Marshall

Is there any reason why you could not say "CS is a food supplement that
enhances the body's natural immune system".  That does not claim to cure
any specific ailment, and a lot of food supplements say that.  Then you
could add that you should start with smaller doses and build up
gradually.

Just wondering about the politics of it all....

Del
----- Original Message ----- 
From: "Marshall Dudley" <[email protected]>
To: <[email protected]>
Sent: Tuesday, February 17, 2004 9:50 AM
Subject: Re: CS>Emailing: ANS00971


The FDA really gives the CS producers a catch 22.  I wanted to include
some
documentation that indicated that if one is chronically ill then they
should
start off with small amounts of CS. This would be a warning to prevent
one from
becoming very sick from a healing crisis.  But I can't do that because
that says
that CS kills pathogens, and then the FDA could come after me. So I am
unable to
give a real warning to a real possible problem due to the FDA wanting
the people
to not know that it works..

Go figure.

Marshall

Thora Rasmussen wrote:

> 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.
> ####
>
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