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by Neil E. Levin, C.C.N.
Guest Editorial
Blaming a rarely unanimous
Congress for restraining the Food
and Drug Administration (FDA),
many “health experts” are cited as claiming
that the 1994 Dietary Supplement
Health and Education Act (DSHEA)
exempts dietary supplements from FDA
control and permits poorly supported
claims. This is absolutely false.
Dietary supplements are regulated as
a special class of food products rather
than as more dangerous pharmaceutical
drugs. All appropriate safety and labeling
laws apply to these products and
were in fact enhanced by DSHEA.
DSHEA instructed the FDA to regulate
“structure-and-function” claims, which
relate only to normal nutrient-body relationships.
The FDA has specifically had
the power to deny label claims if not
based on science, and has frequently had
battles in federal courts over their
overzealous denials of legitimate claims.
They often lose these cases by going
beyond the intent of Congress by preventing
truthful, non-misleading statements
from appearing on product labels.
I strongly support DSHEA and the
current regulation of herbs, vitamins and
other dietary supplements as a special
category of food. The safety level of
these products is much greater than for
drugs so over-regulating them is not
appropriate. These products are hundreds
of times safer than drugs, according
to annual fatality figures from the
American Association of Poison Control
Centers. On the other hand, outrageous
and unscientific claims give the natural
health business a bad name and should
not be supported. Responsible businesses
do not engage in this kind of hype nor
deserve to be associated with those who
do.
While there are a few who seek unfair
advantage by making illegal or unethical
claims, it is equally ridiculous to deny all
of the science behind dietary supplements
and also to try to blame those
who responsibly “toe the line.” There are
industry organizations that provide selfpolicing
of the dietary supplement
industry. That has been necessary
because of the FDA claims that they
don’t have the money or personnel to
implement current regulations but there
have been dozens of enforcement actions
taken against minor product claims.
The FDA admits on its Web site
that it has full authority to regulate
the manufacture, safety and
label claims of dietary supplements.
DSHEA, passed unanimously by
Congress, actually added regulation of
manufacturing practices by the FDA,
which has not yet been accomplished. It
has also set up structures for reporting
adverse reactions to supplements, as
needed. Other regulations have been
passed which control the labeling of
products so that the lack of consistency
between different manufacturers would
be eliminated. This all benefits the consumer.
It is unfortunate that supplements are
often judged as interfering with drugs.
In a more perfect world, the safer natural
remedies would be the first choice of
intervention. This would include diet,
exercise, nutritional supplements, etc.,
before choosing a lifetime hooked on
dangerous prescription drug cocktails.
Many drugs have their own interactions
that are themselves little studied. And
while the natural substances are more
forgiving of potency variations and biochemical
variations between people,
drug doses need to be carefully calibrated
to the individual (this is not often
done as carefully as necessary). Blaming
vitamins, foods and spices for interfering
with drugs could be viewed as backwards;
the drugs should be carefully
screened against the individual’s diet and
supplementation for proper dosing at
the lowest possible level. Failure to do
this results in the estimated 100,000
annual death toll in this country of prescription
drug fatalities. Why do the
self-described “quackbusters” take on
only products which compete with their
own imperfect practice of medicine,
which causes so many deaths? Despite
the annual billions of doses taken, there
are less than 10 deaths a year from all
plants eaten, mostly from poisonous
wild mushrooms.
Neil E. Levin a certified clinical
nutritionist is affiliated with The Fruitful
Yield, Inc. in Bloomingdale, Illinois.
Phone 630-942-8094 ext. 215.
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