Colgate Disputes Aquafresh Iso-Active Bacteria Removal Claim In NAD Case

A National Advertising Division recommendation that GlaxoSmithKline discontinue the claim that Aquafresh iso-active Whitening Toothpaste "removes 3x more bacteria" than ordinary toothpaste is a significant blow to a campaign centered on the superiority of the firm's "breakthrough" product.

In a case brought to the Council of Better Business Bureau division's attention by competitor Colgate-Palmolive, the watchdog group assessed the claims and supporting studies which compared iso-active to an "ordinary" toothpaste - Colgate Total , which is also a category leader.

In 2009 GSK launched iso-active products in its Aquafresh and Sensodyne toothpaste brands, positioned as a "breakthrough" technology that is packaged in a canister and delivers "twice the foam volume as ordinary toothpaste" (¹ (Also see "Glaxo Iso-Active Toothpastes Employ Double Foam, Claim Triple Efficacy" - Pink Sheet, 21 Sep, 2009.)).

The iso-active foaming action is stimulated by isopentane in the formula, which evaporates immediately upon use, creating a gel-to-foam action that promotes cleaning and bacterial removal, Glaxo says.

In TV, print and Internet ads and on packaging, GSK claimed its product works beyond ordinary toothpaste and has superior bacterial removal, noting it removes "3x more bacteria" as it whitens.

Colgate Total Not Appropriate As Control Product

The term "ordinary" in the claims refers to toothpastes that do not contain the iso-active foaming ingredient, GSK told NAD. The U.K.-based firm added it chose Colgate Total as the control in its study since the product is the leading toothpaste in the U.S. and has foaming action typical in toothpastes.

In its complaint to NAD, Colgate contended that GSK's ads sought to convey the idea that because iso-active generates more foam than ordinary toothpaste, it provides superior bacteria removal from the mouth, which Colgate says is not true.

The challenger added its Colgate Total product was not an appropriate control in the study because the product's triclosan antibacterial ingredient sets it apart from regular fluoride toothpastes on the market, which renders incorrect GSK's claims that iso-active works better than "ordinary" toothpastes.

After reviewing the study design and the claims, NAD sided with Colgate, maintaining Colgate Total was not an appropriate control to represent "ordinary" toothpastes.

The watchdog group noted Colgate Total is the only toothpaste approved and accepted by both FDA and the American Dental Association for prevention of plaque and gingivitis, and therefore is set apart from other toothpastes on the market.

NAD noted Colgate Total works by immediately killing bacteria in the mouth and continuing to kill bacteria after brushing, though the study design only looked at the number of live bacteria captured.

Additionally, NAD maintained consumers would perceive the "ordinary" toothpastes to refer to traditional fluoride-containing toothpastes, versus GSK's contention that "ordinary" would convey products without iso-active foaming action.

That consumer takeaway supports Colgate's position that its Total formula - which is not a traditional fluoride paste - cannot represent "ordinary" products.

The watchdog group stressed its well-established position that an advertiser is responsible for all reasonable interpretations of its claims, and not simply the messages it wishes to convey.

NAD contended that because the Glaxo did not use an ordinary toothpaste in the study, among other flaws, it should discontinue the "removes 3x more bacteria" claim, among others.

Study Flaw: Apples To Oranges Comparison

GSK's advertising claims were based on several stuides including its "Bosma Study," a blinded, randomized clinical study of 34 subjects, in which iso-active demonstrated statistically significant superior removal of bacteria compared to Colgate Total, with the product removing 3.28 times as many bacteria as the control.

In the iso-active-supporting studies, subjects brushing with either an isopentane toothpaste or the control spat twice - after 30 seconds and again after 60 seconds of brushing - into a container, and then rinsed with sterile water before spitting a third time into the same container.

The analysis consisted of measuring the live bacteria and amount of oral debris in the expectorated samples.

GSK maintained it accounted for the triclosan in Colgate Total by neutralizing its antibacterial properties - as well as those produced by sodium lauryl sulfate, a wetting agent used in both formulas and in other toothpastes that lowers the surface tension of a liquid - during the first minute and 40 seconds, thus rendering Colgate Total like any "ordinary" toothpaste. Therefore, the advertiser maintained that it evened the playing field for the products in the study.

The long-lasting antibacterial effects of Colgate Total in the study, GSK maintained, were irrelevant, since the Aquafresh ads are not making a sustained benefit claim.

However, NAD disagreed. Despite GSK's efforts to neutralize the early antimicrobial action of the toothpaste, the firm's choice of Colgate Total in the study was simply an "inappropriate" one.

"Rather than attempting to work around (or control for) this confounding factor, it could easily have been removed from the equation entirely by using an 'ordinary' fluoride toothpaste - without an antibacterial agent - which would far more reliably have demonstrated any comparative benefit of its Aquafresh iso-active versus 'ordinary' toothpaste," NAD said.

The watchdog group also was critical of the study's focus on live bacteria since triclosan in the challenger's product could have killed a large percentage of bacteria before removal from the mouth, though that number was never measured.

"The control sample may have contained significant numbers of dead bacteria (attributable to triclosan's antibacterial effects), which, given the conflicting evidence, may or may not have commenced during brushing and continued to kill bacteria in the expectorated samples prior to analysis," NAD said.

In the context of the claims, consumers would be unlikely to draw a distinction between bacteria removal and bacteria killed, thus giving an unfair advantage in consumer perception to the GSK product.

NAD also concluded that other language in the ads - such as "Healthy Gums. Strong Teeth. Fresh Breath." conveys a "reasonable, but unsupported" message of sustained oral care benefits, though there is no evidence in the record showing that bacteria removed from the mouth within the first two minutes of brushing confers a sustained benefit.

In response to NAD's decision, GSK said it disagrees, but will take the recommendations into consideration in future advertising.

- Eileen Francis ( ² [email protected] )