It is my understanding that non drug products cannot make cure
claims, so
anything mentioning the actual way to use it would not be allowed.
This
letter was trickily written. It actually does not say it is
dangerous. It
just says the limitations on labelling. I am unsure on what the US
rules
for dosage are, but I think what they are saying is that dosages
need to be
clearly marked. In Canada many things will have dosage
recommendations at a
level that will not harm anyone, but for those people doing their own
research, they will take however much they want. If necessary,
warnings can
also be included to indicate if, for example, a rash or stomache
ache occurs
to discontinue use. Here in Canada, there is no way you could
possibly
figure out how to use products unless you obtained the information
in a
different spot than the bottle. Here, those 2 things cannot legally
exist
together. That is why we often see one site with product info that
does not
really tell us how much to take and when. The light warning against
argyria
looks like just a scare tactic without actually lying. The abuse
that is
required to cause it is so way beyond even most radical users, but
they just
"gotta" throw that in there. Wouldn't it be interesting to see this
type of
warning on every drug, food, and OTC medicine. No one would leave
there
house!! We'd all be scared to death!!
Thora
-----Original Message-----
From: bob smith [mailto:[email protected]]
Sent: Monday, February 16, 2004 2:33 PM
To: [email protected]
Subject: CS>Emailing: ANS00971
I just came across this article. I had never heard of these
restrictions on
CS. My understanding was that they did not find it harmful. But
there
could be no claims made as to its benefits. Bob Smith
FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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.
T99-39 Print Media: 301-827-6242
August 17, 1999
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.
####
--
The Silver List is a moderated forum for discussing Colloidal Silver.
Instructions for unsubscribing are posted at: http://silverlist.org
To post, address your message to: [email protected]
Silver List archive:
http://escribe.com/health/thesilverlist/index.html
Address Off-Topic messages to: [email protected]
OT Archive: http://escribe.com/health/silverofftopiclist/index.html
List maintainer: Mike Devour <[email protected]>
