Re: Time to admit silver works folks.

From: A_Weisman (a_weisman_at_yahoo.com)
Date: 12/04/04 

Date: 4 Dec 2004 07:21:56 -0800

dali <weeble@wabble.com> wrote in message news:<bqf2r0tff7tnbnjg17o2vhtr1vrh7etet4@4ax.com>...
> On 04 Dec 2004 01:56:45 GMT, chuckpadams04@aol.com (ChuckPAdams04)
> wrote:
>
> >Troll.
> >
> >ABUSE REPORT SENT YOU SILVER FRAUD.
> >
> >
> >CPA
>
> Call the FDA to Oh wait they agree silver does work

Absolute utter freaking bull***.

Bad enough you silver freaks come here to proselytize about the silver
(which ALL of you sell too).

But to utterly blatantly say something so completely false and
misleading, well the silver must have rotted away whatever brain you
ever had.

Yeah silver works. To cause agryia and other health problems.

==================================================================

The following is shortened, highlighting the important stuff. Edited
places
will be marked with a [....].

Federal Register: August 17, 1999 (Volume 64, Number 158)]
[Rules and Regulations][Page 44653-44658]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au99-6]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
21 CFR Part 310[Docket No. 96N-0144]
Over-the-Counter Drug Products Containing Colloidal Silver
Ingredients or Silver SaltsAGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final
rule
establishing that all over-the-counter (OTC) drug products containing
colloidal
silver ingredients or silver[[Page 44654]] salts for internal or
external use
are NOT GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND ARE MISBRANDED.
FDA is
issuing this final rule because many OTC drug products containing
colloidal
silver ingredients or silver salts are being marketed for numerous
serious
disease conditions and FDA is NOT AWARE OF ANY SUBSTANTIAL SCIENTIFIC
EDIDENCE
THAT SUPPORTS THE USE OF OTC COLLOIDAL SILVER INGREDIENTS or silver
salts for
these disease conditions.

DATES: This regulation is effective September 16, 1999.
FOR FURTHER INFORMATION CONTACT: Bradford W. Williams, Center for
Drug
Evaluation and Research (HFD-310), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 301-594-0063.SUPPLEMENTARY
INFORMATION:
I. Background ... declare that all OTC drug products
containing colloidal silver ingredients or silver salts are NOT
GENERALLY
RECOGNIZED AS SAFE AND EFFECTIVE, and are new drugs and
misbranded within the meaning of section .... Colloidal silver
is a suspension of silver particles in a colloidal base. In recent
years, colloidal silver preparations of unknown formulation have been
appearing in retail outlets. These products are labeled for numerous
disease conditions, many of which are serious diseases. The dosage
form
of these colloidal silver products is usually oral, but product
labeling also contains directions for topical and,
occasionally,intravenous
use.
    FDA has NOT APPROVED A NEW DRUG APPLICATION (NDA) for any
colloidal silver
product. NONE of the silver salts evaluated as part of FDA's OTC
drug review WAS FOUND TO BE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE
for its
intended use(s). FDA is NOT AWARE OF ANY SUBSTANTIAL SCIENTIFIC
EVIDENCE THAT
SUPPORTS THE USE OF OTC COLLOIDAL SILVER INGREDIENTS OR SILVER SALTS
FOR
DISEASE CONDITIONS. The agency invited any interested
parties to collect and submit any existing data and information that
support the safety and effectiveness of colloidal silver ingredients
or
silver salts for any of the uses not already evaluated under the OTC
drug review. Interested persons were invited to submit written
comments
on the proposed regulation and on the agency's economic impact
determination by January 13, 1997.
    ...
    Based on the information set forth in the proposed rule, and after
consideration of the information submitted by the public comments (as
summarized as follows), FDA is declaring that all OTC drug products
containing colloidal silver ingredients or silver salts are not
generally recognized as safe and effective, and are new drugs and
misbranded within the meaning of section 201(p) of the act. Adequate
safety and effectiveness data have not been provided to establish
general recognition of the safety and effectiveness of colloidal
silver
or silver salt ingredients for any OTC drug uses. The data submitted
did not include the required absorption, metabolism, tissue
distribution, accumulation, excretion, and pharmacodynamics (effect of
the drug at its action site) of silver in the body, both when taken
internally and applied externally, and of the effect of the particle
size of the silver on these systemic effects.
    FDA is amending subpart E of part 310 (21 CFR part 310) to add
Sec. 310.548 for OTC drug products containing colloidal silver
ingredients or silver salts. The agency has expanded proposed
Sec. 310.548(a) to include some additional silver ingredients.
II. Public Comments and the Agency's ResponseA. General Comments
    1. Many comments agreed with the proposed rule. One of these
comments cautioned against the DANGERS of using untested drugs and
recalled that Laetrile MISLED UNSUSPECTING PEOPLE IN SEARCH OF A QUICK
CANCER
CURE. Another comment provided personal experience as a victim of
argyria who
had been DISFIGURED for 40 years as a result of using
colloidal silver. This comment included an excerpt from a book that
recorded 114 cases of argyria compiled in the 1930's. The comment
contended that many marketers of colloidal silver deny the POTENTIAL
FOR HARM
and often MISQUOTE OR DISTORT THE HISTORICAL ARTICLES DEALING WITH
THESE
PRODUCTS.
    A physician, who was formerly a pharmacist, recounted his own
experience in reviewing cases of argyria. The victims had ingested
silver products in the 1940's and 1950's. The physician was concerned
that a product that does not have any rational use would lead to the
redevelopment of argryia as a clinical problem. Another physician/
ophthalmologist commented that colloidal silver is DANGEROUS QUACKERY.
    The agency appreciates these comments in support of its proposal.
B. Comments on Safety and Effectiveness
    2. One comment expressed concern that many different silver
products being marketed are inferior products and are not even true
colloids. Another comment stated that the vast majority of silver
products being sold are FRADULENT PRODUCTS. The comment noted that it
had tested a number of these products and found that several actually
had no silver content, one did not contain the silver particle size as
stated on the label, and only one product exceeded all stated purity
and stability claims found on the label. The comment added that many
of
the products were only duplicates of older colloidal silver products.
The comment considered these ``newer'' products as having the same
dangers, intermittent effectiveness, and lack of stability as the
older
products. The comment contended that the vast majority of the
colloidal
silver products it tested are TOTALLY USELESS, some were DANGEROUS to
ingest, and some were possibly a THREAT TO LIFE. The comment stated
that it is a major problem to keep off the market these so-called
``colloidal silver'' products that contain significant amounts of
silver ions and silver salts. ...
  ...
    
    3. Several comments submitted information purporting to support
the
safety of colloidal silver and other silver ingredients. The comments
contended that silver is nontoxic and has minimal side effects.,....
Several
comments mentioned that argyria, a blue
skin discoloration resulting from prolonged administration of silver
compounds and accumulation in the body, is the main side effect that
occurs. ... The comment
concluded that the dilute, mild silver protein products marketed today
are similar to pre-1938 colloidal silver solutions and do not cause
argyria. ...
    Another comment presented the results of several animal (rat)
studies involving acute or chronic administration of various amounts
of
colloidal silver (mild silver protein in colloidal suspension),
approximately 1,500 parts per million (ppm), either by intravenous
(IV)
injection or in drinking water. ...The investigator reported that no
abnormal
clinical or
behavioral signs were observed after 12 days of treatment. In another
followup chronic IV rat study, three rats were injected with 1,500 ppm
colloidal silver three times per week for 4 weeks (a total of 18 mg
per
300 gram (g) rat), and three rats served as controls. ... there were
no
differences in body weight and no clinical
signs or gross pathologic changes between the treated and control
groups....The rats
showed no clinical signs of gross pathological changes at the end of
the treatment period. Three rats received regular drinking water and
served as controls. The investigator stated that the data do not
provide information about the metabolic fate of the silver, but
support
safety if extrapolated to humans because a 60-kg person would have to
be given 3,600 mg to receive an amount equivalent to the rats' highest
dose (18 mg/300 g rat).
    The agency does not consider this information adequate to
establish
general recognition of the safety of silver salts or colloidal silver
ingredients for OTC drug use. THE COMMENTS THEMSELVES INDICATE THAT
IONIC
SILVER SALTS AND HIGHLY CONCENTRATED MILD SILVER PROTEIN CLEARLY ARE
NOT SAFE
FOR for OTC use. The animal data indicate that mild silver
protein in colloidal suspension at low concentrations may be safe in
rats when administered in specific concentrations for up to 40 days.
Additional data are needed in humans on the absorption, metabolism,
tissue distribution, accumulation, excretion, and pharmacodynamics of
silver in the body, both when taken internally and applied externally,
and of the effect of the particle size of the silver on these systemic
effects. The agency concludes that a full pharmacologic profile that
is
relevant to human use is needed.
    4. Several comments submitted information purporting to support
the
effectiveness of colloidal silver and other silver ingredients. One
comment provided a partial list of the more than 650 diseases that
colloidal silver has been used against and included a number of
testimonials. Another comment stated that silver will kill 650 disease
organisms, but it DOES NOT CURE 650 DISEASES. ...
Another comment noted the antimicrobial and bacteriostatic effects of
diluted colloidal silver protein solutions. ...
    Another comment, from a physician, described a double-blind
clinical study that he conducted using a commercial colloidal silver
product.... ...The men reported that
nocturia (frequency of urination) ranged from one to five times a
night. The physician assumed that the men had benign prostatic
hypertrophy because of their age and the onset of symptoms in recent
years. Of the 22 men, 15 took colloidal silver and 7 took placebo
(colored water). ...At the end of the study,
four men (all on the colloidal silver) reported considerable
improvement in the nocturia, with a reduction from 2 to 4 times to 1
time each night, while six other men (five on the colloidal silver)
noted some improvement in the nocturia. TWO MEN WITH A HISTORY OF
TRANSURETHRAL
RESECTION OF THE PROSTATE, WHO WERE ON THE COLLOIDAL SILVER, DID NOT
REPORT ANY
IMPROVEMENT.
  ...The physician concluded
that the results of this study merit further investigation by the
medical community.
    
    The agency finds that the previous studies are not adequate and
well-controlled clinical studies of the type described in Sec.... that
need to
be conducted. The studies have major
methodic flaws. There needs to be a clear statement of the objectives
of the investigation and a protocol containing a specific study
design,
the method of subject selection (with inclusion and exclusion
criteria), the method of assigning subjects to treatment and control
groups, well-defined methods for measuring the subjects' responses,
and
methods for analysis of the study results. Adequate measures need to
be
taken to minimize bias on the part of the subjects, observers, and
analysts of the data, which is done by adequate blinding. The agency
is
unable to determine the adequacy of the blinding in the physician's
study because the placebo was described as ``colored water.'' The
agency is not able to ascertain the degree of similarity or difference
that existed in the appearance of the colloidal silver product and the
placebo to determine how well the study was blinded. ...
Likewise, the conditions described in the case reports provided by one
comment need to be studied in adequate and well-controlled clinical
trials. Finally, the information that silver will kill 650 disease
organisms and that a Bredig Sol of silver at 30 ppm is an effective
germicide for both gram-positive and gram-negative bacteria, fungi,
yeasts, and viruses needs to be related to in vivo treatment for
specific disease conditions. The agency concludes that the data and
information submitted are not sufficient to establish general
recognition of effectiveness for colloidal silver or other silver
ingredients for any specific OTC condition....
.,.. None of the comments provided any
evidence to show that the composition and the labeling of colloidal
silver or silver salt drug products have remained unchanged since 1938
or 1962. Without such evidence, the products cannot qualify for either
grandfather exemption, and there is no need to set any guidelines as
requested by one comment.D. Freedom of Choice
    6. A number of comments included individual testimonials or
expressions of belief that colloidal silver benefited their health and
that of their family members or friends. A few comments mentioned
benefits experienced by pets. Many of the comments stated that the
proposed rule would deny them the freedom of choice to select their
owndrugs.
    FDA's statutory mandate includes protection and promotion of the
public health by ensuring that drugs are not only safe but also
effective for their intended use. The Commissioner of Food and Drugs'
decision on the status of Laetrile, published in the Federal Register
of August 5, 1977 (42 FR 39788), expresses the agency's position on
freedom of choice with respect to ensuring that drugs are not only
safe, but also effective. That statement reads in part:
    In passing the 1962 Amendments to the act--the amendments that
require that a drug be proved effective before it may be marketed--
Congress indicated its conclusions that the absolute freedom to
choose an ineffective drug was properly surrendered in exchange for
the freedom from the danger to each person's health and well-being
from the sale and use of WORTHLESS DRUGS * * *. To the extent thatany
freedom
[[Page 44657]]has been surrendered by the passage of the legislation
which bans
from the marketplace drugs that have not been proven to be
effective, that surrender was a rational decision which has resulted
in the achievement of a greater freedom from the dangers to health
and welfare represented by such drugs.
    Agency regulations in 21 CFR 330.10(a)(4)(ii) state that the
standards for effectiveness for an OTC drug that is generally
recognized as effective include a requirement for controlled clinical
investigations. Isolated case reports, random experience, and reports
lacking the details that permit scientific evaluation are not
considered adequate to establish effectiveness. Testimonials from
consumers cannot be considered as adequate proof of effectiveness or
safety. None of the comments presented any evidence of safety or
effectiveness beyond personal experience.
    In the absence of data demonstrating that the ingredients present
in OTC drug products containing colloidal silver ingredients or silver
salts are generally recognized as safe and effective, these
ingredients
cannot be included in an OTC drug product. After the effective date of
the final regulation, any such OTC drug product initially introduced
or
initially delivered for introduction into interstate commerce (unless
it is the subject of an approved NDA, of which there currently are
none) that is not in compliance with this regulation will be subject
to
regulatory action.E. The Dietary Supplement Health and Education Act
(DSHEA)
    7. Several comments, from consumers, stated that the specific
product they used did not make any claims and might be considered a
dietary supplement. None of the comments provided any labeling or
specifics about the products they used.
    This final rule addresses products marketed as OTC drugs. A
product
that is not intended for OTC ``drug'' use in accord with section
201(g)(1) of the act would not be subject to this final rule. A
product
containing silver could, under certain circumstances, be marketed as a
dietary supplement if it meets the definition in section 201(ff) of
the
act and other applicable requirements. Among other things, such a
product's label must state that the product is a dietary supplement
and
meet other labeling requirements of the act. (See, e.g., section
403(q), (r), and (s) of the act (21 U.S.C. 343(q), (r), and (s)).) It
must also meet the safety requirements of the act. (See, e.g., 21
U.S.C. 342(a), (f), and (g).) FDA may take regulatory action against a
product marketed as a dietary supplement when authorized to do so
bythe act.
    A dietary supplement containing colloidal silver or silver salts
may not be labeled in whole or in part for topical use. Section
201(ff)(2)(A)(i) of the act requires that a dietary supplement is a
product that is ``intended for ingestion.'' The term ingestion has
been
addressed by the court in United States v. Ten Cartons, Ener-B Nasal
Gel, 888 F. Supp. 393 (E.D.N.Y.), aff'd, 72 F.3d 285 (2d Cir. 1995). A
topical product could not be a dietary supplement.III. Analysis of
Impacts
    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and
benefits
of available regulatory alternatives and, when regulation is
necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Under the Regulatory
Flexibility Act, if a rule has a significant impact on a substantial
number of small entities, an agency must analyze regulatory options
that would minimize any significant impact of the rule on
smallentities.
    Title II of the Unfunded Mandates Reform Act (2 U.S.C. 1501 et
seq.) requires that agencies prepare a written statement and economic
analysis before proposing any rule that may result in an expenditure
in
any one year by State, local, and tribal governments, in the
aggregate,
or by the private sector, of $100 million (adjusted annually for
inflation). As the agency stated in the proposed rule, this rulemaking
is not expected to pose a significant impact on small business because
only a limited number of products are affected (61 FR 53685 at 53687).
    The agency believes that this final rule is consistent with the
principles set out in the Executive Order and in these two statutes.
The purpose of this final rule is to establish that all OTC drug
products containing colloidal silver ingredients or silver salts for
internal or external use are not generally recognized as safe and
effective and are misbranded. The agency's Drug Listing System
identifies a multitude of silver-containing products. These products
may contain silver, silver ion, silver chloride, silver cyanide,
silver
iodide, silver oxide, or silver phosphate.
    All of these manufacturers are considered small entities, using
the
U.S. Small Business Administration designation for this industry
(750employees).
    Manufacturers will no longer be able to market OTC drug products
containing any silver ingredients after the effective date of the
final
rule. While the manufacturers may incur a loss of revenue from some of
these products, some silver products for internal use may be able to
continue to be marketed as dietary supplements, provided they meet,
among other regulatory requirements applicable to dietary supplements,
the definition of dietary supplements in section 201(ff) of the act
and
meet the labeling requirements of section 403 of the act.
    Manufacturers have been aware of the possible effects on the
status
of these OTC silver drug products since October 1996 and have not
submitted adequate safety and effectiveness data to the agency. Since
publication of the 1996 proposal and with the 30-day implementation
date after publication of the final rule, manufacturers should have
ample time to deplete most of their remaining stock of OTC drug
products containing the affected ingredients.

There is more - to read the entire article, go to :

http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.txt

============================================================

Between October 1993 and September 1994, the FDA issued warning
letters to five
colloidal silver marketers::

    * Higher Education Library Publications (H.E.L.P.), of
Springfield, Utah,
was ordered to stop claiming that its colloidal silver product was
effective as
a natural antibiotic and might be effective against cancer,
genito-urinary
diseases, tuberculosis, and AIDS.
    * Nutrition, Inc., of Arvada, Colorado, was ordered to stop
stating or
implying that its Silvicidal, when administered orally or
intravenously, was
nontoxic, FDA-approved, and was a broad-spectrum antibiotic that
killed
bacteria and all virus and fungal infections. In addition, it was
falsely
claimed to be effective against a long list of specific diseases.
    * Reseau International of Cincinnati, Ohio was ordered to stop
claiming
that its colloidal silver product was a "natural antibiotic and
anti-inflammatory immune system stimulant" and that it was effective
against
cancer, staph, strep, influenza, general body infections,
inflammation,
impaired immune system, fungus toxicity, tonsillitis, Meniere's
symptoms,
whooping cough, shingles, syphilis, cholera, and malaria. The labeling
also
stated that colloidal silver could cause major growth stimulation of
human
tissues and can regenerate
    * Silverado Inc., of Bountiful, Utah, was warned to stop making
false
claims that its colloidal silver product was effective as an
antibiotic,
anti-inflammatory, anti-viral, and anti-fungal agent and that it could
stimulate the immune system.
    * Unic, of Carmichael, California, was ordered to stop claiming
that its
colloidal silver product was effective against many diseases and could
heal
burn-damaged tissue without scarring.

In October 1996, the FDA proposed to ban the use of colloidal silver
or silver
salts in over-the-counter products [7]. A Final Rule banning such use
was
issued on August 17, 1999 and became effective September 16th. The
rule applies
to any nonprescription colloidal silver or silver salt product claimed
to be
effective in preventing or treating any disease [8]. Silver products
can still
be sold as "dietary supplements" provided that no health claims are
made for
them. During 2000, the FDA issued warnings to more than 20 companies
whose Web
sites were making illegal therapeutic claims for colloidal silver
products.

In 2000, the Federal Court of Australia banned Vital Earth Company Pty
Limited
and its director Darryl John Jones from falsely representing that the
colloidal
silver produced by their "Vital Silver 3000 Zapper," "Vital Silver
2000
Automatic" and "Vital Silver 2000":

    * Can kill all disease-causing bacteria, fungi and virus within
six minutes
of contact
    * Has no harmful side effects; that colloidal silver could be used
as an
antibiotic for all the acquired diseases of active AIDS
    * Is effective with more than 650 different pathogenic bacteria
and virus
types
    * Has been used successfully against diseases including AIDS,
cholera,
diabetes, leprosy, leukemia, lupus, skin cancer, syphilis and whooping
cough.

The company was also ordered to pay AUS$9000 in costs and to provide
refunds
[9].

In 2001, the FTC obtained consent agreements with two companies:

    * Robert C. Spencer and Lisa M. Spencer, doing business as Aaron
Company
(Palm Bay, Florida). Colloidal silver has been medically proven to
kill over
650 disease-causing organisms in the body and is effective in curing
diseases
ranging from cancer and multiple sclerosis to HIV/AIDS [10].
    * ForMor, Inc., doing business as ForMor International, and its
president,
Stan Gross (Birmingham, Alabama) agreed not to make unsubstantiated
claims that
colloidal silver is effective in treating over 650 infectious
diseases, has no
adverse side effects, and is effective against arthritis, blood
poisoning,
cancer, cholera, diphtheria, diabetes, dysentery, gonorrhea, herpes,
influenza,
leprosy, lupus, malaria, meningitis, rheumatism, shingles, staph
infections,
strep infections, syphilis, tuberculosis, whooping cough, and yeast
infections
[10].

In 2002, the FTC obtained a consent agreement with Kris Pletschke,
doing
business as Raw Health, agreed to stop making unsubstantiated claims
that its
colloidal silver product could treat or cure 650 different diseases;
eliminate
all pathogens in the human body in six minutes or less; and is
medically proven
to kill every destructive bacterial, viral, and fungal organism in the
body,
including anthrax, Ebola, Hanta, and flesh-eating bacteria [12].

In 2002, the Australian Therapeutic Goods Administration amended its
rules so
that water-treatment products containing substances like colloidal
silver for
which therapeutic claims are made must meet the requirements of
medicines
included in the Australian Register of Therapeutic Goods. This means
that such
products can no longer be legally marketed without proof that they are
safe and
effective for their intended purpose. The amendment was based on
clnclusions
that:

    * There is little evidence to support therapeutic claims made for
colloidal
silver products;
    * The risk to consumers of silver toxicity outweighs the value of
trying an
unsubstantiated treatment, and bacterial resistance to silver can
occur
    * Efforts should be made to curb the illegal availability of
colloidal
silver products, which is a significant public health issue [11] .

=======================================================

FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

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FDA Talk Papers are prepared by the Press Office to guide FDA
personnel in
responding with consistency and accuracy to questions from the public
on
subjects of current interest. Talk Papers are subject to change as
more
information becomes available.

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T99-39 Print Media: 301-827-6242
August 17, 1999 Broadcast Media: 301-827-3434
                           Consumer Inquiries: 888-INFO-FDA
FDA ISSUES FINAL RULE ON
OTC DRUG PRODUCTS CONTAINING COLLOIDAL SILVER>
The FDA has issued a Final Rule declaring that all over- the-counter
(OTC) drug
products containing colloidal <silver> or <silver> salts are not
recognized as
safe and effective and are misbranded.
Colloidal <silver> is a suspension of <silver> particles in a
colloidal
(gelatinous) base. In recent years, colloidal <silver> preparations of
unknown
formulation have been appearing in stores. These products are labeled
to treat
adults and children for diseases including HIV, AIDS, cancer,
tuberculosis,
malaria, lupus, syphilis, scarlet fever, shingles, herpes, pneumonia,
typhoid,
tetanus and many others.

According to the Final Rule, a colloidal <silver> product for any drug
use will
first have to be approved by FDA under the new drug application
procedures. The
Final rule classifies colloidal <silver> products as misbranded
because
adequate directions cannot be written so that the general public can
use these
drugs safely for their intended purposes. They are also misbranded
when their
labeling falsely suggests that there is substantial scientific
evidence to
establish that the drugs are safe and effective for their intended
uses.

The indiscriminate use of colloidal <silver> solutions has resulted in
cases of
argyria, a permanent blue-gray discoloration of the skin and deep
tissues.

Colloidal <silver> ingredients and <silver> salts include <silver>
proteins,
mild <silver> protein, strong <silver> protein, <silver> chloride, and
<silver>
iodide. The dosage form of these colloidal <silver products is usually
oral,
but product labeling also contains directions for topical and,
occasionally,
intravenous use.

In reaching its decision, FDA considered all of the information
described in
the proposed rule (October 15, 1996) and submitted by the public in
response to
that proposal, the Final Rule becomes effective on September 16, 1999,
30 days
after publication.

============================================================================

> Silvadene - Marion Laboratories: FDA Approved Silver Sulfadiazine
> Cream
> Silvadene is an FDA approved topical cream used in over 70% of
> hospitals in the United States to prevent bacterial infections at burn
> sites, improve tissue healing, reduce scarring, and is often
> prescribed as a topical treatment for skin graft donor sites. This
> silver-rich cream ( a chemically produced silver salt compound ) is
> FDA approved as a topical antifungal and antibacterial for external
> use, and available on with a prescription. Silvadene has been proven
> effective against both gram-positive and gram-negative bacteria,
> including resistant strains.
>
> I could print these silver products all day long. I guess all these
> doctors using silver are quacks huh? sure. history is already being
> made and the use of silver will continue. period.
>
>
> IMO silver should be used with traditional abx for serious infections.
> Hit the bacteria in as many ways as possible.