The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. Please click the link below provided for more information regarding Colloidal Silver from the FDA.

http://www.gpoaccess.gov/cfr/index.html

Consumer information available from FDA Website regarding Colloidal Silver

August 17, 1999

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.

http://www.fda.gov/bbs/topics/ANSWERS/ANS00971.html

PLEASED BE ADVISED THAT RAPHA LABORATORIES HAS BEEN ACTIVELY WARNING CONSUMERS AGAINST THE USE OF SILVER SALTS WHICH ARE KNOWN TO CAUSE ARGYRIA

Code of Federal Regulations information on FDA Website

regarding Colloidal Silver

[63 FR 13528, Mar. 20, 1998]
Sec. 310.548  Drug products containing colloidal silver ingredients or
          silver salts offered over-the-counter (OTC) for the treatment
          and/or prevention of disease.

    (a) Colloidal silver ingredients and silver salts have been marketed in over-the-counter (OTC) drug products for the treatment and prevention of numerous disease conditions. There are serious and complicating aspects to many of the diseases these silver ingredients purport to treat or prevent. Further, there is a lack of adequate data to establish general recognition of the safety and effectiveness of colloidal silver ingredients or silver salts for OTC use in the treatment or prevention of any disease. These ingredients and salts include, but are not limited to, silver proteins, mild silver protein, strong silver protein, silver, silver ion, silver chloride, silver cyanide, silver iodide, silver oxide, and silver phosphate.
    (b) Any OTC drug product containing colloidal silver ingredients or silver salts that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing. 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 as set forth in part 312 of this chapter.
    (d) After September 16, 1999, any such OTC drug product containing colloidal silver or silver salts initially introduced or initially delivered for introduction into interstate commerce that is not in compliance with this section is subject to regulatory action.

[64 FR 44658, Aug. 17, 1999]

http://frwebgate5.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=302084305001+2+0+0&WAISaction=retrieve

FDA News

FTC and FDA Crackdown on Internet Marketers

of Bogus SARS Prevention Products

Deceptive and Misleading Claims Must be Removed Immediately

The Federal Trade Commission and the Food and Drug Administration (FDA) are warning Web site operators, manufacturers and distributors who suggest that their products will protect against, treat, or even cure Severe Acute Respiratory Syndrome (SARS), that they are aware of no scientific proof for such claims and that the Web site operators must remove any misleading or deceptive claims from the Internet. A coordinated Internet "surf" found 48 sites touting a wide variety of SARS treatment or prevention products. The FTC also retrieved seven promotions for SARS products from its spam database. The two agencies sent warnings to Web site operators, and e mail solicitors, cautioning that it is against the law to make claims about SARS protection or treatment, or any other health benefit, without rigorous scientific support. FDA has sent 8 warning letters to manufacturers and distributors who are making misleading claims. The FTC and FDA staff will follow up by revisiting the targeted sites to determine whether the Web site operators have deleted or revised unproven claims.   ...read more

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00904.html

Discussion regarding dietary supplements being a Food or Drug