What Is It?
Sodium Fluoride occurs as a white crystalline solid. Sodium Fluoride is used in the formulation of dentifrices, mouthwashes and breath fresheners.
Why Is It Used?
Sodium Fluoride aids in the prevention of dental cavities as an Ingredients that aid in the prevention of dental cavities. In the United States, anticaries agents are regulated as Over-The-Counter (OTC) drug ingredients.. It also polishes the teeth, reduces oral odor, and otherwise cleanses and deodorizes the teeth and mouth.
Sodium Fluoride is also known as sodium monofluoride. Sodium Fluoride is found in the form of cubic or tetragonal crystals.
The Food and Drug Administration (FDA) permits Sodium Flouride to be used as an Indirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage.. Sodium Fluoride is also permitted for use as an ingredient in Over-the-Counter (OTC) anticaries drug products. The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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 birth defects.
Link to FDA Code of Federal Regulations for Sodium Fluoride
Sodium 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). When Sodium Fluoride is used in products they must be labeled “contains sodium fluoride”.
Sodium Fluoride, and other fluoride containing ingredients are not permitted in dentifrices, mouthwashes or breath drops marketed in Canada.
More Scientific Information
Sodium Fluoride is an inorganic salt, the sodium salt of hydrofluoric acid. 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 Ingredients that unite or bond surfaces together. 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.
Find out more about the regulation of over-the-counter drugs by the Food and Drug Administration
Find out more about the regulation of Food Additives by the Food and Drug Administration
- Food Ingredients and Packaging
- Food Contact Substances
- Substances Generally Recognized As Safe (“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.)
- Search the Code of Federal Regulation
- EU Cosmetics Inventory