Is it FOOD or is it a DRUG?
What's the real Definition of a Disease?
Herbs and spices used in
foods can provide such excellent benefits to our bodies that they become
classified as "drugs" according to the FDA when claims are made about
their efficacy. When we were kids and someone got a cold in our
house the first thing we got from Mom was a hot lemonade with honey, a
garlic sandwich, a few Vitamin C tablets, a zinc tablet and a warm
turtle neck sweater with some essential oils on the chest, throat and
nostrils. Our colds generally didn't last too long when we hit
them will the full arsenal. A lot of people know that this type of
thing "loosens up" a cold and provides a faster recovery time. But
if someone were to try to package this idea and sell a packaged lemonade
with honey, vitamin C and Zinc which said, "Cold Remedy" on the label,
it would then be considered a drug.
We know that everything
our bodies need to beat of disease is found in herbs, spices and all
sorts of foods. We also know that food today isn't what it used to
be 50 years ago, this is well documented by Private and Government
studies. We know that all forms of nutrition are important for the
body to regenerate itself. Herein also lies a challenge with the
labeling of Colloidal Silver. Colloidal Silver is a simple product
found in nature and available in our natural food and water supplies.
Even in very small quantities Colloidal Silver has been found to kill
many forms of bacteria. A compendium study on water done at
University of British Columbia Canada showed that silver levels in water
had a dramatic effect on maintaining healthy water for mammalian life.
Common sense would also
tell us that either God or if you believe in Evolution caused Silver to
be there for good reason. How many things would Scientists say are
redundant in nature? How many elements on earth are truly
redundant? It doesn't appear as too many intelligent people would
stand up and say anything is redundant to some aspect of life, and isn't
important in the big picture. The complexity of the Natural world
is astounding, and the definitions and applications of terms and
definitions is a formidable challenge that all regulatory bodies,
business and consumers face alike. Here are some excepts of
various discussions regarding this matter provided from FDA dockets that
you may find of value.
DEPARTMENT OF HEALTH
AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
PUBLIC MEETING ON REGULATIONS ON SUPPLEMENTS MADE FOR
FDA policy must require structure/function claims to be supported by
solid scientific substantiation. Nowhere does the law exempt
structure/function claims from the requirement that they be truthful and
You can apply the misbranding provisions of the FD&C Act to start with
and then consider anti-deception concepts in the FTC Act.
have no doubt that there are problematic claims for which even the most
basic substantiation files could not exist because the scientific
literature is silent on the claim's structure or function effect. A few
well-targeted warning letters in these instances would be very effective
in sending the message that folklore is not substantiation and the
statutory disclaimer does not provide a carte blanche.
like to have a definition that has clarity, consistency, accuracy, and
common sense in the definition of disease, accuracy meaning that it's
true, consistency meaning that when it's used by multiple people it's
used in the same way, clarity meaning that most of us could understand
it, and common sense, which unfortunately is often lacking in a lot of
these regulations, would mean that it coheres with the thoughts that
most people would understand when they bring to this issue.
Given this goal, unfortunately, it seems to me unlikely that we'll be
able to achieve all of these different qualities for several reasons.
First of all, the history of supplement regulation, and this is just how
things have evolved and the context in which we find ourselves now in
having to kind of contort our positions to ally with past history. For
instance, nutritional diseases obviously are diseases by any definition
and yet they're specifically excluded because of historical matters and
the way this came up.
Secondly, the activities and the desires of the folks who manufacture
these products to market them effectively, right up to and some would
say beyond the limits of the law and common sense in making claims.
Thirdly, the very great difficulty that we have and the confusion and
sort of hair-splitting distinctions between diseases and symptoms and
where does one begin and one end. As some of the materials that were
distributed before point out, what conceivable difference could one make
between seizures, which are a symptom, and epilepsy, which is a disease;
between wheezing, which is a symptom, and asthma, which is a disease.
The proposed rule, having its problems--all definitions have their
problems--is better since it includes signs, symptoms, laboratory
measurements in that definition of disease.
Sixth, FDA should insist that any dietary supplement making even a
statement of nutritional support, i.e., structure/function claim, let
alone a disease claim, adhere to standards of quality, safety, efficacy,
and purity commensurate with those required for pharmaceuticals.
Seven, DSHEA was intended to create parity between dietary supplements
and foods, not between supplements and drugs. A statement of
nutritional support must be just that. It must be limited to the
nutritional value of the supplement and not its pharmacological
activity. This will allow for better and more informed consumer choice
about the difference between drugs and dietary supplements.
The FDA should consider adopting various kinds of regulatory disclaimers
to help understanding in the food supplement label area rather than
looking at how to prohibit statements. Not only did they say they
should do that, they said they are required by the Constitution to do
The only way that something can be prohibited is if it's an inherently
misleading claim that has no substantiation. If it's not an inherently
misleading claim, other avenues besides prohibition need to be looked
at... to read the entire docket click on link:
Food and Drug Administration
FDA Consumer June 1981
The Long Struggle For The
Many forces combined to
create the need for the 1906 Food and Drugs Act. James Harvey Young
traces the history of the law and the conditions that led to its
enactment. The author is professor of history at Emory University and is
the author of many books and articles on food and drug regulatory
It is the
goal of our company to best serve the needs of our customers and to do
this we share our experiences with Colloidal Silver and that of
customers who have written us to tell their experience. It must be
clearly understood that no two people will necessarily have equal
results with our products. We simply cannot and will not guarantee
this and we never have made these guarantees. We do offer an
extremely high quality product and we do offer a refund when a customer
has legitimately tried our product as recommended and believes they
receives no benefits. We make no claims that are misleading or
inflated in order to garner sales, the information on our site is from
public domain sources or from customer testimonies.
is 20 parts per million (ppm) Colloidal Silver which is not considered
by either Homeopaths or Allopaths to be of a highly potent strength.
We provide a product that replicates what might have once been found in
Natural food and water sources. People have been drinking well water for
millennia which has been found to contain very high Total Dissolved
Solids (TDS) 100-500 parts per million or more, and some well water
contains metals like arsenic, lead, cadmium that are known to be
dangerous for humans. In comparative terms, Colloidal Silver at 20
ppm is extremely low of a dosage and is non-toxic at these low
concentrations, but provides bacterial killing power. Common sense
would tell us there is good reason to drink Colloidal Silver Water, and
replenish the amounts of Natural Silver that our bodies require for good
benefits a person receives because of taking the Colloidal Silver is a
question that can only be answered on an individual basis, we are
delighted to reports that come in and welcome your comments and input
about any of our products.