| | Tips
for the Savvy Supplement User:
Making Informed Decisions 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. The Food and Drug Administration,
health professionals, and other health-related 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.
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.
The FDA's Center for Food Safety and Applied Nutrition has prepared these tips
and resources to help you become a savvy dietary supplement user. The principles
underlying these tips are similar to those principles a savvy consumer would use
for any product. Basic
Points to Consider - 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, on the National Academy of Sciences Web site at ww.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports.
- Should
I check with my doctor or health-care 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 (OTC) 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 two to three 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 the FDA.
You, your health-care provider, or anyone may report a serious adverse event
or illness directly to the FDA if you believe it is related to the use of any
dietary supplement product. Report these concerns to MedWatch, the FDA's safety
information and adverse event reporting system, by calling 1-800-FDA-1088, by
fax at 1-800-FDA-0178 or online at www.fda.gov/medwatch/how.htm.
The 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 the FDA online 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 the FDA has the responsibility to take action against any unsafe dietary supplement
product that reaches the market. If the FDA can prove that claims on marketed
dietary supplement products are false and misleading, the agency may take action
against products with such claims. Tips
on Searching the Web 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 (such as the American Medical
Association, American Diabetes Association, American Heart Association, National
Institutes of Health, National Academy of Sciences, or the FDA)? 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, such as 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 (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;
for example, 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 are the Internet and 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."
More
Tips and To-Do's - 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 personal
testimonials (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:
Questionable Assumption #1 --
"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.
Questionable Assumption #2 -- "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.
Questionable Assumption #3
-- "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.
Questionable Assumption #4 -- "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 event reports from consumers using their products?
Note:
You may obtain more information on how the FDA regulates dietary supplements and
on the manufacturers' responsibilities for the products they market at "Questions
and Answers," www.cfsan.fda.gov/~dms/ds-faq.html.
For
More Information The
following are selected references about dietary supplements that may help users
understand and evaluate information encountered on the Internet or in the marketplace.
For additional tips on finding and evaluating health information on the Internet,
see www.cfsan.fda.gov/
~dms/ds-savvy.html#resources. Product
Claims and Labeling - Claims
That Can Be Made for Conventional Foods and Dietary Supplements
www.cfsan.fda.gov/~dms/hclaims.html
An FDA explanation of the various kinds of claims that can be made for
foods and supplements (Updated April 2001). - Staking
a Claim to Good Health
www.fda.gov/fdac/features/1998/698_labl.html
Reviews the health claims that the FDA has authorized for use on food
labels. (FDA Consumer, November-December 1998.) - FDA
Dietary Supplement Questions and Answers
www.cfsan.fda.gov/~dms/ds-faq.html
Provides information about what dietary supplements are and how they
are regulated, including the labeling and claims that can be made for supplements.
- 'Miracle'
Health Claims: Add a Dose of Skepticism
www.ftc.gov/bcp/conline/pubs/health/frdheal.htm
This joint Federal Trade Commission (FTC)/FDA information piece focuses
on how to assess claims and seek advice and avoid becoming a victim of health
fraud. The information discusses how to minimize being cheated out of money, time,
and health (September 2001). - The
Story of the Laws Behind the Labels
www.cfsan.fda.gov/~lrd/history1.html
This article on the history of food and drug laws provides useful insights
on the regulation of health claims over the years (FDA Consumer, June 1981).
Advertising
Dietary Supplements - Dietary
Supplements: An Advertising Guide for Industry
www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.htm
This document describes the factors that the FTC takes into account in deciding
whether an ad is truthful or misleading. You can use them to judge the advertisements
you see. Dietary
Supplements and Kids
Reprinted
from FDA Consumer. This article originally appeared in the March-April 2002 FDA
Consumer.
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