Dietary supplements are
some of the hottest selling items on the market today. Surveys
show that more than half of the U.S. adult population uses
these products. In 1996 alone, consumers spent more than $6.5
billion on dietary supplements, according to Packaged Facts
Inc., a market research firm in New York City.
But even with all the business they generate,
consumers still ask questions about dietary supplements:
Can their claims be trusted? Are they safe? Does the Food
and Drug Administration approve them?
Many of these questions come in the wake
of the 1994 Dietary Supplement Health and Education Act, or
DSHEA, which set up a new framework for FDA regulation of dietary
supplements. It also created an office in the National Institutes
of Health to coordinate research on dietary supplements, and
it called on President Clinton to set up an independent dietary
supplement commission to report on the use of claims in dietary
supplement labeling.
In passing DSHEA, Congress recognized first,
that many people believe dietary supplements offer health benefits
and second, that consumers want a greater opportunity to determine
whether supplements may help them. The law essentially gives
dietary supplement manufacturers freedom to market more products
as dietary supplements and provide information about their
products' benefits--for example, in product labeling.
The Council for Responsible Nutrition, an
organization of manufacturers of dietary supplements and their
suppliers, welcomes the change. "Our philosophy has been ...
to maintain consumer access to products and access to information
[so that consumers can] make informed choices," says John Cordaro,
the group's president and chief executive officer.
But in choosing whether to use dietary supplements,
FDA answers consumers' questions by noting that under DSHEA,
FDA's requirement for premarket review of dietary supplements
is less than that over other products it regulates, such as
drugs and many additives used in conventional foods.
This means that consumers and manufacturers
have responsibility for checking the safety of dietary supplements
and determining the truthfulness of label claims.
Anatomy of the Requirements for Dietary Supplement
Labels
Information that will be required on the
labels of dietary supplements includes:
- Statement of identity (e.g., "ginseng")
- Net quantity of contents (e.g., "60 capsules")
- Structure-function claim and the statement "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."
- Directions for use (e.g., "Take one capsule
daily.")
- Supplement Facts panel (lists serving
size, amount, and active ingredient)
- Other ingredients in descending order
of predominance and by common name or proprietary blend.
- Name and place of business of manufacturer,
packer or distributor. This is the address to write for more
product information.
For more info, see link, dietary
supplement labels in PDF format.
What Is a Dietary Supplement?
Traditionally, dietary supplements referred
to products made of one or more of the essential nutrients,
such as vitamins, minerals, and protein. But DSHEA broadens
the definition to include, with some exceptions, any product
intended for ingestion as a supplement to the diet. This includes
vitamins; minerals; herbs, botanicals, and other plant-derived
substances; and amino acids (the individual building blocks
of protein) and concentrates, metabolites, constituents and
extracts of these substances.
It's easy to spot a supplement because DSHEA
requires manufacturers to include the words "dietary supplement" on
product labels. Also, starting in March 1999, a "Supplement
Facts" panel has been required on the labels of most dietary
supplements.
FDA oversees safety, manufacturing and product
information, such as claims, in a product's labeling, package
inserts, and accompanying literature. The Federal Trade Commission
regulates the advertising of dietary supplements.
One thing dietary supplements are not is
drugs. A drug, which sometimes can be derived from plants used
as traditional medicines, is an article that, among other things,
is intended to diagnose, cure, mitigate, treat, or prevent
diseases. Before marketing, drugs must undergo clinical studies
to determine their effectiveness, safety, possible interactions
with other substances, and appropriate dosages, and FDA must
review these data and authorize the drugs' use before they
are marketed. FDA does not authorize or test dietary supplements.
A product sold as a dietary supplement and
touted in its labeling as a new treatment or cure for a specific
disease or condition would be considered an unauthorized--and
thus illegal--drug. Labeling changes consistent with the provisions
in DSHEA would be required to maintain the product's status
as a dietary supplement.
Another thing dietary supplements are not
are replacements for conventional diets, nutritionists say.
Supplements do not provide all the known--and perhaps unknown--nutritional
benefits of conventional food.
At DrugNatural™, we carry the most
reliable and trustworthy brand names. Please feel comfortable
in your purchase from us.
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