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Action by the FDA |
FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
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.
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.
and make your own decisions about how to live a happy life and how to work for a better world."
Linus Pauling, two time Nobel laureate (Chemistry and Peace)