FDA TALK PAPERI just came across this article. I had never heard of these restrictions on CS. My understanding was that they did not find it harmful. But there could be no claims made as to its benefits. Bob Smith
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
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T99-39 Print Media: 301-827-6242
August 17, 1999
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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