Colloidal Silver Ingredients Not Safe, Effective In OTCs - FDA Final Rule
This article was originally published in The Tan Sheet
Executive Summary
Rat studies showing no adverse effects from colloidal silver ingredients fail to demonstrate safety in humans, FDA says in a final rule declaring silver constituents in OTC drugs for internal or external use not generally recognized as safe and effective and misbranded.
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Colloidal silver warnings
Eight FDA letters sent in early January to Web sites selling colloidal silver products advise the agency "has no information that your product is [GRAS/E] for the referenced conditions." Products may be considered "new drugs" under the FD&C Act and may not be legally marketed without FDA approval, the agency maintains. The sites claim colloidal silver products "mitigate more than 650 types of infections" and "destroy over 600 germs and bacteria," according to the letters. In a final rule issued in August 1999, FDA declared silver constituents in OTC drugs for internal or external use not GRAS/E (1"The Tan Sheet" Aug. 23, 1999, p. 5)
Colloidal silver "cure-all" OTC products not safe and effective -- FDA proposed rule.
COLLOIDAL SILVER-CONTAINING OTC PRODUCTS LACK SAFETY/EFFICACY DATA and would be misbranded under a proposed rule published by FDA in an Oct. 15 Federal Register notice. Comments on whether the substance can be generally recognized as safe and effective (GRAS) may be submitted to the agency within 90 days. Colloidal silver historically has been marketed with claims to treat a number of disease conditions.