Stannous Fluoride

What Is It?

Stannous Fluoride occurs as a white crystalline solid. Stannous Fluoride is used in the formulation of oral care products.

Why Is It Used?

In OTC drug products, Stannous Fluoride aids in the prevention of dental cavities as an anticaries agent. It also serves to polish the teeth, reduce oral odor, and cleanse or deodorize the teeth and mouth.

Scientific Facts

Stannous Fluoride is an inorganic salt also known as tin difluoride. Inorganic Salts are the compounds formed when an inorganic base reacts with an inorganic acid. Under these circumstances, the base provides the cation while the anion is derived from the acid. In the naming of inorganic salts, the name of the cation (or cations) normally precedes the name of the anion.

Safety Information

The Food and Drug Administration (FDA) has approved Stannous Fluoride for use as an ingredient in Over-the-Counter (OTC) anticaries drug products. Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

The relationship between the consumption of fluoridated drinking-water and morbidity or mortality due to cancer has been examined in a large number of epidemiological studies, performed in many countries. There is no consistent evidence of an association between the consumption of controlled fluoridated drinking-water and increased morbidity or mortality due to cancer. Epidemiological studies show no evidence of an association between the consumption of fluoridated drinking-water by mothers and increased risk of spontaneous abortion or congenital malformation.

FDA Code of Federal Regulations for Stannous Fluoride

Stannous Fluoride may be used in oral hygiene products marketed in the European Union at a maximum concentration of 0.15% calculated as F. When mixed with other fluorine compounds, total F concentration must not exceed 0.15% (see Annex III). Products containing Stannous Flouride must be labeled “contains Stannous Fluoride”.

Stannous Fluoride and other fluoride ingredients are not permitted in dentifrices, mouthwashes or breath drops marketed in Canada.

More Scientific Information

Stannous Fluoride is an inorganic salt formed from tin and fluoride ions. Fluorides are released into the environment naturally through the weathering and dissolution of minerals, in emissions from volcanoes and in marine aerosols. Fluorides are also released into the environment via coal combustion and process waters and waste from various industrial processes, including steel manufacture, primary aluminum, copper and nickel production, phosphate ore processing, phosphate fertilizer production and use, glass, brick and ceramic manufacturing, and glue and adhesive production. The use of fluoride-containing pesticides as well as the controlled fluoridation of drinking-water supplies also contribute to the release of fluoride from man-made sources.