ACT Dry Mouth 'Immediate,' 'Moisturizing,' 'Lubricating' Claims OK In Review Appeal
Executive Summary
Council of Better Business Bureaus' advertising review appeals panel says Sanofi didn't support claiming ACT Dry Mouth Lozenges "are uniquely formulated to stimulate saliva flow” because no evidence supported uniqueness. On review of initial findings from August 2018 on GSK challenge, which markets Biotene dry mouth products, panel considered appeals by both firms.
Neither Sanofi nor GlaxoSmithKline PLC got results it wanted in the second round of an industry self-regulation review of advertising for Sanofi's ACT Dry Mouth line after disagreeing with the first round's answers.
The Council of Better Business Bureaus' National Advertising Review Board said in a June 13 report that Sanofi did not support claiming ACT Dry Mouth Lozenges "are uniquely formulated to stimulate saliva flow” because no evidence the firm provided supported uniqueness.
Additionally, NARB agreed with the CBBB's National Advertising Division finding, published in August 2018 following a review on a challenge by GSK, that Sanofi's data and other evidence did not support a “long-lasting relief” claim for ACT Dry Mouth Mouthwash. However, NARB reported that it "did not share NAD’s concerns regarding an 'immediate' claim."
The panel of industry, legal and academic professionals accepted Sanofi's ingredient analysis as proper substantiation for the claim and said it was not disputed that a mouthwash formulated with the goal of addressing dry mouth would provide an immediate benefit to users.
NARB also upheld Sanofi's appeal of NAD's finding that the firm did not substantiate claiming ACT Dry Mouth Mouthwash “soothes dry mouth.” The panel, which CBBB appoints to consider arguments from firms advertising consumer products that object to findings by NAD or the Electronic Retailing Self-Regulation Program, said the French firm supported the claim.
GSK’s appeal to NARB was on NAD's finding that Sanofi supported the ACT Dry Mouth Mouthwash claim “relieve dry mouth symptoms by moisturizing and lubricating dry oral tissue.” The panel said it arrived at the same conclusion as NAD but through different reasoning – after NAD found Sanofi's clinical study substantiated moisture-related claims, NARB found the firm's ingredient analysis provided proper support.
Sanofi, represented by its US consumer health business which markets the ACT brand, Chattem Inc. advised the panel that it was willing to withdraw the reference to “uniquely” in the formulation claim for ACT Dry Mouth Lozenges.
Sanofi appealed NAD's finding that its evidence did not support claims that ACT Dry Mouth mouthwash “provides immediate, long-lasting relief” and “soothes dry mouth” in addition to the lozenges being uniquely formulated to stimulate saliva flow and soothe and moisturize dry mouth.
GSK challenged Sanofi's ACT Dry Mouth claims because the UK firm markets the Biotene dry mouth oral care line. Biodene has pre-market medical device approval from FDA for an indication of lubricating and coating the interior of the mouth and gums with moisture, helping alleviate even severe symptoms of dry mouth. (Also see "ACT Dry Mouth Claims Get Parched In Industry Self-Regulation Review " - HBW Insight, 23 Aug, 2018.)
However, the ACT Dry Mouth line, like other ACT brand products, is marketed under an OTC drug monograph for products indicated to help prevent cavities. Dry mouth, though, is not a monograph indication.
GSK challenged ad claims for all four ACT Dry Mouth formats: toothpaste, mouthwash, lozenges and spray/rinse. The appeals to NARB were limited to the mouthwash and lozenge products.
Glaxo also challenged Triumph Pharmaceuticals Inc.'s SmartMouth Dry Mouth Oral Rinse advertising in a 2018 NAD review that led to Triumph withdrawing contested claims. However, as NAD concluded for ACT Dry Mouth, it did not recommend that Triumph change the product's name as it did not constitute a misleading claim. (Also see "Consumer Health Ad Claim Reviews: NutriO2, SmartMouth, Active Iron" - HBW Insight, 14 Jun, 2018.)
Firms using ad claims subject to NAD and ERSP reviews rarely outright agree with recommendations that counter their arguments. While most simply state they do not agree but will comply with the recommendations, some appeal the conclusions to NARB.
CBBB's advertising review recommendations are not binding but are forwarded to the Federal Trade Commission if firms refuse to comply. FTC says it prioritizes investigating ad claims identified by CBBB's divisions, and also expects that firms linked to those ads will reconsider and cooperate in industry self-regulation rather than potentially face more costly litigation brought on by a commission complaint. (Also see "Prestige Brands Stands By Nix Lice 'Kill' Claims Despite NAD Objection" - Pink Sheet, 10 Apr, 2017.)