NAD Recommends Triumph Pharmaceuticals Discontinue Certain Claims for SmartMouth Dry Mouth Products Following a Challenge from GSK

New York, NY – June 13, 2018 – The National Advertising Division has recommended that Triumph Pharmaceuticals, Inc., discontinue challenged claims for the company’s SmartMouth Dry Mouth Products. NAD did not, however, recommend that Triumph change the name of its dry mouth products.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

Triumph’s claims were challenged by GlaxoSmithKline Healthcare, L.P., the maker of Biotene products.

Both parties manufacture over-the-counter products intended to help relieve the symptoms of “dry mouth.” However, the advertiser’s SmartMouth Dry Mouth Oral Rinse is marketed as a cosmetic while the challenger’s Biotene products are marketed as “saliva substitutes,” and are categorized as medical devices by Food and Drug Administration (FDA). The challenger asserted that its Biotene artificial saliva products have been the subject of several clinical trials confirming their efficacy. GSK maintained that the advertiser seeks to claim the same benefits for the same consumers without going through the same process.

“Dry mouth,” as NAD noted in its decision, is a broad term that can refer to a wide range of symptoms including fleeting dryness associated with eating salty foods or drinking alcohol, or sustained oral dryness caused by prescription medications or chronic disease.

At the outset of NAD’s review, the advertiser informed NAD in writing that it will permanently discontinue a number of the challenged claims, including

  • “Never have dry mouth. Never have bad breath”
  • “SmartMouth rinse and mints work together to eliminate and prevent” dry mouth
  • “SmartMouth … gets rid of dry mouth”
  • “Regularly using this rinse will help prevent tooth decay by stopping dry mouth early on”
  • “eliminates dry mouth,” [for SmartMouth Dry Mouth Oral Rinse]
  • “eliminates dry mouth,” [for SmartMouth Dry Mouth Mints]
  • “clinically proven to eliminate unpleasant dry mouth”
  • “eliminates [dry mouth] instantly”
  • “eliminates [dry mouth … at once”
  • “provides instant relief for dry mouth”
  • “stop dry mouth”
  • “NEW”

In reliance on the advertiser’s representation that the claims have been permanently discontinued, NAD did not review the claims on their merits. The voluntarily discontinued claims will be treated, for compliance purposes, as though NAD recommended their discontinuance and the advertiser agreed to comply.

Turning to the remaining challenged claims, NAD recommended that the advertiser discontinue dry mouth efficacy claims, including claims that SmartMouth Dry Mouth Oral Rinse “soothes and moisturizes,” provides “dry mouth relief,” and that its SmartMouth Dry Mouth Mints provide “soothing moisture for a dry mouth.” NAD noted nothing in its decision prevents the advertiser from promoting the more general benefits, like those provided by sucking sugarless candy or wetting the mouth, that its product may provide to a subset of dry mouth sufferers.

NAD determined that the advertiser did not support its claims that SmartMouth Dry Mouth has “24-hour bad breath prevention,” “prevent[s] the return of bad breath for 12 full hours,” is “the only dry mouth rinse that relieves bad breath for 12 hours with only one use,” “prevents sulfur gas from returning for 12 hours with each rinse in dry mouth sufferers,” and “PM Rinse—Eliminates Morning Breath,” and recommended the claims be discontinued. Nothing in its decision, NAD noted, prevents the advertiser from promoting its mechanism of action for freshening breath or generally marketing its Dry Mouth product as “breath freshening.”

In the absence of extrinsic evidence in the record that the product name is misleading, NAD declined to recommend that the use of the term “Dry Mouth” in the product names be discontinued. NAD noted that the terms “Rehydrating,” “Moisture-Lock Technology,” and “Moisturizing [in the context of the SmartMouth Dry Mouth Mints name], expressly convey to consumers that the products are efficacious at relieving dry mouth symptoms. Accordingly, NAD recommended that the claims be discontinued.

Triumph, in its advertiser’s statement, said that “until further data is developed to support new claims, including 510(k) clearance from the FDA, Triumph will, in a commercially reasonable timeframe, discontinue the use of the more specific dry mouth statements referenced in NAD’s recommendations.”

Note A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.