The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. The FDA also has the responsibility to determine if new medical procedures are safe and if they need to be regulated or performed by a professional. The FDA has determined that Teeth Whitening is a cosmetic procedure. According to the Federal, Food, and Drug Act (FD&C Act, sec. 201(i)):
The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”
In short, this means that teeth whitening is considered to be a cosmetic procedure and that it is considered safe for home use. This also means that it is OK for these cosmetic teeth whitening companies to operate, as long as they do not cross the line by practicing dentistry. What this means is that as long as you are the one that is applying the teeth whitening gel, putting the teeth whitening tray in your mouth, and putting the teeth whitening light on your mouth, the company is not practicing dentistry. This is essentially you purchasing the teeth whitening product and using the company's equipment.
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