The FDA uses two mechanisms to regulate OTC drugs: drug monographs and NDAs. A drug monograph identifies active ingredients that are deemed to be safe and effective for a specific therapeutic need. Most OTC fluoride-containing dentifrices are regulated through the Anticaries, Antiplaque-Antigingivitis, and Tooth Desensitizer monographs. If a dentifrice contains a drug that is not included in a monograph, it must be approved through an NDA. Therapeutic dentifrices brought to market under one of these two regulatory pathways can make claims related to treating or preventing disease.
The ADA is a professional society that takes great interest in informing the public on the safety and efficacy of oral care products. This is done primarily by awarding its Seal of Acceptance. The ADA Seal of Acceptance program is a rigorous, voluntary process in which manufacturers can choose to participate for specific products.
Fluoride was the first therapeutic ingredient used in dentifrice. Fluoride helps prevent caries by enhancing remineralization and inhibiting demineralization. The three fluoride ingredients approved by the FDA for use in dentifrices are stannous fluoride (SnF2), sodium fluoride (NaF), and sodium monofluorophosphate (Na2PO3F).
Since the introduction of early fluoride dentifrices, many other ingredients have been discovered and added to dentifrice to provide multiple additional benefits, including the following:
Additional dentifrice ingredients include humectants, binders, buffers, flavors, sweeteners, and surfactants. These ingredients stabilize the product and create esthetic benefits for the consumer. They are needed to keep the dentifrice properly mixed with a palatable consistency. Not all dentifrice ingredients are compatible, however, so manufacturers must formulate products in a way that does not interfere with the bioavailability of the therapeutic ingredients. Creating a dentifrice that delivers important therapeutic and cosmetic benefits, while at the same time being acceptable to the consumer, requires the manufacturer to delicately balance the overall formulation.