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The FDA Takes Motion

On September sixteen, 1999, The FDA issued a last ruling on any and all
colloidal silver merchandise. With a brisk pen-stroke invoking the FDA's broad energy, the ruling proclaimed and entered
into legislation that any silver substance in a gelatinous resolution couldn't
be offered as a medicinal substance. The ruling categorized colloidal silver as an unclassified drug.
Any colloidal silver merchandise marketed as having medicinal properties
are actually in violation of federal regulation.

Nevertheless, because of the truth that silver is each a pure substance And never a managed substance, it continues to be protected beneath the The Dietary Complement Well being and Schooling Act.
Underneath this regulation, any labeling and/or promoting
referring to any well being advantages of the substance in query is unlawful.
The substance should be labeled as a dietary complement and will not be marketed for exterior use.

The innocent bystander may assume that the FDA took this motion primarily
based on collected analysis knowledge that demonstrates
that colloidal silver is a dangerous substance, and thus the general public needs
to be protected from its use. Nonetheless, this isn't the
case. The next letter, written by the FDA in compliance with
the liberty of knowledge Act, clearly reveals that the FDA's motion to ban colloidal silver gross sales was NOT motivated by ANY information suggesting hurt:

The FDA Admits it has no Clinical Knowledge Suggesting
Remoted Silver is Unsafe for Human Use

October 14th, 1999

Meals and Drug Administration
U.S. Division Of Well being and
Human Providers
Public Well being Service
5600 Fishers Lane
Rockville, MD 20857

Expensive Sirs/Madam,

[img]https://cdn3.volusion.com/pahfr.ubfkh/v/vspfiles/photos/WTM-2.gif?1345366206[/img]Pursuant to the liberty of data
Act and in regard your August seventeenth, 1999 ruling concerning colloidal silver, might you please provide the next documentation on which you primarily based your determination?

1. The variety of deaths associated to the consumption of colloidal silver.

2. The variety of allergic reactions to the consumptionof colloidal silver.

Three. The variety of dangerous drug interactions from
each OTC and prescription medication when mixed with colloidal silver.

Four. The variety of reported instances of Argyria from colloidal silver made with the AC or DC electrical course of.

5. The variety of instances of Argyria from colloidal silver that
didn't include protein stabilizers.
Thanks to your time and consideration of this request.

-----------------------------------------------------

The FDA response:

Public Well being Service
Heart for Drug Analysis and Analysis
Workplace of coaching and Communication
Freedom of data Employees HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857
Division OF Well being AND HUMAN Providers

--------------------------------------------------------------------------------

November three, 1999

In Response Discuss with File: F99-22589

[ Identify Eliminated ], WA 98408

Expensive [ title eliminated ]:

That is in response to your request of 10/14/ninety nine, through which you requested adversarial
occasions related to using Colloidal Silver. Your request was acquired in the middle for Drug Analysis and Analysis on 10/25/ninety nine.

We've got searched the information from FDA's Hostile Occasion Reporting System (AERS) and have been unable to find any instances that can be attentive to your request.

Costs of $three.50 (Search $three.50, Assessment $zero, Reproduction $zero, Laptop time
$zero) will likely be included in a month-to-month bill.
Don't Ship ANY Fee Till YOU Obtain AN Bill.

If there are any issues with this response, please notify us in writing of
your particular downside(s). Please reference the above file quantity.

Sincerely,

Hal Stepper
Freedom of knowledge Technician
Workplace of coaching and Communications
Freedom of data Workers, HFD-205

Evaluating Colloidal Silver Based mostly on the FDA Ruling

The conscientious individual, armed with the above data,
would little doubt consider that the FDA has merely decided that
colloidal silver has both no worth in human well being functions, or that any attainable worth
stays extremely questionable on account of lack of scientific proof.
The FDA, one would assume, is sincerely following its
main function of defending the general public from potential abuse by unscrupulous firms and unduly optimistic dreamers-- defending them from turning blue from argyria and naivety.

Sadly, this isn't the reality. Whereas the FDA does have legitimate factors in opposition to the "colloidal silver trade" as
an entire, none of those factors has something to do with whether or not or not remoted silver is protected in affordable portions or whether or not or not it's efficient in preventing infections.
Not solely has the FDA authorized at the very least one silver product to be used in wound
care, however the FDA has finished its personal analysis
to find out if colloidal silver has potential as a major medicinal substance:

"The FDA has examined colloidal silver extensively and located that totally different microorganisms succumb to its motion at a large number of concentrations and publicity occasions. If any of this data entered the general public area, the FDA would consider their very own analysis "unsubstantiated medical claims" and cause sufficient to categorise colloidal silver as a brand new drug..." - Peter Lindeman,
lengthy earlier than the FDA's September sixteen ruling

Whereas, as famous above, the FDA should observe the letter of
its personal legal guidelines, it is evident that the MOTIVE behind the
FDA's ruling is pushed by forces unrelated to the security, the situation of argyria, or the potential effectiveness of
true colloidal silver. One Said motivating issue was that many
merchandise of unknown substance and high quality had been being marketed below the
label of colloidal silver. A few of these merchandise undoubtedly
had been, and are, of questionable high quality. There definitely aren't any established requirements for the manufacturing of colloidal silver.

Nevertheless, the FDA's underlying motives reveal themselves when inspecting their public relations methods:

The FDA, figuring out full effectively the distinction between totally
different sorts of silver merchandise, purposefully and maliciously makes an attempt
to confuse the general public by misrepresenting silver merchandise.
The FDA highlights the antiquated use of silver proteins and
compounds, whereas sidestepping the reality that remoted silver isn't any extra like these
merchandise than hydrogen alone is like water.

In doing so, the FDA fails to uphold the general public belief.

The FDA bullies organizations ( as might be proven beneath ) that aren't able to know the letter of the legislation, quite than educate them as a matter of
public accountability and curiosity.

The FDA has mounted an more and more hostile marketing campaign towards colloidal silver.

It's deeply troubling that such a vital company because the FDA can now not be trusted to uphold the general public belief it was based to preserve.
The FDA must be held accountable each for its true motives and its actions.
It's true that the letter of the regulation have to be honored.
Nevertheless, the spirit of the regulation ought to outline how the
letter of the legislation is enforced.

Many of those points will must be settled in a excessive courtroom of legislation. It's unlikely
that the problem of colloidal silver will likely
be a authorized battle floor ( for the reason that FDA
defines, guidelines, and enforces legal guidelines concerning silver
use ) however we strongly recommend that anybody excited
by the reality do unbiased analysis on pending court docket instances in opposition to the FDA ( which is outdoors of the scope
of this work ).

Till that point, we are able to solely query the liberal funds allowed to the FDA which
is evidently considerable sufficient to permit them to constantly harass individuals promoting silver
wire and 9 volt batteries ( amongst others ). If Congress continues to imagine that such expenditures are well worth the hefty
value tag, then we nonetheless query the Strategies the FDA makes use of to realize its goal.
We imagine a federal authorities sponsored unbiased ethics evaluate
is lengthy overdue.

The next letter is an instance of what the FDA
is asking "Cyber Letters" which were despatched to firms advertising colloidal silver:

January eight, 2001
[ title and tackle eliminated ]
Ref. No. 01-HFD-3101-068.

Expensive:
That is to advise you that the Meals and Drug Administration (FDA) has reviewed
your internet site on the Web handle: http://www.ionicminerals.com and has decided that
the product "Ionic Silver Mineral Water" being
provided is promoted for circumstances that trigger the product to be
a drug underneath part 201(g) of the Federal Meals, Drug,
and Beauty Act (the Act) [21 USC 321(g)]. The product
could also be thought-about a drug as a result of the therapeutic claims as proven in your net site set up its supposed use as a drug.
Examples of some claims noticed in your net site embrace, partially: Ionic Silver Mineral Water Natures Antibiotic Pneumonia.
Shingles, genital wart, ringwormproven to kill over 650 totally different sorts of
micro organism, fungus, viruses, and illness
organisms. AnthraxTuberculosisCerebrospinal meningitisFurthermore, FDA
has no info that your product is usually acknowledged as protected and efficient for the above referenced situations
and subsequently, it might even be a new drug below part 201 (p) of the Act
[21 USC 321(p)].

New medication might not be legally marketed within the US with out prior approval from FDA as described in part 505 (a) of the Act [21 USC 355(a)].
FDA approves new medication on the idea of scientific knowledge
submitted by a drug sponsor to reveal that the drug
is secure and efficient.

FDA is conscious that Web distributors could not know that the merchandise
they provide are regulated as medicine or that these
medicine are usually not in compliance with the legislation. Many of those merchandise could also be legally marketed as dietary supplements or as cosmetics if sure therapeutic claims are faraway from the promotional supplies and the merchandise in any other case
adjust to all relevant provisions of the Act and FDA laws.

Beneath the Act, as amended by the Dietary Complement Well being
and Training Act (DSHEA), dietary supplements could also
be legally marketed with claims that they're meant to have an effect on the construction or perform of the physique (construction/operate claims) if sure circumstances are met.
Claims that dietary supplements are meant to stop, diagnose, mitigate,
deal with, or cure illness (illness claims) excepting well
being claims authorized to be used by FDA, is probably not made as they trigger
the merchandise to be medicine. The meant use of a product could also be established by way of product labels and labeling,
catalogs, brochures, audio and videotapes, Web websites, or different circumstances surrounding the distribution of the product.
FDA has printed a Last Rule meant to make clear the distinction between statements
allowed as construction/perform claims and people who characterize illness claims.
This doc is out there on the web at http://vm.cfsan.fda.gov/~lrd/fr000106.html. As well as, solely merchandise which can be meant for ingestion could also be lawfully marketed
as dietary supplements.

Topical merchandise and merchandise meant to enter into the physique straight by
means of the pores and skin or mucosal tissues, equivalent to transdermal or sublingual merchandise, will not
be dietary supplements. For these merchandise,
illness or construction/perform claims could trigger them to be new medication. Extra data is offered
in Title 21, Code of Federal Rules, (21 CFR) Elements 310 and 330-358.
These elements embrace the ultimate Guidelines for
varied OTC substances or merchandise that will or is probably
not legally marketed with out prior approval.

Moreover, your Web site could also be topic to statutes enforced by the Federal Commerce Fee
(FTC). Sections 5 and 12 of the Federal Commerce Fee Act,
15 U.S.C. Sections forty five and fifty two. You might be inspired
to seek the advice of the FTC Net site at http://www.ftc.gov/bcp/conline/pubs/dietsupp.htm for additional data.
The FTC Internet site additionally supplies copies of
complaints and orders which have been filed by the FTC in opposition to firms making deceptive or misleading promoting claims on the web.
A few of these complaints and orders may be discovered 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. Associated questions needs to be directed
to the FTC at (202) 326-3090.

This letter is just not supposed to be an all-inclusive evaluate of your net site and merchandise your agency could market.
It's your duty to make sure that each one merchandise marketed
by your agency are in compliance with the statutes administered by each the FDA and FTC.
For those who want further data or have questions regarding any merchandise distributed via your internet site,
please contact FDA. You might attain FDA electronically (e-mail) at Leggett@CDER.FDA.GOV, or chances are you'll reply in writing to Don Leggett , Compliance Officer, Meals and Drug Administration, HFD-310, 7520 Standish Place, Rockville,
MD 20855 or by phone at (301) 594-0063.

Sincerely yours,
/s/
David J. Horowitz, Esq.
Appearing Director
Workplace of Compliance
Heart for Drug Analysis and Analysis
Meals and Drug Administration

The FDA goes again and forth between two key phrases in its commentaries, literature, and letters: "the FDA has no info that your product is usually acknowledged as protected and efficient for the above referenced circumstances" and "...usually are not usually acknowledged as secure and efficient..."
The FDA is aware of it should watch out treading these
grounds.

The next letter was despatched by the Federal Commerce Fee to
an internet site thatsells no merchandise. The FTC, teamed up with the FDA, on this
case has overstepped authorized boundaries to encroach upon authorized freedom of expression. We are able to solely hope this was carried out
out of incompetence quite than focused suppression of data:

UNITED STATES OF AMERICA
FEDERAL Commerce Fee
BUREAU OF Client Safety
WASHINGTON, D.C. 20580

By way of Digital MAIL

RE: Discover OF POTENTIAL Unlawful Advertising OF Merchandise
OR THERAPIES To stop, Deal with, OR CURE ANTHRAX, SMALLPOX, OR Different DISEASES OR
Well being HAZARDS: Instant Motion REQUIRED

DATE: November 20, 2001

Your Net Site claims that a product or therapy you promote is efficient within the remedy or cure of anthrax, smallpox, or one other illness or well being hazard
that could be related to current experiences about
threats of terrorism. We're conscious of no scientific foundation for such
claims. With out competent and dependable scientific proof to substantiate these claims,
the claims are unlawful below the Federal Commerce Fee Act and have to be discontinued instantly.
Violations of the FTC Act might lead to authorized motion within the type of Federal District
Courtroom Injunction or Administrative Order. An order additionally could
require that you just pay cash again to shoppers.

As well as, in case you are advertising and marketing a dietary complement,
remember that FDA prohibits any labeling claims that a dietary complement
is meant to forestall, mitigate, deal with, or cure anthrax, smallpox, or
another illness underneath the Federal Meals,
Drug, and Beauty Act as amended by the Dietary Complement Well being
and Training Act of 1994. Such claims would require that the product be submitted for FDA approval as a brand new drug.
Additionally, representatives of the dietary complement business
have issued a joint information launch stating that dietary
supplements shouldn't be promoted as a treatment or cure for
anthrax and that no dietary supplements have been confirmed to deal with or stop anthrax.
The joint assertion of the American Natural Merchandise Affiliation, Client Healthcare Merchandise Affiliation, Council for Accountable Nutrition, Nationwide Nutritional Foods
Affiliation, and Utah Pure Merchandise Alliance is hooked up.

FTC investigators have copied and preserved the pages of your on-line promotional supplies and might be revisiting your Internet site quickly.

In case your Internet site contains any categorical of implied declare
about the advantage of any product or therapy for anthrax, smallpox,
or different illness that's not substantiated by competent
and dependable scientific proof, or is in any other case misleading or fraudulent, you should discontinue these claims instantly.

The following letter was written by Ebay.com having lastly given in to
authorities strain to ban ALL gross sales of colloidal silver associated merchandise, whether or
not they're mislabeled or not. Discover the misinformation within the
letter. In response to Ebay, the FDA claimed that colloidal silver merchandise are unsafe.
We will solely hope that Ebay misunderstood the FDA,
and that the FDA didn't in fact make this erroneous declare:

Expensive [ title eliminated ],

eBay appreciates the actual fact that you just selected to record your
public sale(s):

[ public sale quantity eliminated ] Colloidal
Silver with us. Nonetheless, it has been delivered to our consideration that the FDA has discovered colloidal silver
merchandise to be unsafe. The FDA has categorized
colloidal silver merchandise to be misbranded as a
result of ample instructions can't be written in order that most people can use these medication safely for his or her meant functions.
They're additionally misbranded when their labeling falsely suggests that there's
substantial scientific proof to determine that the medication are secure and efficient for his or her meant makes use of.
Based mostly on this info, eBay has decided that the
sale of objects containing colloidal silver
will now not be allowed on our site. Due to this fact, these auctions have been ended
and all related charges have been refunded to your account.

For a whole textual content of the ruling by the FDA
on this matter, please view the next web page:

http://www.fda.gov/bbs/subjects/Solutions/ANS00971.html

Please use the next hyperlink to view the FDA's About Me Web page for extra
data:

http://members.ebay.com/aboutme/usfda/

Per our present insurance policies for prescription medicine and meals merchandise, eBay does
not permit the itemizing of any elements of prescription or
over-the-counter
medicine except the sale of such elements with out a prescription has been
authorized by the Meals & Drug Administration (FDA).
As well as, eBay does
not enable listings containing drug claims - that's,
a declare that the merchandise
is meant to be used within the analysis, cure, mitigation, therapy, or
prevention of illness in people and/or animals (e.g., pharmaceutical medication,
contact lenses, misbranded dietary supplements). For extra data,
please overview the next pages:

http://pages.ebay.com/assist/group/png-prescription.html
and
http://pages.ebay.com/assist/neighborhood/png-meals.html

Please view our guideline web page for a greater understanding of our public sale pointers and the way they have an effect on the best way you
checklist your objects:
http://pages.ebay.com/assist/neighborhood/png-checklist.html

For data on infringing or unlawful objects or for different eBay itemizing
pointers, please view:
http://pages.ebay.com/assist/group/png-objects.html

For extra data on why eBay has ended an public sale, please go to:
http://pages.ebay.com/assist/group/png-endauction.html

Future auctions listed that fail to satisfy our itemizing pointers might be ended
early and repeated violations might jeopardize your account standing.
We worth you as a member of our neighborhood and want to proceed this relationship, so we should ask you to
chorus from any violations of the Itemizing Insurance policies or Consumer Settlement sooner or later.

We thanks upfront on your understanding and cooperation.

Please be at liberty to contact us with any questions or issues you could have on our present itemizing
insurance policies.

Regards,
ricardo x (ended@ebay.com)
eBay Inc

The present technique of enforcement and prosecution of firms advertising and marketing colloidal silver is a concentrated and joint effort between the FDA and the FTC.

Nevertheless, there's a notable distinction in coverage
between the 2 companies. In contrast to the FDA, the FTC DOES settle for scientific proof as justifiable
in making Sure claims about objects on the market.

[img]https://cdn3.volusion.com/pahfr.ubfkh/v/vspfiles/photos/CSS_16-2.gif?1345579775[/img]To quote
the FTC versus Aaron Firm ( settlement settlement ):

"'Competent and dependable scientific proof' shall imply exams, analyses, analysis, research, or different proof primarily based on the experience of pros within the related space, that has been performed and evaluated in an goal method by individuals certified to take action, utilizing procedures typically accepted within the career to yield correct and dependable outcomes."

Within the matter of constructing claims of efficacy, the FTC forbids it, except: "...until, on the time the illustration is made, respondents possess and depend on competent and
dependable scientific proof that substantiates the illustration."

Subsequently, it is feasible to be in compliance with the FTC whereas
violating legislation established by the FDA. This could also be why
there are some cautious corporations that aren't
main targets within the "Operation Cure All"
marketing campaign. The FTC, apparently, is in a much better place
to handle prosecution than the FDA.

Each the FDA and the FTC's definition of colloidal silver is sadly missing: "'Colloidal Silver product' shall imply any product containing or purporting to comprise colloidal silver or silver salts, together with however not restricted to Aarons Colloidal Silver."

Language that the FDA and FTC use is often very ambiguous.

A minimum of three classifications of silver merchandise are really required to precisely
cowl the wide selection of silver merchandise
in use immediately. The FDA would actually be doing a public service if it established three separate classifications, and
prioritized their actions based mostly on scientifically out
there proof on security:

1) Silver compounds identified to be toxic -
labeled as not typically considered protected,
retaining the unclassified drug standing.

2) Mild silver proteins, silver proteins, numerous silver compounds ( those which have adequately been researched ) and options with greater than 50 ppm silver content material - categorized as "no info that establishes these merchandise as protected",
retaining the unclassified drug standing.

Three) Remoted silver merchandise, which means ionic and particulate silver in remoted type, between 1 and 50 PPM, in distilled water in colloidal ( and/or ionic ) kind - categorised as
GRAS ( Typically Thought to be Secure ) with the unclassified drug standing Eliminated.

The FDA likes to argue that there are not any USP
requirements for manufacturing. This may be settled in very brief order to various levels of excellence
primarily based on presently obtainable research endorsed by the EPA.

None of those efforts would change the truth of the legislation or permit
corporations to make unsubstantiated medical
claims about merchandise. What it could do,
nevertheless, is deprioritize the vital consideration of remoted silver merchandise and correctly
focus the vitality concerned in legislation enforcement.

In any case, scientifically, silver isn't any extra a drug within the
physique than easy H2O. By the letter of the regulation, if I say
"H2O cures dehydration" I'm making a drug declare.

It ought to be acknowledged that the Colloidal Silver Database Web site has had no destructive experiences with any governmental company, nor are we
focused on spearheading a political or authorized struggle
in opposition to any company. We're solely focused on documenting and
exploring the pertinent points within the spirit of public curiosity.