FDA Bans Colloidal Silver Products, Cites Lack of Data

FDA Consumer, Nov, 1999

Under a rule recently finalized by FDA, drug products containing colloidal silver or silver salts are not recognized as safe and effective. These products, labeled to treat a wide variety of illnesses in adults and children, including AIDS, cancer, syphilis, scarlet fever, shingles, herpes, and pneumonia, have caused some people's skin to take on a permanent blue-gray discoloration.

FDA concluded that colloidal silver products (suspensions of silver particles in a gelatinous base) are misbranded because adequate directions cannot be written to allow consumers to use them safely. These products are also misbranded, FDA said, when their labeling falsely suggests that there is substantial scientific evidence to establish that they are safe and effective for their labeled uses. (For an enforcement action involving colloidal silver, see page 36.)

The FDA final rule, which was published in the Aug. 17 Federal Register and became effective Sept. 16, requires that any colloidal silver product intended to be used as a drug will have to be approved by FDA under the agency's new drug application procedures before being marketed.