Claims for Therapeutic vs. Cosmetic Benefits

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 are required to follow these definitions.³Dentifrices contain ingredients that help reduce caries, plaquegingivitis, hypersensitivity,dental erosion, calculus (anti-tarter), stain, and halitosis. Some ingredients provide a therapeutic benefit, while other ingredients or additives contribute to the cosmetic benefits or physical properties of the dentifrice.

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 benefit claims cannot be made for it. Many nontherapeutic ingredients are described later in this course.^3,5