The use of dentifrice as part of normal daily hygiene practices in the United States is widespread. In fact, there are so many dentifrice options in the oral care aisle today it can be overwhelming. Patients often turn to dental professionals for a product recommendation that will meet their specific oral care needs and desires. Understanding the regulatory environment that guides product claims as well as the process used by credentialing bodies to evaluate products is important as professionals discuss home care options with patients.
In the United States, the Food and Drug Administration (FDA) regulates therapeutic agents to ensure product safety and efficacy. Drugs can enter the market by one of two regulatory pathways. The most common pathway for over-the-counter (OTC) drugs is under the OTC Monograph system. There are three monographs that regulate OTC dentifrices.
The second pathway is through a new drug application (NDA), which is used for new drug products that fall outside the range of ingredients already included in the OTC Monograph system. NDAs for dentifrices are uncommon, and require the manufacturer to demonstrate that the product is safe and effective through comprehensive clinical testing.
The American Dental Association (ADA), as the leading US dental professional association, takes an interest in educating the public on the safety and efficacy of oral health products. Its primary mechanism for this is by awarding the ADA Seal of Acceptance to qualifying products.
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