Grandma, What White Teeth You Have! But it’s Still Such a Gray Area

Tooth whiteners – drugs or cosmetics or both?  In the case of certain tooth whiteners, the regulatory status remains gray, apparently with no prospect of illumination from the Agency.

As we reported back in 2014, FDA’s interest in the regulation of peroxide-containing tooth whiteners began in the early 1990s not too many years after these products were introduced to the market. In 1991, FDA sent Warning Letters to several manufacturers stating that it considered products which claimed to whiten teeth by bleaching were unapproved new drugs being marketed in violation of the Food, Drug, and Cosmetic Act.  One of the manufacturers (Den-Met Holdings, LLC) sued FDA asserting its product (Rembrandt Lighten Bleaching Gel) was a cosmetic, rather than a drug under the statute.  Den-Mat withdrew its case in 1992 after FDA agreed to review new information submitted and determine whether the new information changed FDA’s position. And then, nothing.

“Fast” forward to 2009 when the American Dental Association submitted a Citizen Petition (Docket No. FDA-2009-P-0566) requesting that FDA establish an “appropriate regulatory classification” for peroxide-containing tooth whiteners citing concerns about their safe use without benefit of professional consultation or examination.  FDA responded in 2014, denying the petition, but leaving open the question of the appropriate regulatory status for peroxide-containing tooth whiteners.   In the response, FDA described the different types of tooth stains and their causes, and concluded that the means by which whitening occurs may be different for different types of stains.  FDA denied the petition stating there was insufficient data to determine whether, as a group, peroxide-containing tooth whiteners that act by a chemical means met the definition of a drug (as well as a cosmetic) and specifically noting the need for data on specific products to determine on a case-by-case basis whether individual products are intended to affect the structure or function of the teeth and/or intended to mitigate or treat a disease.  In conclusion, FDA stated that without further data illuminating the mechanism of action, it could not answer the question of whether all tooth whiteners as a group met the definition of a drug.

FDA has said no more about it since 2014. Meanwhile, in the private sector, battles over tooth whiteners have continued over the years with a very recent case before the National Advertising Division about Optic White Toothpaste (NAD Case #6914, 2/23/21) and a number of false advertising cases about whitening products pending in the courts.  As a result of that recent activity, the trade journal HBW Insight (a subscription publication) reported recently that it had reached out to FDA for clarification on the regulatory status of these products.  US FDA’s Position Hasn’t Changed On Hydrogen Peroxide Teeth Whiteners – HBW News, 18 Mar 2021.  As described by HBW News, there does not appear to be any change in FDA’s position on peroxide-containing tooth whiteners and they appear to remain in the gray zone where they have dwelled for the past 30 or so years.

Perhaps at some point FDA will utilize the new processes established under OTC Monograph Reform (see our blog here) to force the issue and issue a proposed order that peroxide-containing tooth whiteners or some subset of them are non-monograph unapproved new drugs, but little in the past decades or recent responses to HBW News suggests it is a priority.