FDA Position On Colloidal Silver

In response to an inquiry received in September 1991, an FDA official stated by letter that " . . . Colloidal Silver is considered to be a pre-1938 drug. These products may continue to be marketed without submitted evidence of safety and effectiveness (required of all prescription drugs marketed after 1938) as long as they are advertised and labeled for the same uses as in 1938 and as long as they are manufactured in the original manner . . . ."

The FDA has revoked that letter. The FDA takes the position that if any claims of medical effectiveness are made regarding Colloidal Silver it is considered a new unapproved drug. (3)

This little bit of history needs to be mentioned because there are, at the time this was written, still a number of multilevel marketers cutting and pasting the text that claimed that colloidal silver was approved by the FDA as a pre-1938 drug. I can only imagine the expression on the face of some FDA officials when they noticed aggressive colloidal silver promoters advertising it as a cure-all and claiming FDA approval as one of their endorsements. You figure out the rest.

Several manufacturers and distributors have received warning letters from the FDA regarding their statements about their colloidal silver products.

Since it costs approximately $300,000,000 and 8 to 12 years to put a new drug through the approval process and since colloidal silver is not patentable it isn't likely to ever happen. It is likely that patented new silver based drugs will be available from large drug companies, however. They will probably be expensive and require a prescription from a physician.

In August of 1996 the FDA published a notice in the Federal Register (64) that included the following statement:

"The Food and Drug Administration (FDA) is proposing to establish that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded. FDA is issuing this proposal because many products containing colloidal silver ingredients or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for these disease conditions." "FDA is proposing that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the Federal Register."

"In October 1994, FDA issued Health Fraud Bulletin #19 (Ref. 6) to address the emerging marketing of colloidal silver products offered for serious disease conditions. In that bulletin, the agency stated that it was not aware of any substantial scientific evidence which demonstrates that any OTC colloidal silver solution is useful to prevent or treat any serious disease condition. The bulletin explained that FDA has not approved a new drug application (NDA) for a colloidal silver product. In addition, the bulletin stated no data or information has been submitted to FDA to document an exemption from the new drug provisions of the Federal Food, Drug and Cosmetic Act (the act) under the 1938 or 1962 grandfather provisions." (64)

"As noted in section I. of this document, a number of silver salts were evaluated as part of FDA's OTC drug review, and none was found to be generally recognized as safe and effective for its intended use(s). Accordingly, FDA concludes at this time that no colloidal silver ingredients or silver salts are generally recognized as safe and effective for OTC use." (64)

"In the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the act. (c) Clinical investigations designed to obtain evidence that any drug product containing colloidal silver or silver salts labeled, represented, or promoted for any OTC drug use is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) After (date 30 days after date of publication of the final rule in the Federal Register), any such OTC drug product containing colloidal silver or silver salts initially introduced or initially delivered for intro into interstate commerce that's not in compliance with this section is subject to regulatory action." (64)

The follwing article found at: http://www.cvm.fda.gov/fda/infores/updates/silver.html

February 12, 1997 - COLLOIDAL SILVER NOT APPROVED FOR TREATING ANIMALS

"FDA has received reports that products containing colloidal silver are being promoted for use in the treatment of mastitis and other serious disease conditions of dairy cattle, as well as for various conditions of companion animals. For example, FDA's Center for Veterinary Medicine has received reports from the Agency's regional milk specialists and State inspectors that colloidal silver products have been found on some dairy farms. Also, recent articles in some farm newspapers and journals promote the use of colloidal silver in treating mastitis and claim that no milk discard is needed. FDA is not aware of any substantial scientific evidence that supports the safe and effective use of colloidal silver ingredients or silver salts for any animal disease condition. Also, in the October 15, 1996 Federal Register, FDA proposed to establish that all over-the-counter human drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded. "

"FDA has taken action against colloidal silver products, and is continuing to investigate the promotion and use of colloidal silver products in dairy and other animals. If necessary, FDA will take further appropriate regulatory
action. "