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People who choose to supplement their diet with a wide range of vitamins,
minerals and other substances may want to know more about the safety of
these products.
The use of dietary supplements continues to increase. The "Nutrition
Business Journal" estimated the total sales of dietary supplements at
$17.8 billion in 2001. The frequency of use of supplements among the
elderly is high compared with the general population, according to a May
2003 report from the National Institutes of Health's Office of Dietary
Supplements.
A dietary supplement is any product intended to supplement the diet which
contains at least one of these ingredients: vitamins, minerals, herbs or
other botanicals, amino acids and substances such as enzymes, organ
tissues, glandulars, metabolites or a combination of these ingredients. To
be designated as a supplement, the item must not be for use as the sole
item of a meal or diet. The Dietary Supplement Health and Education Act,
or DSHEA, of 1994 places dietary supplements in a special category under
the general umbrella of "foods."
According to FDA regulations, information that must be on a dietary
supplement label includes:
- A descriptive name of the product stating that it is a supplement.
- The name and address of the manufacturer, packer or distributor.
- A list of each ingredient contained in the product.
- The net contents of the product.
- A supplement facts panel. The manufacturer is responsible for ensuring
that the supplement facts label and ingredient list are accurate, that the
dietary ingredients are safe and that the content matches the amount
declared on the label.
- Ingredients not listed on the supplement facts panel must be listed in
the other ingredient statement beneath the panel. Other ingredients could
include water, sweeteners, gelatin, starch, colors, stabilizers,
preservatives and flavors.
There are no rules that limit a serving size or the amount of a nutrient
in any form of dietary supplements. This decision is made by the
manufacturer and does not require FDA review or approval. Consumers who
want more detailed information than what is listed about a specific
product may contact the manufacturer.
The manufacturer is responsible for establishing its own manufacturing
practice guidelines to ensure that the dietary supplements it produces are
safe and contain the ingredients listed on the label. No provisions exist
in the law for FDA to "approve" dietary supplements for safety or
effectiveness before they reach the consumer. The FDA monitors safety
after the product has been marketed.
The responsibility for ensuring the validity of claims for dietary
supplements rests with the manufacturer, FDA and, in the case of
advertising, with the Federal Trade Commission. Advertising and
promotional material received in the mail are subject to regulation by the
U.S. Postal Inspection Service.
If you or your health-care provider suspect that you have suffered an
adverse effect from the use of a dietary supplement, you should report
your concerns to the FDA's MedWatch hotline at 1-800-FDA-1088. You can
also submit a report by fax to 1-800-FDA-0178 or to visit online click here for the
FDA MedWatch Web Site.
Be aware that some supplements interfere with the action of medications,
creating a variety of ill effects. Large doses of either single-nutrient
supplements or high potency vitamin-mineral combinations may be harmful.
Some supplements may produce undesirable effects such as fatigue, diarrhea
and hair loss when taken in large amounts. Too much of one mineral can
interfere with the absorption of other minerals you may need.
Before taking supplements, ask your doctor or a registered dietitian to
evaluate your eating habits, recommend beneficial changes and determine
whether a supplement is appropriate for you. If you wish to supplement
your diet, a multi-vitamin/mineral product that does not exceed 100
percent of the Recommended Dietary Intake is the best strategy. This is
not as a replacement, but a supplement. The elderly may need more vitamin
B12, and the 1,500 mg recommendation for calcium for the elderly may
indicate they need a calcium supplement.
The most cost-effective way to promote good health is to exercise
regularly and eat a wide selection of foods. There simply is no substitute
for the nutritional benefits of food.
Additional information about dietary supplements is available from these
Internet resources:
- Extension fact sheet 9.338 - Food vs. Pills, click here for the Extension Web Site..
- Center for Food Safety and Applied Nutrition, "Tips for the Savvy
Supplement User: Making Informed Decisions and Evaluating Information"
.
- National Institutes of Health, Dietary Supplements: Background
Information at .
For more information, contact your local
Colorado State University Extension office.
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