems between patient and doctor when it comes to using
supplements along with a mainstream treatment. This situation should
improve as more studies are done and better information becomes
available.
We encourage you to gather as much information as possible on
the dietary supplement you are thinking about. Then, approach your
doctor with the information you have, and ask for an open conversation.
Ask for his or her professional opinion as to whether the treatment is
safe and medically sound, and how it might be safely used along with
your cancer treatment. Remember to make sure that your doctor knows
about other medicines, vitamins, and supplements that you are already
taking.
Common misconceptions about dietary
supplements
Megadosing: The "More is better" myth
Many people wonder why dietary supplements like vitamins,
herbals, and botanicals are sold without a prescription from a doctor,
while medicines (or drugs) are more closely regulated and controlled.
People often make the mistake of assuming that because supplements are
sold over the counter, sometimes with little or no direction on the
label, they are completely safe to take, even in high doses. In the
1990s there was a trend of "megadosing" antioxidants such as vitamin C,
beta carotene, and vitamin E. Even though no scientific studies have
ever proven that large doses of vitamin C can prevent or cure colds,
many people still think this is true. You may have heard a number of
claims about the benefits of taking large doses of certain vitamins.
But the practice of using large doses of vitamins to fight disease in
humans is not supported by the available scientific evidence so far.
In fact, large doses of some vitamins or minerals can be
dangerous and toxic. For example, too much vitamin C can interfere with
the body's ability to absorb copper, a metal that is essential to our
body chemistry. Also, too much phosphorous can inhibit the body's
absorption of calcium. Large doses of vitamins A, D, and K are not
eliminated quickly by the body and can easily reach toxic levels when
too much is taken.
Talk with your doctor before taking large doses of any
vitamin, mineral, or other supplement. Your nurse or pharmacist may
also be able to give you more information on safe dosages. Even when
vitamin doses are not high enough to cause toxic effects, the overall
impact on health may be negative. For example, several large studies
found that, on average, people taking vitamin E supplements lived no
longer than those who didn't. Some even died sooner, particularly of
heart failure.
The "Natural is safe" and "Natural is
better" myths
In today's cultural climate, you will not find much support
for the idea that a man-made or refined substance is better or safer
than one sold in its unrefined, natural state. But supplements that
claim to be "all natural" are not always better or safer than refined
or manufactured substances. Keep in mind that some of the most toxic
substances in the world occur naturally. Poison mushrooms, for example,
are completely natural but not safe or helpful to humans. Many plants
in nature are toxic, even deadly, if taken internally.
Botanical supplements (such as garlic, ginger, ginkgo biloba,
echinacea, and others) are made of plant material, so many of them are
sold as "natural" products. But plants are made up of many chemicals.
Some of these chemicals can be helpful while others are poisonous or
can cause allergies in humans. Botanicals that market themselves as
"all natural" are not always the most helpful ones, since they are not
refined to remove potentially harmful chemicals.
Botanicals can contain any or all parts of the plant,
including roots, stems, flowers, leaves, pollen, and juices. Different
parts of plants can have very different effects on humans. For example,
dandelion root is a laxative (it causes bowel movements), while
dandelion leaves contain a diuretic (a chemical that increases
urination). If you decide to use a botanical supplement, make sure you
know what parts of the plant were put into it. If you are unsure,
contact the company and ask them how they make their supplement.
Remember, too, that safety and dose are related. The leaves or
roots of some plants can be safely consumed in small amounts as an
herb. But concentrated extracts sold as liquids or pills may contain
the plant's chemicals in far greater amounts and may not be safe.
The "It's been used for thousands of years,
so it must be good" myth
Knowing that a botanical has been used in folk or traditional
medicine for thousands of years is helpful, but is not convincing proof
of safety. If small amounts of a plant caused painful or
life-threatening side effects right away, its use is unlikely to have
persisted in folk medicine or traditional medical systems. But
traditional medical systems thousands or even hundreds of years ago did
not have the scientific methods to detect long-term side effects. So,
if a plant seemed useful over the short term but actually increased the
risk of chronic disease (like cancer, heart failure, or kidney failure)
after years of use, those side effects would not have been noticed.
It is also helpful to find out whether a plant is being used
now like it was in its traditional use. For example, tea prepared from
a certain plant might have been safely used in traditional Chinese
medicine to treat occasional bouts of asthma when given by an
experienced practitioner. On the other hand, daily use of much higher
doses taken in a concentrated form with no expert supervision might be
quite unsafe.
The "It can't hurt to take supplements with
my regular medicines" myth
Many people assume that dietary supplements are always safe to
take along with prescription drugs. This is not true. For example,
certain botanicals can block or speed up the body's absorption of some
prescription drugs, causing the person to have too much or too little
of the prescribed drug in their bloodstream. Most drug companies and
producers of herbal supplements do not do research on possible drug
interactions, so the risks of taking supplements with many drugs are
unknown.
Talk with your health care team about any supplements you are
taking or wish to take. Your doctor or pharmacist can tell you of any
known interactions with medicines you may be taking. Unfortunately,
there are always new drugs and supplements for which interactions have
not yet been studied. Talk with your doctor or pharmacist about the
chance of interactions if you are taking newer drugs or supplements.
FDA regulation of drugs versus dietary
supplements
All over-the-counter and prescription drugs are regulated in
the United States by the Food and Drug Administration (FDA). Because
dietary supplements (including all forms of botanicals and vitamins)
are not considered drugs, they are not
put through the same strict safety and effectiveness requirements that
other drugs are.
FDA regulation of drugs
In general, new drugs are considered by the FDA to be unsafe
until they are proven safe by clinical trials. And the FDA must approve
any new drug before it can be legally sold in the United States.
Clinical trials are tests done under well-controlled conditions on
human volunteers. These tests must be done even on drugs that are to be
sold over the counter (without a prescription). The FDA approval
process requires that the drug be proven in a series of several
clinical trials. These clinical trials must show "substantial evidence"
that the drug is both safe and effective for each of its intended uses.
Once the FDA approves the drug, it must be manufactured under
carefully monitored conditions and packaged with complete information
on the best dose, route, and schedule. The package information must
include a listing of known side effects, contraindications (special
conditions under which using the drug would cause too much risk), or
unsafe interactions with other drugs. Once the general public is using
a new drug, doctors are required to report to the FDA any ill effects
their patients may have. This data ensures that any side effects not
seen in the clinical trials will eventually be found and kept track of
for the safety of other people.
FDA regulation of dietary supplements
In 1994, the Dietary Supplement Health and Education Act
(DSHEA) defined dietary supplements as a category of food, which put
them under different regulations than drugs. They are considered safe
until proven otherwise. Under the DSHEA, dietary supplements cannot
contain any ingredients that may have "a significant or unreasonable
risk of illness or injury" when the supplement is used as directed on
the label, or under normal conditions of use if there are no directions
on the label. If a dietary supplement contains a new ingredient, the
manufacturer must provide the FDA with adequate proof that the
ingredient is safe before the supplement is marketed to the public.
But manufacturers are not required to test new ingredients or
supplements in clinical trials, which would help find risks and
potential interactions with drugs or other substances. The DSHEA gives
the FDA permission to stop a company from making a dietary supplement,
but only when the FDA proves that the product poses a significant risk
to the health of Americans. They are found unsafe only after they cause
harm. This approach is the reverse of the way over-the-counter and
prescription medicines are treated.
Because dietary supplements are usually self-prescribed, there
is no controlled system for reporting bad reactions and side effects.
If a supplement has unknown side effects or interactions with other
drugs, foods, or supplements, they are not likely to be discovered as
quickly as those of new drugs on the market.
What kinds of problems have there been with
supplements and herbs?
Since they became widely available in 1994, the FDA has found
problems with some dietary supplements. Products such as herbs were
sometimes tainted with germs, pesticides, or toxic heavy metals. Others
did not contain what was listed on the label at all. Still others
contained more or less than the amount claimed on the label. Vitamin
supplements, for example, were sometimes found to contain much less
than the stated amounts on the labels. Some "herbal" supplements have
been found to contain prescription drugs that were not listed on their
labels. These kinds of problems can cause serious health issues for the
person who takes the supplement.
Manufacturing guidelines for dietary
supplements
It is generally the manufacturer's responsibility to see that
the supplements they make are standardized, quality products that meet
the specifications described on their label. Many manufacturers have
always followed careful, consistent production standards and market
only high-quality, correctly labeled supplements. But less honest
manufacturers, or those who are less careful, make supplements that
contain little or none of the products listed on the label. Some
supplements contain a larger dose than the label lists, possibly due to
poor quality controls. There have even been reported cases of toxic
products.
New guidelines are already in place for the production of most
dietary supplements, and will cover all supplement makers by 2010. As
part of these regulations, in 2007 the Department of Health and Human
Services put out a set of standards (called Good Manufacturing
Processes, or GMPs) for producing dietary supplements. After the 2007
standards go fully into effect (in 2010), it is likely that most
supplements will contain what the label says they do. But it's
important to know that, even since the new rules started going into
effect, there have been many times when supplements were tainted with
real drugs or dangerous substances.
How will the new FDA rules affect herbs and
supplements?
The 2007 FDA rules require that dietary supplements follow
standards called Good Manufacturing Practices, or GMPs. This means that
dietary supplements must:
- be produced in a quality manner
- not contain any contaminants or impurities
- be labeled with the actual ingredients in the product
The companies will still sell their products in much the same
manner as before. But if companies are following the new rules, the
supplements will be more likely to contain what is listed on the label.
The new rules address the quality of manufacturing processes for
dietary supplements and the accurate listing of their ingredients on
the label. It is important to know what the new rules do not do:
- The new rules do not limit consumers' access to dietary
supplements.
- The rules do not address the safety of the supplements'
ingredients.
- The rules do not address the supplements' effects on health
as long as proper manufacturing techniques are used.
Even so, the improvements in quality and label accuracy will
make supplements less likely to cause harm as long as these rules are
followed. These rules went into effect for large supplement makers in
June of 2008, and mid-sized companies in 2009. They go into effect for
the smaller supplement makers in June of 2010.
It is important to remember that, like all laws, the new
regulations will not stop dishonest or criminal sellers from selling
supplements that are falsely labeled. It will be up to the FDA and
other law enforcement groups to try and stop criminal manufacturers
once they have been discovered. As quickly as some of these groups have
been surfacing, that may be hard to do. See our document Complementary and Alternative
Methods for Cancer Management for more
information on quackery and fraud.
New rules on dietary supplements help in
some ways, but not others
Though the law doesn't cover every supplement maker until
2010, the good news is that there are national standards in place that
require careful production and help ensure the quality of dietary
supplements.
On the other hand, there are concerns about what is not
changing under the new rules. For instance, there is no requirement
that herbs and other substances be tested to find out how they affect
the body, or how safe they are. And despite the rules, you still hear
about products that are sold as herbs or "all natural" compounds, but
are tainted with drugs or other harmful substances. So it falls to you,
the consumer, to gather truthful information about using these products
safely.
The USP standard
The U.S. Pharmacopeia (USP) is an independent organization
dedicated to quality control for the strength, quality, and purity of
pharmaceuticals. In 1997, the USP began publishing standards for
dietary supplements. These standards focus on the strength, quality,
purity, packaging, and labeling of dietary supplements and are updated
yearly. The USP also does product testing and site visits for companies
who join their program.
Makers of dietary supplements are not required by law to
follow USP standards, but many of them choose to do so anyway. The new
FDA rule may not be as stringent as the USP standards, so companies
that have used these standards before may continue to do so. You can
still look for products that use USP standards. The label may have the
initials USP after the name of the product, or contain a note that it
conforms to USP standards. Some companies have the initials "NF" for
National Formulary on their labels (The National Formulary is allied
with USP, and has standards that more specifically relate to herbs and
botanicals.) Some supplements even have both initials.
Reading dietary supplement labels
Before you buy a supplement, look at the label carefully. It
is easy to misread the claims that are being made about the product.
The manufacturers of dietary supplements are allowed to make 4 kinds of
claims, which are explained below, on the labels of their products:
- nutritional claims
- claims of well being
- health claims
- structure or function claims
Nutritional
claims: These are statements about the general effects
dietary supplements, vitamins, and minerals have on diseases known to
be caused by nutrient deficiency. For example, "vitamin C prevents
scurvy." These claims do not need to be approved by the FDA. But the
label must also state how many cases of the disease occur in the United
States. Consumers must weigh the risk of getting scurvy against the
potential risks of the supplement itself.
Claims of well
being: These are just that -- statements such as "makes
you feel better." These claims also do not require pre-approval by the
FDA. (See our document Complementary and Alternative
Methods for Cancer Management and Placebo Effect
for more information on these kinds of effects.)
Health claims:
These are statements about known health benefits of certain compounds.
For example, risk-reduction claims such as "folate may reduce the
chance of pregnant women delivering an infant with neural tube defects"
fall into this category. The FDA must pre-approve all health claims,
and requires that they be supported by evidence from scientific
studies. Remember that risk-reduction claims are not the same as
prevention claims.
Structure or function claims: These are the most hotly debated
and confusing to consumers. They are claims about the effect of the
dietary supplement on the structure or function of the body. The FDA
published a ruling in January 2000 that explained exactly what kinds of
structure or function claims would be acceptable for dietary
supplements. Dietary supplements may not make any claims regarding the
treatment of disease. But the following product descriptions are
acceptable as structure or function claims for dietary supplements:
- The product's mechanism of action ("works as an
antioxidant")
- The product's effects on cellular structure ("helps
membrane stability")
- The product's effects on the body's physiology ("promotes
normal urinary flow")
- The product's effects on chemical or lab test results
("supports normal blood glucose")
- Claims of maintenance ("helps maintain a healthy
circulatory system")
- Other non-disease claims ("helps you relax")
- Claims for common conditions and symptoms related to life
stages ("reduces irritability, bloating, and cramping associated with
premenstrual syndrome")
Structure or function claims are not reviewed by the FDA. In
fact, labels that carry them must also include the 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."
The FDA requires this disclaimer on supplement labels because
it is easy for consumers to misunderstand structure or function claims.
For example, many consumers believe that a statement such as "helps
maintain vision acuity" means the product has been proven to prevent
vision loss, or that a statement such as "helps maintain a healthy
prostate gland" means the product has been proven to prevent or remove
diseases like prostate cancer. Do not assume that because a product
claims to support or promote healthy body function that it prevents or
reduces the risk of any disease, including cancer. Products that are
proven to have a significant effect on any disease are considered drugs
by the FDA and are strictly regulated as such.
Guidelines for choosing dietary supplements
safely
- Investigate before you buy or use. There are many resources
in libraries and on the Internet. But much of this information comes
from the makers of the products, and can be biased or wrong. Look for
materials from reliable third parties, such as researchers or
government agencies. (See the "Additional Resources" section for some
places to start.)
- Check with your doctor or other health care provider before
you try a supplement. While your doctor might not know about all the
products available, he or she should hopefully prevent you from making
a dangerous mistake.
- If you are shopping for a botanical (herb or other plant
supplement), make sure to find a product that uses only the effective
part of the plant. Avoid botanicals that have been made using the
entire plant, unless the entire plant is recommended.
- Does the label provide a way to contact the company if you
have questions or concerns about their product? Reputable manufacturers
will give contact information on the label or packaging of their
products.
- Avoid products that claim to be "miracle cures,"
"breakthroughs," or "new discoveries," to have benefits but no side
effects, or to be based on a "secret ingredient" or method. Such claims
are almost always fraudulent, and the product may contain harmful
substances or contaminants.
- Try to avoid mixtures of many different supplements. The
more ingredients, the greater the chances of harmful effects. Mixtures
also make it harder to know which substance is causing any side
effects.
- Start only one product at a time. Notice any side effects
you have while taking the product. If you have a rash, sleeplessness,
restlessness, anxiety, nausea, vomiting, diarrhea, constipation, or
severe headache, stop talking the supplement. Report any reaction to
your doctor, and serious ones to the FDA. (See the next section, "How to
report serious adverse reactions.")
- During pregnancy or if you are breastfeeding, avoid any
dietary supplements not prescribed by a doctor. Few, if any, of these
products have been studied for safety, and their effects on a growing
fetus or infant are largely unknown.
- Do not take any self-prescribed remedy instead of the
medicine prescribed by your doctor without talking about it with your
doctor first.
- Do not depend on any non-prescription product to cure
cancer or any other serious disease. No matter what they claim, if it
sounds too good to be true, it probably is.
- Follow the dosage limits on the label. Overdoses can be
deadly. Do not take a dietary supplement for any longer than experts
recommend.
- Never give a supplement to a baby or a child under the age
of 18 without talking to the child's doctor. A child processes
nutrients and drugs differently from an adult, and the effects of many
products in children are not known.
- Avoid products that claim to treat a wide variety of
unrelated illnesses. If a supplement claims that it can diagnose,
treat, cure, or prevent disease, such as "cures cancer," the product is
being sold illegally as a drug.
How
to report serious adverse reactions
If you or someone in your family suffers serious harm or
illness as a result of supplement use, first call your doctor or other
health care provider. After you have been treated, you or your doctor
can report the adverse reaction to the FDA by calling 1-800-FDA-1088.
Or you can go to the FDA's MedWatch Web site at www.fda.gov/medwatch/report/consumer/consumer.htm.
The FDA considers an adverse event serious if it causes any of
these:
- death
- a life-threatening situation
- admission to a hospital or a longer-than-expected hospital
stay
- permanent disability
- a birth defect
- a requirement for medical or surgical care to prevent
permanent impairment or damage
When you talk to the FDA, you will need to tell them:
- the name and telephone number of the person who got sick or
had the problem; if that person cannot be reached, the FDA will need
the name and number of another person who can give more information if
needed
- a description of the problem and how it was addressed
- the name (including the brand or manufacturer) of the
product
Along with the above required information, you will be asked
about the age, weight, and sex of the person who had the problem. The
FDA staff will ask when and how much of the supplement was taken, and
for how long. They will want to know where and when the product was
purchased, lot number, and expiration date if available. This
information is generally not required, but if you can get it, it can
greatly help them follow up on the problem.
After you make a report to the FDA, you should notify the
manufacturer of the product (listed on the label) and the store,
seller, or Internet vendor where you bought the product.
Be aware
Know the ingredients in herbal medicines and dietary
supplements you take. To help protect consumers, the FDA recommends
that people using these products consider these suggestions:
- Look for supplements with the USP on the label. This
indicates that the manufacturer of the product followed standards set
by the US Pharmacopoeia in making the product.
- Realize that the use of the term "natural" on an herbal
product is no guarantee that the product is safe. Poisonous mushrooms,
for example, are natural but not safe.
- Take into account the name and reputation of the
manufacturer or distributor. Herbal products and other dietary
supplements made by nationally known food or drug manufacturers are
more likely to have been made under tight quality controls because
these companies have a reputation to uphold.
- If you need more information about the supplement, contact
the manufacturer. Ask about the company's manufacturing practices and
the quality-control conditions under which the product was made.
Additional Resources
More Information from Your American Cancer
Society
We have selected some related information that may also be
helpful to you. These materials may be ordered from our
toll-free number, 1-800-227-2345.
Along with the above, information on many different types of
complementary and alternative treatments are available at no cost to
you from the American Cancer Society. You can find them on our Web site
or request them from our toll-free number as noted above.
Book
The following book is available from the American Cancer
Society. Call us to ask about costs or to place your order.
National organizations and Web sites*
Along with the American Cancer Society, other sources of
information and support include:
National
Institutes of Health Office of Dietary Supplements
Telephone: 301-435-2920
Web site: http://ods.od.nih.gov
U.S. Food and
Drug Administration
Toll-free number: 1-888-INFO-FDA (1-888-463-6332)
Web site: www.fda.gov
U.S. Department
of Agriculture, Food and Nutrition Information Center
Toll-free number: 1-888-INFO-FDA (1-888-463-6332)
Web site: http://fnic.nal.usda.gov
Choose "Dietary Supplements" from the left menu bar
Center for Food
Safety and Applied Nutrition (CFSAN)
Toll-free number: 1-888-SAFEFOOD (1-888-723-3366)
Web site: www.cfsan.fda.gov
Memorial Sloan
Kettering Cancer Center
About Herbs and Botanicals
Web site: www.mskcc.org/mskcc/html/11570.cfm
MedWatch
Toll-free number: 1-800-FDA-1088 (1-800-332-1088)
Web site: www.fda.gov/medwatch
Choose "submit report" if you wish to report an adverse event
U.S.
Pharmacopeia (USP)
Toll-free number: 1-800-227-8772
Web site: www.usp.org
National Council
Against Health Fraud
Web site: www.ncahf.org
*Inclusion on
this list does not imply endorsement by the American Cancer Society.
No matter who you are, we can help. Contact us anytime, day or
night, for information and support. Call us at 1-800-227-2345 or
visit www.cancer.org.
References
Kurtzweil P. An FDA Guide to Dietary Supplements. FDA
Consumer; January 1999. Accessed at: www.cfsan.fda.gov/~dms/fdsupp.html
on May 29, 2009.
Bronstein AC, Spyker LR Jr, Green JL, et al. 2007 Annual
Report of the American Association of Poison Control Centers' National
Poison Data System (NPDS): 25th Annual Report.
Online Publication Date: 01 December 2008. Accessed at:
www.aapcc.org/DNN/Portals/0/NPDS%20reports/2008%20AAPCC%20Annual%20Report.pdf
on May 29, 2009.
Office of Dietary Supplements, National Institutes of Health.
Background Information. Accessed at:
http://dietary-supplements.info.nih.gov/Health_Information/Health_Information.aspx
on May 29, 2009.
U.S. Department of Health and Human Services, Office of the
Inspector General. Adverse Event Reporting For Dietary Supplements: An
Inadequate Safety Valve. April 2001. Accessed at:
http://oig.hhs.gov/oei/reports/oei-01-00-00180.pdf on May 29, 2009.
U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition. Dietary Supplement Current Good Manufacturing
Practices (CGMPs) and Interim Final Rule (IFR) Facts. June 22, 2007.
Accessed at: www.cfsan.fda.gov/~dms/dscgmps6.html on May 29, 2009.
U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition. Dietary Supplement Health and Education Act of 1994.
December 1, 1995. Accessed at: www.cfsan.fda.gov/~dms/dietsupp.html on
May 29, 2009.
U.S. Food and Drug Administration. Dietary Supplements.
Overview. Accessed at: www.cfsan.fda.gov/~dms/supplmnt.html on May 29,
2009.
U.S. Food and Drug Administration, FDA 101: Dietary
Supplements. Accessed at
www.fda.gov/consumer/updates/supplements080408.html on May 29, 2009.
Last Medical Review: 06/11/2009
Last Revised: 06/11/2009
|
