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:
Plaque/gingivitis/malodor reduction: Plaque, gingivitis, and halitosis are caused by bacteria. Antibacterial-containing dentifrices can help prevent these conditions. Stannous fluoride is the only agent currently used in dentifrices sold in the U.S. that is recognized by the ADA as being effective for controlling plaque, gingivitis and malodor.
Antihypersensitivity: Dentinal hypersensitivity can be treated by chemically depolarizing nerve endings in the tooth or by blocking dentinal tubules. Potassium nitrate is the most common nerve desensitizing agent. Stannous fluoride, arginine + calcium carbonate, strontium acetate, and calcium sodium phosphosilicate are tubule occluding agents used in newer antihypersensitivity dentifrices across the globe.
Calculus control: Polyphosphates, such as SHMP, are effective anticalculus agents. They chelate (bind) calcium and inhibit plaque calcification.
Stain removal/Whitening: Stain removal or tooth whitening is achieved through chemical or physical action. Polyphosphates are good stain removal agents. They displace stain molecules that have attached to the tooth pellicle. Abrasives remove tooth stain through a physical action. Dentifrices with an RDA of 250 or lower are considered safe for everyday use.
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.