The US Federal Food Drug & Cosmetic Act defines a cosmetic as an article intended to be applied to the human body to cleanse, beautify, promote attractiveness, or alter the appearance. In contrast, a therapeutic drug is defined as an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or article intended to affect the structure or any function of the body. Manufacturer claims for therapeutic vs. cosmetic benefits thus have to follow these definitions.1
The key therapeutic areas for dentifrices are caries, gingivitis and sensitivity. In addition, several oral care products are marketed with cosmetic claims such as whitens teeth, reduces bad breath, and protects against tartar. If an ingredient is not included in an OTC monograph or is not approved under an NDA, it is not considered a drug, and therapeutic claims cannot be made for it. Many nontherapeutic ingredients are described later in this course.1,3
