Professionally applied and prescribed fluoride products.

Abstract

The US regulatory process relative to the marketing of sodium fluoride dietary supplements and professionally applied topical fluorides is examined with regard to interactions of ADA, NIH, academia, and the FDA, as well as resultant effects on industry, practitioners, and patients. Restrictions on noncaries use of fluoride limit commercial claims, but not professional practice. Prenatal fluoride supplements are still unapproved. Finally, the effects of generic competition and the regulatory process on costs, sales, quality of professional fluoride products and on new product research are discussed.