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U.S. Department of Health and Human Services
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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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