Has ADA tarnished OTC tooth whiteners? FDA steps up investigation; Plus+White maker files suit

Drug Store News, Jan 9, 1995 by Lisa I. Fried

NEW YORK -- The American Dental Association's warning about the perils of over-the-counter tooth whiteners has prompted a lawsuit from one manufacturer and harsh words from others. It has also breathed new life into the Food and Drug Administration's two-year-long investigation of the category and left retailers wondering what might become of the most profitable segment of the oral care category.

In mid-December, CCA, manufacturer of Plus White products, filed a lawsuit against the ADA for false advertising, commercial disparagement and unfair competition. The suit centers on a video news release issued by the ADA in November as part of a major media campaign about OTC tooth whiteners.

In late November, the ADA issued a full-blown media alert to 700 TV news stations, 500 newspaper and magazine journalists and 10,000 small newspapers about the "dangers" of OTC tooth whiteners.

The video news release implied that specific OTC whitening products may be dangerous. In the video, which resembles a news program, a voice-over warns that OTC tooth whiteners "may contain chemicals, which when used without the supervision of a dentist can actually damage healthy teeth and soft tissue in the mouth."

As the voice-over is heard, the camera focses on Booster Toothpaste, White Step Whitening Toothpaste, Plus White Anti-Stain Fluoride Gel, Plus White Desensitizing Toothpaste, Rembrandt Brushing Gel and Rembrandt Mouth Refreshing Rinse.

The press materials sent to print media mentioned peroxide as the potentially dangerous chemical but did not cite the specific products by name.

Although peroxide is not identified as the chemical in the video release, accompanying materials from the ADA make it clear that the association has some doubts about peroxide use in dental products.

Ironically, White Step tooth-paste, the two Plus White products and Rembrandt's mouth rinse do not contain peroxide. Rembrandt's Brushing Gel does contain peroxide, but it is not a whitener.

The video also shows a consumer reading the label of Plus White Anti-Stain Oral Rinse while the voice-over issues this warning: "The Food and Drug Administration recommends that consumers who are considering over-the-counter whitening products talk with their dentist first."

In fact, the ADA mischaracterized the FDA's position on tooth whiteners. "We don't have the basis to agree or disagree with the ADA's position," said Brad Williams, director of the FDA's drug labeling compliance division, explaining that the FDA is still studying whether to classify OTC whiteners as cosmetics or drugs.

"What I [told the ADA] is a standard FDA statement," said Williams. "Anyone who is concerned about medication they are using should consult their health care professional." Nevertheless the ADA's interest in the category will push the FDA to speed up its ongoing investigation, Williams said.

Manufacturer response

Executives from CCA and Den-Mat, manufacturer of Rembrandt products, immediately complained to the ADA about the media campaign and pressed the association to issue a retraction.

Consequently the ADA issued a retraction to the 700 broadcast journalists who were sent the video news release. The retraction alerted the stations to discontinue using the videos and destroy or return them to the ADA. The press release explained that the recall was necessary "due to a potential misunderstanding of some of the visuals depicting oral health care products."

It specifically urged the media to "discontinue use of any footage showing Plus White, Rembrandt or any other products identifiable by product name," as the two brands named do not contain hydrogen peroxide, "the ingredient that may cause oral health problems when not administered under the supervision of a dentist."

At press time, it was not clear how many TV stations had run some or all of the video news release, according to the ADA.

Although the ADA believed it had resolved the matter fairly, CCA thinks otherwise. On Dec. 14, it filed a lawsuit against the group and its production company. The suit, filed in U.S. District Court in the Southern District of New York, seeks damages in an amount to be determined.

"We don't know what the damage is at the moment," said John Desirderio, attorney, Bass & Ullman, which represents CCA. "By the time this comes to trial, we should [know more]."

"We are shocked that the ADA would spend enormous sums to produce and distribute a video containing misinformation," said David Edell, CCA Industries' president and chief executive officer.

No formal reply from ADA

At press time, the ADA had received a copy of the complaint but had not yet issued a formal response.

"We are disappointed that CCA felt it was necessary to file suit since we believe, through the actions we had taken, that we had responded to all of their requests and resolved this matter voluntarily," said Kathleen Todd, associate general counsel, ADA.

For Den-Mat, which also sells whitening products to dentists, the situation is a bit more sticky. The company doesn't want to alienate dentists, but it also believes that the ADA mischaracterized its OTC products.