Procter & Gamble urges FDA to deny a citizen petition by the American Dental Association to reclassify commercially available tooth-whiteners as drugs, saying ADA members' financial interests motivated the petition.

"Their desired outcome is to restrict direct-to-consumer access to tooth-whiteners that offer results comparable to in-office and dentist-dispensed products," P&G says in an April 28 ¹ letter to FDA Commissioner Margaret Hamburg.

Since the introduction of tooth whiteners like P&G's Crest Whitestrips over the past decade, millions of consumers have switched from in-office visits to store-bought whiteners, the firm states, noting the products are "extensively" tested and appropriately classified as cosmetics.

P&G penned the letter in response to a citizen ² petition ADA filed Nov. 20, in which it urged FDA to reconsider the classification of tooth-bleaching systems as cosmetics, stating it sends the misleading message that the products are "innocuous" (³ Also see "Dental Association Petitions FDA To Evaluate Tooth Whitening Treatments" - Pink Sheet, 30 November, 2009.).

The association stated that bleaching materials can affect filling materials, result in mismatched color of teeth with existing fillings or crowns and corrode mucous membrane or skin, causing a burning sensation, tissue damage and sensitivity. Therefore, ADA suggested the products would be more appropriately classified as drugs.

ADA's Petition Challenged As Incomplete

However, P&G argues in its letter that ADA relied heavily on a report prepared under the direction of the ADA Council on Scientific Affairs, and failed to include information ADA knew was "unfavorable" to its position.

"There is published and easily accessible scientific literature that addresses most of [their] concerns, but these are not referenced in the petition," P&G says, noting it has shared the published data with ADA on numerous occasions over the past several years.

P&G included an attachment summarizing the supporting safety data - spanning 2000 to 2010 - in its letter to the agency.

The firm published data as late as August 2009 supporting the safety of whitening strips for people with dry mouth (⁴ Also see "Research & Development In Brief" - Pink Sheet, 5 October, 2009.).

P&G notes its previous research includes a "comprehensive battery" of clinical trails on the products.

Additionally, the Cincinnati-based company employs a "scientifically advanced and thorough pre-clinical program" including "leading edge" research on hard tissue (enamel and dentin), restorative materials used in dentistry and toxicological assessments.

ADA commented on P&G's letter in a May 6 e-mail, stating simply that it has asked FDA to establish "appropriate" classifications for tooth whiteners and it is "confident that the FDA will know best how to use the information it gathers."

In 1991, FDA warned the makers of six tooth-whitening products that claims for bleaching teeth made their products unapproved new drugs.

Slightly more than a year later, however, the agency said it was rethinking its position on tooth whiteners in response to data that show the products may not fit the statutory definition of drugs, and may be cosmetics.

The issue also is a heated one in Europe, where the Scientific Committee on Consumer Products determined that oral hygiene products and tooth whiteners containing more than 0.1 percent hydrogen peroxide cannot be deemed safe in the absence of long-term clinical data assessing possible adverse effects (⁵ Also see "Shine More Safety Data On Tooth Whiteners With Hydrogen Peroxide – SCCP" - Pink Sheet, 11 February, 2008.).

- Eileen Francis

P&G Defends Tooth Whitening Cosmetic Classification In FDA Letter

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