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Colloidal Silver and The FDA

On September 16, 1999, The FDA issued a final ruling on any and all colloidal silver products. With the a brisk pen-stroke invoking the FDA's broad power, the ruling proclaimed and entered into law that any silver substance in a gelateous solution could not be sold as a medicinal substance. The ruling categorized colloidal silver as an unclassified drug. Any colloidal silver products marketed as medicinal 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 medicinal labelling and/or advertising referring to any benefits of the substance in question is unlawful. The substance must be labelled 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 abuse. 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:

Below is an interesting answer by the FDA  to an FOI request to them regarding their findings 

October 14th, 1999

Food and Drug Administration
U.S. Department Of Health and
Human Services
Public Health Service
5600 Fishers Lane
Rockville, MD 20857

Dear Sirs/Madam,

Persuant 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 consumption
of 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.

Sincerely,

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

Dear Mr. Finnigan:

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.

 

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