Concerned about the strength of teeth-whitening chemicals and by the growing number of non-dental venues through which they’re being sold, the American Dental Assn. today asked the U.S. Food and Drug Administration to evaluate the compounds for safety and classify them.
Currently, teeth whiteners, which commonly use hydrogen peroxide or carbamide peroxide as the active ingredient, are neither drug nor cosmetic device nor medical device, according to the dental association.
The ADA wants the FDA to put the chemicals in a category and evaluate them for safety.
Depending on the outcome of that evaluation, the whitening compounds could be available on an unrestricted, over-the-counter basis or, if determined to be at the upper end of risky, could be restricted to prescription-only availability.
“Without appropriate regulation, the application of chemically-based tooth whitening/bleaching agents may result in harm to both hard and soft tissues in the mouth,” the ADA said in a letter to FDA Commissioner Dr. Margaret Hamburg.
Dr. Ron Zentz, senior director of the ADA’s Council on Scientific Affairs, said the FDA was supposed to have classified whiteners years ago but never finished the task.
Zentz said there was no particular tipping point for the ADA’s request, but the letter to Hamburg notes that a lot of business is being transacted outside of dentists’ offices, with potential harm to consumers – not to mention to dentists’ bottom lines.
“The tremendous expansion of products available directly to consumers and application of products in venues such as shopping malls, cruise ships, and salons is troubling since consumers have little or no assurance regarding the safety of product ingredients, doses or the professional qualifications of individuals employed in these non-dental settings,” the letter states.
-- Andrew Zajac
Photo illustration credit: Los Angeles Times