The U.S. Food and Drug Administration (FDA) has denied a citizen petition asking the agency to re-categorize tooth-whitening products as drugs instead of cosmetics, stating that, among other things, it lacks specific information about the way peroxide-containing whiteners work to support that action.

Submitted to FDA in 2009 by the American Dental Association (ADA), the petition, which claims that tooth-whitening products can cause damage to patients’ teeth and soft tissue in the mouth, and are “easily over-used and abused by individuals who assume that the products are safe since they are readily available,” requested that the agency “review and establish an appropriate regulatory classification for tooth-whitening preparations that act by chemical means to lighten tooth color.” Specifically, ADA asked the agency to re-classify tooth-whitening products as drugs, voicing concerns about consumers’ use of the products without consulting dental professionals.

Emphasizing that to meet the drug definition, tooth whiteners must affect the structure and function of teeth or be meant to treat a disease, Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock wrote in an April 22, 2014, letter, “we would need to examine each product on a case-by-case basis to determine whether it meets the statutory definition of drug as well as the definition of cosmetic. Without further data illuminating the mechanism of action of peroxide-containing tooth whiteners that work by chemical means, or knowing the intended uses of specific products, we cannot answer the question of whether all tooth whiteners as a group meet the definition of a drug.”

Previous FDA efforts in the 1990s to regulate tooth-whitening products as drugs were reportedly thwarted by strong opposition from industry representatives who argued that the products are “generally safe and correctly classified as cosmetics.” See, April 23, 2014.