NAD Recommends Chattem Discontinue Certain Claims for ACT ‘Dry Mouth’ Products, Finds Certain Claims Supported; Chattem, GSK to Appeal

New York, NY – Aug. 22, 2018 – The National Advertising Division has recommended that Chattem, Inc., manufacturer of the ACT brand of oral care products, discontinue certain advertising claims for the company’s ACT “Dry Mouth” products, including claims that ACT Dry Mouth Mouthwash “provides immediate, long-lasting relief” and “soothes dry mouth” and that ACT Dry Mouth Lozenges are uniquely formulated to stimulate saliva flow and soothe and moisturize dry mouth. Chattem said it will appeal those findings.

NAD also determined that the advertiser could support the claim “Moisturizes Dry Mouth” for its mouthwash product, a finding that GSK will cross-appeal.

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

The claims at issue were challenged before NAD by GlaxoSmithKline Consumer Healthcare, L.P., the manufacturer of competing Biotene brand oral care products.

As NAD noted in its decision, both Chattem and GSK manufacture products intended to help consumers who experience “dry mouth,” a broad term that can refer to a wide range of symptoms including fleeting dryness associated with eating salty foods or drinking alcohol, but also sustained oral dryness caused by prescription medications or chronic disease. More advanced symptoms can lead to serious health problems such as difficulty tasting or chewing, oral discomfort, and increased chance of tooth decay or infection.

The challenger’s Biotene products are marketed as “saliva substitutes” – products that are categorized as medical devices by Food and Drug Administration (FDA) and require FDA pre-market authorization. GSK challenged claims by Chattem that ACT Dry Mouth products relieve dry mouth and provide “soothing” comfort, “moisturizing” benefits, and protection from a “constant dry feeling.”

NAD, in its decision, said the advertiser does not market ACT Dry Mouth products as “saliva substitutes.” Chattem asserted that the claimed benefits are different than those that would require the products to be marketed as a “saliva substitute” and contended that they are fully substantiated.

At the outset of this dispute, the advertiser informed NAD in writing that it either had or will permanently discontinue challenged claims that include:

  • “ACT Dry Mouth Toothpaste provides an oral care solution that delivers the soothing moisturization you need, plus it helps protect from the harmful effects of dry mouth;”
  • “With a soothing mint flavor, alcohol free ACT Total Care Dry Mouth Rinse does more than other dry mouth formulas. Did you know that dry mouth affects 10% of all adults and 25% of those over 65;”
  • “ACT Dry Mouth Lozenges are uniquely formulated to stimulate saliva flow and fight the harmful effects of dry mouth;”
  • ACT Dry Mouth Spray with Xylitol is “Specially formulated to help relieve dry mouth [and] helps fight the harmful effects of dry mouth, including cavities, bad breath, and the constant dry feeling;”
  • “ACT Dry Mouth: Relief When You Need It;”
  • “ACT Dry Mouth Regimen. Dry Mouth Symptom Relief;”
  • “ACT Dry Mouth Regimen. Symptom Relief at Home and On the Go;” and
  • “ACT Dry Mouth Relief Complete Regimen. All products are formulated to aid in the treatment of dry mouth.”

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.

The advertiser identified three challenged claims for its ACT Dry Mouth Spray with Xylitol that were made without its direction by third party retailers that it did not disseminate itself. The advertiser stated that it notified third party retailers about the three claims:

  • “Specially formulated to help relieve dry mouth;”
  • Helps fight the harmful effects of dry mouth, including cavities, bad breath, and the constant dry feeling;” and
  • “Formulated with Optaflow and xylitol to help soothe, moisturize, and refresh dry mouth.”

Following its review of the evidence in the record, NAD recommended that Chattem discontinue claims that ACT Dry Mouth Mouthwash “provides immediate, long-lasting relief” and “soothes dry mouth.” NAD noted that a mouthwash study presented by the advertiser could support claims that the rinse “moisturizes dry mouth,” “effectively moisturizes and lubricates the mouth,” and “coat[s] oral tissues and lock[s] in moisture.”

NAD recommended that the advertiser discontinue the claims that ACT Dry Mouth Toothpaste “provides the soothing moisturization you need [and] helps protect from the harmful effects of dry mouth, including … the constant dry feeling,” “helps moisturize and soothe oral tissues,” “contains an Intensive Moisturizing System that moisturizes oral tissues,” “soothes dry mouth,” “moisturizes mouth tissue,” and provides “soothing dry mouth symptom relief.”  NAD noted that nothing in this decision prevents the advertiser from stating the ingredients in its product or making other claims appropriate for a non-irritating fluoride-based toothpaste.

NAD recommended the advertiser discontinue its claims that ACT Dry Mouth Lozenges “stimulate saliva flow and fight the harmful effects of dry mouth,” and that the product soothes and moisturizes dry mouth. NAD noted that nothing in the decision prevents the advertiser from promoting the more general benefits described by FDA and leading oral health organizations that sugarless sucking candy or wetting the mouth may provide or from making truthful claims related to the product’s formulation or ingredients.

NAD recommended the advertiser discontinue its claims that ACT Dry Mouth Spray “soothe[s], moisturize[s], and refresh[es] dry mouth” and that it “starts working instantly,” but noted that nothing in its decision prevents the advertiser from stating the ingredients in its product.

NAD declined to recommend that the product names be discontinued.

Chattem, in its advertiser statement, said the company would appeal certain recommendations.

“Chattem appeals,” the company said, “because it believes NAD’s analysis in this matter, and in prior proceedings … is inconsistent with NAD’s reasonable basis (and not perfection) standard. Chattem also appeals because it believes NAD’s findings are not well harmonized” with FDA clearance of a separate company’s claims for dry mouth products.

Chattem said it would comply with NAD’s decision regarding the company’s toothpaste and spray products.

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.