Over The Counter Drugs Containing Colloidal Silver Considered
WASHINGTON, D.C. (SafetyAlerts)
- The FDA has issued a decision declaring that all over- the-counter (OTC) drug products
containing colloidal silver or silver salts are not recognized as safe and effective, and
In recent years, colloidal silver preparations of
unknown formulation have been appearing in stores claiming 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.
The indiscriminate use of colloidal silver
solutions has resulted in cases of argyria, a permanent blue-gray discoloration of the
skin and deep tissues.
The colloidal silver products have been classified
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.
According to the ruling, a colloidal silver
product for any drug use will first have to be approved by FDA under the new drug
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.
Consumers with questions about these products can
contact the FDA at 1-888-INFO-FDA