FDA Rulings Regarding Colloidal Silver Enacted in 1999
By Vince Goetsch © 1997- present. All Rights Reserved
This article is a review, analysis, and commentary published initially in 1999 regarding what were at that time, newly enacted FDA rulings regarding colloidal silver. The topics and FDA rulings referenced are still relevant, however, for official information regarding FDA or other U.S. regulatory agencies rules, policies or other matters, you should consult those agencies directly.
To gain an understanding regarding the FDA’s position regarding colloidal silver, let’s take a look at some of the relevant documents originally located at the FDA website regarding regulation.
“[Federal Register: August 17, 1999 (Volume 64, Number 158)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au99-6]”. (End quote)
Document located Originally located at: http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.txt
The final FDA ruling (at the time of this writing in 1999) is 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
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 itself as an (OTC) drug, the FDA established that there was not sufficient proof to establish safety and effectiveness as an (OTC) drug. A timetable was established for manufacturers and interested parties to submit information to the FDA, a fact-finding timetable 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)
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 concerning adverse monetary effects resulting from the regulation upon them, to be a concern that would significantly impact on the U.S. 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 also responsible for taking other considerations into account, such as “D. Freedom of Choice” 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 are 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.
Clinical evidence which would sufficiently prove products efficacy and safety as was sought by the FDA per their guidelines was not met by the Data that producers of colloidal silver products supplied to the FDA from 1996 up to their ruling. As per comments in the FDA ruling manufacturers that did submit data, was primarily by written “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
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”.
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
Office Communication, Training and Manufacturers Assistance (HFM-40)
Center for Biologics Evaluation and Research (CBER)
1401 Rockville Pike, Rockville, MD 20852-1448
(Fax) 888-CBERFAX or 301-827-3844
(Voice Information) 800-835-4709 301-827-1800
Development & Approval Process (CBER)
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)
“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)
“The studies need replication by other investigators and need to follow Sec. 314.126.” (End quote)
Research that is done that is not meet established FDA criteria is not admissible and will be a waste of time to the researcher.
Definitions and terms
“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)
Regarding the regulation, 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 if there is ever to be a time that the research data is to be reliably understood and valid scientifically. Vague descriptions, as well as the erroneous inclusion of unrelated preparations described as colloids, causes confusion miscommunication, misinterpretation, and misidentification throughout the industry.
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. The need for accurate and appropriate definitions and specifications for identification about terminology used cannot be overstated.
It is wise to recognize that this is an emerging technology, although there is 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 to be inclusive of every type of silver containing material. Still it is not scientifically accurate to do so in this instance.
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.”
Originally located at http://www.fda.gov/cder/pike.htm
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 misbranded. 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 then 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 state in an aqueous solution.
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.
( Regarding regulation of colloidal silver 1996 – 1999) FDA TALK PAPER, T99-39, August 17, 1999, http://www.fda.gov/bbs/topics/ANSWERS/ANS00971.html
The original FDA ruling regarding colloidal silver document that was originally at the URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/081799a.txt
Rulemaking History for OTC Colloidal Silver Drug Products
Colloidal Silver Final Rule: Classifies silver salts (internal or external use) as monograph [PDF]
Regarding manufacture of Colloidal Silver, we recommend reading the following business education materials:
FDA Guidance for Industry [PDF]
Federal Trade Commission
Dietary Supplements: An Advertising Guide for Industry at https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
Federal Trade Commission
Frequently Asked Questions: A Guide for Small Business at:
Federal Trade Commission
Advertising and Marketing on the Internet: The Rules of the Road at: https://www.ftc.gov/tips-advice/business-center/guidance/advertising-marketing-internet-rules-road
FTC Online Advertising and Marketing: https://www.ftc.gov/tips-advice/business-center/advertising-and-marketing/online-advertising-and-marketing
Important toxicity related documents:
(1) Chronic toxicity data by U.S. EPA. The EPA:
(2) Toxicity Summary for SILVER Risk Assessment Information System (RAIS)
(3) Guidelines for drinking water quality Exacted from:
Guidelines for drinking-water quality, 2nd ed. Vol. 2. Health criteria and other supporting information. Geneva, World Health Organization, 1996. pp. 338-343.
Center for Drug Evaluation and Research Along The Pike, August 1999, Volume 5, Issue 8 Link
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
PDF US FDA Cyber Letters, Enforcement Activities by FDA
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 Complementary and Alternative Medicine
FDA website Type Colloidal Silver in the Search window. Many documents too numerous for us to review and or list here are available for viewing.
FYI, a doc to look for: Ref. No. 01-HFD-3101-097
U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition FDA Prime Connection. SUBJECT: Colloidal Silver
STATEMENTS OF: John M. Taylor Director, Office of Enforcement, Office of Regulatory Affairs Food and Drug Administration from mid-1990s to Present:
Additionally, you can search via the link below for this relevant document:
STATEMENTS 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
» The End