|
The FDA ruling on colloidal silver in 1999 formally
established that all colloidal silver products are unclassified drugs.
This document explores the Food and Drug Administration's actions since
that time, noting inconsistancies and biases concerning the FDA's action
against the use of colloidal silver.
Many people, based upon the controversies
associated with silver use, believe that the FDA is anti-silver.
Many people believe that the FDA and other governmental
agenices have no reason to believe in the effectiveness of silver products,
and that their position is that silver is not safe for use with the
human body. We
recommend our visitors view our material: Silver
Medical Products.
Featured:
Simple Colloidal Silver Generator Tutorial
|
 Would
you like to learn about the fundamental principles of colloidal silver
production? Our basic tutorial
provides the necessary core information to build an advanced generator,
even though the tutorial itself is focused on the most simple generator
possible. Learn the principles, and avoid errors in judgement such
as using an air bubbler, not keeping electrodes clean, and more. View
our Make Your Own Basic Colloidal Silver
Generator tutorial.
|
| |
The FDA Takes Action
On September 16, 1999, The FDA issued a final ruling on
any and all colloidal silver products. With a brisk pen-stroke invoking
the FDA's broad power, the ruling proclaimed and entered into law that
any silver substance in a gelatinous solution could not be sold as a
medicinal substance. The ruling categorized colloidal silver as an unclassified
drug. Any colloidal silver products marketed as having medicinal properties
are now in violation of federal law.
However, due to the fact that silver is both a natural
substance AND not a controlled substance, it is still protected under
the The Dietary Supplement Health and Education Act. Under this law,
any labeling and/or advertising referring to any health benefits of the
substance in question is unlawful. The substance must be labeled as a
dietary supplement and may NOT be marketed for external use.
The innocent bystander might assume that the FDA took this
action based on collected research data that demonstrates that colloidal
silver is a harmful substance, and thus the public should be protected
from its use. HOWEVER, this is not the case. The following letter, written
by the FDA in compliance with the Freedom of Information Act, clearly
shows that the FDA's action to ban colloidal silver sales was NOT motivated
by ANY data suggesting harm:
The FDA Admits
it has no Clinical Data Suggesting Isolated Silver is Unsafe
for Human Use October 14th, 1999 Food and Drug Administration
U.S. Department Of Health and
Human Services
Public Health Service
5600 Fishers Lane
Rockville, MD 20857 Dear Sirs/Madam, Pursuant to the Freedom of Information Act and in regard
your August 17th, 1999 ruling regarding colloidal silver, could you
please supply the following documentation on which you based your decision? 1. The number of deaths related to the consumption of
colloidal silver. 2. The number of allergic reactions to the consumptionof
colloidal silver. 3. The number of harmful drug interactions from both
OTC and prescription drugs when combined with colloidal silver. 4. The number of reported cases of Argyria from colloidal
silver made with the AC or DC electrical process. 5. The number of cases of Argyria from colloidal silver
that did not contain protein stabilizers. Thank you for your time and consideration of this request. Sincerely, -----------------------------------------------------
The FDA response: Public Health Service
Center for Drug Evaluation and Research
Office of Training and Communication
Freedom of Information Staff HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857
DEPARTMENT OF HEALTH AND HUMAN SERVICES -------------------------------------------------------------------------------- November 3, 1999 In Response Refer to File: F99-22589 [ Name Removed ], WA 98408 Dear [ name removed ]: This is in response to your request of 10/14/99, in which
you requested adverse events associated with the use of Colloidal Silver.
Your request was received in the Center for Drug Evaluation and Research
on 10/25/99. We have searched the records from FDA's Adverse Event
Reporting System (AERS) and have been unable to locate any cases that
would be responsive to your request. Charges of $3.50 (Search $3.50, Review $0, Reproduction
$0, Computer time $0) will be included in a monthly invoice. DO NOT
SEND ANY PAYMENT UNTIL YOU RECEIVE AN INVOICE. If there are any problems with this response, please
notify us in writing of your specific problem(s). Please reference
the above file number. Sincerely, Hal Stepper
Freedom of Information Technician
Office of Training and Communications
Freedom of Information Staff, HFD-205
Evaluating Colloidal Silver Based on the FDA Ruling
The conscientious person, armed with the above
knowledge, would no doubt consider that the FDA has simply determined
that colloidal silver has either no value in human health applications,
or that any possible value remains highly questionable due to
lack of scientific evidence. The FDA, one would think, is sincerely
following its primary purpose of protecting the public from potential
abuse by unscrupulous companies and unduly optimistic dreamers--
protecting them from turning blue from argyria and naivety.
Unfortunately, this is not the truth. While the FDA does have valid
points against the "colloidal silver industry" as a whole,
none of these points has anything to do with whether or not isolated
silver is safe in reasonable quantities or whether or not it is effective
in fighting infections. Not only has the FDA approved at least one
silver product for use in wound care, but the FDA has done its own
research to determine if colloidal silver has potential as a significant
medicinal substance:
"The FDA has tested colloidal silver
extensively and found that different microorganisms
succumb to its action at a wide variety of concentrations and
exposure times. If any of this information entered the public
domain, the FDA would consider their own research "unsubstantiated
medical claims" and reason enough to classify colloidal
silver as a new drug..." - Peter Lindeman, long before the
FDA's September 16 ruling
While, as noted above, the FDA must follow
the letter of its own laws, it is clear that the MOTIVE behind
the FDA's ruling is driven by forces unrelated to the safety,
the condition of argyria, or the potential effectiveness of true
colloidal silver. One STATED motivating factor was that many
products of unknown substance and quality were being marketed
under the label of colloidal silver. Some of these products undoubtedly
were, and are, of questionable quality. There certainly are no
established standards for the production of colloidal silver.
However, the FDA's underlying motives
reveal themselves when examining their public relations strategies:
-
The FDA, knowing full well the distinction between different
kinds of silver products, purposefully and maliciously
attempts to confuse the public by misrepresenting silver products.
The FDA highlights the antiquated use of silver proteins and compounds,
while sidestepping the truth that isolated silver is no more like
these products than hydrogen alone is like water.
It is deeply troubling that such a necessary agency
as the FDA can no longer be trusted to uphold the public trust it
was founded to preserve. The FDA needs to be held accountable both
for its true motives and its actions. It is true that the letter
of the law must be honored. However, the spirit of the law should
define how the letter of the law is enforced.
Many of these issues will need to be settled in a high
court of law. It is unlikely that the issue of colloidal silver will
be a legal battle ground ( since the FDA defines, rules, and enforces
laws regarding silver use ) but we strongly suggest that anyone interested
in the truth do independent research on pending court cases against
the FDA ( which is outside of the scope of this work ).
Until that time, we can only question the liberal budget
allowed to the FDA which is evidently abundant enough to allow them
to continuously harass people selling silver wire and nine volt batteries
( among others ). If Congress continues to believe that such expenditures
are worth the hefty price tag, then we still question the METHODS
the FDA uses to achieve its objective. We believe a federal government
sponsored independent ethics review is long overdue.
The following letter is an example of what the FDA
is calling "Cyber Letters" that have been sent to companies
marketing colloidal silver:
January 8, 2001
[ name and address removed ]
Ref. No. 01-HFD-3101-068.
Dear:
This is to advise you that the Food and Drug Administration (FDA) has reviewed
your web site at the Internet address: http://www.ionicminerals.com and has
determined that the product "Ionic Silver Mineral Water" being
offered is promoted for conditions that cause the product to be a drug under
section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21
USC 321(g)]. The product may be considered a drug because the therapeutic
claims as shown on your web site establish its intended use as a drug. Examples
of some claims observed on your web site include, in part: Ionic Silver Mineral
Water “ …Nature’s Antibiotic Pneumonia. Shingles, genital
wart, ringworm…proven to kill over 650 different kinds of bacteria,
fungus, viruses, and disease organisms…. Anthrax…Tuberculosis…Cerebrospinal
meningitis…” Furthermore,
FDA has no information that your product is generally recognized as safe
and effective for the above referenced conditions and therefore,
it may also be a “new drug” under section 201 (p) of the Act [21
USC 321(p)].
New drugs may not be legally marketed in the US without prior approval from
FDA as described in section 505 (a) of the Act [21 USC 355(a)]. FDA approves
new drugs on the basis of scientific data submitted by a drug sponsor to
demonstrate that the drug is safe and effective.
FDA is aware that Internet distributors may not know that the products they
offer are regulated as drugs or that these drugs are not in compliance with
the law. Many of these products may be legally marketed as dietary supplements
or as cosmetics if certain therapeutic claims are removed from the promotional
materials and the products otherwise comply with all applicable provisions
of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education
Act (DSHEA), dietary supplements may be legally marketed with claims that
they are intended to affect the structure or function of the body (structure/function
claims) if certain conditions are met. Claims that dietary supplements are
intended to prevent, diagnose, mitigate, treat, or cure disease (disease
claims) excepting health claims authorized for use by FDA, may not be made
as they cause the products to be drugs. The intended use of a product may
be established through product labels and labeling, catalogs, brochures,
audio and videotapes, Internet sites, or other circumstances surrounding
the distribution of the product. FDA has published a Final Rule intended
to clarify the distinction between statements allowed as structure/function
claims and those that represent disease claims. This document is available
on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html. In addition,
only products that are intended for ingestion may be lawfully marketed as
dietary supplements.
Topical products and products intended to enter into the body directly through
the skin or mucosal tissues, such as transdermal or sublingual products,
are not dietary supplements. For these products, disease or structure/function
claims may cause them to be new drugs. Additional information is available
in Title 21, Code of Federal Regulations, (21 CFR) Parts 310 and 330-358.
These parts include the Final Rules for various OTC ingredients or products
that may or may not be legally marketed without prior approval.
Furthermore, your Internet site may be subject to statutes enforced by the
Federal Trade Commission (FTC). Sections 5 and 12 of the Federal Trade Commission
Act, 15 U.S.C. Sections 45 and 52. You are encouraged to consult the FTC
Web site at http://www.ftc.gov/bcp/conline/pubs/dietsupp.htm for further
information. The FTC Web site also provides copies of complaints and orders
that have been filed by the FTC against companies making misleading or deceptive
advertising claims on the Internet. Some of these complaints and orders can
be found at http://www/ftc/gov/opa/2000/06/lanelabs.htm, http://www.ftc.gov/opa/2000/04/cureall2.htm,
and http://www.ftc.gov/opa/1999/9906/opcureall.htm. You may want to review
your advertisement in light of these standards. Related questions should
be directed to the FTC at (202) 326-3090.
This letter is not intended to be an all-inclusive review of your web site
and products your firm may market. It is your responsibility to ensure that
all products marketed by your firm are in compliance with the statutes administered
by both the FDA and FTC. If you need additional information or have questions
concerning any products distributed through your web site, please contact
FDA. You may reach FDA electronically (e-mail) at Leggett@CDER.FDA.GOV, or
you may respond in writing to Don Leggett , Compliance Officer, Food and
Drug Administration, HFD-310, 7520 Standish Place, Rockville, MD 20855 or
by telephone at (301) 594-0063.
Sincerely yours,
/s/
David J. Horowitz, Esq.
Acting Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
The FDA goes back and forth between two key phrases
in its commentaries, literature, and letters: "the FDA has
no information that your product is generally recognized as safe
and effective for the above referenced conditions" and "...are
not generally recognized as safe and effective..." The FDA
knows it must be careful treading these grounds.
The following letter was sent by the Federal Trade
Commission to a website that sells no products. The
FTC, teamed up with the FDA, in this case has overstepped legal boundaries
to encroach upon legal freedom of expression. We can only hope this
was done out of incompetence rather than targeted suppression of
information:
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580
VIA ELECTRONIC MAIL
RE: NOTICE OF POTENTIAL ILLEGAL MARKETING OF PRODUCTS
OR THERAPIES TO PREVENT, TREAT, OR CURE ANTHRAX, SMALLPOX, OR OTHER
DISEASES OR HEALTH HAZARDS: IMMEDIATE ACTION REQUIRED
DATE: November 20, 2001
Your Web Site claims that a product or therapy you
sell is effective in the treatment or cure of anthrax, smallpox,
or another disease or health hazard that may be associated with
recent reports about threats of terrorism. We are aware of no scientific
basis for such claims. Without competent and reliable scientific
evidence to substantiate these claims, the claims are illegal under
the Federal Trade Commission Act and must be discontinued immediately.
Violations of the FTC Act may result in legal action in the form
of Federal District Court Injunction or Administrative Order. An
order also may require that you pay money back to consumers.
In addition, if you are marketing a dietary supplement,
be aware that FDA prohibits any labeling claims that a dietary
supplement is intended to prevent, mitigate, treat, or cure anthrax,
smallpox, or any other disease under the Federal Food, Drug, and
Cosmetic Act as amended by the Dietary Supplement Health and Education
Act of 1994. Such claims would require that the product be submitted
for FDA approval as a new drug. Also, representatives of the dietary
supplement industry have issued a joint news release stating that
dietary supplements should not be promoted as a remedy or cure
for anthrax and that no dietary supplements have been proven to
treat or prevent anthrax. The joint statement of the American Herbal
Products Association, Consumer Healthcare Products Association,
Council for Responsible Nutrition, National Nutritional Foods Association,
and Utah Natural Products Alliance is attached.
FTC investigators have copied and preserved the pages
of your online promotional materials and will be revisiting your
Web site soon. If your Web site includes any express of implied
claim about the benefit of any product or therapy for anthrax,
smallpox, or other disease that is not substantiated by competent
and reliable scientific evidence, or is otherwise deceptive or
fraudulent, you must discontinue these claims immediately.
The next letter was written by Ebay.com having finally
given in to government pressure to ban ALL sales of colloidal silver
related products, whether they are mislabeled or not. Notice the
misinformation in the letter. According to Ebay, the FDA claimed
that colloidal silver products are unsafe. We can only hope that
Ebay misunderstood the FDA, and that the FDA did not in truth make
this erroneous claim:
Dear [ name removed ],
eBay appreciates the fact that you chose to list
your auction(s):
[ auction number removed ] Colloidal Silver with us. However, it has been
brought to our attention that the FDA has found colloidal silver products
to be unsafe. The FDA has classified colloidal silver products to be
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. Based on this information, eBay has determined that
the sale of items containing colloidal silver will no longer be allowed on
our site. Therefore, these auctions have been ended and all associated fees
have been refunded to your account.
For a complete text of the ruling by the FDA in this
matter, please view the following page:
http://www.fda.gov/bbs/topics/ANSWERS/ANS00971.html
Please use the following link to view the FDA's About
Me Page for more
information:
http://members.ebay.com/aboutme/usfda/
Per our current policies for prescription drugs and
food products, eBay does
not permit the listing of any components of prescription or over-the-counter
drugs unless the sale of such components without a prescription has been
approved by the Food & Drug Administration (FDA). In addition, eBay does
not allow listings containing drug claims - that is, a claim that the item
is intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans and/or animals (e.g., pharmaceutical drugs,
contact lenses, misbranded dietary supplements). For more information,
please review the following pages:
http://pages.ebay.com/help/community/png-prescription.html
and
http://pages.ebay.com/help/community/png-food.html
Please view our guideline page for a better understanding
of our auction guidelines and how they affect the way you list
your items:
http://pages.ebay.com/help/community/png-list.html
For information on infringing or illegal items or
for other eBay listing
guidelines, please view:
http://pages.ebay.com/help/community/png-items.html
For more information on why eBay has ended an auction,
please visit:
http://pages.ebay.com/help/community/png-endauction.html
Future auctions listed that fail to meet our listing
guidelines will be ended early and repeated violations may jeopardize
your account status. We value you as a member of our community
and wish to continue this relationship, so we must ask you to refrain
from any violations of the Listing Policies or User Agreement in
the future.
We thank you in advance for your understanding and
cooperation.
Please feel free to contact us with any questions
or concerns you may have on our existing listing policies.
Regards,
ricardo x (ended@ebay.com)
eBay Inc
The current method of enforcement
and prosecution of companies marketing colloidal silver is a concentrated
and joint effort between the FDA and the FTC. However, there is
a notable difference in policy between the two agencies. Unlike
the FDA, the FTC DOES accept scientific
evidence as justifiable in making CERTAIN claims about items for
sale.
To quote the FTC versus Aaron Company
( settlement agreement ):
"'Competent and reliable
scientific evidence' shall mean tests, analyses, research, studies,
or other evidence based on the expertise of professionals in
the relevant area, that has been conducted and evaluated in an
objective manner by persons qualified to do so, using procedures
generally accepted in the profession to yield accurate and reliable
results."
In the matter of making claims of
efficacy, the FTC forbids it, unless: "...unless, at the time
the representation is made, respondents possess and rely upon competent
and
reliable scientific evidence that substantiates the representation."
Therefore, it is possible to be
in compliance with the FTC while violating law established by the
FDA. This may be why there are some careful companies that are
not primary targets in the "Operation Cure All" campaign.
The FTC, apparently, is in a far better position to handle prosecution
than the FDA.
Both the FDA and the FTC's definition
of colloidal silver is sadly lacking: "'Colloidal Silver
product' shall mean any product containing or purporting to contain
colloidal silver or silver salts, including but not limited to
Aaron’s Colloidal Silver."
Language that the FDA and FTC use is usually
very ambiguous. At least three classifications of silver products
are truly required to accurately cover the wide range of silver
products in use today. The FDA would truly be doing a public
service if it established three separate classifications, and
prioritized their actions based on scientifically available evidence
on safety:
1) Silver compounds known to
be toxic - classified as not generally regarded as safe, retaining
the unclassified drug status.
2) Mild silver proteins, silver
proteins, various silver compounds ( the ones which have adequately
been researched ) and solutions with more than 50 ppm silver
content - classified as "no information that establishes
these products as safe", retaining the unclassified drug
status.
3) Isolated silver products,
meaning ionic and particulate silver in isolated form, between
1 and 50 PPM, in distilled water in colloidal ( and/or ionic
) form - classified as GRAS ( Generally Regarded as Safe )
with the unclassified drug status REMOVED.
The FDA likes to argue that there are no USP
standards for production. This can be settled in very short order
to varying degrees of excellence based on currently available
studies endorsed by the EPA.
None of these efforts would change the reality
of the law or allow companies to make unsubstantiated medical
claims about products. What it WOULD do, however, is deprioritize
the critical attention of isolated silver products and properly
focus the energy involved in law enforcement.
After all, scientifically, silver is no more
a drug in the body than simple H2O. By the letter of the law,
if I say "H2O cures dehydration" I am making a drug
claim.
It should be stated that the Colloidal Silver
Database Website has had no negative experiences with any governmental
agency, nor are we interested in spearheading a political or
legal fight against any agency. We are only interested in documenting
and exploring the pertinent issues in the spirit of public interest.
All
Content Copyright 2007 AVRA unless otherwise specified content
copyright 2007 AVRA and managed by -
Website Designs, Las Vegas
 back
to top 
Silver
Colloidal Silver
Safety with Using Colloidal Silver
EPA
Silver Safety Studies ---- FDA
and Colloidal Silver ----Silver
Compound Toxicity ----FAQ:
Silver Salts, Proteins and Isolated Silver ----Argyria
and Colloidal Silver ----Argyria:
Reported Cases ----Cure
for Argyria ----Herxheimer
Reaction ----Silver
Side Effects Poll ----Roger
Altman Silver Elimination Study ----World
Health Organization Silver Toxicity Data-------Mark
Metcalf
|
