Hey guys!
I don't know if you have seen this or not but a friend sent it to me. I
didn't notice it on the list if I missed it before I am sorry. I thought I
would send it anyway and see what you all thought.
Janis
FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in
responding with consistency and accuracy to questions from the public on
subjects of current interest. Talk Papers are subject to change as more
information becomes available.
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T99-39 Print Media: 301-827-6242
August 17, 1999 Broadcast Media: 301-827-3434
Consumer Inquiries: 888-INFO-FDA
FDA ISSUES FINAL RULE ON
OTC DRUG PRODUCTS CONTAINING COLLOIDAL SILVER>
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.
Colloidal <silver> is a suspension of <silver> particles in a colloidal
(gelatinous) base. 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.
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.
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