Are Fluoride Varnishes FDA approved?

Fluoride varnishes are approved as Class II Medical Devices ( FDA 510 K compliance) for use as a cavity liner and/or tooth desensitizer. Fluoride varnishes is not FDA approved as caries preventive agents. They are used “off-label” for preventing dental caries. FDA approval is not required to use fluoride varnish off-label. (USFDA, 1998, USP DI, 2006) Many medications are currently prescribed and administered for off-label use, and many drugs used in medical practice for children have never been tested in children. The FDA regulation states: “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the products use and effects.” (USFDA, 1998; AAP, 2002)