[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR310.548]

[Page 49]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
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]