FDA Final Rule On silver and the Silver Lady HORROR Story Brent won't tell you about!
a_weisman_at_yahoo.com
Date: 03/25/05
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Date: 24 Mar 2005 16:31:41 -0800
Silver:
NOT safe
NOT effective
NOT approved for human use internally
ILLEgal
Don't listen to the LIARS and silver cult profiteers like BRENT THE
LIAR!
Don't listen to the silver profiteer cultists!
They LIE
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
http://www.access.gpo.gov/su_docs/aces/aces140.html#frbrowse
------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final
rule
establishing that all over-the-counter (OTC) drug products
containing
colloidal silver ingredients or silver salts for internal or
external
use are not generally recognized as safe and effective and are
misbranded. FDA is issuing this final rule because many OTC drug
products containing colloidal silver ingredients or silver salts
are
being marketed for numerous serious disease conditions and FDA is
not
aware of any substantial scientific evidence
that supports the use of OTC colloidal silver ingredients or silver
salts for these disease conditions.
DATES: This regulation is effective September 16, 1999.
FOR FURTHER INFORMATION CONTACT: Bradford W. Williams, Center for
Drug
Evaluation and Research (HFD-310), Food and Drug Administration,
7520
Standish Pl., Rockville, MD 20855, 301-594-0063.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 15, 1996 (61 FR 53685), FDA
published a proposed rule to declare that all OTC drug products
containing colloidal silver ingredients or silver salts are not
generally recognized as safe and effective, and are new drugs and
misbranded within the meaning of section 201(p) of the Federal
Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). Colloidal
silver
is a suspension of silver particles in a colloidal base. In recent
years, colloidal silver preparations of unknown formulation have
been
appearing in retail outlets. These products are labeled for
numerous
disease conditions, many of which are serious diseases. The dosage
form
of these colloidal silver products is usually oral, but product
labeling also contains directions for topical and, occasionally,
intravenous use.
FDA has not approved a new drug application (NDA) for any colloidal
silver product. None of the silver salts evaluated as part of FDA's
OTC
drug review was found to be generally recognized as safe and
effective
for its intended use(s). FDA is not aware of any substantial
scientific
evidence that supports the use of OTC colloidal silver ingredients
or
silver salts for disease conditions. The agency invited any
interested
parties to collect and submit any existing data and information
that
support the safety and effectiveness of colloidal silver
ingredients
or
silver salts for any of the uses not already evaluated under the
OTC
drug review. Interested persons were invited to submit written
comments
on the proposed regulation and on the agency's economic impact
determination by January 13, 1997.
In response to the proposal, the agency received 251 responses.
Copies
of these comments are on public display in the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm.
1061, Rockville, MD 20852. Additional information that has come to
the
agency's attention since publication of the proposal is also on
public
display in the Dockets Management Branch.
Based on the information set forth in the proposed rule, and after
consideration of the information submitted by the public comments
(as
summarized as follows), FDA is declaring that all OTC drug products
containing colloidal silver ingredients or silver salts are not
generally recognized as safe and effective, and are new drugs and
misbranded within the meaning of section 201(p) of the act.
Adequate
safety and effectiveness data have not been provided to establish
general recognition of the safety and effectiveness of colloidal
silver
or silver salt ingredients for any OTC drug uses. The data
submitted
did not include the required absorption, metabolism, tissue
distribution, accumulation, excretion, and pharmacodynamics (effect
of
the drug at its action site) of silver in the body, both when taken
internally and applied externally, and of the effect of the
particle
size of the silver on these systemic effects.
FDA is amending subpart E of part 310 (21 CFR part 310) to add Sec.
310.548 for OTC drug products containing colloidal silver
ingredients
or silver salts. The agency has expanded proposed Sec. 310.548(a)
to
include some additional silver ingredients.
...
Silver Lady/colloidal silver/agyria/Rosemary Jacob's story page
http://homepages.together.net/~rjstan/rose1.html
>>From Cheryl's Lyme Alt Med Page
http://www.aero-vision.com/~cheryl/alt.html:
Colloidal Silver Pros:
CS PROS
CS Cons:
Colloidal Silver CONS
http://www.quackwatch.com/01QuackeryRelatedTopics/PhonyAds/silverad.html
The Silver Supplement Fraud
Guess who took the colloidal silver (CS)? Rosemary did. That's why
she
is slate-gray. The condition is called argyria. It is irreversible
and
cannot be covered by makeup.
Actually, Rosemary's doctor in New York prescribed CSP for her back
in
the fifties as a treatment for allergies. It was sold as a drug
then.
Today it is sold as a dietary supplement. You can find it in
"health
food" stores and on the Internet. You can even buy the equipment to
make your own. It was snake oil when it was given to Rosemary. It
is
snake oil now.
The only thing Rosemary recommends CSP for is a gray skin dye. She
knows that it is safe, effective, and permanent when used for that
purpose. She also knows that being a gray person in a black and
white
world can have a serious negative impact on your social and
economic
life.
Promoters claim that CSP prevents and cures 650 diseases including
Aids and cancer. They say that people with even a trace of silver
in
their bodies don't get sick!
Both Rosemary and the FDA have asked them for their proof. All they
get are quotes from old quacks who manufactured the stuff at the
turn
of the century, misquotes from reputable authors and wonderful
anecdotes. "I've taken it everyday for four years and feel great,"
the
saleslady says.
The only problem Rosemary has with the anecdotes is that they are
selectively chosen to sell CSP. The promoters refuse to include her
negative anecdotes or those of all the other argyric people
recorded
in the medical literature. Rosemary had breast cancer at the age of
42. The silver in her body made her face so gray that the nurses in
pre-op thought that she was in cardiac arrest! The promoters won't
tell you this though.
The FDA has told the promoters that if they want to continue making
medical claims for CSP they will have to first have it approved as
a
drug. Of course, that doesn't stop them from selling the stuff as a
"dietary supplement." It just prevents them from legally writing
their
claims on the label or putting them in their ads.
And, oh yes, if you do decide to use CSP, have the product analysed
by
an independent lab. According to the dietary supplement industry
itself, a lot of the stuff tested that is labelled colloidal silver
really isn't. You see "dietary supplements," thanks to intense
industry lobbying are unregulated by any government agency. So very
often what is on the label isn't in the bottle. In fact, what is in
the bottle may even be something more toxic than CSP. Buyer beware!
P.S. Rosemary will gladly provide you with documentation and
references. Just ask!
Here's Rosemary's story in her words...
http://homepages.together.net/~rjstan/rose2.html
Rosemary's Story
ROSEMARY JACOBS
Background
For forty years I tried to blend into the crowd, but when I
discovered that the quacks were back, I knew that I couldn't do
that
anymore. I had to stand up and shout, "Look at me! I'm gray." I had
to
warn the public. A local newspaper broke my story with the
headline,
"The silver woman from Long Island. The face that no one forgets."
I wasn't always gray. I was born white in Brooklyn, New York, in
1942.
When I was eleven years old, my mother mentioned to an MD -- an
eye,
ear, nose and throat specialist on Long Island -- that I always had
a
cold. He told her that it had to be allergies and prescribed nose
drops that contained silver with instructions to take them
"intermittently as needed."
Rosemary, Mom, the family dog
Diagnosis
Right after starting high school at the age of 14, my friends and I
volunteered to work in the local hospital as "candy stripers." The
hospital was run by a Catholic order of nursing sisters who
required
that all new volunteers attend a class at their convent once a week
on
Saturday mornings. The nun who gave the course was also a nurse and
a
pharmacist. One morning when I walked in she was very startled by
my
appearance.
"Why are you that color?" she asked. What color? No one had noticed
that my color was weird until then. She repeated, "Why are you that
color? Ask the doctor." Suddenly everyone noticed. I was
slate-gray.
We had a family friend, a general practitioner, who made an
appointment for me to see a dermatologist. Meanwhile, Saturday
rolled
around again and I went back to class. This time Sister greeted me
with, "You're taking nose drops, aren't you?" I told her I was.
"Stop," she said. "They have silver in them. That's why you're
gray."
She had seen another nursing sister at the hospital with the same
skin
discoloration which was also caused by nose drops, probably from
the
same doctor who was on their staff. The dermatologist took one look
at
me and diagnosed argyria - a permanent, irreversible skin
discoloration caused by the ingestion of silver.
A biopsy confirmed the diagnosis showing all the little specks of
silver in my skin. Unfortunately, that is the only information that
I
have ever been able to get about the drug that disfigured me. No
one
ever sued doctors back then.
When as a young adult I had difficulty getting jobs because people
didn't like my appearance, the lawyers I consulted told me that New
York is one of the few states with a statute of limitations on
malpractice suits. I never really wanted to sue the doctor. He was
a
good person who made a tragic mistake. He read the ads from drug
companies instead of the medical literature. (1)(2)(3)
Old Garbage
All kinds of silver medicinals, as well as many other dubious and
noxious drugs, were used by desperate physicians before the advent
of
antibiotics. Any student of history can tell you how ineffective
they
were.
Colloidal silver (CSP) is not a new alternative remedy. It is an
old,
discarded traditional one that homeopaths and other people calling
themselves "alternative health-care practitioners" have pulled out
of
the garbage pail of useless and dangerous drugs and therapies,
things
mainstream medicine threw away decades ago.
In 1935 Gaul & Staud wrote about colloidal silver in The Journal of
the American Medical Association (JAMA), "The alarming increase of
argyrosis leaves little doubt as to our purpose in this report.
There
has been an accumulation of indubitable clinical evidence which
makes
it imperative to present before those who prescribe, dispense or
use
these drugs the danger entailed therein...The obvious
responsibility
for this injudicious medication rests with the circularized
advertisements by the various manufacturers to the physicians;" (4)
In 1940 Bryant added, "Conscientious observers in the field of
otolaryngology can no longer doubt the occurrence of generalized
argyria caused by intranasal silver medications," and "A persistent
indifferent attitude to this on the part of otolaryngologist might
be
condoned if it were possible through the use of such medication to
achieve beneficial results for the patient which could not be
achieved
other wise, but quite the contrary is the case."
He goes on to state that these silver preparations should be
supplanted by a weak ephedrine or neosynephrin in an isotonic
solution. (5) He continues, "The use of silver-containing nasal
medication over even a few weeks is dangerous and accomplishes
nothing
that cannot be accomplished safely and more efficiently by other
means." (6)
The New Old Miracle
In 1995 I discovered that CSP, one of the drugs that causes
argyria,
was again being aggressively promoted. It was being sold over the
Internet where you could buy equipment to make your own, in "health
food stores" and by MLMs (multilevel marketers). Promoters were
claiming that silver is an "essential mineral" and that even a
trace
amount in the body prevents serious illness. They also claimed that
it
was a pre-1938 OTC (over-the-counter drug) that cures 650 specific
conditions and diseases such as cancer, AIDS, acne, and lupus. They
passed off their promotional material on the Internet and in books
and
magazines as if it were the gospel truth.
I thought the promoters were ignorant people who had made a
terrible
mistake, but when I contacted several of them and discovered that
they
were not interested in hearing my story, they would not change
their
ads and they refused to include my negative anecdotes along with
their
positive ones, I knew that they weren't ignorant.
They were quacks who were deliberately lying to sell their product.
The response I got from the owner of a store that sells the stuff
was
pretty typical. I told him that my skin is gray from the ingestion
of
silver adding that silver in my body has never benefited me. I had
breast cancer at the age of 42. In the year that I was born, 1942,
a
Dr. Levine wrote an article in the New England Journal of Medicine
stating that all doctors had seen cases of argyria, but it was
rarely
reported in the medical literature. (7) In searching that
literature
for thirty years I have never found any evidence that silver in a
person's body benefits anyone other than the quack who sold it.
If, in fact, it did do all the wonderful things that the promoters
claim, Queen Victoria and the Rockefellers would still be alive and
they would be gray like me.
I gave the merchant a fist full of medical literature to
substantiate
my claims and asked for proof that the product he sold with the
colloidal silver label on it was in fact safe and effective for
something, anything. I wanted to know how he knew that it actually
did
all the great things claimed and how he knew that it wouldn't cause
argyria. He said he'd have to contact his supplier and get back to
me.
The "Evidence"
When he phoned and said that he had the material I had requested,
he
added that he didn't think it would interest me.
How wrong he was.
He wasn't there when I went to pick it up. His wife, visibly
uncomfortable with me in the store, seemed to be hoping that I'd
glance at the "evidence" and leave. Instead, I asked if I could
take
it next door to copy. Reluctantly, she agreed.
What a gold mine that turned out to be. The same names, Dr. Henry
Crookes, Sir Malcolm Morris, A. Legge Roe, and R.J. Hartman -- to
name
a few -- kept popping up in all the promotional material. While
most
promoters pretended that these people were contemporary
researchers,
some of the material that the store owner gave me contained
citations
with dates. These "authors" were ancient.
Old Quacks
I went to the nearest medical history library and pulled the
citations. Henry Crookes was a pioneer CSP manufacturer in England
at
the turn of the century. (8) He sold many different alleged
colloidal
preparations under the Collosol trade name. (9) Collosol Argentum
was
the brand name of his colloidal silver. (10) Malcolm Morris was
rumored to be on his board of directors. (11)
In 1919 JAMA's Council on Pharmacy and Chemistry ruled that
Collosol
Argentum, along with several other of the Crookes' Laboratory
products, were "inadmissible to New and Nonofficial Remedies,"
stating
that "In the few cases in which the therapeutic claims for these
preparations were examined, the claims were found to be so
improbable
or exaggerated as to have necessitated the rejection of these
products." (12)
Further down in the same article referring to Collosol Hydrargyrum
and
Collosol Ferrum they said that, "If either of these preparations
were
injected intravenously as directed, death might result, making the
physician morally if not legally liable." (13)
A. Legge Roe did write about the great success he had treating
gonorrhoeal opthamalia with collosol argentum. He also stated, "It
is
the most useful preparation that has been placed in our hands since
the introduction of cocaine." (14)
In 1939 Hartman, a chemist not a medical doctor, included a chapter
on
colloids in medicine in his chemistry book. On p.536 he said that
CSP
is safe enough to be put into the eyes and nose. He also stated on
the
same page that, "Intramuscular injections of colloidally suspended
lead are of value in arresting certain cancerous growths." (15) His
source for all the material on colloids in medicine was Crookes
Laboratories.
I felt as if I were doing quack genealogy. A quack quoting a quack
quoting a quack.
Misquoted Reputable Authors
Another article about silver that colloidal silver promoters often
referred to was one by Jim Powell which appeared in the March 1978
edition of the now defunct popular magazine Science Digest. They
always referred to it as "Our Mightiest Germ Fighter."
When I tracked down the magazine, I discovered that the article
didn't
mention colloidal silver and that the full title was, "Perhaps it
soon
will be recognized as OUR MIGHTIEST GERM FIGHTER."
Why do you think promoters never mention the first half of the
title?
Could it be because they know that the promise never materialized
and
they don't want readers to find out?
Another reference constantly appearing in the quack promotional
material is the book ARGYRIA, (16) which truly is the definitive
work
on the subject. It was written in 1939 by Hill and Pillsbury.
Promoters say that it states that "properly prepared colloidal
silver"
never caused argyria and that 95 percent of the cases resulted from
silver nitrate.
What the book really says, and I'm probably one of the few people
on
earth who has a copy, is that in a study of 214 cases for which
data
was available, "silver nitrate is the responsible compound in over
half the cases. Again it must be pointed out that the number of
cases
due to other compounds may be no real indication of their relative
capacity for the production of argyria, but rather an evidence of
their popularity as a medicinal agent." (17)
Regarding CSP, "It is impossible to make a definitive statement
concerning the amount of a colloidal silver compound which may be
instilled into a body cavity without the possibility of argyria."
(18)
The authors called for further studies and warning labels on all
silver medicinals. (19) They also pointed out that it had never
been
determined whether or not individual susceptibilities exist. Are
some
people more likely to develop argyria than others? (20) We still
don't
know.
Hill & Pillsbury added, "there is no evidence indicating that the
giving of extremely small amounts of silver over a prolonged period
in
any way lessens the danger of argyria from any given amount of
silver
compound." (21)
In 1975 Goodman & Gilman stated that, "There is no acceptable
evidence
that the routine use of silver solutions for the prophylaxis of
colds
or other respiratory tract infections is at all efficacious, and
cases
of argyria have resulted from this practice. Fortunately, the
colloidal silver preparations are now in a deserved oblivion." (22)
There is no animal model for argyria. (23) It can take decades to
develop. (24) There have been reported cases in which it did not
appear until several years after the drug was discontinued. (25)
Silver workers have developed argyria, presumably from inhaling
silver
dust. (26) One person's skin discoloration was caused by the
electrolytic action between a gold and a silver filing. Saliva
caused
the silver to go into solution. (27)
1990s Snake Oil
Contrary to promoters' claims, we still ingest silver in our diets.
(28) Some drinking water contains silver. At what concentration of
silver does drinking water turn into CSP? I've never been able to
get
a salesperson to tell me this. Hopefully all they are really
selling
is very expensive, distilled water, but no one knows for sure since
CSP is now sold as a "dietary supplement." As such it is
unregulated
by any government agency. Only the manufacturer knows what's in the
bottle.
On p. 26 of the April 1997 issue of Vegetarian Times, a magazine
that
promotes supplements, it states that the National Nutritional Foods
Association (NNFA), a trade group in Newport Beach, CA, says that
"some metal colloid products have been found to be high in toxic
metals such as aluminum. Others have no detectable levels of the
desirable metal listed on the label." NNFA advises consumers taking
colloidal silver to have it analyzed by an independent laboratory.
A doctor told me that he had a bottle of CSP prepared by a
pharmacist
analyzed and discovered that it was just very expensive tap water.
I
find it very interesting that probably thousands of people are all
reporting similar wonderful health and medical benefits from
products
that only have one thing in common, the labels all say "colloidal
silver."
I believe this is ample proof that individuals and doctors are not
capable of determining whether or not a drug is safe and effective.
Scientific investigations start with anecdotal evidence, but they
don't end there.
Index
http://homepages.together.net/~rjstan/rose3.html
Silver Fraud
http://homepages.together.net/~rjstan/rose1.html
My Story
http://homepages.together.net/~rjstan/rose2.html
FAQs
http://homepages.together.net/~rjstan/rose6.html
Links
http://homepages.together.net/~rjstan/rose10.html
E-mail
mailto:rjs...@together.net
================================================================================
Colloidal Silver: Risk without Benefit
http://www.quackwatch.org/01QuackeryRelatedTopics/PhonyAds/silverad.html
Colloidal Silver:
Risk Without Benefit
Stephen Barrett, M.D.
Colloidal silver is a suspension of submicroscopic metallic silver
particles in a colloidal base. Long-term use of silver preparations
can lead to argyria, a condition in which silver salts deposit in
the
skin, eyes, and internal organs, and the skin turns ashen-gray.
Many
cases of argyria occurred during the pre-antibiotic era when silver
was a common ingredient in nosedrops. When the cause became
apparent,
doctors stopped recommending their use, and reputable manufacturers
stopped producing them. The official drug guidebooks (United States
Pharmacopeia and National Formulary) have not listed colloidal
silver
products since 1975.
Dubious AdsIn recent years, silver-containing products have been
marketed with unsubstantiated claims that they are effective
against
AIDS, cancer, infectious diseases, parasites, chronic fatigue,
acne,
warts, hemorrhoids, enlarged prostate, and many other diseases and
conditions. Some marketers claim that colloidal silver is effective
against hundreds of diseases.
During 1997 and 1998, Changes International, a Florida-based
multilevel company, stated:
Our colloidal silver contains 99.99% pure silver particles
suspended
indefinitely in demineralized water that kills bacteria and
viruses.
It can be applied topically and/or absorbed into the blood stream
sub-lingually (under the tongue), thereby avoiding the negative
effects of traditional antibiotics that kill good bacteria in the
lower digestive tract.
An all natural antibiotic alternative in the purest form available.
The presence of colloidal silver near a virus, fungi, bacterium or
any
other single celled pathogen disables its oxygen-metabolism enzyme,
its chemical lung, so to say. The pathogens suffocates and dies,
and
is cleared out of the body by the immune, lymphatic and elimination
systems.
Unlike pharmaceutical antibiotics which destroy beneficial enzymes,
colloidal silver leaves these beneficial enzymes intact. Thus
colloidal silver is absolutely safe for humans, reptiles, plants
and
all multi-celled living matter.
It is impossible for single-celled germs to mutate into
silver-resistant forms, as happens with conventional antibiotics.
Also, colloidal silver cannot interact or interfere with other
medicines being taken. Colloidal silver is truly a safe, natural
remedy for many of mankind's ills. Colloidal silver can be taken
indefinitely because the body does not develop a tolerance to it
[1]
Seasilver International,
http://www.seasilver.com/
a California-based multilevel company, claims that American are
suffering from "silver deficiency." Although silver is not an
essential nutrient, product information posted on the company's Web
site states:
The depletion of minerals in our soil has left us deficient of
silver,
one of our most essential trace minerals, causing a drastic
increase
in immune system disorders in our society in the last decade.
Research
has taught us that all disease is allowed to manifest itself
because
of a weakened immune system. In over 20 years of worldwide research
on
Colloidal Silver, numerous interviews with government agencies,
health
care practitioners and their patients, no other nutrient, herb or
drug
(prescription or over-the-counter) is as safe and effective against
all known forms of unfriendly virus, bacteria, and fungus.
Additionally, while it is generally known that most antibiotics
kill
only perhaps 6 or 7 different disease organisms, reports have shown
that Colloidal Silver has been used successfully in the treatment
of
over 650 diseases! Furthermore, strains of disease organisms fail
to
develop in the presence of Colloidal Silver. Colloidal Silver's
greatest attribute is its unique ability to function as a superior
second immune system in the body! [2]
The ad below is from the July 1996 issue of Alternative Medicine
Digest.
[ad won't copy and paste go to site if you want to view it]
Critical Studies and Case Reports
In 1995, an herbal distributor named Leslie Taylor tested nine
commonly marketed colloidal silver products available at
health-food
stores and concluded:
Two of the products were contaminated with microorganisms.
The amount of silver suspended in solution varied from product to
product and would gradually decrease over time.
Only five products actually showed antibacterial activity in a
laboratory test. To perform the test, she prepared a culture plate
with Staphylococcus aureas bacteria, which can cause infections in
humans. She then placed a drop from each product on the plate and
used
disks of two common antibiotics as controls. After eight hours of
incubation, she found that bacterial growth had been inhibited
around
the antibiotics and four of the products.
Of course, the fact that a product inhibits bacteria in a
laboratory
culture doesn't mean it is effective (or safe) in the human body.
In
fact, products that kill bacteria in the laboratory would be more
likely to cause argyria because they contain more silver ions that
are
free to deposit in the user's skin.
FDA laboratory studies have found that the amount of silver in some
product samples has varied from 15.2% to 124% of the amount listed
on
the product labels. The amount of silver required to produce
argyria
is unknown. However, the FDA has concluded that the risk of using
silver products exceeds any unsubstantiated benefit [3]. So far,
nine
cases of argyria related to silver products have been reported:
A 56-year-old man who had sold and used colloidal silver for three
years, developed blue/gray discoloration of his fingernails
accompanied by a very high blood level of silver [4].
A married couple who had three years of daily consumption of a
drink
prepared by administering an electrolytic charge to a bowl of water
that contained a silver bar [5].
Another couple had been taking a silver-containing "dietary
supplement" prescribed by a naturopath [5].
A mentally ill man who had been drinking silver-containing herbal
tea
for about 10 months [5].
Stan Jones, Montana's Libertarian Party candidate for the
U.S. Senate, who reportedly started taking colloidal silver in 1999
for fear that Y2K disruptions might lead to a shortage of
antibiotics.
He made his own concoction by electrically two silver wires in a
glass
of water [6].
Two men, ages 63 and 76, developed argyria after a year of product
use
inspired by Internet claims [7]. Enforcement Actions
Between October 1993 and September 1994, the FDA issued warning
letters to five colloidal silver marketers::
Higher Education Library Publications (H.E.L.P.), of Springfield,
Utah, was ordered to stop claiming that its colloidal silver
product
was effective as a natural antibiotic and might be effective
against
cancer, genito-urinary diseases, tuberculosis, and AIDS.
Nutrition, Inc., of Arvada, Colorado, was ordered to stop stating
or
implying that its Silvicidal, when administered orally or
intravenously, was nontoxic, FDA-approved, and was a broad-spectrum
antibiotic that killed bacteria and all virus and fungal
infections.
In addition, it was falsely claimed to be effective against a long
list of specific diseases.
Reseau International of Cincinnati, Ohio was ordered to stop
claiming
that its colloidal silver product was a "natural antibiotic and
anti-inflammatory immune system stimulant" and that it was
effective
against cancer, staph, strep, influenza, general body infections,
inflammation, impaired immune system, fungus toxicity, tonsillitis,
Meniere's symptoms, whooping cough, shingles, syphilis, cholera,
and
malaria. The labeling also stated that colloidal silver could cause
major growth stimulation of human tissues and can regenerate
Silverado Inc., of Bountiful, Utah, was warned to stop making false
claims that its colloidal silver product was effective as an
antibiotic, anti-inflammatory, anti-viral, and anti-fungal agent
and
that it could stimulate the immune system.
Unic, of Carmichael, California, was ordered to stop claiming that
its
colloidal silver product was effective against many diseases and
could
heal burn-damaged tissue without scarring.
In October 1996, the FDA proposed to ban the use of colloidal
silver
or silver salts in over-the-counter products [8]. A Final Rule
banning
such use was issued on August 17, 1999 and became effective
September
16th. The rule applies to any nonprescription colloidal silver or
silver salt product claimed to be effective in preventing or
treating
any disease [9]. Silver products can still be sold as "dietary
supplements" provided that no health claims are made for them.
During
2000, the FDA issued warnings to more than 20 companies
http://www.fda.gov/cder/warn/cyber/cyber2000.htm
whose Web sites were making illegal therapeutic claims for
colloidal
silver products.
In 2000, the Federal Court of Australia banned Vital Earth Company
Pty
Limited and its director Darryl John Jones from falsely
representing
that the colloidal silver produced by their "Vital Silver 3000
Zapper," "Vital Silver 2000 Automatic" and "Vital Silver 2000":
Can kill all disease-causing bacteria, fungi and virus within six
minutes of contact
Has no harmful side effects; that colloidal silver could be used as
an
antibiotic for all the acquired diseases of active AIDS
Is effective with more than 650 different pathogenic bacteria and
virus types
Has been used successfully against diseases including AIDS,
cholera,
diabetes, leprosy, leukemia, lupus, skin cancer, syphilis and
whooping
cough.
The company was also ordered to pay AUS$9000 in costs and to
provide
refunds [10].
In 2001, the FTC obtained consent agreements with two companies:
Robert C. Spencer and Lisa M. Spencer, doing business as Aaron
Company
(Palm Bay, Florida). Colloidal silver has been medically proven to
kill over 650 disease-causing organisms in the body and is
effective
in curing diseases ranging from cancer and multiple sclerosis to
HIV/AIDS [11].
ForMor, Inc., doing business as ForMor International, and its
president, Stan Gross (Birmingham, Alabama) agreed not to make
unsubstantiated claims that colloidal silver is effective in
treating
over 650 infectious diseases, has no adverse side effects, and is
effective against arthritis, blood poisoning, cancer, cholera,
diphtheria, diabetes, dysentery, gonorrhea, herpes, influenza,
leprosy, lupus, malaria, meningitis, rheumatism, shingles, staph
infections, strep infections, syphilis, tuberculosis, whooping
cough,
and yeast infections [11].
In 2002, the FTC obtained a consent agreement with Kris Pletschke,
doing business as Raw Health, http://www.rawhealth.net/ agreed to stop
making unsubstantiated claims that its colloidal silver product
could
treat or cure 650 different diseases; eliminate all pathogens in
the
human body in six minutes or less; and is medically proven to kill
every destructive bacterial, viral, and fungal organism in the
body,
including anthrax, Ebola, Hanta, and flesh-eating bacteria [12].
In 2002, the Australian Therapeutic Goods Administration amended
its
rules so that water-treatment products containing substances like
colloidal silver for which therapeutic claims are made must meet
the
requirements of medicines included in the Australian Register of
Therapeutic Goods. This means that such products can no longer be
legally marketed without proof that they are safe and effective for
their intended purpose. The amendment was based on clnclusions
that:
There is little evidence to support therapeutic claims made for
colloidal silver products;
The risk to consumers of silver toxicity outweighs the value of
trying
an unsubstantiated treatment, and bacterial resistance to silver
can
occur
Efforts should be made to curb the illegal availability of
colloidal
silver products, which is a significant public health issue [13] .
References
1. Product brochure. Changes International, 1997. Downloaded in
1998.
Seasilver International Product Information
http://web.archive.org/web/19981207065006/seasilver.com/productinfo.htm
, accessed October 12, 1998.
2. Fung MC, Bowen DL. Silver products for medical indications:
risk-benefit assessment
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&...
Journal of Toxicology and Clinical Toxicology 34:119-26, 1996.
4. Gulbranson SH and others. Argyria following the use of dietary
supplements containing colloidal silver protein.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&...
Cutis 66:373-374, 2000.
5. Hori K and others. Believe it or not -- Silver still poisons!
Veterinary and Human Toxicology 44(5):291-292, 2002.
6. Blue Is the color of my candidate's skin.
http://www.foxnews.com/printer_friendly_story/0%2C3566%2C64692%2C00.html
Associated Press, Oct 2, 2002
7. Cohen LE and others. Effects of Internet quackery: Argyria in
the
silver state. Federal Practitioner 21(4):9-17, 2004.
8. Federal Register
http://www.access.gpo.gov/su_docs/aces/aaces002.html
61:53685-53688, 1996. (To access this document, search the 1996
volume
for "colloidal silver.")
9. FDA. Final rule: Over-the-counter drug products containing
colloidal silver ingredients or silver salts.
http://frwebgate4.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=06028...
Federal Register 64:44653-44658, 1999. Download PDF version
http://frwebgate4.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=06028...
10. Refunds for buyers of alternative therapy devices.
http://www.accc.gov.au/media/mr2000/mr-87-00.htm
News release, Australian Competition and Consumer Commission., May
5,
20
11. "Operation Cure.All" wages new battle in ongoing war against
Internet health fraud
http://www.ftc.gov/opa/2001/06/cureall.htm
12. . FTC news release, June 14, 2001.
FTC announces first two enforcement actions against purveyors of
bioterrorism defense products.
http://www.ftc.gov/opa/2002/02/vitalraw.htm
FTC news release, Feb 27, 2002.
13. Regulation of colloidal silver and related products.
http://www.tga.health.gov.au/docs/html/csilver.htm
Therapeutic Goods Administration Web site, Aug 19, 2003.
For Further Information
Rosemary Jacobs
http://homepages.together.net/~rjstan/
, an argyria victim, has made a detailed study of the colloidal
silver
marketplace and is willing to answer questions.
mailto:rjs...@together.net
This article was revised on May 5, 2004.
-------------------------------------------------------------------
Between October 1993 and September 1994, the FDA issued warning
letters to five
colloidal silver marketers::
* Higher Education Library Publications (H.E.L.P.), of
Springfield, Utah,
was ordered to stop claiming that its colloidal silver product was
effective as
a natural antibiotic and might be effective against cancer,
genito-urinary
diseases, tuberculosis, and AIDS.
* Nutrition, Inc., of Arvada, Colorado, was ordered to stop
stating or
implying that its Silvicidal, when administered orally or
intravenously, was
nontoxic, FDA-approved, and was a broad-spectrum antibiotic that
killed
bacteria and all virus and fungal infections. In addition, it was
falsely
claimed to be effective against a long list of specific diseases.
* Reseau International of Cincinnati, Ohio was ordered to stop
claiming
that its colloidal silver product was a "natural antibiotic and
anti-inflammatory immune system stimulant" and that it was
effective
against
cancer, staph, strep, influenza, general body infections,
inflammation,
impaired immune system, fungus toxicity, tonsillitis, Meniere's
symptoms,
whooping cough, shingles, syphilis, cholera, and malaria. The
labeling also
stated that colloidal silver could cause major growth stimulation
of
human
tissues and can regenerate
* Silverado Inc., of Bountiful, Utah, was warned to stop making
false
claims that its colloidal silver product was effective as an
antibiotic,
anti-inflammatory, anti-viral, and anti-fungal agent and that it
could
stimulate the immune system.
* Unic, of Carmichael, California, was ordered to stop claiming
that its
colloidal silver product was effective against many diseases and
could heal
burn-damaged tissue without scarring.
In October 1996, the FDA proposed to ban the use of colloidal
silver
or silver
salts in over-the-counter products [7]. A Final Rule banning such
use
was
issued on August 17, 1999 and became effective September 16th. The
rule applies
to any nonprescription colloidal silver or silver salt product
claimed to be
effective in preventing or treating any disease [8]. Silver
products
can still
be sold as "dietary supplements" provided that no health claims are
made for
them. During 2000, the FDA issued warnings to more than 20
companies
whose Web
sites were making illegal therapeutic claims for colloidal silver
products.
In 2000, the Federal Court of Australia banned Vital Earth Company
Pty Limited
and its director Darryl John Jones from falsely representing that
the
colloidal
silver produced by their "Vital Silver 3000 Zapper," "Vital Silver
2000
Automatic" and "Vital Silver 2000":
* Can kill all disease-causing bacteria, fungi and virus within
six minutes
of contact
* Has no harmful side effects; that colloidal silver could be
used as an
antibiotic for all the acquired diseases of active AIDS
* Is effective with more than 650 different pathogenic bacteria
and virus
types
* Has been used successfully against diseases including AIDS,
cholera,
diabetes, leprosy, leukemia, lupus, skin cancer, syphilis and
whooping cough.
The company was also ordered to pay AUS$9000 in costs and to
provide
refunds
[9].
In 2001, the FTC obtained consent agreements with two companies:
* Robert C. Spencer and Lisa M. Spencer, doing business as Aaron
Company
(Palm Bay, Florida). Colloidal silver has been medically proven to
kill over
650 disease-causing organisms in the body and is effective in
curing
diseases
ranging from cancer and multiple sclerosis to HIV/AIDS [10].
* ForMor, Inc., doing business as ForMor International, and its
president,
Stan Gross (Birmingham, Alabama) agreed not to make unsubstantiated
claims that
colloidal silver is effective in treating over 650 infectious
diseases, has no
adverse side effects, and is effective against arthritis, blood
poisoning,
cancer, cholera, diphtheria, diabetes, dysentery, gonorrhea,
herpes,
influenza,
leprosy, lupus, malaria, meningitis, rheumatism, shingles, staph
infections,
strep infections, syphilis, tuberculosis, whooping cough, and yeast
infections
[10].
In 2002, the FTC obtained a consent agreement with Kris Pletschke,
doing
business as Raw Health, agreed to stop making unsubstantiated
claims
that its
colloidal silver product could treat or cure 650 different
diseases;
eliminate
all pathogens in the human body in six minutes or less; and is
medically proven
to kill every destructive bacterial, viral, and fungal organism in
the body,
including anthrax, Ebola, Hanta, and flesh-eating bacteria [12].
In 2002, the Australian Therapeutic Goods Administration amended
its
rules so
that water-treatment products containing substances like colloidal
silver for
which therapeutic claims are made must meet the requirements of
medicines
included in the Australian Register of Therapeutic Goods. This
means
that such
products can no longer be legally marketed without proof that they
are safe and
effective for their intended purpose. The amendment was based on
clnclusions
that:
* There is little evidence to support therapeutic claims made for
colloidal
silver products;
* The risk to consumers of silver toxicity outweighs the value of
trying an
unsubstantiated treatment, and bacterial resistance to silver can
occur
* Efforts should be made to curb the illegal availability of
colloidal
silver products, which is a significant public health issue [11] .
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