Description of the US Monograph System

In 1962, an amendment was passed to the US Federal Food, Drug, and Cosmetics Act (FD&C) requiring that marketed drug products not only had to be safe, but they also had to be effective. At that time, hundreds of thousands of OTC drugs were on the market, and time and resources were too limited to ensure that all these OTC drugs complied with the new regulations.

To ease the approval of OTC therapies considered safe by virtue of their extensive historical use, the monograph drug review mechanism was instituted in 1972. Under this process, the FDA convenes committees to review safety and efficacy data submitted for therapeutic ingredients in the OTC market. The end result of the process is a published document that lists certain therapeutic ingredients (referred to as active ingredients) and the requirements for marketing products that contain those active ingredients. These requirements include a number of parameters, including the intended use, drug dosage or concentration, dosage forms, allowable combinations with other drugs, required labeling, and any special packaging or testing requirements.1

There are several classes of monographed OTC drugs for oral use, including anticaries agents, tooth desensitizers, oral antiseptics, anesthetics, and analgesics. Therapeutic dentifrices are regulated by three separate monographs: Anticaries, Antiplaque-Antigingivitis, and Tooth Desensitizer (Table 1).

Table 1. Oral Care Monographs: Dentifrices Are Regulated with Three Separate Monographs.
MonographCurrent Status*Example IndicationExample Ingredients and Products
AnticariesFMPrevents cavitiesSodium fluoride (Aquafresh Extreme Clean)
Sodium monofluorophosphate (Colgate Cavity Protection)
Stannous fluoride (Crest PRO-HEALTH)
Tooth DesensitizerTFMHelps reduce sensitivityPotassium nitrate (Sensodyne)
Stannous fluoride (Crest PRO-HEALTH)
Antiplaque-AntigingivitisANPRPrevents plaque and gingivitisStannous fluoride (Crest PRO-HEALTH)
* FM—Final Monograph; TFM—Tentative Final Monograph; ANPR—Advanced Notice of Proposed Rulemaking

One factor that differentiates OTC fluoride dentifrices from prescription fluoride dentifrices is the amount of fluoride they contain as a therapeutic ingredient. Fluoride is a known anticaries ingredient, but it can be toxic if excessive levels are ingested. Although dentifrices are not intended to be ingested, there is enough safety concern to warrant stricter regulations for higher dose products. Most OTC fluoride dentifrices contain 1000–1500 parts per million (ppm) of fluoride and are considered conventional fluoride dentifrices. The maximum allowable fluoride in a monographed OTC dentifrice is 1500 ppm for a sodium monofluorophosphate dentifrice and 1150 ppm for sodium fluoride and stannous fluoride dentifrices. Some prescription-strength fluoride dentifrices contain as much as 5000 ppm of fluoride. Because this level of fluoride is not allowed in an OTC product under the anticaries monograph, these types of products must be prescribed by a dentist.2,3