Action by the FDA

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.