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
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.
- In
doing so, the FDA fails to uphold the public
trust.
- The
FDA bullies organizations ( as will be shown below )
that are not in a position to know the letter of the
law, rather than educate them as a matter of public
responsibility and interest.
- The
FDA has mounted an increasingly hostile campaign
against colloidal silver.
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.
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.
|
