U.S. Food and
Drug Administration
FDA Consumer magazine
March-April 2002
Table
of Contents
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
Other Sources
- MedWatch
www.fda.gov/medwatch/safety.htm
FDA safety information and adverse event reporting program.
- The Food and Nutrition Board
www.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports
The Food and Nutrition Board (FNB) of the National Academy of Sciences, as
part of its mission, establishes principles and guidelines for adequate dietary
intake. The FNB issues reports such as "Dietary Reference Intakes: Thiamin,
Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin,
and Choline."
- Nutrition.gov
www.nutrition.gov/home/index.php3
Nutrition.gov, a new federal resource, provides easy access to all online
federal government information on nutrition, including dietary supplements.
- Medline Plus Health Information: Vitamin and Mineral Supplements
www.nlm.nih.gov/medlineplus/vitaminandmineralsupplements.html
Medline Plus Health Information is a service of the National Library of Medicine,
National Institutes of Health (NIH) that provides information on health topics,
including vitamin and mineral supplements.
- International Bibliographic Information on Dietary Supplements (IBIDS)
http://ods.od.nih.gov/databases/ibids.html
The International Bibliographic Information on Dietary Supplements (IBIDS)
is a database of published international scientific literature on dietary
supplements, including vitamins, minerals, and botanicals maintained by the
NIH Office of Dietary Supplements.
- National Center for Complementary and Alternative Medicine, NIH
http://nccam.nih.gov
The National Center for Complementary and Alternative Medicine (NCCAM) at
the NIH (www.nih.gov) is dedicated to exploring
complementary and alternative healing practices in the context of rigorous
science; training CAM researchers; and disseminating authoritative information.
For updates on dietary supplements, see www.cfsan.fda.gov/~dms/supplmnt.html.
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