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FDA & Colloidal Silver

Silver Bullet Enterprises

Producers of Safe, Simple and Economical

Colloidal Silver Generators

and related Products...  

111 W.S. 1st Street, #110

Johnstown, Colorado 80534





We are retailers of Colloidal Silver Generation Equipment. We believe that the information we provide and the equipment we sell can help you to improve the quality of life for yourself and your family . That is our goal.

FDA & Colloidal Silver

The following document is a copy of the August 17, 1999 "FDA Talk Paper", taken directly from the FDA website.
It describes the August 16, 1999 "Final Rule" on Colloidal Silver, effective September 16, 1999.


The FDA has issued a Final Rule declaring that all over- the-counter (OTC) drug products containing colloidal silver or silver salts are not recognized as safe and effective and are misbranded. [ note that this rule exempts prescription medications containing colloidal silver ...ed.]
Colloidal silver is a suspension of silver particles in a colloidal (gelatinous) base. [ note that this definition differs from the classical definition of a colloid by requiring suspension in a gelatinous base rather than a liquid ... ed] In recent years,  colloidal silver preparations of unknown formulation have been appearing in stores. These products are labeled to treat adults and children for diseases including HIV, AIDS, cancer, tuberculosis, malaria, lupus, syphilis, scarlet fever, shingles, herpes, pneumonia, typhoid, tetanus and many others.

According to the Final Rule, a colloidal silver product for any drug use will first have to be approved by FDA under the new drug application procedures. The Final rule classifies colloidal silver products as 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.

The indiscriminate use of colloidal silver solutions has resulted in cases of argyria, a permanent blue-gray discoloration of the skin and deep tissues. [ Editor's note: We can only find a handful of these cases, less than 5, from over 10,000,000 estimated US colloidal silver users]

Colloidal silver ingredients and silver salts include silver proteins, mild silver protein, strong silver protein, silver chloride, and silver iodide. The dosage form of these colloidal silver products is usually oral, but product labeling also contains directions for topical and, occasionally, intravenous use.

In reaching its decision, FDA considered all of the information described in the proposed rule (October 15, 1996) and submitted by the public in response to that proposal, the Final Rule becomes effective on September 16, 1999, 30 days after publication.

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

Link to our article on FDA Approvals  {FDA "Approvals" & You}

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We are not licensed Medical Professionals. We endeavor to provide accurate and useful information BUT we do not guarantee the accuracy of information on this site or any site to which we have linked. We specifically deny all liability for the use of any information on this site. We strongly recommend consultation with licensed professionals prior to beginning, ending or changing the course of treatment for any medical condition.

Silver Bullet Enterprises

Producers of Safe, Simple and Economical Colloidal Silver

Generators and related Products...