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Potential / hypothetical uses for Colloidal Silver / Silver Mineral Water, FDA, FTC, EPA, Regulation, Research Guidelines and General Information. An Investigative - Analytical and Hypothetical Overview.

By Vincent Goetsch

Use of this site constitutes your willing agreement to the " Terms of use " and Legal Disclaimer & notices.

Interest in colloidal silver / silver mineral water is has been increasing for various reasons. This article is intended to address various concepts and information that reseachers should consider.

The first point to consider is that Colloidal silver is regulated by the FDA and is not approved as an OTC (over the counter) drug by the FDA. There is no RDA (Recommended Daily Allowance) established, nor is the need, role or safety regarding nutritional use established clinically / scientifically. Therefore; by providing this information we are not implying nor recommending such use, nor, that anyone self diagnose and treat their own illness using silver or other minerals dispersed into water using the Colloid Master or by other means. This information is provided for educational purposes only.

There are many hypothectal potential applications for colloidal silver, or more accurately described as we suggest making it; silver mineral water, it should not be assumed that it is only used as a dietary supplement.

Researching silver dispersions and other forms and preparations may involve a wide variety of disciplines, depending on the intended use or application.

As mentioned elsewhere; many things can be considered colloidal, e.g., human cells, plant cells, pathogens, clay used as casting slip in ceramics, polymer latex, nanoparticles, emulsions, micro-emulsions, liposomes, paints, inks, cosmetics, self leveling concrete just to name a few generalizations.

Many industries employ colloidal chemistry, such as paper mills, electronic component manufacturing, geology, pharmacology, medicine, food industry, water purification for example.

Generally speaking our focus is on the form of colloidal silver that is most accurately described as "mineral water", meaning silver particles that are self suspended in water in a colloidal like state, with no other additives. The Colloid Master is designed with a focus on this form of silver dispersion.

Hypothetical areas of research and potential applications may include: Cleaning solvent used to destroy bacteria on surfaces such as fiberglass shower stalls, sinks, counter tops, cutting boards, dishwater, floor cleaner, carpet stain remover, toilet cleaner disinfectant. Surfactant for cleaning; windows, mirrors, TV and Computer Screens, wood furniture, chrome fixtures. Add to laundry water to increase cleaning power. Use in the water to feed house plants, as well as a foliage spray to kill undesirable organisms. Hydroponics, growth stimulator and or growth medium. Plant life extender, reportedly cut flowers may last twice as long as they otherwise would, this could effect a florists bottom line. Food production industry, such as cheese factory grow rooms, as an anti-microbial agent to eliminate phage. The combination of silver, copper and small amounts of hydrogen peroxide may be effective for sterilization of dental / medical waste water which is regarded as toxic waste. Storage fluid for medical instruments. Bacteria proof building coatings. Making inexpensive water treatment equipment, such as impregnating ceramic filters to create safe drinking water in 3rd world countries. Swimming pool, hot tub and steam room fungicide/ Bacteriacide. Washing vegetables. Mouthwash, Deodorant. Drinking water sterilization in the cattle, hog and poultry industries. Research by qualified individuals is what is now needed to prove or disprove these and many other potential / hypothetical uses.

There are practical applications other than for use as a dietary supplement etc. For example:

In an article by UPI Science Writer Mike Martin titled " New Silver-Coated Steel Frames For Bacteria-Resistant Homes?" Dated 3-10-1, The following quote from the article explains one of the many interesting, developing applications as well:

"A 100-year-old steel manufacturer has teamed with an entrepreneurial biotech firm to build the world's first germ-resistant home. AK Steel, of Middletown, Ohio, and Boston-based AgION Technologies are constructing an 11,000-square-foot house using steel coated with a patented anti-microbial compound
made of silver zeolite. Zeolite, commonly used in water softeners, acts as a chemical pump that slowly releases silver ion, a well-known anti-microbial agent, according to an AgION white paper. Bacteria are less likely to develop resistance to disinfectants such as silver than to antibiotics such as penicillin."

-End Quote-


To gain an understanding regarding the FDA's position regarding colloidal silver, lets take a look at some documents, of specific interest are quotes from a web page located at the FDA web site, of particular interest is the document regarding regulation described below, which we will hereafter refer to.


"[Federal Register: August 17, 1999 (Volume 64, Number 158)]

[Rules and Regulations]

[Page 44653-44658]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr17au99-6]". (End quote)

The referenced page may be viewed directly by clicking here: Click here to read the document

Document located at: http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.txt

(Note: you will be leaving the site if you click here, bookmark or click back to return here).

In recent years there has been a lot of discussion about colloidal silver, what has been confusing to many involved is why the FDA appeared to be against it? In analysis the FDA became involved in the process several years ago, because numerous (unsubstantiated) health claims were being made about colloidal silver. Because of existing laws these claims, and other appeals regarding the issue that were made to the FDA, this caused the FDA to become involved. In the process of doing their job they investigated the issue and made recommendations based on existing facts that were available, or were made available to them. Facts that were presented to them that met their protocols or the lack thereof were used to make their determinations. The final result is their current position (at the time of this writing) as follows:

"SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule establishing that all over-the-counter (OTC) drug products containing <colloidal> <silver> ingredients or silver


[[Page 44654]]


salts for internal or external use are not generally recognized as safe and effective and are misbranded.
FDA is issuing this final rule because many OTC drug products containing <colloidal> <silver> ingredients
or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC <colloidal> <silver> ingredients or silver
salts for these disease conditions.

DATES: This regulation is effective September 16, 1999. (End quote).

In 1996 the FDA made an appeal to the industry at large to provide proofs of safety and effectiveness. Because of inadequacies of available data regarding the effectiveness and safety of colloidal silver to be included in or by it's self as an (OTC) drug, the FDA established that there was not sufficient proof to establish safety and effectiveness as an (OTC) drug. A time table was established for manufacturers and others interested to submit information to the FDA, a fact finding time table was established and regulation was proposed.


"In the Federal Register of October 15, 1996 (61 FR 53685), FDA published a proposed rule to declare that all OTC drug products containing <colloidal> <silver> ingredients or silver salts are not generally recognized as safe and effective, and are new drugs and misbranded within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p))". (End quote)

"In response to the proposal, the agency received 251 responses. Copies of these comments are on public display in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852." (End quote).

"FDA is not aware of any substantial scientific evidence that supports the use of OTC <colloidal> <silver> ingredients or silver salts for disease conditions. The agency invited any interested parties to collect and submit any existing data and information that support the safety and effectiveness of <colloidal> <silver> ingredients or silver salts for any of the uses not already evaluated under the OTC drug review. Interested persons were invited to submit written comments on the proposed regulation and on the agency's economic impact determination by January 13, 1997." (End quote)

The regulation is quite clear and unambiguous.

It is apparent in reviewing the FDA's "III. Analysis of Impacts" regarding the companies impacted by federal regulation. The entities involved in colloidal silver production were determined to be small companies.

There are many issues that the FDA must consider when dealing with a situation such as colloidal silver production. Economic impacts are one such concern:

"FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options
that would minimize any significant impact of the rule on small entities." (End quote).

The FDA determined that if these companies did not meet established criteria to cause concern for significant impact on the economy.

"rule was published and became effective. The analysis shows that this final rule is not economically
significant under Executive Order 12866 and that the agency has considered the burden to small entities. Thus, this economic analysis, together with other relevant sections of this document, serves as the
agency's final regulatory flexibility analysis, as required under the Regulatory Flexibility Act. Finally, this analysis shows that the Unfunded Mandates Reform Act does not apply to the final rule because
it would not result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million." (End quote)

In reviewing the FDA's "III. Analysis of Impacts" finding, the companies involved were identified as small companies, in fact their finding indicates that the industry as a whole was too small to truly impact the economy, as ascertained by the FDA's established standards and methods of review of this issue.

The FDA is an agency that is designed to protect us. In keeping with the letter of the law they were compelled to make their recommendations based on facts that meet their criteria, facts that were presented to them or were made available, or the lack thereof influenced the determination. Other considerations such as "D. Freedom of Choice" were also taken into account as evidence by the following:

"In passing the 1962 Amendments to the act--the amendments that require that a drug be proved effective before it may be marketed-- Congress indicated its conclusions that the absolute freedom to choose an ineffective drug was properly surrendered in exchange for the freedom from the danger to each person's health and well-being from the sale and use of worthless drugs * * *." (End quote)

There are strict standards by which the FDA operates. Where the problem comes in is that there is no effective means to communicate the FDA's desire for information with those that poses such information. The problem is that there is no log of people who are manufacturers or researchers regarding colloidal silver that the FDA sends a letter of appeal to during their search for valid information. There is no established forum. A researcher must somehow know of their interest, and then contact the FDA directly. If contact is made, and research is submitted, in order for it to be taken seriously, it must meet their minimum requirements.

It has been established that most of the companies affected by FDA regulation were small in size. (Under 750 employees). Many of these companies probably employing less than 10 people. It is easy to assume that these small companies do not have the means to purchase expensive test equipment.

Furthermore it easy to imagine that such companies would also be limited in their ability to finance the cost to conduct tests that meet the FDA's protocols. Clinical evidence which would sufficiently prove their products efficacy and safety is what the FDA sought. Apparently they were unable to comply, for whatever reasons. Many producers of colloidal silver products, apparently determined the performance, safety and efficacy of their product primarily by "testimony" from users of the product. This is not an admissible form of proof to the FDA.

"Testimonials from consumers cannot be considered as adequate proof of effectiveness or safety. None of the comments presented any evidence of safety or effectiveness beyond personal experience." (End quote)

There was also an assumption that colloidal silver was a pre FDA drug and therefore "Grandfathered" in.

"C. The Grandfather Clauses of the Act" (End quote)

"The ``grandfather exemption'' was discussed in detail in the proposed rule (61 FR 53685 to 53686).

None of the comments provided any evidence to show that the composition and the labeling of <colloidal> <silver> or silver salt drug products have remained unchanged since 1938 or 1962.

Without such evidence, the products cannot qualify for either grandfather exemption, and there is no need to set any guidelines as requested by one comment. (End quote).

If you read the above statement carefully it does not say "The grandfather exemption" may never apply, it says the one comment they received, and the appeal thus made, did not justify doing so.


The FDA has clearly defined protocols which need to be followed in order for research submitted to them to be considered valid.

"The agency finds that the previous studies are not adequate and well-controlled clinical studies of the type described in Sec. 314.126 (21 CFR 314.126) that need to be conducted. The studies have major
methodic flaws.

There needs to be a clear statement of the objectives of the investigation and a protocol containing a specific study design, the method of subject selection (with inclusion and exclusion criteria), the method of assigning subjects to treatment and control groups, well-defined methods for measuring the subjects' responses, and methods for analysis of the study results.

Adequate measures need to be taken to minimize bias on the part of the subjects, observers, and
analysts of the data, which is done by adequate blinding." (End quote)

Those of you wishing to do serious research regarding colloidal silver, and who also wish for such data to prove that colloidal silver may be safe for (OTC) over the counter applications. It would be a wise for you to read the following FDA document:

"Guidance for Industry
Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products".

This document can be viewed or saved to disk on line, using adobe acrobat. To get Adobe acrobat for free here: http://www.adobe.com
View the document here:
Additionally copies of the above document (HFD-210) are available from: the Drug Information Branch (HFD-210) Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane, Rockville, MD 20857
Tel (301) 827-4573
Internet: http://www.fda.gov/cder/guidance/index.htm

Or
Office Communication, Training and Manufacturers Assistance (HFM-40)
Center for Biologics Evaluation and Research (CBER)
1401 Rockville Pike, Rockville, MD 20852-1448 http://www.fda.gov/cber/guidelines.htm

(Fax) 888-CBERFAX or 301-827-3844
(Voice Information) 800-835-4709 301-827-1800

At this juncture it is prudent to explain that the regulatory ruling by the FDA does not prohibit all sales of colloidal silver. What the ruling prohibits is the inclusion of it in (OTC) over the counter products. It means that colloidal silver as a drug or contained in an over the counter product (pharmaceutical) currently is not allowed, because it is unproven as safe and effective as a Human Drug or Biological Product intended for such use.


"This final rule addresses products marketed as OTC drugs. A product that is not intended for OTC ``drug'' use in accord with section 201(g)(1) of the act would not be subject to this final rule.

A product containing silver could, under certain circumstances, be marketed as a dietary supplement if it meets the definition in section 201(ff) of the act and other applicable requirements. Among other things, such a product's label must state that the product is a dietary supplement and meet other labeling requirements of the act. (See, e.g., section 403(q), (r), and (s) of the act (21 U.S.C. 343(q), (r), and (s)).)

It must also meet the safety requirements of the act. (See, e.g., 21 U.S.C. 342(a), (f), and (g).)

FDA may take regulatory action against a product marketed as a dietary supplement when authorized to do so by the act.

A dietary supplement containing <colloidal> <silver> or silver salts may not be labeled in whole or in part for topical use.

Section 201(ff)(2)(A)(i) of the act requires that a dietary supplement is a product that is ``intended for ingestion.'' The term ingestion has been addressed by the court in United States v. Ten Cartons, Ener-B Nasal Gel, 888 F. Supp. 393 (E.D.N.Y.), aff'd, 72 F.3d 285 (2d Cir. 1995).

A topical product could not be a dietary supplement." (End quote)

Additionally:

"If consumers purchase these products marketed as dietary supplements and if the product bears a statement claiming a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States, describes the role of a nutrient or dietary ingredient intended to affect the structure or function of the body in humans, characterizes the documented mechanism by which a
nutrient or dietary supplement acts to maintain such structure or function, or describes general well-being from consumption of a nutrient or dietary ingredient, then the labeling will have to inform them that

``This statement has not been evaluated by the Food and Drug Administration.

This product is not intended to diagnose, treat, cure, or prevent any disease.'' (See 21 U.S.C. 343(r)(6).)" (End quote)


As you can see there is allowance for colloidal silver in the market place when presented as a dietary ingredient or supplement. Careful attention to labeling, safety requirements and refraining from statements that are not allowed by the FDA need to be observed if colloidal silver is to marketed in this manner.

Another point which should be addressed is that the FDA ruling regarding colloidal silver in (OTC) products is not a final outcome in that, an appeal could still be made for reconsideration. It is final with regard to the established time frame that came and went regarding current regulation, and is therefore their current position, and regulation is defined.

This does not mean that the ruling cannot be overturned. What will be required to overturn the ruling is sufficient evidence.

I have read reports by analysts that estimate that getting a new drug approved by the FDA may cost in excess of 100 million dollars and many years to do so. It is also my understanding that some changes have been implemented by the federal government to decrease the overall cost and speed the approval process. Though this may be discouraging to small companies, it does not mean that it has to end here.

If researchers representing their area of expertise will focus on research that is within their means, and follow proper protocols. Then collectively the evidence thus accumulated will serve to open the door for all involved.

"The studies need replication by other investigators and need to follow Sec. 314.126." (End quote)

In order for the FDA to reconsider their ruling, such things as method of production (Bredig method for instance), attributes of the colloid, parts per million, form of colloid (organic, ionic forms, oxides, salts) etc. will need to be established, or at the very minimum a very clear description of the actual substance and its attributes will need to be addressed before conducting / submitting research that will be used to argue reconsideration. Research that is done that is not admissible may not be a waste of time to the researcher, but if not done properly it will not be valid evidence for FDA reconsideration.

In short, there is a need to establish protocols for methods of colloidal silver production that yield consistent results, as well as clearly defined attributes and descriptions that differentiate one substance from another.

My point is amplified by the quote below from the FDA, which was in response to a comment submitted to the FDA before the ruling was made

"Another comment stated that many of the <colloidal> <silver> products it analyzed are considered ``Bredig Sols'' (simple <colloidal> <silver>), referring to Bredig, Heidelberg, 1893. The comment added that a pure Bredig Sol is simply elemental silver in distilled water," (End quote)

"The comment contended that the agency had not reviewed the Bredig Sols and disagreed with the
agency's assumptions that there is an analogous comparison between <colloidal> <silver> proteins and other silver compounds to a simple Bredig Sol." (End quote)

The term "colloidal silver" obviously does not mean the same thing to all people.


In review I have found that semantics is a critical issue. There does not appear to be a definitive description regarding exactly what colloidal silver is, or when used it inappropriately includes silver preparations that should be defined differently.

There is not a clear delineation separating various silver containing products. There is work to be done to differentiate and identify the difference between a colloid and other more appropriate descriptions. Vague descriptions and inappropriate inclusion of unrelated preparations leave too much room for miscommunication, misinterpretation and misidentification.

For instance colloidal silver as an aqueous solution, should not be in the same category as other so called colloidal silver products such as mild silver proteins, compounds and salts, since it is scientifically inappropriate to call different substances and formulations by the same term. Appropriate definitions and specifications for identification in reference to terminology used is so important it cannot be overstated.

It is wise to recognize that this is an emerging technology, although conceptual scientific terminology is established that can be used to identify silver containing substances, it would not be unusual to find that more appropriate terms and clarification of terms would lead to different classifications and descriptions of silver containing substances.

To illustrate what I mean. The following is a formal description of a colloid.

Colloid: 1. A gelatinous substance made up of very small, insoluble, nondiffusible particles larger than molecules but small enough so that they remain suspended in a fluid medium without settling to the bottom: a colloid does not affect the freezing point, boiling point, or vapor tension of the medium in which it is suspended.

  • Webster New World Dictionary, College Edition (Copyright) 1968-


I reviewing the terminology used by the FDA, and the way in which it is used, I have found the following uses of terms and points for consideration:

"In the Federal Register of October 15, 1996 (61 FR 53685), FDA published a proposed rule to declare that all OTC drug products containing <colloidal> <silver> ingredients or silver salts are not generally recognized as safe and effective, and are new drugs and misbranded within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(p)). <Colloidal> <silver>
is a suspension of silver particles in a colloidal base." (End quote).

Those of you familiar with scientific terminology, will immediately recognize that the phrase
"<Colloidal> <silver> is a suspension of silver particles in a colloidal base" describes the "silver" as being separate from the "colloidal base" and not a description of the "silver" particles in a colloidal state. The reason, perhaps, is because the FDA staff realize that such use of the term "colloidal" would otherwise not be accurate.

I have been contacted by several people about my use of the term colloidal silver as a description of electrically sintered silver particles in water. For instance "The colloidal silver description you have given is not like any colloid I have ever known." -Chemist-

It would seem that this chemist had a valid point.

Another description used in reference to the FDA ruling by the CDER (Center for Drug Evaluation and Research) newsletter called " Along the Pike" " Volume 5 Issue 8" August 1999."
Viewable at:
http://www.fda.gov/cder/pike.htm

(Note: The newsletter is in adobe acrobat PDF format, therefore you will need Abobe Acrobat Reader free software to view the original document.) Adobe Acrobat is available free here: Http://www.adobe.com/products/acrobat/readstep.html

In the August, 1999 Volume 5 Issue 8 of the CDER Newsletter called "Along the Pike" in an article titled "FDA Issues Final Rule ON OTC Drug Products Containing Colloidal Silver" Within the first few paragraphs is a definition for colloidal silver. Here is how the article starts:

"The FDA has issued a final rule on Aug. 16 declaring that all over-the-counter drug products containing colloidal silver or silver salts are not recognized as safe and effective and are mis branded. The rule becomes effective Sept. 16. Colloidal silver is a suspension of silver particles in a gelatinous base."

Who would be better able to define what colloidal silver is than the Center for Drug Evaluation and Research? They are the body primarily responsible for the evaluation process.

The definition describes "silver" particles as separate and in a second medium a "gelatinous base,"
This does not describe silver particles self suspended in a colloidal like manner in water, an aqueous solution.

The form of silver solution preparation I am most familiar with, and one that shows promise regarding use in research for such things as an antibiotic alternative is comprised of atomic clusters of silver. The ideal particle size seems to be approximately 8 to 12 atoms in a cluster. Since the above description of "colloid" quoted previously from "Webster's Dictionary" states the particles in a colloid are larger than molecules, the term colloid may be inappropriate to describe the preparation since water molecules may easily form around silver particles clustered in this manner.

In further analysis, a solution is said to be a mixture of two or more substances. When discussing atomic sized clusters of silver in water, this would be described as an aqueous solution. The solvent being the substance in greatest quantity, namely water and other substances being described as solutes. Water with silver that is smaller than water molecules, may be more accurately described as an "aqueous solution of silver solutes, or rather; aqueous silver solute or silver sol.

This should be easy to establish as true where applicable. Furthermore; the term colloid could be argued to be appropriate on all accounts when describing micro silver clusters in water. Since it is known that the effect of solutes on water alters the freezing and boiling point of water. Using somewhat dated terminology, but commonly know, namely Arogadro's number, which in essence, describes one "mole" as the measurement of the amount of neutrons or protons of an element which are equivalent to one gram. Mole fraction is the amount of moles of the solute relevant to the total number of moles in the solution. Molarity is the total number of moles per liter of solution.

It is known that for each mole of solute that is dissolved in water the freezing point is decreased by 1.86 degrees. For every mole of solute in water the boiling point is increased by 0.52 degrees.

If an aqueous solution of silver contains particles that are smaller than the water molecules. If the presence of the silver changes the boiling and freezing point of water, then these facts would invalidate the term "colloidal silver" to describe such a solution.

I have sent a sample of a aqueous silver solution to a corporation that is a surfactant manufacturer. They did some analysis of the aqueous silver solution, and found that it is a surfactant, it decreases surface tension of larger volumes of water when added to the other water, as well as having a decreased surface tension initially. They found that the silver solution possessed attributes that would lend it to be a very good penetrant as well.

As you can see, there is a need to establish jargon that can be agreed upon, and used by differing areas of science and industry.

If for example the above definition is agreed upon to be an accurate definition for colloidal silver, then even if only one pont used to describe a colloid in the above example found in Webster's 1968 Dictionary was invalidated, a new term would need to be used to describe the solution I sent to the surfactant company. The end result; the term colloidal silver when used to describe an aqueous silver solution is a misnomer! A better more accurate description must be agreed upon.

A more accurate description of a preparation of atomic clusters of silver solute in water would be "aqueous solution of silver." Another appropriate term might easily be "mineral water."
Some argument could be made that silver is insoluble and that it would then not be accurately described as an "aqueous solution." If that would be the case, I think it is splitting hairs, the definition still more accurately describes the preparation than a colloid does.

Apparently the reason that silver in water is identified as a colloid is because the particles stay in suspension and do not fall the bottom of the container. Calling it a colloid was the easy way out. Though it may be perplexing to accurately describe why the particles behave the way they do, it is not reason enough to wrongly categorize the substance.

The main reason it is called colloidal silver, regardless of the manufacturing process, is it was an easy way to communicate the anomalous state of the silver.

Colloidal chemistry has identified that many colloids are normally held in suspension by action of cation and anion particles, there is also another point to consider. This is especially important since it appears that the use of the term colloidal silver is directly related to an attempt to describe the particles being suspended and not falling to the bottom of the container.

The term colloidal silver does describe silver in a gelatinous base, and since this is what is described I have doubt that any researcher or person I know or who as bought, researched or used what has been described as colloidal silver has actually used colloidal silver.

The reason that colloidal silver was identified as it was, is most likely due to the historical use of the term, and an attempt to describe why it stays in suspension. Names stick, since colloidal silver was a known substance there was simply a natural migration of the term inappropriately to other forms of silver preparation.

The structuring of the water may likely be the reason for the attributes ascribed to colloidal silver such as remaining in suspension as well as other phenomenon such as antibiotic like properties. If these points are reconciled and further validated, the ultimate description for this type of aqueous silver preparation may more accurately be: " Structured aqueous solution of silver." "SASOS / Silver Mineral Water".

Our experience is that the majority of people doing research are using some form of "Bredig method" or at least normally by means of inducting electrical current to create the silver solution. Normally silver electrodes suspended in water, which then creates a silver dispersion by electrically sintering organic silver into particles, that flow into the H2O. Under ideal circumstances the silver is sintered into a specific particle size, the particles then form into micro clusters, but are not primarily ionized.

Some research indicates that silver particle clusters ranging from 8 to 14 atoms is the most desirable range. We would agree with this suggestion for reasons outlined in other articles. What should be noted is that this is not an established industry protocol, and may have little or nothing to do with silver in a gelatinous base. Also it should be noted that just because an electrical process is used to sinter silver into water, it does not mean the same results are obtained in each case.

Different silver solution production approaches yield different results, it is easy to comprehend that FDA examination of any reports sent to them would need a full explanation of the substance used, first and foremost! How else will they identify the substance used in clinical testing?

An example of how there are differences in results from similar processes is the addition of salt to the water before beginning the Bredig process. The addition of salt is used to cause the water to become an electrolyte thus speeding the sintering process. However; use of salt during the production may produce high levels of salts, this would influence the overall relevancy (or lack thereof) to the FDA.

Therefore attention must be applied to the documentation of each step involved. At the very minimum a very explicit documentation of analysis of the resulting colloid to be used in the research must be carefully considered and documented. Such facts should also be contained in the material and data submitted to the FDA.

Since the cost of the clinical studies that would be required to have colloidal silver accepted by the FDA as an OTC drug would be costly to an individual organization. It is not likely that a currently existing colloidal silver producer will be able to provide the required data independently.

Considering that there is not the financial motivation for larger companies to do the legwork.
For example, if a pharmaceutical company determined that they could not patent an organic mineral such as is found in common bredig method colloidal silver, the mineral content of which is found in nature, and that therefore they would not be able to patent it for exclusivity. Financial motivation to spend many years and possibly 100 million dollars to get it approved would simply not be justifiable. The CEO might have to look for a new job as a result.

As you can see in this scenario, It is not likely that we will see a larger company attempt to do so. Unless there is a financial interest, and it proves it to be a solid investment, it just won't happen.

It is more likely that large pharmaceutical companies (the ones most positioned to prove safety and efficacy) would view colloidal silver in much the same way that the oil and energy barrens would view free energy devices. As a threat to their bottom line$.

If every mothers son or daughter could produce colloidal silver using currently available methods costing under $200. Furthermore; if it is proven that the resulting colloidal silver is as good as, or better than all antibiotics, but without the adverse reactions. They would then have an inexhaustible supply of natural antibiotics. How could a pharmaceutical company view this as in their best interest?

Are there practical applications for colloidal silver?

How about inexpensive water filtration? POTTERS FOR PEACE


The original FDA ruling document can be viewed by clicking the link below. Click here to read the document

FDA TALK PAPER, T99-39, August 17, 1999 If you are considering making colloidal silver for any commercial purpose, you can educate yourself with regard to policy by the FTC, FDA & EPA with the materials linked below. These links are not intended to be all inclusive, and are provided for general information and educational purposes only.

We recommend reading the following FTC business education materials:

Dietary Supplements: An Advertising Guide for Industry at: www.ftc.gov/opa/1998/9811/dietary.htm

Frequently Asked Questions Questions: A guide for Small Business at: www.ftc.gov/bcp/conline/pubs/buspubs/ad-faqs.htm

Advertising and Marketing on the Internet: The Rules of the Road at: www.ftc.gov/bcp/conline/pubs/buspubs/ruleroad.htm


Important toxicity related documents:
(1) Chronic toxicity data by U.S. EPA. The EPA regarding web site: "Reach for life colloidal silver information: http://reach-for-life.com/prodinfo/colsil_iris.htm

(2) Toxicity Summary for SILVER Risk Assessment Information System (RAIS)
http://risk.lsd.ornl.gov/tox/profiles/silver_f_V1.shtml


(3) Guidelines for drinking water quality Exracted from:
Guidelines for drinking-water quality, 2nd ed. Vol. 2. Health criteria and other supporting information. Geneva, World Health Organization, 1996. pp. 338-343.
http://who.int/water_sanitation_health/GDWQ/Chemicals/silverfull.htm


Other documents in PDF format:

Center for Drug evaluation and research Along The Pike, August 1999, Volume 5, Issue 8

Department of Health and Human Services, Ref. No. 01-HFD-3101-078 Federal Register / Vol. 63, No 381 Thursday, February 26, 1998 / Notices 9795 Center For Veterinary Medicine

Ref. No. 01-HFD-3101-084

If you are a professional researcher, there are a number of organizations that may provide guidance with regard to various research projects that you may wish to contemplate, such as:

National Institutes of Health (NIH), National Center for Complimentary and Alternative Medicine


In closing I want to remind the reader that this is simply "an anylitical - investigative - hypothetical overview". It is highly recommend reading the FDA document front to back entirely. It contains lots of information not discussed here. Since quotes seen here may not contain the entire FDA statements it is important that you read the original document, so that you can view the context and other factors in which it is presented to achieve a complete understanding. Information contained here is not intended to be complete, exhaustive, nor the final word on these subjects. All information is provided AS-IS, and for informational purposes only.

Ref. No. 01-HFD-3101-097

FDA web site Type Colloidal Silver in the Search Powered by Google. Many documents too numerous for us to review and or list here are available for viewing.

U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition FDA Prime Connection. SUBJECT: Colloidal Silver

STATEMENT OF: John M. Taylor Director, Office of Enforcement, Office of Regulatory Affairs Food and Drug Administration Before the Special Committee on Aging John B. Breaux, Chairman United States Senate September 10, 2001


  

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