The FDA, the ADA, and What You Need to Know
by Rodney Ogrin, DDS

In a business climate where patients can sue their dentists over a toothbrush, thoughts of limiting liability are prudent. What kind of exposure do you have regarding the use of bleaching gel? How do you play it safe? What are acceptable risks? Only you can answer these questions for yourself, but these are some of the issues on the table to consider:

  • The ADA has accepted only 10% carbamide peroxide for at-home use.
  • Because a company has an ADA approved product does not mean their products with KNO3 in them or their higher concentrations of carbamide peroxide (11%, 13%,15%, 16%, 20%, 22%, 30%) have been ADA accepted.
  • In my experience, most dentists are not postponing the use of higher concentrations until the ADA finally gives their blessing, but have already moved to the efficacy and predictability of the higher concentrations.
  • Higher concentrations of carbamide peroxide have been used successfully for a decade and, to my knowledge, without a single lawsuit. Even Ultradent (Opalescence) has gone to 15% and 20% carbamide peroxide gels.
  • After ten years of whitening, there are no studies indicating that higher concentrations of carbamide peroxide have a negative effect on enamel or the pulp.
  • The FDA classifies carbamide peroxide for teeth whitening as a cosmetic, which limits the testing requirements and regulations.
  • The FDA classifies potassium nitrate (KNO3) as a drug --which is regulated at a much higher level than cosmetics.
  • The FDA is aware of concerns that nitrates from potassium nitrate may be involved in the production of certain forms of cancer (i.e. gastric and liver cancer). Ingested nitrates can be converted in the oral cavity and the stomach to nitrites, which in turn can lead to endogenous nitrosation in the stomach. (1)
  • The ADA traditionally takes a relatively long period of time to sort out such seemingly conflicting issues.

Dentists are left to make their own product selection decisions. Based on what we now know, the acceptance of higher concentrations looks good --as they are backed by years of safety and success. On the other hand, the issue of KNO3 faces many complications such as an FDA warning and regulatory classification confusion.

1 .Oral Health Care Drug Products for OTC Human Use..., Federal Register Vol. 56, No.185, 21
CFR Parts 356 & 369, Sep. 24, 1991, 48302:48347