Silver and the FDA
...How to fight the flu...naturally...
...How to fight the flu...naturally...
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
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.
Public Health Service
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.
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:
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:
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:
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:
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):
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
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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 ):
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
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:
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.
times since August 2009
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
Page Last Modified: 03/2/17 07:46