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Over The Counter Drugs Containing Colloidal Silver Considered Unsafe, Misleading

WASHINGTON, D.C. (SafetyAlerts) - The FDA has issued a decision 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.

In recent years, colloidal silver preparations of unknown formulation have been appearing in stores claiming 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.

The indiscriminate use of colloidal silver solutions has resulted in cases of argyria, a permanent blue-gray discoloration of the skin and deep tissues.

The colloidal silver products have been classified 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.

According to the ruling, a colloidal silver product for any drug use will first have to be approved by FDA under the new drug application procedures.

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.

Consumers with questions about these products can contact the FDA at 1-888-INFO-FDA

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.