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Silver NOT Safe NOT Effective NOT Approved!
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| a_weisman@yahoo.com 2005-01-31, 11:20 am |
| =3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
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AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
http://www.access.gpo.gov/su_docs/a...0.html#frbrowse
------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a=AD=AD final
rule
establishing that all over-the-counter (OTC) drug products
c=AD=ADontaining
colloidal silver ingredients or silver salts for internal or=AD=AD
external
use are not generally recognized as safe and effective and a=AD=ADre
misbranded. FDA is issuing this final rule because many OTC =AD=ADdrug
products containing colloidal silver ingredients or silver s=AD=ADalts
are
being marketed for numerous serious disease conditions and F=AD=ADDA is
not
aware of any substantial scientific evidence
that supports the use of OTC colloidal silver ingredients or=AD=AD silver
salts for these disease conditions.
DATES: This regulation is effective September 16, 1999.
FOR FURTHER INFORMATION CONTACT: Bradford W. Williams, Cente=AD=ADr for
Drug
Evaluation and Research (HFD-310), Food and Drug Administrat=AD=ADion,
7520
Standish Pl., Rockville, MD 20855, 301-594-0063.
SUPPLEMENTARY INFORMATION:
I=2E Background
In the Federal Register of October 15, 1996 (61 FR 53685), F=AD=ADDA
published a proposed rule to declare that all OTC drug produ=AD=ADcts
containing colloidal silver ingredients or silver salts are =AD=ADnot
generally recognized as safe and effective, and are new drug=AD=ADs and
misbranded within the meaning of section 201(p) of the Feder=AD=ADal
Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). Colloid=AD=ADal
silver
is a suspension of silver particles in a colloidal base. In =AD=ADrecent
years, colloidal silver preparations of unknown formulation =AD=ADhave
been
appearing in retail outlets. These products are labeled for
=AD=ADnumerous
disease conditions, many of which are serious diseases. The =AD=ADdosage
form
of these colloidal silver products is usually oral, but prod=AD=ADuct
labeling also contains directions for topical and, occasiona=AD=ADlly,
intravenous use.
FDA has not approved a new drug application (NDA) for any co=AD=ADlloidal
silver product. None of the silver salts evaluated as part o=AD=ADf FDA's
OTC
drug review was found to be generally recognized as safe and=AD=AD
effective
for its intended use(s). FDA is not aware of any substantial
scientific
evidence that supports the use of OTC colloidal silver ingre=AD=ADdients
or
silver salts for disease conditions. The agency invited any
=ADinterested
parties to collect and submit any existing data and informat=AD=ADion
that
support the safety and effectiveness of colloidal silver
ing=AD=ADredients
or
silver salts for any of the uses not already evaluated under=AD=AD the
OTC
drug review. Interested persons were invited to submit writt=AD=ADen
comments
on the proposed regulation and on the agency's economic impa=AD=ADct
determination by January 13, 1997.
In response to the proposal, the agency received 251 respons=AD=ADes.
Copies
of these comments are on public display in the Dockets Manag=AD=ADement
Branch (HFA-305), Food and Drug Administration, 5630 Fishers=AD=AD Lane,
rm.
1061, Rockville, MD 20852. Additional information that has c=AD=ADome to
the
agency's attention since publication of the proposal is also=AD=AD on
public
display in the Dockets Management Branch.
Based on the information set forth in the proposed rule, and=AD=AD after
consideration of the information submitted by the public com=AD=ADments
(as
summarized as follows), FDA is declaring that all OTC drug p=AD=ADroducts
containing colloidal silver ingredients or silver salts are =AD=ADnot
generally recognized as safe and effective, and are new drug=AD=ADs and
misbranded within the meaning of section 201(p) of the act.
=AD=ADAdequate
safety and effectiveness data have not been provided to esta=AD=ADblish
general recognition of the safety and effectiveness of collo=AD=ADidal
silver
or silver salt ingredients for any OTC drug uses. The data
s=AD=ADubmitted
did not include the required absorption, metabolism, tissue
distribution, accumulation, excretion, and pharmacodynamics =AD=AD(effect
of
the drug at its action site) of silver in the body, both whe=AD=ADn taken
internally and applied externally, and of the effect of the
=AD=ADparticle
size of the silver on these systemic effects.
FDA is amending subpart E of part 310 (21 CFR part 310) to a=AD=ADdd Sec.
310.548 for OTC drug products containing colloidal silver
in=AD=ADgredients
or silver salts. The agency has expanded proposed Sec. 310.5=AD=AD48(a)
to
include some additional silver ingredients.
..=2E.
Silver Lady/colloidal silver/agyria/Rosemary Jacob's story =AD=ADpage
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
http://www.wishgranted.com/
CS Cons:
Colloidal Silver CONS
http://www.quackwatch.com/01Quacker...s/silverad.html
The Silver Supplement Fraud
Guess who took the colloidal silver (CS)? Rosemary did. That=AD=AD's why
she
is slate-gray. The condition is called argyria. It is irreve=AD=ADrsible
and
cannot be covered by makeup.
Actually, Rosemary's doctor in New York prescribed CSP for h=AD=ADer back
in
the fifties as a treatment for allergies. It was sold as a d=AD=ADrug
then.
Today it is sold as a dietary supplement. You can find it in=AD=AD
"health
food" stores and on the Internet. You can even buy the equip=AD=ADment to
make your own. It was snake oil when it was given to Rosemar=AD=ADy. It
is
snake oil now.
The only thing Rosemary recommends CSP for is a gray skin dy=AD=ADe. She
knows that it is safe, effective, and permanent when used fo=AD=ADr that
purpose. She also knows that being a gray person in a black =AD=ADand
white
world can have a serious negative impact on your social and
=AD=ADeconomic
life.
Promoters claim that CSP prevents and cures 650 diseases inc=AD=ADluding
Aids and cancer. They say that people with even a trace of s=AD=ADilver
in
their bodies don't get sick!
Both Rosemary and the FDA have asked them for their proof. A=AD=ADll they
get are quotes from old quacks who manufactured the stuff at=AD=AD the
turn
of the century, misquotes from reputable authors and wonderf=AD=ADul
anecdotes. "I've taken it everyday for four years and feel g=AD=ADreat,"
the
saleslady says.
The only problem Rosemary has with the anecdotes is that the=AD=ADy are
selectively chosen to sell CSP. The promoters refuse to incl=AD=ADude her
negative anecdotes or those of all the other argyric people
=AD=ADrecorded
in the medical literature. Rosemary had breast cancer at the=AD=AD age of
42. The silver in her body made her face so gray that the nu=AD=ADrses in
pre-op thought that she was in cardiac arrest! The promoters=AD=AD won't
tell you this though.
The FDA has told the promoters that if they want to continue=AD=AD making
medical claims for CSP they will have to first have it appro=AD=ADved as
a
drug. Of course, that doesn't stop them from selling the stu=AD=ADff as a
"dietary supplement." It just prevents them from legally wri=AD=ADting
their
claims on the label or putting them in their ads.
And, oh yes, if you do decide to use CSP, have the product a=AD=ADnalysed
by
an independent lab. According to the dietary supplement indu=AD=ADstry
itself, a lot of the stuff tested that is labelled colloidal=AD=AD silver
really isn't. You see "dietary supplements," thanks to inten=AD=ADse
industry lobbying are unregulated by any government agency. =AD=ADSo very
often what is on the label isn't in the bottle. In fact, wha=AD=ADt is in
the bottle may even be something more toxic than CSP. Buyer =AD=ADbeware!
P=2ES. 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=AD=AD do
that
anymore. I had to stand up and shout, "Look at me! I'm gray.=AD=AD" I had
to
warn the public. A local newspaper broke my story with the
h=AD=ADeadline,
"The silver woman from Long Island. The face that no one for=AD=ADgets."
I wasn't always gray. I was born white in Brooklyn, New York=AD=AD, in
1942.
When I was eleven years old, my mother mentioned to an MD --=AD=AD an
eye,
ear, nose and throat specialist on Long Island -- that I alw=AD=ADays had
a
cold. He told her that it had to be allergies and prescribed=AD=AD 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 friend=AD=ADs and I
volunteered to work in the local hospital as "candy stripers=AD=AD." The
hospital was run by a Catholic order of nursing sisters who
=AD=ADrequired
that all new volunteers attend a class at their convent once=AD=AD a week
on
Saturday mornings. The nun who gave the course was also a nu=AD=ADrse and
a
pharmacist. One morning when I walked in she was very startl=AD=ADed by
my
appearance.
"Why are you that color?" she asked. What color? No one had =AD=ADnoticed
that my color was weird until then. She repeated, "Why are y=AD=ADou that
color? Ask the doctor." Suddenly everyone noticed. I was
sla=AD=ADte-gray.
We had a family friend, a general practitioner, who made an
appointment for me to see a dermatologist. Meanwhile, Saturd=AD=ADay
rolled
around again and I went back to class. This time Sister gree=AD=ADted me
with, "You're taking nose drops, aren't you?" I told her I w=AD=ADas.
"Stop," she said. "They have silver in them. That's why you'=AD=ADre
gray."
She had seen another nursing sister at the hospital with the=AD=AD same
skin
discoloration which was also caused by nose drops, probably =AD=ADfrom
the
same doctor who was on their staff. The dermatologist took o=AD=ADne 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 spec=AD=ADks of
silver in my skin. Unfortunately, that is the only informati=AD=ADon that
I
have ever been able to get about the drug that disfigured me=AD=AD. No
one
ever sued doctors back then.
When as a young adult I had difficulty getting jobs because=AD=AD people
didn't like my appearance, the lawyers I consulted told me t=AD=ADhat New
York is one of the few states with a statute of limitations =AD=ADon
malpractice suits. I never really wanted to sue the doctor. =AD=ADHe was
a
good person who made a tragic mistake. He read the ads from =AD=ADdrug
companies instead of the medical literature. (1)(2)(3)
Old Garbage
All kinds of silver medicinals, as well as many other dubiou=AD=ADs and
noxious drugs, were used by desperate physicians before the =AD=ADadvent
of
antibiotics. Any student of history can tell you how ineffec=AD=ADtive
they
were.
Colloidal silver (CSP) is not a new alternative remedy. It i=AD=ADs an
old,
discarded traditional one that homeopaths and other people c=AD=ADalling
themselves "alternative health-care practitioners" have pull=AD=ADed out
of
the garbage pail of useless and dangerous drugs and therapie=AD=ADs,
things
mainstream medicine threw away decades ago.
In 1935 Gaul & Staud wrote about colloidal silver in The Jou=AD=ADrnal of
the American Medical Association (JAMA), "The alarming incre=AD=ADase of
argyrosis leaves little doubt as to our purpose in this repo=AD=ADrt.
There
has been an accumulation of indubitable clinical evidence wh=AD=ADich
makes
it imperative to present before those who prescribe, dispens=AD=ADe or
use
these drugs the danger entailed therein...The obvious
respon=AD=ADsibility
for this injudicious medication rests with the circularized
advertisements by the various manufacturers to the physician=AD=ADs;" (4)
In 1940 Bryant added, "Conscientious observers in the field =AD=ADof
otolaryngology can no longer doubt the occurrence of general=AD=ADized
argyria caused by intranasal silver medications," and "A per=AD=ADsistent
indifferent attitude to this on the part of otolaryngologist=AD=AD might
be
condoned if it were possible through the use of such medicat=AD=ADion to
achieve beneficial results for the patient which could not b=AD=ADe
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 isotoni=AD=ADc
solution. (5) He continues, "The use of silver-containing na=AD=ADsal
medication over even a few weeks is dangerous and accomplish=AD=ADes
nothing
that cannot be accomplished safely and more efficiently by o=AD=ADther
means." (6)
The New Old Miracle
In 1995 I discovered that CSP, one of the drugs that causes
=AD=ADargyria,
was again being aggressively promoted. It was being sold ove=AD=ADr the
Internet where you could buy equipment to make your own, in =AD=AD"health
food stores" and by MLMs (multilevel marketers). Promoters w=AD=ADere
claiming that silver is an "essential mineral" and that even=AD=AD a
trace
amount in the body prevents serious illness. They also claim=AD=ADed that
it
was a pre-1938 OTC (over-the-counter drug) that cures 650 sp=AD=ADecific
conditions and diseases such as cancer, AIDS, acne, and lupu=AD=ADs. They
passed off their promotional material on the Internet and in=AD=AD books
and
magazines as if it were the gospel truth.
I thought the promoters were ignorant people who had made a
=AD=ADterrible
mistake, but when I contacted several of them and discovered=AD=AD that
they
were not interested in hearing my story, they would not chan=AD=ADge
their
ads and they refused to include my negative anecdotes along =AD=ADwith
their
positive ones, I knew that they weren't ignorant.
They were quacks who were deliberately lying to sell their p=AD=ADroduct.
The response I got from the owner of a store that sells the =AD=ADstuff
was
pretty typical. I told him that my skin is gray from the ing=AD=ADestion
of
silver adding that silver in my body has never benefited me.=AD=AD I had
breast cancer at the age of 42. In the year that I was born,=AD=AD 1942,
a
Dr. Levine wrote an article in the New England Journal of Me=AD=ADdicine
stating that all doctors had seen cases of argyria, but it w=AD=ADas
rarely
reported in the medical literature. (7) In searching that
li=AD=ADterature
for thirty years I have never found any evidence that silver=AD=AD in a
person's body benefits anyone other than the quack who sold =AD=ADit.
If, in fact, it did do all the wonderful things that the pro=AD=ADmoters
claim, Queen Victoria and the Rockefellers would still be al=AD=ADive and
they would be gray like me.
I gave the merchant a fist full of medical literature to
sub=AD=ADstantiate
my claims and asked for proof that the product he sold with =AD=ADthe
colloidal silver label on it was in fact safe and effective =AD=ADfor
something, anything. I wanted to know how he knew that it ac=AD=ADtually
did
all the great things claimed and how he knew that it wouldn'=AD=ADt cause
argyria. He said he'd have to contact his supplier and get b=AD=ADack to
me.
The "Evidence"
When he phoned and said that he had the material I had reque=AD=ADsted,
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=AD=AD I'd
glance at the "evidence" and leave. Instead, I asked if I co=AD=ADuld
take
it next door to copy. Reluctantly, she agreed.
What a gold mine that turned out to be. The same names, Dr. =AD=ADHenry
Crookes, Sir Malcolm Morris, A. Legge Roe, and R.J. Hartman =AD=AD-- to
name
a few -- kept popping up in all the promotional material. Wh=AD=ADile
most
promoters pretended that these people were contemporary
rese=AD=ADarchers,
some of the material that the store owner gave me contained
=AD=ADcitations
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 E=AD=ADngland
at
the turn of the century. (8) He sold many different alleged
=AD=ADcolloidal
preparations under the Collosol trade name. (9) Collosol Arg=AD=ADentum
was
the brand name of his colloidal silver. (10) Malcolm Morris =AD=ADwas
rumored to be on his board of directors. (11)
In 1919 JAMA's Council on Pharmacy and Chemistry ruled that
=AD=ADCollosol
Argentum, along with several other of the Crookes' Laborator=AD=ADy
products, were "inadmissible to New and Nonofficial Remedies=AD=AD,"
stating
that "In the few cases in which the therapeutic claims for t=AD=ADhese
preparations were examined, the claims were found to be so
i=AD=ADmprobable
or exaggerated as to have necessitated the rejection of thes=AD=ADe
products." (12)
Further down in the same article referring to Collosol Hydra=AD=ADrgyrum
and
Collosol Ferrum they said that, "If either of these preparat=AD=ADions
were
injected intravenously as directed, death might result, maki=AD=ADng the
physician morally if not legally liable." (13)
A=2E Legge Roe did write about the great success he had treati=AD=ADng
gonorrhoeal opthamalia with collosol argentum. He also state=AD=ADd, "It
is
the most useful preparation that has been placed in our hand=AD=ADs since
the introduction of cocaine." (14)
In 1939 Hartman, a chemist not a medical doctor, included a =AD=ADchapter
on
colloids in medicine in his chemistry book. On p.536 he said=AD=AD that
CSP
is safe enough to be put into the eyes and nose. He also sta=AD=ADted on
the
same page that, "Intramuscular injections of colloidally sus=AD=ADpended
lead are of value in arresting certain cancerous growths." (=AD=AD15) His
source for all the material on colloids in medicine was Croo=AD=ADkes
Laboratories.
I felt as if I were doing quack genealogy. A quack quoting a=AD=AD quack
quoting a quack.
Misquoted Reputable Authors
Another article about silver that colloidal silver promoters=AD=AD often
referred to was one by Jim Powell which appeared in the Marc=AD=ADh 1978
edition of the now defunct popular magazine Science Digest. =AD=ADThey
always referred to it as "Our Mightiest Germ Fighter."
When I tracked down the magazine, I discovered that the arti=AD=ADcle
didn't
mention colloidal silver and that the full title was, "Perha=AD=ADps it
soon
will be recognized as OUR MIGHTIEST GERM FIGHTER."
Why do you think promoters never mention the first half of t=AD=ADhe
title?
Could it be because they know that the promise never materia=AD=ADlized
and
they don't want readers to find out?
Another reference constantly appearing in the quack promotio=AD=ADnal
material is the book ARGYRIA, (16) which truly is the defini=AD=ADtive
work
on the subject. It was written in 1939 by Hill and Pillsbury=AD=AD.
Promoters say that it states that "properly prepared colloid=AD=ADal
silver"
never caused argyria and that 95 percent of the cases result=AD=ADed from
silver nitrate.
What the book really says, and I'm probably one of the few p=AD=ADeople
on
earth who has a copy, is that in a study of 214 cases for wh=AD=ADich
data
was available, "silver nitrate is the responsible compound i=AD=ADn over
half the cases. Again it must be pointed out that the number=AD=AD of
cases
due to other compounds may be no real indication of their re=AD=ADlative
capacity for the production of argyria, but rather an eviden=AD=ADce of
their popularity as a medicinal agent." (17)
Regarding CSP, "It is impossible to make a definitive statem=AD=ADent
concerning the amount of a colloidal silver compound which m=AD=ADay be
instilled into a body cavity without the possibility of argy=AD=ADria."
(18)
The authors called for further studies and warning labels on=AD=AD all
silver medicinals. (19) They also pointed out that it had ne=AD=ADver
been
determined whether or not individual susceptibilities exist.=AD=AD Are
some
people more likely to develop argyria than others? (20) We s=AD=ADtill
don't
know.
Hill & Pillsbury added, "there is no evidence indicating tha=AD=ADt the
giving of extremely small amounts of silver over a prolonged=AD=AD period
in
any way lessens the danger of argyria from any given amount =AD=ADof
silver
compound." (21)
In 1975 Goodman & Gilman stated that, "There is no acceptabl=AD=ADe
evidence
that the routine use of silver solutions for the prophylaxis=AD=AD of
colds
or other respiratory tract infections is at all efficacious,=AD=AD and
cases
of argyria have resulted from this practice. Fortunately, th=AD=ADe
colloidal silver preparations are now in a deserved oblivion=AD=AD." (22)
There is no animal model for argyria. (23) It can take decad=AD=ADes to
develop. (24) There have been reported cases in which it did=AD=AD not
appear until several years after the drug was discontinued. =AD=AD(25)
Silver workers have developed argyria, presumably from inhal=AD=ADing
silver
dust. (26) One person's skin discoloration was caused by the
electrolytic action between a gold and a silver filing. Sali=AD=ADva
caused
the silver to go into solution. (27)
1990s Snake Oil
Contrary to promoters' claims, we still ingest silver in our=AD=AD diets.
(28) Some drinking water contains silver. At what concentrat=AD=ADion of
silver does drinking water turn into CSP? I've never been ab=AD=ADle to
get
a salesperson to tell me this. Hopefully all they are really=AD=AD
selling
is very expensive, distilled water, but no one knows for sur=AD=ADe since
CSP is now sold as a "dietary supplement." As such it is
unr=AD=ADegulated
by any government agency. Only the manufacturer knows what's=AD=AD in the
bottle.
On p. 26 of the April 1997 issue of Vegetarian Times, a maga=AD=ADzine
that
promotes supplements, it states that the National Nutritiona=AD=ADl Foods
Association (NNFA), a trade group in Newport Beach, CA, says=AD=AD that
"some metal colloid products have been found to be high in t=AD=ADoxic
metals such as aluminum. Others have no detectable levels of=AD=AD the
desirable metal listed on the label." NNFA advises consumers=AD=AD taking
colloidal silver to have it analyzed by an independent labor=AD=ADatory.
A doctor told me that he had a bottle of CSP prepared by a
p=AD=ADharmacist
analyzed and discovered that it was just very expensive tap =AD=ADwater.
I
find it very interesting that probably thousands of people a=AD=ADre all
reporting similar wonderful health and medical benefits from=AD=AD
products
that only have one thing in common, the labels all say "coll=AD=ADoidal
silver."
I believe this is ample proof that individuals and doctors a=AD=ADre not
capable of determining whether or not a drug is safe and eff=AD=ADective.
Scientific investigations start with anecdotal evidence, but=AD=AD 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
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=AD=AD=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D
Colloidal Silver: Risk without Benefit
http://www.quackwatch.org/01Quacker...s/silverad.html
Colloidal Silver:
Risk Without Benefit
Stephen Barrett, M.D.
Colloidal silver is a suspension of submicroscopic metallic =AD=ADsilver
particles in a colloidal base. Long-term use of silver prepa=AD=ADrations
can lead to argyria, a condition in which silver salts depos=AD=ADit in
the
skin, eyes, and internal organs, and the skin turns ashen-gr=AD=ADay.
Many
cases of argyria occurred during the pre-antibiotic era when=AD=AD silver
was a common ingredient in nosedrops. When the cause became
=AD=ADapparent,
doctors stopped recommending their use, and reputable manufa=AD=ADcturers
stopped producing them. The official drug guidebooks (United=AD=AD States
Pharmacopeia and National Formulary) have not listed colloid=AD=ADal
silver
products since 1975.
Dubious AdsIn recent years, silver-containing products have =AD=ADbeen
marketed with unsubstantiated claims that they are effective=AD=AD
against
AIDS, cancer, infectious diseases, parasites, chronic fatigu=AD=ADe,
acne,
warts, hemorrhoids, enlarged prostate, and many other diseas=AD=ADes and
conditions. Some marketers claim that colloidal silver is ef=AD=ADfective
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
s=AD=ADuspended
indefinitely in demineralized water that kills bacteria and
=AD=ADviruses.
It can be applied topically and/or absorbed into the blood s=AD=ADtream
sub-lingually (under the tongue), thereby avoiding the negat=AD=ADive
effects of traditional antibiotics that kill good bacteria i=AD=ADn the
lower digestive tract.
An all natural antibiotic alternative in the purest form ava=AD=ADilable.
The presence of colloidal silver near a virus, fungi, bacter=AD=ADium or
any
other single celled pathogen disables its oxygen-metabolism =AD=ADenzyme,
its chemical lung, so to say. The pathogens suffocates and d=AD=ADies,
and
is cleared out of the body by the immune, lymphatic and elim=AD=ADination
systems.
Unlike pharmaceutical antibiotics which destroy beneficial e=AD=ADnzymes,
colloidal silver leaves these beneficial enzymes intact. Thu=AD=ADs
colloidal silver is absolutely safe for humans, reptiles, pl=AD=ADants
and
all multi-celled living matter.
It is impossible for single-celled germs to mutate into
silver-resistant forms, as happens with conventional antibio=AD=ADtics.
Also, colloidal silver cannot interact or interfere with oth=AD=ADer
medicines being taken. Colloidal silver is truly a safe, nat=AD=ADural
remedy for many of mankind's ills. Colloidal silver can be t=AD=ADaken
indefinitely because the body does not develop a tolerance t=AD=ADo it
[1]
Seasilver International,
http://www.seasilver.com/
a California-based multilevel company, claims that American =AD=ADare
suffering from "silver deficiency." Although silver is not a=AD=ADn
essential nutrient, product information posted on the compan=AD=ADy's Web
site states:
The depletion of minerals in our soil has left us deficient =AD=ADof
silver,
one of our most essential trace minerals, causing a drastic
=AD=ADincrease
in immune system disorders in our society in the last decade=AD=AD.
Research
has taught us that all disease is allowed to manifest itself=AD=AD
because
of a weakened immune system. In over 20 years of worldwide r=AD=ADesearch
on
Colloidal Silver, numerous interviews with government agenci=AD=ADes,
health
care practitioners and their patients, no other nutrient, he=AD=ADrb or
drug
(prescription or over-the-counter) is as safe and effective =AD=ADagainst
all known forms of unfriendly virus, bacteria, and fungus.
Additionally, while it is generally known that most antibiot=AD=ADics
kill
only perhaps 6 or 7 different disease organisms, reports hav=AD=ADe shown
that Colloidal Silver has been used successfully in the trea=AD=ADtment
of
over 650 diseases! Furthermore, strains of disease organisms=AD=AD fail
to
develop in the presence of Colloidal Silver. Colloidal Silve=AD=ADr's
greatest attribute is its unique ability to function as a su=AD=ADperior
second immune system in the body! [2]
The ad below is from the July 1996 issue of Alternative Medi=AD=ADcine
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 ni=AD=ADne
commonly marketed colloidal silver products available at
hea=AD=ADlth-food
stores and concluded:
Two of the products were contaminated with microorganisms.
The amount of silver suspended in solution varied from produ=AD=ADct to
product and would gradually decrease over time.
Only five products actually showed antibacterial activity in=AD=AD a
laboratory test. To perform the test, she prepared a culture=AD=AD plate
with Staphylococcus aureas bacteria, which can cause infecti=AD=ADons in
humans. She then placed a drop from each product on the plat=AD=ADe and
used
disks of two common antibiotics as controls. After eight hou=AD=ADrs of
incubation, she found that bacterial growth had been inhibit=AD=ADed
around
the antibiotics and four of the products.
Of course, the fact that a product inhibits bacteria in a
la=AD=ADboratory
culture doesn't mean it is effective (or safe) in the human =AD=ADbody.
In
fact, products that kill bacteria in the laboratory would be=AD=AD more
likely to cause argyria because they contain more silver ion=AD=ADs that
are
free to deposit in the user's skin.
FDA laboratory studies have found that the amount of silver =AD=ADin some
product samples has varied from 15.2% to 124% of the amount =AD=ADlisted
on
the product labels. The amount of silver required to produce=AD=AD
argyria
is unknown. However, the FDA has concluded that the risk of =AD=ADusing
silver products exceeds any unsubstantiated benefit [3]. So =AD=ADfar,
nine
cases of argyria related to silver products have been report=AD=ADed:
A 56-year-old man who had sold and used colloidal silver for=AD=AD 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=AD=AD a
drink
prepared by administering an electrolytic charge to a bowl o=AD=ADf 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 h=AD=ADerbal
tea
for about 10 months [5].
Stan Jones, Montana's Libertarian Party candidate for the
U=2ES. Senate, who reportedly started taking colloidal silver=AD=AD in 1999
for fear that Y2K disruptions might lead to a shortage of
an=ADtibiotics.
He made his own concoction by electrically two silver wires =AD=ADin a
glass
of water [6].
Two men, ages 63 and 76, developed argyria after a year of p=AD=ADroduct
use
inspired by Internet claims [7]. Enforcement Actions
Between October 1993 and September 1994, the FDA issued warn=AD=ADing
letters to five colloidal silver marketers::
Higher education Library Publications (H.E.L.P.), of Springf=AD=ADield,
Utah, was ordered to stop claiming that its colloidal silver=AD=AD
product
was effective as a natural antibiotic and might be effective=AD=AD
against
cancer, genito-urinary diseases, tuberculosis, and AIDS.
Nutrition, Inc., of Arvada, Colorado, was ordered to stop st=AD=ADating
or
implying that its Silvicidal, when administered orally or
intravenously, was nontoxic, FDA-approved, and was a broad-s=AD=ADpectrum
antibiotic that killed bacteria and all virus and fungal
inf=AD=ADections.
In addition, it was falsely claimed to be effective against =AD=ADa long
list of specific diseases.
Reseau International of Cincinnati, Ohio was ordered to stop=AD=AD
claiming
that its colloidal silver product was a "natural antibiotic =AD=ADand
anti-inflammatory immune system stimulant" and that it was
e=AD=ADffective
against cancer, staph, strep, influenza, general body infect=AD=ADions,
inflammation, impaired immune system, fungus toxicity, tonsi=AD=ADllitis,
Meniere's symptoms, whooping cough, shingles, syphilis, chol=AD=ADera,
and
malaria. The labeling also stated that colloidal silver coul=AD=ADd cause
major growth stimulation of human tissues and can regenerate
Silverado Inc., of Bountiful, Utah, was warned to stop makin=AD=ADg false
claims that its colloidal silver product was effective as an
antibiotic, anti-inflammatory, anti-viral, and anti-fungal a=AD=ADgent
and
that it could stimulate the immune system.
Unic, of Carmichael, California, was ordered to stop claimin=AD=ADg that
its
colloidal silver product was effective against many diseases=AD=AD and
could
heal burn-damaged tissue without scarring.
In October 1996, the FDA proposed to ban the use of colloida=AD=ADl
silver
or silver salts in over-the-counter products [8]. A Final Ru=AD=ADle
banning
such use was issued on August 17, 1999 and became effective
=AD=ADSeptember
16th. The rule applies to any nonprescription colloidal silv=AD=ADer or
silver salt product claimed to be effective in preventing or=AD=AD
treating
any disease [9]. Silver products can still be sold as "dieta=AD=ADry
supplements" provided that no health claims are made for the=AD=ADm.
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
c=AD=ADolloidal
silver products.
In 2000, the Federal Court of Australia banned Vital Earth C=AD=ADompany
Pty
Limited and its director Darryl John Jones from falsely
repr=AD=ADesenting
that the colloidal silver produced by their "Vital Silver 30=AD=AD00
Zapper," "Vital Silver 2000 Automatic" and "Vital Silver 200=AD=AD0":
Can kill all disease-causing bacteria, fungi and virus withi=AD=ADn six
minutes of contact
Has no harmful side effects; that colloidal silver could be =AD=ADused as
an
antibiotic for all the acquired diseases of active AIDS
Is effective with more than 650 different pathogenic bacteri=AD=ADa and
virus types
Has been used successfully against diseases including AIDS,
=AD=ADcholera,
diabetes, leprosy, leukemia, lupus, skin cancer, syphilis an=AD=ADd
whooping
cough.
The company was also ordered to pay AUS$9000 in costs and to=AD=AD
provide
refunds [10].
In 2001, the FTC obtained consent agreements with two compan=AD=ADies:
Robert C. Spencer and Lisa M. Spencer, doing business as Aar=AD=ADon
Company
(Palm Bay, Florida). Colloidal silver has been medically pro=AD=ADven to
kill over 650 disease-causing organisms in the body and is
e=AD=ADffective
in curing diseases ranging from cancer and multiple sclerosi=AD=ADs to
HIV/AIDS [11].
ForMor, Inc., doing business as ForMor International, and it=AD=ADs
president, Stan Gross (Birmingham, Alabama) agreed not to ma=AD=ADke
unsubstantiated claims that colloidal silver is effective in=AD=AD
treating
over 650 infectious diseases, has no adverse side effects, a=AD=ADnd is
effective against arthritis, blood poisoning, cancer, choler=AD=ADa,
diphtheria, diabetes, dysentery, gonorrhea, herpes, influenz=AD=ADa,
leprosy, lupus, malaria, meningitis, rheumatism, shingles, s=AD=ADtaph
infections, strep infections, syphilis, tuberculosis, whoopi=AD=ADng
cough,
and yeast infections [11].
In 2002, the FTC obtained a consent agreement with Kris Plet=AD=ADschke,
doing business as Raw Health, http://www.rawhealth.net/ agreed to stop
making unsubstantiated claims that its colloidal silver prod=AD=ADuct
could
treat or cure 650 different diseases; eliminate all pathogen=AD=ADs in
the
human body in six minutes or less; and is medically proven t=AD=ADo kill
every destructive bacterial, viral, and fungal organism in t=AD=ADhe
body,
including anthrax, Ebola, Hanta, and flesh-eating bacteria [=AD=AD12].
In 2002, the Australian Therapeutic Goods Administration ame=AD=ADnded
its
rules so that water-treatment products containing substances=AD=AD like
colloidal silver for which therapeutic claims are made must =AD=ADmeet
the
requirements of medicines included in the Australian Registe=AD=ADr of
Therapeutic Goods. This means that such products can no long=AD=ADer be
legally marketed without proof that they are safe and effect=AD=ADive for
their intended purpose. The amendment was based on clnclusio=AD=ADns
that:
There is little evidence to support therapeutic claims made =AD=ADfor
colloidal silver products;
The risk to consumers of silver toxicity outweighs the value=AD=AD of
trying
an unsubstantiated treatment, and bacterial resistance to si=AD=ADlver
can
occur
Efforts should be made to curb the illegal availability of
c=AD=ADolloidal
silver products, which is a significant public health issue =AD=AD[13] .
References
1=2E Product brochure. Changes International, 1997. Downloade=AD=ADd in
1998.
Seasilver International Product Information
http://web.archive.org/web/19981207...productinfo.htm
, accessed October 12, 1998.
2=2E Fung MC, Bowen DL. Silver products for medical indication=AD=ADs:
risk-benefit assessment
http://www.ncbi.nlm.nih.gov/entrez/...db=3DPubMed&...
Journal of Toxicology and Clinical Toxicology 34:119-26, 19=AD=AD96.
4=2E Gulbranson SH and others. Argyria following the use of di=AD=ADetary
supplements containing colloidal silver protein.
http://www.ncbi.nlm.nih.gov/entrez/...db=3DPubMed&...
Cutis 66:373-374, 2000.
5=2E Hori K and others. Believe it or not -- Silver still pois=AD=ADons!
Veterinary and Human Toxicology 44(5):291-292, 2002.
6=2E Blue Is the color of my candidate's skin.
http://www.foxnews.com/printer_frie...64692%2C00.html
Associated Press, Oct 2, 2002
7=2E Cohen LE and others. Effects of Internet quackery: Argyri=AD=ADa in
the
silver state. Federal Practitioner 21(4):9-17, 2004.
8=2E Federal Register
http://www.access.gpo.gov/su_docs/aces/aaces002.html
61:53685-53688, 1996. (To access this document, search the 1=AD=AD996
volume
for "colloidal silver.")
9=2E FDA. Final rule: Over-the-counter drug products containin=AD=ADg
colloidal silver ingredients or silver salts.
http://frwebgate4.access.gpo.gov/cg...ocID=3D06028...
Federal Register 64:44653-44658, 1999. Download PDF version
http://frwebgate4.access.gpo.gov/cg...ocID=3D06028...
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 Commissio=AD=ADn., May
5,
20
11. "Operation Cure.All" wages new battle in ongoing war aga=AD=ADinst
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 purveyor=AD=ADs 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 colloi=AD=ADdal
silver
marketplace and is willing to answer questions.
mailto:rjs...@together.net
This article was revised on May 5, 2004.
------------------------------------------------------------=AD-------
Between October 1993 and September 1994, the FDA issued warn=AD=ADing
letters to five
colloidal silver marketers::
* Higher education Library Publications (H.E.L.P.), of
S=ADpringfield, Utah,
was ordered to stop claiming that its colloidal silver produ=AD=ADct was
effective as
a natural antibiotic and might be effective against cancer,
=ADgenito-urinary
diseases, tuberculosis, and AIDS.
* Nutrition, Inc., of Arvada, Colorado, was ordered to s=ADtop
stating or
implying that its Silvicidal, when administered orally or
in=ADtravenously, was
nontoxic, FDA-approved, and was a broad-spectrum antibiotic =AD=ADthat
killed
bacteria and all virus and fungal infections. In addition, i=AD=ADt was
falsely
claimed to be effective against a long list of specific dise=AD=ADases.
* Reseau International of Cincinnati, Ohio was ordered t=ADo s=ADtop
claiming
that its colloidal silver product was a "natural antibiotic =AD=ADand
anti-inflammatory immune system stimulant" and that it was
e=AD=ADffective
against
cancer, staph, strep, influenza, general body infections,
in=ADflammation,
impaired immune system, fungus toxicity, tonsillitis, Menier=AD=ADe's
symptoms,
whooping cough, shingles, syphilis, cholera, and malaria. Th=AD=ADe
labeling also
stated that colloidal silver could cause major growth stimul=AD=ADation
of
human
tissues and can regenerate
* Silverado Inc., of Bountiful, Utah, was warned to stop=AD ma=ADking
false
claims that its colloidal silver product was effective as an=AD=AD
antibiotic,
anti-inflammatory, anti-viral, and anti-fungal agent and tha=AD=ADt it
could
stimulate the immune system.
* Unic, of Carmichael, California, was ordered to stop c=ADlai=ADming
that its
colloidal silver product was effective against many diseases=AD=AD and
could heal
burn-damaged tissue without scarring.
In October 1996, the FDA proposed to ban the use of colloida=AD=ADl
silver
or silver
salts in over-the-counter products [7]. A Final Rule banning=AD=AD such
use
was
issued on August 17, 1999 and became effective September 16t=AD=ADh. The
rule applies
to any nonprescription colloidal silver or silver salt produ=AD=ADct
claimed to be
effective in preventing or treating any disease [8]. Silver
=AD=ADproducts
can still
be sold as "dietary supplements" provided that no health cla=AD=ADims are
made for
them. During 2000, the FDA issued warnings to more than 20
c=AD=ADompanies
whose Web
sites were making illegal therapeutic claims for colloidal s=AD=ADilver
products.
In 2000, the Federal Court of Australia banned Vital Earth C=AD=ADompany
Pty Limited
and its director Darryl John Jones from falsely representing=AD=AD that
the
colloidal
silver produced by their "Vital Silver 3000 Zapper," "Vital =AD=ADSilver
2000
Automatic" and "Vital Silver 2000":
* Can kill all disease-causing bacteria, fungi and virus=AD wi=ADthin
six minutes
of contact
* Has no harmful side effects; that colloidal silver cou=ADld =ADbe
used as an
antibiotic for all the acquired diseases of active AIDS
* Is effective with more than 650 different pathogenic b=ADact=ADeria
and virus
types
* Has been used successfully against diseases including =ADAID=ADS,
cholera,
diabetes, leprosy, leukemia, lupus, skin cancer, syphilis an=AD=ADd
whooping cough.
The company was also ordered to pay AUS$9000 in costs and to=AD=AD
provide
refunds
[9].
In 2001, the FTC obtained consent agreements with two compan=AD=ADies:
* Robert C. Spencer and Lisa M. Spencer, doing business =ADas =ADAaron
Company
(Palm Bay, Florida). Colloidal silver has been medically pro=AD=ADven to
kill over
650 disease-causing organisms in the body and is effective i=AD=ADn
curing
diseases
ranging from cancer and multiple sclerosis to HIV/AIDS [10].
* ForMor, Inc., doing business as ForMor International, =ADand=AD its
president,
Stan Gross (Birmingham, Alabama) agreed not to make unsubsta=AD=ADntiated
claims that
colloidal silver is effective in treating over 650 infectiou=AD=ADs
diseases, has no
adverse side effects, and is effective against arthritis, bl=AD=ADood
poisoning,
cancer, cholera, diphtheria, diabetes, dysentery, gonorrhea,=AD=AD
herpes,
influenza,
leprosy, lupus, malaria, meningitis, rheumatism, shingles, s=AD=ADtaph
infections,
strep infections, syphilis, tuberculosis, whooping cough, an=AD=ADd yeast
infections
[10].
In 2002, the FTC obtained a consent agreement with Kris Plet=AD=ADschke,
doing
business as Raw Health, agreed to stop making unsubstantiate=AD=ADd
claims
that its
colloidal silver product could treat or cure 650 different
d=AD=ADiseases;
eliminate
all pathogens in the human body in six minutes or less; and =AD=ADis
medically proven
to kill every destructive bacterial, viral, and fungal organ=AD=ADism in
the body,
including anthrax, Ebola, Hanta, and flesh-eating bacteria [=AD=AD12].
In 2002, the Australian Therapeutic Goods Administration ame=AD=ADnded
its
rules so
that water-treatment products containing substances like col=AD=ADloidal
silver for
which therapeutic claims are made must meet the requirements=AD=AD of
medicines
included in the Australian Register of Therapeutic Goods. Th=AD=ADis
means
that such
products can no longer be legally marketed without proof tha=AD=ADt they
are safe and
effective for their intended purpose. The amendment was base=AD=ADd on
clnclusions
that:
* There is little evidence to support therapeutic claims=AD ma=ADde for
colloidal
silver products;
* The risk to consumers of silver toxicity outweighs the=AD va=ADlue of
trying an
unsubstantiated treatment, and bacterial resistance to silve=AD=ADr can
occur
* Efforts should be made to curb the illegal availabilit=ADy o=ADf
colloidal
silver products, which is a significant public health issue =AD=AD[11] .
| |
| a_weisman@yahoo.com 2005-02-09, 3:13 pm |
| Check mate game set and match brent
a_weisman@yahoo.com wrote:
>
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=AD=AD=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D
>
>
>
> AGENCY: Food and Drug Administration, HHS.
>
>
> ACTION: Final rule.
> http://www.access.gpo.gov/su_docs/a...0.html#frbrowse
> ------------------------------------------------------------
> SUMMARY: The Food and Drug Administration (FDA) is issuing a=AD=AD
final
> rule
> establishing that all over-the-counter (OTC) drug products
> c=AD=ADontaining
>
>
> colloidal silver ingredients or silver salts for internal or=AD=AD
> external
>
>
> use are not generally recognized as safe and effective and a=AD=ADre
> misbranded. FDA is issuing this final rule because many OTC =AD=ADdrug
> products containing colloidal silver ingredients or silver s=AD=ADalts
> are
> being marketed for numerous serious disease conditions and F=AD=ADDA is
> not
>
>
> aware of any substantial scientific evidence
> that supports the use of OTC colloidal silver ingredients or=AD=AD
silver
>
> salts for these disease conditions.
>
>
> DATES: This regulation is effective September 16, 1999.
>
>
> FOR FURTHER INFORMATION CONTACT: Bradford W. Williams, Cente=AD=ADr for
> Drug
> Evaluation and Research (HFD-310), Food and Drug Administrat=AD=ADion,
> 7520
>
>
> Standish Pl., Rockville, MD 20855, 301-594-0063.
>
>
> SUPPLEMENTARY INFORMATION:
>
>
> I. Background
>
>
> In the Federal Register of October 15, 1996 (61 FR 53685), F=AD=ADDA
> published a proposed rule to declare that all OTC drug produ=AD=ADcts
> containing colloidal silver ingredients or silver salts are =AD=ADnot
> generally recognized as safe and effective, and are new drug=AD=ADs and
> misbranded within the meaning of section 201(p) of the Feder=AD=ADal
> Food,
> Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). Colloid=AD=ADal
> silver
>
>
> is a suspension of silver particles in a colloidal base. In
=AD=ADrecent
> years, colloidal silver preparations of unknown formulation =AD=ADhave
> been
>
>
> appearing in retail outlets. These products are labeled for
> =AD=ADnumerous
> disease conditions, many of which are serious diseases. The
=AD=ADdosage
> form
> of these colloidal silver products is usually oral, but prod=AD=ADuct
> labeling also contains directions for topical and, occasiona=AD=ADlly,
> intravenous use.
>
>
> FDA has not approved a new drug application (NDA) for any
co=AD=ADlloidal
>
> silver product. None of the silver salts evaluated as part o=AD=ADf
FDA's
>
> OTC
> drug review was found to be generally recognized as safe and=AD=AD
> effective
> for its intended use(s). FDA is not aware of any substantial
> scientific
> evidence that supports the use of OTC colloidal silver
ingre=AD=ADdients
> or
>
>
> silver salts for disease conditions. The agency invited any
> =ADinterested
> parties to collect and submit any existing data and informat=AD=ADion
> that
> support the safety and effectiveness of colloidal silver
> ing=AD=ADredients
> or
> silver salts for any of the uses not already evaluated under=AD=AD the
> OTC
> drug review. Interested persons were invited to submit writt=AD=ADen
> comments
> on the proposed regulation and on the agency's economic impa=AD=ADct
> determination by January 13, 1997.
>
>
> In response to the proposal, the agency received 251 respons=AD=ADes.
> Copies
> of these comments are on public display in the Dockets Manag=AD=ADement
> Branch (HFA-305), Food and Drug Administration, 5630 Fishers=AD=AD
Lane,
> rm.
> 1061, Rockville, MD 20852. Additional information that has c=AD=ADome
to
> the
> agency's attention since publication of the proposal is also=AD=AD on
> public
> display in the Dockets Management Branch.
>
>
> Based on the information set forth in the proposed rule, and=AD=AD
after
> consideration of the information submitted by the public com=AD=ADments
> (as
>
>
> summarized as follows), FDA is declaring that all OTC drug
p=AD=ADroducts
>
> containing colloidal silver ingredients or silver salts are =AD=ADnot
> generally recognized as safe and effective, and are new drug=AD=ADs and
> misbranded within the meaning of section 201(p) of the act.
> =AD=ADAdequate
> safety and effectiveness data have not been provided to esta=AD=ADblish
> general recognition of the safety and effectiveness of collo=AD=ADidal
> silver
> or silver salt ingredients for any OTC drug uses. The data
> s=AD=ADubmitted
> did not include the required absorption, metabolism, tissue
> distribution, accumulation, excretion, and pharmacodynamics
=AD=AD(effect
>
> of
> the drug at its action site) of silver in the body, both whe=AD=ADn
taken
>
> internally and applied externally, and of the effect of the
> =AD=ADparticle
> size of the silver on these systemic effects.
>
>
> FDA is amending subpart E of part 310 (21 CFR part 310) to a=AD=ADdd
Sec.
>
> 310.548 for OTC drug products containing colloidal silver
> in=AD=ADgredients
>
>
> or silver salts. The agency has expanded proposed Sec. 310.5=AD=AD48(a)
> to
> include some additional silver ingredients.
> ...
>
>
> Silver Lady/colloidal silver/agyria/Rosemary Jacob's story =AD=ADpage
> http://homepages.together.net/~rjstan/rose1.html
>
>
>
>
>
> http://www.aero-vision.com/~cheryl/alt.html:
>
> Colloidal Silver Pros:
> CS PROS
>
>
> http://www.wishgranted.com/
>
>
> CS Cons:
> Colloidal Silver CONS
>
http://www.quackwatch.com/01Quacker...s/silverad.html
>
>
>
> The Silver Supplement Fraud
>
>
> Guess who took the colloidal silver (CS)? Rosemary did. That=AD=AD's
why
> she
> is slate-gray. The condition is called argyria. It is
irreve=AD=ADrsible
> and
> cannot be covered by makeup.
>
>
> Actually, Rosemary's doctor in New York prescribed CSP for h=AD=ADer
back
>
> in
> the fifties as a treatment for allergies. It was sold as a d=AD=ADrug
> then.
>
>
> Today it is sold as a dietary supplement. You can find it in=AD=AD
> "health
> food" stores and on the Internet. You can even buy the equip=AD=ADment
to
>
> make your own. It was snake oil when it was given to Rosemar=AD=ADy. It
> is
> snake oil now.
>
>
> The only thing Rosemary recommends CSP for is a gray skin dy=AD=ADe.
She
> knows that it is safe, effective, and permanent when used fo=AD=ADr
that
> purpose. She also knows that being a gray person in a black =AD=ADand
> white
>
>
> world can have a serious negative impact on your social and
> =AD=ADeconomic
> life.
>
>
> Promoters claim that CSP prevents and cures 650 diseases
inc=AD=ADluding
> Aids and cancer. They say that people with even a trace of s=AD=ADilver
> in
> their bodies don't get sick!
>
>
> Both Rosemary and the FDA have asked them for their proof. A=AD=ADll
they
>
> get are quotes from old quacks who manufactured the stuff at=AD=AD the
> turn
>
>
> of the century, misquotes from reputable authors and wonderf=AD=ADul
> anecdotes. "I've taken it everyday for four years and feel
g=AD=ADreat,"
> the
> saleslady says.
>
>
> The only problem Rosemary has with the anecdotes is that the=AD=ADy are
> selectively chosen to sell CSP. The promoters refuse to incl=AD=ADude
her
>
> negative anecdotes or those of all the other argyric people
> =AD=ADrecorded
> in the medical literature. Rosemary had breast cancer at the=AD=AD age
of
>
> 42. The silver in her body made her face so gray that the nu=AD=ADrses
in
>
> pre-op thought that she was in cardiac arrest! The promoters=AD=AD
won't
> tell you this though.
>
>
> The FDA has told the promoters that if they want to continue=AD=AD
making
>
> medical claims for CSP they will have to first have it appro=AD=ADved
as
> a
> drug. Of course, that doesn't stop them from selling the stu=AD=ADff as
a
>
> "dietary supplement." It just prevents them from legally wri=AD=ADting
> their
> claims on the label or putting them in their ads.
>
>
> And, oh yes, if you do decide to use CSP, have the product
a=AD=ADnalysed
>
> by
> an independent lab. According to the dietary supplement indu=AD=ADstry
> itself, a lot of the stuff tested that is labelled colloidal=AD=AD
silver
>
> really isn't. You see "dietary supplements," thanks to inten=AD=ADse
> industry lobbying are unregulated by any government agency. =AD=ADSo
very
>
> often what is on the label isn't in the bottle. In fact, wha=AD=ADt is
in
>
> the bottle may even be something more toxic than CSP. Buyer
=AD=ADbeware!
>
>
>
> 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=AD=AD do
> that
> anymore. I had to stand up and shout, "Look at me! I'm gray.=AD=AD" I
had
>
> to
> warn the public. A local newspaper broke my story with the
> h=AD=ADeadline,
> "The silver woman from Long Island. The face that no one
for=AD=ADgets."
>
>
> I wasn't always gray. I was born white in Brooklyn, New York=AD=AD, in
> 1942.
> When I was eleven years old, my mother mentioned to an MD --=AD=AD an
> eye,
> ear, nose and throat specialist on Long Island -- that I alw=AD=ADays
had
> a
>
>
> cold. He told her that it had to be allergies and prescribed=AD=AD 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 friend=AD=ADs and
I
>
> volunteered to work in the local hospital as "candy stripers=AD=AD."
The
> hospital was run by a Catholic order of nursing sisters who
> =AD=ADrequired
> that all new volunteers attend a class at their convent once=AD=AD a
week
>
> on
> Saturday mornings. The nun who gave the course was also a nu=AD=ADrse
and
> a
>
>
> pharmacist. One morning when I walked in she was very startl=AD=ADed by
> my
> appearance.
>
>
> "Why are you that color?" she asked. What color? No one had
=AD=ADnoticed
>
> that my color was weird until then. She repeated, "Why are y=AD=ADou
that
>
> color? Ask the doctor." Suddenly everyone noticed. I was
> sla=AD=ADte-gray.
> We had a family friend, a general practitioner, who made an
> appointment for me to see a dermatologist. Meanwhile, Saturd=AD=ADay
> rolled
>
>
> around again and I went back to class. This time Sister gree=AD=ADted
me
> with, "You're taking nose drops, aren't you?" I told her I w=AD=ADas.
> "Stop," she said. "They have silver in them. That's why you'=AD=ADre
> gray."
>
>
> She had seen another nursing sister at the hospital with the=AD=AD same
> skin
> discoloration which was also caused by nose drops, probably =AD=ADfrom
> the
> same doctor who was on their staff. The dermatologist took o=AD=ADne
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 spec=AD=ADks of
> silver in my skin. Unfortunately, that is the only informati=AD=ADon
that
> I
>
>
> have ever been able to get about the drug that disfigured me=AD=AD. No
> one
> ever sued doctors back then.
>
>
> When as a young adult I had difficulty getting jobs because=AD=AD
people
> didn't like my appearance, the lawyers I consulted told me t=AD=ADhat
New
>
> York is one of the few states with a statute of limitations =AD=ADon
> malpractice suits. I never really wanted to sue the doctor. =AD=ADHe
was
> a
> good person who made a tragic mistake. He read the ads from =AD=ADdrug
> companies instead of the medical literature. (1)(2)(3)
>
>
> Old Garbage
> All kinds of silver medicinals, as well as many other dubiou=AD=ADs and
> noxious drugs, were used by desperate physicians before the
=AD=ADadvent
> of
>
>
> antibiotics. Any student of history can tell you how ineffec=AD=ADtive
> they
>
>
> were.
>
>
> Colloidal silver (CSP) is not a new alternative remedy. It i=AD=ADs an
> old,
>
>
> discarded traditional one that homeopaths and other people
c=AD=ADalling
> themselves "alternative health-care practitioners" have pull=AD=ADed
out
> of
>
>
> the garbage pail of useless and dangerous drugs and therapie=AD=ADs,
> things
>
>
> mainstream medicine threw away decades ago.
>
>
> In 1935 Gaul & Staud wrote about colloidal silver in The Jou=AD=ADrnal
of
>
> the American Medical Association (JAMA), "The alarming incre=AD=ADase
of
> argyrosis leaves little doubt as to our purpose in this repo=AD=ADrt.
> There
>
>
> has been an accumulation of indubitable clinical evidence wh=AD=ADich
> makes
>
>
> it imperative to present before those who prescribe, dispens=AD=ADe or
> use
> these drugs the danger entailed therein...The obvious
> respon=AD=ADsibility
> for this injudicious medication rests with the circularized
> advertisements by the various manufacturers to the physician=AD=ADs;"
(4)
>
>
>
> In 1940 Bryant added, "Conscientious observers in the field =AD=ADof
> otolaryngology can no longer doubt the occurrence of general=AD=ADized
> argyria caused by intranasal silver medications," and "A
per=AD=ADsistent
>
> indifferent attitude to this on the part of otolaryngologist=AD=AD
might
> be
>
>
> condoned if it were possible through the use of such medicat=AD=ADion
to
> achieve beneficial results for the patient which could not b=AD=ADe
> 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 isotoni=AD=ADc
> solution. (5) He continues, "The use of silver-containing na=AD=ADsal
> medication over even a few weeks is dangerous and accomplish=AD=ADes
> nothing
> that cannot be accomplished safely and more efficiently by o=AD=ADther
> means." (6)
>
>
> The New Old Miracle
> In 1995 I discovered that CSP, one of the drugs that causes
> =AD=ADargyria,
> was again being aggressively promoted. It was being sold ove=AD=ADr the
> Internet where you could buy equipment to make your own, in
=AD=AD"health
>
> food stores" and by MLMs (multilevel marketers). Promoters w=AD=ADere
> claiming that silver is an "essential mineral" and that even=AD=AD a
> trace
> amount in the body prevents serious illness. They also claim=AD=ADed
that
>
> it
> was a pre-1938 OTC (over-the-counter drug) that cures 650
sp=AD=ADecific
> conditions and diseases such as cancer, AIDS, acne, and lupu=AD=ADs.
They
>
> passed off their promotional material on the Internet and in=AD=AD
books
> and
> magazines as if it were the gospel truth.
>
>
> I thought the promoters were ignorant people who had made a
> =AD=ADterrible
> mistake, but when I contacted several of them and discovered=AD=AD that
> they
> were not interested in hearing my story, they would not chan=AD=ADge
> their
> ads and they refused to include my negative anecdotes along =AD=ADwith
> their
> positive ones, I knew that they weren't ignorant.
>
>
> They were quacks who were deliberately lying to sell their
p=AD=ADroduct.
>
>
>
> The response I got from the owner of a store that sells the =AD=ADstuff
> was
>
>
> pretty typical. I told him that my skin is gray from the
ing=AD=ADestion
> of
>
>
> silver adding that silver in my body has never benefited me.=AD=AD I
had
> breast cancer at the age of 42. In the year that I was born,=AD=AD
1942,
> a
> Dr. Levine wrote an article in the New England Journal of
Me=AD=ADdicine
> stating that all doctors had seen cases of argyria, but it w=AD=ADas
> rarely
>
>
> reported in the medical literature. (7) In searching that
> li=AD=ADterature
> for thirty years I have never found any evidence that silver=AD=AD in a
> person's body benefits anyone other than the quack who sold =AD=ADit.
>
>
> If, in fact, it did do all the wonderful things that the
pro=AD=ADmoters
> claim, Queen Victoria and the Rockefellers would still be al=AD=ADive
and
>
> they would be gray like me.
>
>
> I gave the merchant a fist full of medical literature to
> sub=AD=ADstantiate
>
>
> my claims and asked for proof that the product he sold with =AD=ADthe
> colloidal silver label on it was in fact safe and effective =AD=ADfor
> something, anything. I wanted to know how he knew that it
ac=AD=ADtually
> did
> all the great things claimed and how he knew that it wouldn'=AD=ADt
cause
>
> argyria. He said he'd have to contact his supplier and get b=AD=ADack
to
> me.
>
>
> The "Evidence"
> When he phoned and said that he had the material I had reque=AD=ADsted,
> 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=AD=AD I'd
> glance at the "evidence" and leave. Instead, I asked if I co=AD=ADuld
> take
> it next door to copy. Reluctantly, she agreed.
>
>
> What a gold mine that turned out to be. The same names, Dr. =AD=ADHenry
> Crookes, Sir Malcolm Morris, A. Legge Roe, and R.J. Hartman =AD=AD-- to
> name
> a few -- kept popping up in all the promotional material. Wh=AD=ADile
> most
> promoters pretended that these people were contemporary
> rese=AD=ADarchers,
> some of the material that the store owner gave me contained
> =AD=ADcitations
>
>
> 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
E=AD=ADngland
> at
>
>
> the turn of the century. (8) He sold many different alleged
> =AD=ADcolloidal
>
>
> preparations under the Collosol trade name. (9) Collosol Arg=AD=ADentum
> was
>
>
> the brand name of his colloidal silver. (10) Malcolm Morris =AD=ADwas
> rumored to be on his board of directors. (11)
>
>
> In 1919 JAMA's Council on Pharmacy and Chemistry ruled that
> =AD=ADCollosol
> Argentum, along with several other of the Crookes' Laborator=AD=ADy
> products, were "inadmissible to New and Nonofficial Remedies=AD=AD,"
> stating
> that "In the few cases in which the therapeutic claims for t=AD=ADhese
> preparations were examined, the claims were found to be so
> i=AD=ADmprobable
>
>
> or exaggerated as to have necessitated the rejection of thes=AD=ADe
> products." (12)
>
>
> Further down in the same article referring to Collosol
Hydra=AD=ADrgyrum
> and
> Collosol Ferrum they said that, "If either of these preparat=AD=ADions
> were
>
>
> injected intravenously as directed, death might result, maki=AD=ADng
the
> physician morally if not legally liable." (13)
>
>
> A. Legge Roe did write about the great success he had treati=AD=ADng
> gonorrhoeal opthamalia with collosol argentum. He also state=AD=ADd,
"It
> is
>
>
> the most useful preparation that has been placed in our hand=AD=ADs
since
>
> the introduction of cocaine." (14)
>
>
> In 1939 Hartman, a chemist not a medical doctor, included a
=AD=ADchapter
>
> on
> colloids in medicine in his chemistry book. On p.536 he said=AD=AD that
> CSP
>
>
> is safe enough to be put into the eyes and nose. He also sta=AD=ADted
on
> the
> same page that, "Intramuscular injections of colloidally
sus=AD=ADpended
> lead are of value in arresting certain cancerous growths." (=AD=AD15)
His
>
> source for all the material on colloids in medicine was Croo=AD=ADkes
> Laboratories.
>
>
> I felt as if I were doing quack genealogy. A quack quoting a=AD=AD
quack
> quoting a quack.
>
>
> Misquoted Reputable Authors
> Another article about silver that colloidal silver promoters=AD=AD
often
> referred to was one by Jim Powell which appeared in the Marc=AD=ADh
1978
> edition of the now defunct popular magazine Science Digest. =AD=ADThey
> always referred to it as "Our Mightiest Germ Fighter."
>
>
> When I tracked down the magazine, I discovered that the arti=AD=ADcle
> didn't
> mention colloidal silver and that the full title was, "Perha=AD=ADps it
> soon
> will be recognized as OUR MIGHTIEST GERM FIGHTER."
>
>
> Why do you think promoters never mention the first half of t=AD=ADhe
> title?
>
>
> Could it be because they know that the promise never materia=AD=ADlized
> and
>
>
> they don't want readers to find out?
>
>
> Another reference constantly appearing in the quack promotio=AD=ADnal
> material is the book ARGYRIA, (16) which truly is the defini=AD=ADtive
> work
>
>
> on the subject. It was written in 1939 by Hill and Pillsbury=AD=AD.
> Promoters say that it states that "properly prepared colloid=AD=ADal
> silver"
> never caused argyria and that 95 percent of the cases result=AD=ADed
from
>
> silver nitrate.
>
>
> What the book really says, and I'm probably one of the few p=AD=ADeople
> on
> earth who has a copy, is that in a study of 214 cases for wh=AD=ADich
> data
> was available, "silver nitrate is the responsible compound i=AD=ADn
over
> half the cases. Again it must be pointed out that the number=AD=AD of
> cases
>
>
> due to other compounds may be no real indication of their
re=AD=ADlative
> capacity for the production of argyria, but rather an eviden=AD=ADce of
> their popularity as a medicinal agent." (17)
>
>
> Regarding CSP, "It is impossible to make a definitive statem=AD=ADent
> concerning the amount of a colloidal silver compound which m=AD=ADay be
> instilled into a body cavity without the possibility of argy=AD=ADria."
> (18)
>
>
> The authors called for further studies and warning labels on=AD=AD all
> silver medicinals. (19) They also pointed out that it had ne=AD=ADver
> been
> determined whether or not individual susceptibilities exist.=AD=AD Are
> some
>
>
> people more likely to develop argyria than others? (20) We s=AD=ADtill
> don't
> know.
>
>
> Hill & Pillsbury added, "there is no evidence indicating tha=AD=ADt the
> giving of extremely small amounts of silver over a prolonged=AD=AD
period
>
> in
> any way lessens the danger of argyria from any given amount =AD=ADof
> silver
>
>
> compound." (21)
>
>
> In 1975 Goodman & Gilman stated that, "There is no acceptabl=AD=ADe
> evidence
> that the routine use of silver solutions for the prophylaxis=AD=AD of
> colds
>
>
> or other respiratory tract infections is at all efficacious,=AD=AD and
> cases
> of argyria have resulted from this practice. Fortunately, th=AD=ADe
> colloidal silver preparations are now in a deserved oblivion=AD=AD."
(22)
>
>
>
> There is no animal model for argyria. (23) It can take decad=AD=ADes to
> develop. (24) There have been reported cases in which it did=AD=AD not
> appear until several years after the drug was discontinued. =AD=AD(25)
>
>
> Silver workers have developed argyria, presumably from inhal=AD=ADing
> silver
> dust. (26) One person's skin discoloration was caused by the
> electrolytic action between a gold and a silver filing. Sali=AD=ADva
> caused
>
>
> the silver to go into solution. (27)
>
>
> 1990s Snake Oil
> Contrary to promoters' claims, we still ingest silver in our=AD=AD
diets.
>
> (28) Some drinking water contains silver. At what concentrat=AD=ADion
of
> silver does drinking water turn into CSP? I've never been ab=AD=ADle to
> get
>
>
> a salesperson to tell me this. Hopefully all they are really=AD=AD
> selling
> is very expensive, distilled water, but no one knows for sur=AD=ADe
since
>
> CSP is now sold as a "dietary supplement." As such it is
> unr=AD=ADegulated
> by any government agency. Only the manufacturer knows what's=AD=AD in
the
>
> bottle.
>
>
> On p. 26 of the April 1997 issue of Vegetarian Times, a maga=AD=ADzine
> that
>
>
> promotes supplements, it states that the National Nutritiona=AD=ADl
Foods
>
> Association (NNFA), a trade group in Newport Beach, CA, says=AD=AD that
> "some metal colloid products have been found to be high in t=AD=ADoxic
> metals such as aluminum. Others have no detectable levels of=AD=AD the
> desirable metal listed on the label." NNFA advises consumers=AD=AD
taking
>
> colloidal silver to have it analyzed by an independent
labor=AD=ADatory.
>
>
> A doctor told me that he had a bottle of CSP prepared by a
> p=AD=ADharmacist
>
>
> analyzed and discovered that it was just very expensive tap
=AD=ADwater.
> I
> find it very interesting that probably thousands of people a=AD=ADre
all
> reporting similar wonderful health and medical benefits from=AD=AD
> products
>
>
> that only have one thing in common, the labels all say "coll=AD=ADoidal
> silver."
>
>
> I believe this is ample proof that individuals and doctors a=AD=ADre
not
> capable of determining whether or not a drug is safe and
eff=AD=ADective.
>
> Scientific investigations start with anecdotal evidence, but=AD=AD 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
>
>
>
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=AD=AD=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
=3D=3D=3D=3D=3D=3D=3D
>
>
>
> Colloidal Silver: Risk without Benefit
>
http://www.quackwatch.org/01Quacker...s/silverad.html
>
>
>
> Colloidal Silver:
> Risk Without Benefit
>
>
> Stephen Barrett, M.D.
>
>
> Colloidal silver is a suspension of submicroscopic metallic
=AD=ADsilver
> particles in a colloidal base. Long-term use of silver
prepa=AD=ADrations
>
> can lead to argyria, a condition in which silver salts depos=AD=ADit in
> the
>
>
> skin, eyes, and internal organs, and the skin turns ashen-gr=AD=ADay.
> Many
> cases of argyria occurred during the pre-antibiotic era when=AD=AD
silver
>
> was a common ingredient in nosedrops. When the cause became
> =AD=ADapparent,
>
>
> doctors stopped recommending their use, and reputable
manufa=AD=ADcturers
>
> stopped producing them. The official drug guidebooks (United=AD=AD
States
>
> Pharmacopeia and National Formulary) have not listed colloid=AD=ADal
> silver
>
>
> products since 1975.
>
>
> Dubious AdsIn recent years, silver-containing products have =AD=ADbeen
> marketed with unsubstantiated claims that they are effective=AD=AD
> against
> AIDS, cancer, infectious diseases, parasites, chronic fatigu=AD=ADe,
> acne,
> warts, hemorrhoids, enlarged prostate, and many other diseas=AD=ADes
and
> conditions. Some marketers claim that colloidal silver is
ef=AD=ADfective
>
> 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
> s=AD=ADuspended
> indefinitely in demineralized water that kills bacteria and
> =AD=ADviruses.
> It can be applied topically and/or absorbed into the blood s=AD=ADtream
> sub-lingually (under the tongue), thereby avoiding the negat=AD=ADive
> effects of traditional antibiotics that kill good bacteria i=AD=ADn the
> lower digestive tract.
>
>
> An all natural antibiotic alternative in the purest form
ava=AD=ADilable.
>
> The presence of colloidal silver near a virus, fungi, bacter=AD=ADium
or
> any
> other single celled pathogen disables its oxygen-metabolism
=AD=ADenzyme,
>
> its chemical lung, so to say. The pathogens suffocates and d=AD=ADies,
> and
> is cleared out of the body by the immune, lymphatic and
elim=AD=ADination
>
> systems.
>
>
> Unlike pharmaceutical antibiotics which destroy beneficial
e=AD=ADnzymes,
>
> colloidal silver leaves these beneficial enzymes intact. Thu=AD=ADs
> colloidal silver is absolutely safe for humans, reptiles, pl=AD=ADants
> and
> all multi-celled living matter.
>
>
> It is impossible for single-celled germs to mutate into
> silver-resistant forms, as happens with conventional antibio=AD=ADtics.
> Also, colloidal silver cannot interact or interfere with oth=AD=ADer
> medicines being taken. Colloidal silver is truly a safe, nat=AD=ADural
> remedy for many of mankind's ills. Colloidal silver can be t=AD=ADaken
> indefinitely because the body does not develop a tolerance t=AD=ADo it
> [1]
>
>
> Seasilver International,
> http://www.seasilver.com/
>
>
> a California-based multilevel company, claims that American =AD=ADare
> suffering from "silver deficiency." Although silver is not a=AD=ADn
> essential nutrient, product information posted on the compan=AD=ADy's
Web
>
> site states:
>
>
> The depletion of minerals in our soil has left us deficient =AD=ADof
> silver,
> one of our most essential trace minerals, causing a drastic
> =AD=ADincrease
> in immune system disorders in our society in the last decade=AD=AD.
> Research
> has taught us that all disease is allowed to manifest itself=AD=AD
> because
> of a weakened immune system. In over 20 years of worldwide
r=AD=ADesearch
>
> on
> Colloidal Silver, numerous interviews with government agenci=AD=ADes,
> health
> care practitioners and their patients, no other nutrient, he=AD=ADrb or
> drug
> (prescription or over-the-counter) is as safe and effective
=AD=ADagainst
>
> all known forms of unfriendly virus, bacteria, and fungus.
> Additionally, while it is generally known that most antibiot=AD=ADics
> kill
> only perhaps 6 or 7 different disease organisms, reports hav=AD=ADe
shown
>
> that Colloidal Silver has been used successfully in the trea=AD=ADtment
> of
> over 650 diseases! Furthermore, strains of disease organisms=AD=AD fail
> to
> develop in the presence of Colloidal Silver. Colloidal Silve=AD=ADr's
> greatest attribute is its unique ability to function as a
su=AD=ADperior
> second immune system in the body! [2]
>
>
> The ad below is from the July 1996 issue of Alternative Medi=AD=ADcine
> 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 ni=AD=ADne
> commonly marketed colloidal silver products available at
> hea=AD=ADlth-food
> stores and concluded:
>
>
> Two of the products were contaminated with microorganisms.
>
>
> The amount of silver suspended in solution varied from produ=AD=ADct to
> product and would gradually decrease over time.
>
>
> Only five products actually showed antibacterial activity in=AD=AD a
> laboratory test. To perform the test, she prepared a culture=AD=AD
plate
> with Staphylococcus aureas bacteria, which can cause infecti=AD=ADons
in
> humans. She then placed a drop from each product on the plat=AD=ADe and
> used
> disks of two common antibiotics as controls. After eight hou=AD=ADrs of
> incubation, she found that bacterial growth had been inhibit=AD=ADed
> around
>
>
> the antibiotics and four of the products.
>
>
> Of course, the fact that a product inhibits bacteria in a
> la=AD=ADboratory
> culture doesn't mean it is effective (or safe) in the human =AD=ADbody.
> In
> fact, products that kill bacteria in the laboratory would be=AD=AD more
> likely to cause argyria because they contain more silver ion=AD=ADs
that
> are
> free to deposit in the user's skin.
>
>
> FDA laboratory studies have found that the amount of silver =AD=ADin
some
>
> product samples has varied from 15.2% to 124% of the amount
=AD=ADlisted
> on
>
>
> the product labels. The amount of silver required to produce=AD=AD
> argyria
> is unknown. However, the FDA has concluded that the risk of =AD=ADusing
> silver products exceeds any unsubstantiated benefit [3]. So =AD=ADfar,
> nine
>
>
> cases of argyria related to silver products have been report=AD=ADed:
> A 56-year-old man who had sold and used colloidal silver for=AD=AD
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=AD=AD a
> drink
> prepared by administering an electrolytic charge to a bowl o=AD=ADf
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 h=AD=ADerbal
> tea
>
>
> for about 10 months [5].
>
>
> Stan Jones, Montana's Libertarian Party candidate for the
> U.S. Senate, who reportedly started taking colloidal silver=AD=AD in
1999
>
> for fear that Y2K disruptions might lead to a shortage of
> an=ADtibiotics.
> He made his own concoction by electrically two silver wires =AD=ADin a
> glass
> of water [6].
>
>
> Two men, ages 63 and 76, developed argyria after a year of
p=AD=ADroduct
> use
> inspired by Internet claims [7]. Enforcement Actions
>
>
> Between October 1993 and September 1994, the FDA issued warn=AD=ADing
> letters to five colloidal silver marketers::
>
>
> Higher education Library Publications (H.E.L.P.), of Springf=AD=ADield,
> Utah, was ordered to stop claiming that its colloidal silver=AD=AD
> product
> was effective as a natural antibiotic and might be effective=AD=AD
> against
> cancer, genito-urinary diseases, tuberculosis, and AIDS.
> Nutrition, Inc., of Arvada, Colorado, was ordered to stop st=AD=ADating
> or
> implying that its Silvicidal, when administered orally or
> intravenously, was nontoxic, FDA-approved, and was a
broad-s=AD=ADpectrum
>
> antibiotic that killed bacteria and all virus and fungal
> inf=AD=ADections.
> In addition, it was falsely claimed to be effective against =AD=ADa
long
> list of specific diseases.
>
>
> Reseau International of Cincinnati, Ohio was ordered to stop=AD=AD
> claiming
>
>
> that its colloidal silver product was a "natural antibiotic =AD=ADand
> anti-inflammatory immune system stimulant" and that it was
> e=AD=ADffective
> against cancer, staph, strep, influenza, general body infect=AD=ADions,
> inflammation, impaired immune system, fungus toxicity,
tonsi=AD=ADllitis,
>
> Meniere's symptoms, whooping cough, shingles, syphilis, chol=AD=ADera,
> and
> malaria. The labeling also stated that colloidal silver coul=AD=ADd
cause
>
> major growth stimulation of human tissues and can regenerate
>
>
> Silverado Inc., of Bountiful, Utah, was warned to stop makin=AD=ADg
false
>
> claims that its colloidal silver product was effective as an
> antibiotic, anti-inflammatory, anti-viral, and anti-fungal a=AD=ADgent
> and
> that it could stimulate the immune system.
> Unic, of Carmichael, California, was ordered to stop claimin=AD=ADg
that
> its
> colloidal silver product was effective against many diseases=AD=AD and
> could
> heal burn-damaged tissue without scarring.
>
>
> In October 1996, the FDA proposed to ban the use of colloida=AD=ADl
> silver
> or silver salts in over-the-counter products [8]. A Final Ru=AD=ADle
> banning
> such use was issued on August 17, 1999 and became effective
> =AD=ADSeptember
>
>
> 16th. The rule applies to any nonprescription colloidal silv=AD=ADer or
> silver salt product claimed to be effective in preventing or=AD=AD
> treating
>
>
> any disease [9]. Silver products can still be sold as "dieta=AD=ADry
> supplements" provided that no health claims are made for the=AD=ADm.
> 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
> c=AD=ADolloidal
> silver products.
> In 2000, the Federal Court of Australia banned Vital Earth
C=AD=ADompany
> Pty
> Limited and its director Darryl John Jones from falsely
> repr=AD=ADesenting
> that the colloidal silver produced by their "Vital Silver 30=AD=AD00
> Zapper," "Vital Silver 2000 Automatic" and "Vital Silver 200=AD=AD0":
>
>
> Can kill all disease-causing bacteria, fungi and virus withi=AD=ADn six
> minutes of contact
> Has no harmful side effects; that colloidal silver could be =AD=ADused
as
>
> an
> antibiotic for all the acquired diseases of active AIDS
>
>
> Is effective with more than 650 different pathogenic bacteri=AD=ADa and
> virus types
> Has been used successfully against diseases including AIDS,
> =AD=ADcholera,
> diabetes, leprosy, leukemia, lupus, skin cancer, syphilis an=AD=ADd
> whooping
> cough.
>
>
> The company was also ordered to pay AUS$9000 in costs and to=AD=AD
> provide
> refunds [10].
>
>
> In 2001, the FTC obtained consent agreements with two compan=AD=ADies:
>
>
> Robert C. Spencer and Lisa M. Spencer, doing business as Aar=AD=ADon
> Company
> (Palm Bay, Florida). Colloidal silver has been medically pro=AD=ADven
to
> kill over 650 disease-causing organisms in the body and is
> e=AD=ADffective
> in curing diseases ranging from cancer and multiple sclerosi=AD=ADs to
> HIV/AIDS [11].
>
>
> ForMor, Inc., doing business as ForMor International, and it=AD=ADs
> president, Stan Gross (Birmingham, Alabama) agreed not to ma=AD=ADke
> unsubstantiated claims that colloidal silver is effective in=AD=AD
> treating
>
>
> over 650 infectious diseases, has no adverse side effects, a=AD=ADnd is
> effective against arthritis, blood poisoning, cancer, choler=AD=ADa,
> diphtheria, diabetes, dysentery, gonorrhea, herpes, influenz=AD=ADa,
> leprosy, lupus, malaria, meningitis, rheumatism, shingles, s=AD=ADtaph
> infections, strep infections, syphilis, tuberculosis, whoopi=AD=ADng
> cough,
>
>
> and yeast infections [11].
>
>
> In 2002, the FTC obtained a consent agreement with Kris
Plet=AD=ADschke,
> doing business as Raw Health, http://www.rawhealth.net/ agreed to
stop
> making unsubstantiated claims that its colloidal silver prod=AD=ADuct
> could
>
>
> treat or cure 650 different diseases; eliminate all pathogen=AD=ADs in
> the
> human body in six minutes or less; and is medically proven t=AD=ADo
kill
> every destructive bacterial, viral, and fungal organism in t=AD=ADhe
> body,
> including anthrax, Ebola, Hanta, and flesh-eating bacteria [=AD=AD12].
>
>
> In 2002, the Australian Therapeutic Goods Administration ame=AD=ADnded
> its
> rules so that water-treatment products containing substances=AD=AD like
> colloidal silver for which therapeutic claims are made must =AD=ADmeet
> the
> requirements of medicines included in the Australian Registe=AD=ADr of
> Therapeutic Goods. This means that such products can no long=AD=ADer be
> legally marketed without proof that they are safe and effect=AD=ADive
for
>
> their intended purpose. The amendment was based on clnclusio=AD=ADns
> that:
>
>
> There is little evidence to support therapeutic claims made =AD=ADfor
> colloidal silver products;
>
>
> The risk to consumers of silver toxicity outweighs the value=AD=AD of
> trying
> an unsubstantiated treatment, and bacterial resistance to si=AD=ADlver
> can
> occur
> Efforts should be made to curb the illegal availability of
> c=AD=ADolloidal
> silver products, which is a significant public health issue =AD=AD[13]
..
>
>
> References
>
>
> 1. Product brochure. Changes International, 1997. Downloade=AD=ADd in
> 1998.
> Seasilver International Product Information
>
http://web.archive.org/web/19981207...productinfo.htm
>
>
>
> , accessed October 12, 1998.
>
>
> 2. Fung MC, Bowen DL. Silver products for medical indication=AD=ADs:
> risk-benefit assessment
>
http://www.ncbi.nlm.nih.gov/entrez/...db=3DPubMed&...
>
>
>
> Journal of Toxicology and Clinical Toxicology 34:119-26, 19=AD=AD96.
>
>
> 4. Gulbranson SH and others. Argyria following the use of di=AD=ADetary
> supplements containing colloidal silver protein.
>
http://www.ncbi.nlm.nih.gov/entrez/...db=3DPubMed&...
>
>
>
> Cutis 66:373-374, 2000.
>
>
> 5. Hori K and others. Believe it or not -- Silver still pois=AD=ADons!
> Veterinary and Human Toxicology 44(5):291-292, 2002.
>
>
> 6. Blue Is the color of my candidate's skin.
>
http://www.foxnews.com/printer_frie...64692%2C00.html
>
>
>
> Associated Press, Oct 2, 2002
>
>
> 7. Cohen LE and others. Effects of Internet quackery: Argyri=AD=ADa 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 1=AD=AD996
> volume
> for "colloidal silver.")
>
>
> 9. FDA. Final rule: Over-the-counter drug products containin=AD=ADg
> colloidal silver ingredients or silver salts.
>
http://frwebgate4.access.gpo.gov/cg...ocID=3D06028...
>
>
>
> Federal Register 64:44653-44658, 1999. Download PDF version
>
http://frwebgate4.access.gpo.gov/cg...ocID=3D06028...
>
>
>
> 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 Commissio=AD=ADn.,
May
> 5,
> 20
>
>
> 11. "Operation Cure.All" wages new battle in ongoing war aga=AD=ADinst
> 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 purveyor=AD=ADs 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 colloi=AD=ADdal
> silver
> marketplace and is willing to answer questions.
> mailto:rjs...@together.net
>
>
> This article was revised on May 5, 2004.
>
>
> ------------------------------------------------------------=AD-------
>
>
> Between October 1993 and September 1994, the FDA issued warn=AD=ADing
> letters to five
> colloidal silver marketers::
>
>
> * Higher education Library Publications (H.E.L.P.), of
> S=ADpringfield, Utah,
> was ordered to stop claiming that its colloidal silver produ=AD=ADct
was
> effective as
> a natural antibiotic and might be effective against cancer,
> =ADgenito-urinary
> diseases, tuberculosis, and AIDS.
> * Nutrition, Inc., of Arvada, Colorado, was ordered to s=ADtop
> stating or
> implying that its Silvicidal, when administered orally or
> in=ADtravenously, was
> nontoxic, FDA-approved, and was a broad-spectrum antibiotic =AD=ADthat
> killed
> bacteria and all virus and fungal infections. In addition, i=AD=ADt was
> falsely
> claimed to be effective against a long list of specific dise=AD=ADases.
> * Reseau International of Cincinnati, Ohio was ordered t=ADo s=ADtop
> claiming
> that its colloidal silver product was a "natural antibiotic =AD=ADand
> anti-inflammatory immune system stimulant" and that it was
> e=AD=ADffective
> against
> cancer, staph, strep, influenza, general body infections,
> in=ADflammation,
> impaired immune system, fungus toxicity, tonsillitis, Menier=AD=ADe's
> symptoms,
> whooping cough, shingles, syphilis, cholera, and malaria. Th=AD=ADe
> labeling also
> stated that colloidal silver could cause major growth stimul=AD=ADation
> of
> human
> tissues and can regenerate
> * Silverado Inc., of Bountiful, Utah, was warned to stop=AD ma=ADking
> false
> claims that its colloidal silver product was effective as an=AD=AD
> antibiotic,
> anti-inflammatory, anti-viral, and anti-fungal agent and tha=AD=ADt it
> could
> stimulate the immune system.
> * Unic, of Carmichael, California, was ordered to stop c=ADlai=ADming
> that its
> colloidal silver product was effective against many diseases=AD=AD and
> could heal
> burn-damaged tissue without scarring.
>
>
> In October 1996, the FDA proposed to ban the use of colloida=AD=ADl
> silver
> or silver
> salts in over-the-counter products [7]. A Final Rule banning=AD=AD such
> use
> was
> issued on August 17, 1999 and became effective September 16t=AD=ADh.
The
> rule applies
> to any nonprescription colloidal silver or silver salt produ=AD=ADct
> claimed to be
> effective in preventing or treating any disease [8]. Silver
> =AD=ADproducts
> can still
> be sold as "dietary supplements" provided that no health cla=AD=ADims
are
>
> made for
> them. During 2000, the FDA issued warnings to more than 20
> c=AD=ADompanies
> whose Web
> sites were making illegal therapeutic claims for colloidal s=AD=ADilver
> products.
>
>
> In 2000, the Federal Court of Australia banned Vital Earth
C=AD=ADompany
> Pty Limited
> and its director Darryl John Jones from falsely representing=AD=AD that
> the
> colloidal
> silver produced by their "Vital Silver 3000 Zapper," "Vital
=AD=ADSilver
> 2000
> Automatic" and "Vital Silver 2000":
>
>
> * Can kill all disease-causing bacteria, fungi and virus=AD wi=ADthin
> six minutes
> of contact
> * Has no harmful side effects; that colloidal silver cou=ADld =ADbe
> used as an
> antibiotic for all the acquired diseases of active AIDS
> * Is effective with more than 650 different pathogenic b=ADact=ADeria
> and virus
> types
> * Has been used successfully against diseases including =ADAID=ADS,
> cholera,
> diabetes, leprosy, leukemia, lupus, skin cancer, syphilis an=AD=ADd
> whooping cough.
>
>
> The company was also ordered to pay AUS$9000 in costs and to=AD=AD
> provide
> refunds
> [9].
>
>
> In 2001, the FTC obtained consent agreements with two compan=AD=ADies:
>
>
> * Robert C. Spencer and Lisa M. Spencer, doing business =ADas =ADAaron
> Company
> (Palm Bay, Florida). Colloidal silver has been medically pro=AD=ADven
to
> kill over
> 650 disease-causing organisms in the body and is effective i=AD=ADn
> curing
> diseases
> ranging from cancer and multiple sclerosis to HIV/AIDS [10].
> * ForMor, Inc., doing business as ForMor International, =ADand=AD its
> president,
> Stan Gross (Birmingham, Alabama) agreed not to make
unsubsta=AD=ADntiated
>
> claims that
> colloidal silver is effective in treating over 650 infectiou=AD=ADs
> diseases, has no
> adverse side effects, and is effective against arthritis, bl=AD=ADood
> poisoning,
> cancer, cholera, diphtheria, diabetes, dysentery, gonorrhea,=AD=AD
> herpes,
> influenza,
> leprosy, lupus, malaria, meningitis, rheumatism, shingles, s=AD=ADtaph
> infections,
> strep infections, syphilis, tuberculosis, whooping cough, an=AD=ADd
yeast
>
> infections
> [10].
>
>
> In 2002, the FTC obtained a consent agreement with Kris
Plet=AD=ADschke,
> doing
> business as Raw Health, agreed to stop making unsubstantiate=AD=ADd
> claims
> that its
> colloidal silver product could treat or cure 650 different
> d=AD=ADiseases;
> eliminate
> all pathogens in the human body in six minutes or less; and =AD=ADis
> medically proven
> to kill every destructive bacterial, viral, and fungal organ=AD=ADism
in
> the body,
> including anthrax, Ebola, Hanta, and flesh-eating bacteria [=AD=AD12].
>
>
> In 2002, the Australian Therapeutic Goods Administration ame=AD=ADnded
> its
> rules so
> that water-treatment products containing substances like
col=AD=ADloidal
> silver for
> which therapeutic claims are made must meet the requirements=AD=AD of
> medicines
> included in the Australian Register of Therapeutic Goods. Th=AD=ADis
> means
> that such
> products can no longer be legally marketed without proof tha=AD=ADt
they
> are safe and
> effective for their intended purpose. The amendment was base=AD=ADd on
> clnclusions
> that:
>
>
> * There is little evidence to support therapeutic claims=AD ma=ADde for
> colloidal
> silver products;
> * The risk to consumers of silver toxicity outweighs the=AD va=ADlue of
> trying an
> unsubstantiated treatment, and bacterial resistance to silve=AD=ADr can
> occur
> * Efforts should be made to curb the illegal availabilit=ADy o=ADf
> colloidal
> silver products, which is a significant public health issue =AD=AD[11]
..
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