FDA Classification of Teeth Whitening Agent

Rockville, Md.—The ADA has petitioned the Food and Drug Administration to review and classify chemically-based tooth whitening agents.

Concerned that the application of unregulated dental products administered by unlicensed technicians or nonprofessionals may be harmful to consumers, the Association urged the FDA to “establish an appropriate regulatory classification for tooth whitening preparations that act by chemical means” to lighten tooth color.

The ADA detailed its concerns in a Nov. 20 letter to FDA Commissioner Margaret Hamburg, M.D., from ADA President Ronald L. Tankersley and ADA Executive Director Kathleen T. O’Loughlin.

The action was prompted by the prevalence of whitening in nondental settings such as malls, kiosks, salons and cruise ships, which offer the services.

In the letter, Drs. Tankersley and O’Loughlin called this “troubling since consumers have little or no assurance regarding product safety or the professional qualifications of individuals employed in these nondental settings.

“Consequently, the ADA has legitimate concerns about the safe use of tooth whitening products without the benefit of professional consultation or examination,” they noted.

In 2008, the increase in teeth-whitening businesses encouraged the ADA House of Delegates to call for the Association to petition the FDA to properly classify tooth whitening and bleaching agents. Resolution 73H-2008 also urged the ADA to support educating the public on the importance of consulting a licensed dentist to determine if whitening/bleaching is an appropriate course of treatment.

In addition, the ADA Council on Scientific Affairs compiled scientific research to describe treatment considerations for dentists before performing these procedures in order to reduce the incidence of adverse outcomes and report these findings to all state dental associations.

Res. 73H-2008 also called for constituent societies, through legislative or regulatory efforts, to support the proposition that administering or applying any intra-oral chemical for the sole purpose of whitening/bleaching of the teeth by whatever technique, except for the lawfully permitted self-application and application by a parent and/or guardian, constitutes the practice of dentistry, and any nondentist engaging in such activity is committing the unlicensed practice of dentistry.