The FDA ruling on colloidal silver in 1999 formally established that all colloidal silver products are unclassified drugs. This document explores the Food and Drug Administration's actions since that time, noting inconsistancies and biases concerning the FDA's action against the use of colloidal silver.
Many people, based upon the controversies associated with silver use, believe that the FDA is anti-silver. Many people believe that the FDA and other governmental agenices have no reason to believe in the effectiveness of silver products, and that their position is that silver is not safe for use with the human body. We recommend our visitors view our material: Silver Medical Products.
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The FDA Takes Action
On September 16, 1999, The FDA issued a final ruling on any and all colloidal silver products. With a brisk pen-stroke invoking the FDA's broad power, the ruling proclaimed and entered into law that any silver substance in a gelatinous solution could not be sold as a medicinal substance. The ruling categorized colloidal silver as an unclassified drug. Any colloidal silver products marketed as having medicinal properties are now in violation of federal law.
However, due to the fact that silver is both a natural substance AND not a controlled substance, it is still protected under the The Dietary Supplement Health and Education Act. Under this law, any labeling and/or advertising referring to any health benefits of the substance in question is unlawful. The substance must be labeled as a dietary supplement and may NOT be marketed for external use.
The innocent bystander might assume that the FDA took this action based on collected research data that demonstrates that colloidal silver is a harmful substance, and thus the public should be protected from its use. HOWEVER, this is not the case. The following letter, written by the FDA in compliance with the Freedom of Information Act, clearly shows that the FDA's action to ban colloidal silver sales was NOT motivated by ANY data suggesting harm:
The FDA Admits it has no Clinical Data Suggesting Isolated Silver is Unsafe for Human Use
October 14th, 1999
Food and Drug Administration
U.S. Department Of Health and
Public Health Service
5600 Fishers Lane
Rockville, MD 20857
Pursuant to the Freedom of Information Act and in regard your August 17th, 1999 ruling regarding colloidal silver, could you please supply the following documentation on which you based your decision?
1. The number of deaths related to the consumption of colloidal silver.
2. The number of allergic reactions to the consumptionof colloidal silver.
3. The number of harmful drug interactions from both OTC and prescription drugs when combined with colloidal silver.
4. The number of reported cases of Argyria from colloidal silver made with the AC or DC electrical process.
5. The number of cases of Argyria from colloidal silver that did not contain protein stabilizers.
Thank you for your time and consideration of this request.
The FDA response:
Public Health Service
Center for Drug Evaluation and Research
Office of Training and Communication
Freedom of Information Staff HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857
DEPARTMENT OF HEALTH AND HUMAN SERVICES
November 3, 1999
In Response Refer to File: F99-22589
[ Name Removed ], WA 98408
Dear [ name removed ]:
This is in response to your request of 10/14/99, in which you requested adverse events associated with the use of Colloidal Silver. Your request was received in the Center for Drug Evaluation and Research on 10/25/99.
We have searched the records from FDA's Adverse Event Reporting System (AERS) and have been unable to locate any cases that would be responsive to your request.
Charges of $3.50 (Search $3.50, Review $0, Reproduction $0, Computer time $0) will be included in a monthly invoice. DO NOT SEND ANY PAYMENT UNTIL YOU RECEIVE AN INVOICE.
If there are any problems with this response, please notify us in writing of your specific problem(s). Please reference the above file number.
Freedom of Information Technician
Office of Training and Communications
Freedom of Information Staff, HFD-205
Evaluating Colloidal Silver Based on the FDA Ruling
The conscientious person, armed with the above knowledge, would no doubt consider that the FDA has simply determined that colloidal silver has either no value in human health applications, or that any possible value remains highly questionable due to lack of scientific evidence. The FDA, one would think, is sincerely following its primary purpose of protecting the public from potential abuse by unscrupulous companies and unduly optimistic dreamers-- protecting them from turning blue from argyria and naivety.
Unfortunately, this is not the truth. While the FDA does have valid points against the "colloidal silver industry" as a whole, none of these points has anything to do with whether or not isolated silver is safe in reasonable quantities or whether or not it is effective in fighting infections. Not only has the FDA approved at least one silver product for use in wound care, but the FDA has done its own research to determine if colloidal silver has potential as a significant medicinal substance:
"The FDA has tested colloidal silver extensively and found that different microorganisms succumb to its action at a wide variety of concentrations and exposure times. If any of this information entered the public domain, the FDA would consider their own research "unsubstantiated medical claims" and reason enough to classify colloidal silver as a new drug..." - Peter Lindeman, long before the FDA's September 16 ruling
While, as noted above, the FDA must follow the letter of its own laws, it is clear that the MOTIVE behind the FDA's ruling is driven by forces unrelated to the safety, the condition of argyria, or the potential effectiveness of true colloidal silver. One STATED motivating factor was that many products of unknown substance and quality were being marketed under the label of colloidal silver. Some of these products undoubtedly were, and are, of questionable quality. There certainly are no established standards for the production of colloidal silver.
However, the FDA's underlying motives reveal themselves when examining their public relations strategies:
The FDA, knowing full well the distinction between different kinds of silver products, purposefully and maliciously attempts to confuse the public by misrepresenting silver products. The FDA highlights the antiquated use of silver proteins and compounds, while sidestepping the truth that isolated silver is no more like these products than hydrogen alone is like water.
It is deeply troubling that such a necessary agency as the FDA can no longer be trusted to uphold the public trust it was founded to preserve. The FDA needs to be held accountable both for its true motives and its actions. It is true that the letter of the law must be honored. However, the spirit of the law should define how the letter of the law is enforced.
Many of these issues will need to be settled in a high court of law. It is unlikely that the issue of colloidal silver will be a legal battle ground ( since the FDA defines, rules, and enforces laws regarding silver use ) but we strongly suggest that anyone interested in the truth do independent research on pending court cases against the FDA ( which is outside of the scope of this work ).
Until that time, we can only question the liberal budget allowed to the FDA which is evidently abundant enough to allow them to continuously harass people selling silver wire and nine volt batteries ( among others ). If Congress continues to believe that such expenditures are worth the hefty price tag, then we still question the METHODS the FDA uses to achieve its objective. We believe a federal government sponsored independent ethics review is long overdue.
The following letter is an example of what the FDA is calling "Cyber Letters" that have been sent to companies marketing colloidal silver:
January 8, 2001
[ name and address removed ]
Ref. No. 01-HFD-3101-068.
This is to advise you that the Food and Drug Administration (FDA) has reviewed
your web site at the Internet address: http://www.ionicminerals.com and has determined that the product "Ionic Silver Mineral Water" being offered is promoted for conditions that cause the product to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)]. The product may be considered a drug because the therapeutic claims as shown on your web site establish its intended use as a drug. Examples of some claims observed on your web site include, in part: Ionic Silver Mineral Water
Natures Antibiotic Pneumonia. Shingles, genital wart, ringworm
proven to kill over 650 different kinds of bacteria, fungus, viruses, and disease organisms
Furthermore, FDA has no information that your product is generally recognized as safe and effective for the above referenced conditions and therefore, it may also be a new drug under section 201 (p) of the Act [21 USC 321(p)].
New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505 (a) of the Act [21 USC 355(a)]. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements or as cosmetics if certain therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with claims that they are intended to affect the structure or function of the body (structure/function claims) if certain conditions are met. Claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims) excepting health claims authorized for use by FDA, may not be made as they cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a Final Rule intended to clarify the distinction between statements allowed as structure/function claims and those that represent disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html. In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements.
Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, disease or structure/function claims may cause them to be new drugs. Additional information is available in Title 21, Code of Federal Regulations, (21 CFR) Parts 310 and 330-358. These parts include the Final Rules for various OTC ingredients or products that may or may not be legally marketed without prior approval.
Furthermore, your Internet site may be subject to statutes enforced by the Federal Trade Commission (FTC). Sections 5 and 12 of the Federal Trade Commission Act, 15 U.S.C. Sections 45 and 52. You are encouraged to consult the FTC Web site at http://www.ftc.gov/bcp/conline/pubs/dietsupp.htm for further information. The FTC Web site also provides copies of complaints and orders that have been filed by the FTC against companies making misleading or deceptive advertising claims on the Internet. Some of these complaints and orders can be found 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. You may want to review your advertisement in light of these standards. Related questions should be directed to the FTC at (202) 326-3090.
This letter is not intended to be an all-inclusive review of your web site and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the statutes administered by both the FDA and FTC. If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may reach FDA electronically (e-mail) at [email protected], or you may respond in writing to Don Leggett , Compliance Officer, Food and Drug Administration, HFD-310, 7520 Standish Place, Rockville, MD 20855 or by telephone at (301) 594-0063.
David J. Horowitz, Esq.
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
The FDA goes back and forth between two key phrases in its commentaries, literature, and letters: "the FDA has no information that your product is generally recognized as safe and effective for the above referenced conditions" and "...are not generally recognized as safe and effective..." The FDA knows it must be careful treading these grounds.
The following letter was sent by the Federal Trade Commission to a website that sells no products. The FTC, teamed up with the FDA, in this case has overstepped legal boundaries to encroach upon legal freedom of expression. We can only hope this was done out of incompetence rather than targeted suppression of information:
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580
VIA ELECTRONIC MAIL
RE: NOTICE OF POTENTIAL ILLEGAL MARKETING OF PRODUCTS OR THERAPIES TO PREVENT, TREAT, OR CURE ANTHRAX, SMALLPOX, OR OTHER DISEASES OR HEALTH HAZARDS: IMMEDIATE ACTION REQUIRED
DATE: November 20, 2001
Your Web Site claims that a product or therapy you sell is effective in the treatment or cure of anthrax, smallpox, or another disease or health hazard that may be associated with recent reports about threats of terrorism. We are aware of no scientific basis for such claims. Without competent and reliable scientific evidence to substantiate these claims, the claims are illegal under the Federal Trade Commission Act and must be discontinued immediately. Violations of the FTC Act may result in legal action in the form of Federal District Court Injunction or Administrative Order. An order also may require that you pay money back to consumers.
In addition, if you are marketing a dietary supplement, be aware that FDA prohibits any labeling claims that a dietary supplement is intended to prevent, mitigate, treat, or cure anthrax, smallpox, or any other disease under the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act of 1994. Such claims would require that the product be submitted for FDA approval as a new drug. Also, representatives of the dietary supplement industry have issued a joint news release stating that dietary supplements should not be promoted as a remedy or cure for anthrax and that no dietary supplements have been proven to treat or prevent anthrax. The joint statement of the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, National Nutritional Foods Association, and Utah Natural Products Alliance is attached.
FTC investigators have copied and preserved the pages of your online promotional materials and will be revisiting your Web site soon. If your Web site includes any express of implied claim about the benefit of any product or therapy for anthrax, smallpox, or other disease that is not substantiated by competent and reliable scientific evidence, or is otherwise deceptive or fraudulent, you must discontinue these claims immediately.
The next letter was written by Ebay.com having finally given in to government pressure to ban ALL sales of colloidal silver related products, whether they are mislabeled or not. Notice the misinformation in the letter. According to Ebay, the FDA claimed that colloidal silver products are unsafe. We can only hope that Ebay misunderstood the FDA, and that the FDA did not in truth make this erroneous claim:
Dear [ name removed ],
eBay appreciates the fact that you chose to list your auction(s):
[ auction number removed ] Colloidal Silver with us. However, it has been brought to our attention that the FDA has found colloidal silver products to be unsafe. The FDA has classified colloidal silver products to be 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. Based on this information, eBay has determined that the sale of items containing colloidal silver will no longer be allowed on our site. Therefore, these auctions have been ended and all associated fees have been refunded to your account.
For a complete text of the ruling by the FDA in this matter, please view the following page:
Please use the following link to view the FDA's About Me Page for more
Per our current policies for prescription drugs and food products, eBay does
not permit the listing of any components of prescription or over-the-counter
drugs unless the sale of such components without a prescription has been
approved by the Food & Drug Administration (FDA). In addition, eBay does
not allow listings containing drug claims - that is, a claim that the item
is intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans and/or animals (e.g., pharmaceutical drugs,
contact lenses, misbranded dietary supplements). For more information,
please review the following pages:
Please view our guideline page for a better understanding of our auction guidelines and how they affect the way you list your items:
For information on infringing or illegal items or for other eBay listing
guidelines, please view:
For more information on why eBay has ended an auction, please visit:
Future auctions listed that fail to meet our listing guidelines will be ended early and repeated violations may jeopardize your account status. We value you as a member of our community and wish to continue this relationship, so we must ask you to refrain from any violations of the Listing Policies or User Agreement in the future.
We thank you in advance for your understanding and cooperation.
Please feel free to contact us with any questions or concerns you may have on our existing listing policies.
ricardo x ([email protected])
The current method of enforcement and prosecution of companies marketing colloidal silver is a concentrated and joint effort between the FDA and the FTC. However, there is a notable difference in policy between the two agencies. Unlike the FDA, the FTC DOES accept scientific evidence as justifiable in making CERTAIN claims about items for sale.
To quote the FTC versus Aaron Company ( settlement agreement ):
"'Competent and reliable scientific evidence' shall mean tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results."
In the matter of making claims of efficacy, the FTC forbids it, unless: "...unless, at the time the representation is made, respondents possess and rely upon competent and
reliable scientific evidence that substantiates the representation."
Therefore, it is possible to be in compliance with the FTC while violating law established by the FDA. This may be why there are some careful companies that are not primary targets in the "Operation Cure All" campaign. The FTC, apparently, is in a far better position to handle prosecution than the FDA.
Both the FDA and the FTC's definition of colloidal silver is sadly lacking: "'Colloidal Silver product' shall mean any product containing or purporting to contain colloidal silver or silver salts, including but not limited to Aarons Colloidal Silver."
Language that the FDA and FTC use is usually very ambiguous. At least three classifications of silver products are truly required to accurately cover the wide range of silver products in use today. The FDA would truly be doing a public service if it established three separate classifications, and prioritized their actions based on scientifically available evidence on safety:
1) Silver compounds known to be toxic - classified as not generally regarded as safe, retaining the unclassified drug status.
2) Mild silver proteins, silver proteins, various silver compounds ( the ones which have adequately been researched ) and solutions with more than 50 ppm silver content - classified as "no information that establishes these products as safe", retaining the unclassified drug status.
3) Isolated silver products, meaning ionic and particulate silver in isolated form, between 1 and 50 PPM, in distilled water in colloidal ( and/or ionic ) form - classified as GRAS ( Generally Regarded as Safe ) with the unclassified drug status REMOVED.
The FDA likes to argue that there are no USP standards for production. This can be settled in very short order to varying degrees of excellence based on currently available studies endorsed by the EPA.
None of these efforts would change the reality of the law or allow companies to make unsubstantiated medical claims about products. What it WOULD do, however, is deprioritize the critical attention of isolated silver products and properly focus the energy involved in law enforcement.
After all, scientifically, silver is no more a drug in the body than simple H2O. By the letter of the law, if I say "H2O cures dehydration" I am making a drug claim.
It should be stated that the Colloidal Silver Database Website has had no negative experiences with any governmental agency, nor are we interested in spearheading a political or legal fight against any agency. We are only interested in documenting and exploring the pertinent issues in the spirit of public interest.
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Safety Issues with Using Colloidal Silver: FDA, WHO, EPA
EPA Silver Safety Studies ----FDA and Colloidal Silver ----Silver Compound Toxicity ----FAQ: Silver Salts, Proteins and Isolated Silver ----Argyria and Colloidal Silver ----Argyria: Reported Cases ----Cure for Argyria ----Herxheimer Reaction ----Silver Side Effects Poll ----Roger Altman Silver Elimination Study ----World Health Organization Silver Toxicity Data-------Mark Metcalf