| February 12, 1997
COLLOIDAL SILVER NOT APPROVED
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.
Use of colloidal silver ingredients in food-producing animals
constitutes a potentially serious public health concern because
of the possibility of residues in milk or meat. According
to several scientific publications mentioned in the October
15, 1996 Federal Register proposal, the human consumption
of silver may result in argyria -- a permanent ashen-gray
or blue discoloration of the skin, conjunctiva, and internal
organs.
In addition to the possible human health concerns, use of
these products to treat a serious illness in animals (including
pets) could potentially endanger the health of the animal
by delaying timely, appropriate treatment.
Colloidal silver-containing products have not been approved
by FDA for use in any animal species. Promoting the use of
colloidal silver for treating animal diseases causes such
products to be misbranded veterinary drugs under the Federal
Food, Drug, and Cosmetic Act (the Act). Labeling colloidal
silver products to treat animals causes such products to be
new animal drugs which are adulterated under the Act.
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.
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Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm
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