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FDA, as well as health professionals and their organizations, receive
many inquiries each year from consumers seeking health-related
information, especially about dietary supplements. Clearly, people
choosing to supplement their diets with herbals, vitamins, minerals, or
other substances want to know more about the products they choose so that
they can make informed decisions about them. The choice to use a dietary
supplement can be a wise decision that provides health benefits. However,
under certain circumstances, these products may be unnecessary for good
health or they may even create unexpected risks.
Given the abundance and conflicting nature of information now available
about dietary supplements, you may need help to sort the reliable
information from the questionable. Below are tips and resources that we
hope will help you be a savvy dietary supplement user. The principles
underlying these tips are similar to those principles a savvy consumer
would use for any product.
-
Do I need to think about my total diet?
Yes. Dietary supplements are intended to supplement the diets of
some people, but not to replace the balance of the variety of foods
important to a healthy diet. While you need enough nutrients, too much
of some nutrients can cause problems. You can find information on the
functions and potential benefits of vitamins and minerals, as well as
upper safe limits for nutrients at the National Academy of Sciences Web
site at:
http://www.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports
.
- Should I check with my doctor or healthcare
provider before using a supplement?
This is a good idea,
especially for certain population groups. Dietary supplements may not be
risk-free under certain circumstances. If you are pregnant, nursing a
baby, or have a chronic medical condition, such as, diabetes,
hypertension or heart disease, be sure to consult your doctor or
pharmacist before purchasing or taking any supplement. While vitamin and
mineral supplements are widely used and generally considered safe for
children, you may wish to check with your doctor or pharmacist before
giving these or any other dietary supplements to your child. If you plan
to use a dietary supplement in place of drugs or in combination with any
drug, tell your health care provider first. Many supplements contain
active ingredients that have strong biological effects and their safety
is not always assured in all users. If you have certain health
conditions and take these products, you may be placing yourself at risk.
- Some supplements may interact with prescription and
over-the-counter medicines.
Taking a combination of supplements
or using these products together with medications (whether
prescription or OTC drugs) could under certain circumstances produce
adverse effects, some of which could be life-threatening. Be alert to
advisories about these products, whether taken alone or in
combination. For example: Coumadin (a prescription medicine), ginkgo
biloba (an herbal supplement), aspirin (an OTC drug) and vitamin E (a
vitamin supplement) can each thin the blood, and taking any of these
products together can increase the potential for internal bleeding.
Combining St. John's Wort with certain HIV drugs significantly reduces
their effectiveness. St. John's Wort may also reduce the effectiveness
of prescription drugs for heart disease, depression, seizures, certain
cancers or oral contraceptives.
- Some supplements can have unwanted effects during surgery:
It is important to fully inform your doctor about the
vitamins, minerals, herbals or any other supplements you are taking,
especially before elective surgery. You may be asked to stop taking
these products at least 2-3 weeks ahead of the procedure to avoid
potentially dangerous supplement/drug interactions -- such as changes
in heart rate, blood pressure and increased bleeding - that could
adversely affect the outcome of your surgery.
- Adverse effects from the use of dietary supplements should be
reported to MedWatch:
You, your health care provider, or
anyone may report a serious adverse event or illness directly to FDA
if you believe it is related to the use of any dietary supplement
product, by calling FDA at 1-800-FDA-1088, by fax at 1-800-FDA-0178 or
reporting on-line at:
http://www.fda.gov/medwatch/how.htm.
FDA would like to know whenever you think a product caused you a
serious problem, even if you are not sure that the product was the
cause, and even if you do not visit a doctor or clinic. In addition to
communicating with FDA on-line or by phone, you may use the MedWatch
form available from the FDA Web site.
- Who is responsible for ensuring the safety and
efficacy of dietary supplements?
Under the law,
manufacturers of dietary supplements are responsible for making sure
their products are safe before they go to market. They are also
responsible for determining that the claims on their labels are accurate
and truthful. Dietary supplement products are not reviewed by the
government before they are marketed, but FDA has the responsibility to
take action against any unsafe dietary supplement product that reaches
the market. If FDA can prove that claims on marketed dietary supplement
products are false and misleading, the agency may take action also
against products with such claims.
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Tips on Searching the Web for Information on
Dietary Supplements |
When searching on the Web, try using directory sites of
respected organizations, rather than doing blind searches with a search
engine. Ask yourself the following questions:
- Who operates the site?
Is the
site run by the government, a university, or a reputable medical or
health-related association (e.g., American Medical Association, American
Diabetes Association, American Heart Association, National Institutes of
Health, National Academies of Science, or U.S. Food and Drug
Administration)? Is the information written or reviewed by qualified
health professionals, experts in the field, academia, government or the
medical community?
- What is the purpose of the
site?
Is the purpose of the site to objectively educate
the public or just to sell a product? Be aware of practitioners or
organizations whose main interest is in marketing products, either
directly or through sites with which they are linked. Commercial sites
should clearly distinguish scientific information from advertisements.
Most nonprofit and government sites contain no advertising; and access
to the site and materials offered are usually free.
- What is the source of the information and does
it have any references?
Has the study been reviewed by
recognized scientific experts and published in reputable peer-reviewed
scientific journals, like the New England Journal of Medicine? Does the
information say "some studies show…" or does it state where the study is
listed so that you can check the authenticity of the references? For
example, can the study be found in the National Library of Medicine's
database of literature citations (PubMed link -
http://www.ncbi.nlm.nih.gov/PubMed/
)
- Is the information
current?
Check the date when the material was posted or
updated. Often new research or other findings are not reflected in old
material, e.g., side effects or interactions with other products or new
evidence that might have changed earlier thinking. Ideally, health and
medical sites should be updated frequently.
- How reliable is the Internet or e-mail
solicitations?
While the Internet is a rich source of
health information, it is also an easy vehicle for spreading myths,
hoaxes and rumors about alleged news, studies, products or findings. To
avoid falling prey to such hoaxes, be skeptical and watch out for overly
emphatic language with UPPERCASE LETTERS and lots of exclamation
points!!!! Beware of such phrases such as: "This is not a hoax" or "Send
this to everyone you know."
- Ask yourself: Does it sound too good to be
true?
Do the claims for the product seem exaggerated or
unrealistic? Are there simplistic conclusions being drawn from a complex
study to sell a product? While the Web can be a valuable source of
accurate, reliable information, it also has a wealth of misinformation
that may not be obvious. Learn to distinguish hype from evidence-based
science. Nonsensical lingo can sound very convincing. Also, be skeptical
about anecdotal information from persons who have no formal training in
nutrition or botanicals, or from personal testimonials (e.g. from store
employees, friends, or online chat rooms and message boards) about
incredible benefits or results obtained from using a product. Question
these people on their training and knowledge in nutrition or medicine.
- Think twice about chasing the latest
headline.
Sound health advice is generally based on a
body of research, not a single study. Be wary of results claiming a
"quick fix" that depart from previous research and scientific beliefs.
Keep in mind science does not proceed by dramatic breakthroughs, but by
taking many small steps, slowly building towards a consensus.
Furthermore, news stories, about the latest scientific study, especially
those on TV or radio, are often too brief to include important details
that may apply to you or allow you to make an informed decision.
- Check your assumptions about the
following:
- #1 Questionable Assumption –
"Even if a product may not help
me, it at least won't hurt me." It's best not to assume that this
will always be true. When consumed in high enough amounts, for a long
enough time, or in combination with certain other substances, all
chemicals can be toxic, including nutrients, plant components, and
other biologically active ingredients.
- #2 Questionable Assumption –
"When I see the term 'natural,'
it means that a product is healthful and safe." Consumers can be
misled if they assume this term assures wholesomeness, or that these
food-like substances necessarily have milder effects, which makes them
safer to use than drugs. The term "natural" on labels is not well
defined and is sometimes used ambiguously to imply unsubstantiated
benefits or safety. For example, many weight-loss products claim to be
"natural" or "herbal" but this doesn't necessarily make them safe.
Their ingredients may interact with drugs or may be dangerous for
people with certain medical conditions.
- #3 Questionable Assumption –
" A product is safe when there
is no cautionary information on the product label." Dietary
supplement manufacturers may not necessarily include warnings about
potential adverse effects on the labels of their products. If
consumers want to know about the safety of a specific dietary
supplement, they should contact the manufacturer of that brand
directly. It is the manufacturer's responsibility to determine that
the supplement it produces or distributes is safe and that there is
substantiated evidence that the label claims are truthful and not
misleading.
- #4 Questionable Assumption –
" A recall of a harmful product
guarantees that all such harmful products will be immediately and
completely removed from the marketplace." A product recall of a
dietary supplement is voluntary and while many manufacturers do their
best, a recall does not necessarily remove all harmful products from
the marketplace.
- Contact the manufacturer for more information
about the specific product that you are purchasing.
If
you cannot tell whether the product you are purchasing meets the same
standards as those used in the research studies you read about, check
with the manufacturer or distributor. Ask to speak to someone who can
address your questions, some of which may include:
- What information does the firm have to substantiate the claims
made for the product? Be aware that sometimes firms supply so-called
"proof" of their claims by citing undocumented reports from satisfied
consumers, or "internal" graphs and charts that could be mistaken for
evidence-based research.
- Does the firm have information to share about tests it has
conducted on the safety or efficacy of the ingredients in the product?
- Does the firm have a quality control system in place to determine
if the product actually contains what is stated on the label and is
free of contaminants?
- Has the firm received any adverse events reports from consumers
using their products?
NOTE: You may obtain more information on how FDA
regulates dietary supplements and on the manufacturers' responsibilities
for the products they market at "Questions and Answers."
http://www.cfsan.fda.gov/~dms/ds-faq.html
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