NAD Recommends Dr. Harold Katz Discontinue Health-Performance Claims for Therabreath Rinse, Lozenges; Company to Appeal

New York, NY – Jan. 8, 2018 – The National Advertising Division has recommended Dr. Harold Katz, LLC, discontinue certain advertising claims for the company’s Therabreath Dry Mouth Treatment products, including claims that the products “relieve” or “fight” dry mouth symptoms. The company said it will appeal NAD’s adverse findings to the National Advertising Review Board.

NAD is an investigative unit of the advertising industry’s system of self-regulation and 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.

At the outset of NAD’s inquiry, the advertiser informed NAD that it would permanently discontinue a number of the challenged claims and modify others and would only make dry mouth related claims for two products: TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges.

Further, the advertiser said it would discontinue “clinically proven” claims and the claims “stops dry mouth” and “reverses dry mouth,” and modify claims other claims to more clearly focus on symptom relief.  NAD noted in its decision that the discontinued claims will be treated for compliance purposes as though NAD recommended their discontinuance or modification and the advertiser agreed to comply.

Turning its attention to the remaining and modified dry mouth-related claims, NAD reviewed the following claims made by the advertiser on its Oral Rinse packaging:

  • “Helps to sooth and moisturize a dry mouth”
  • “natural salivary enhancer”
  • “[created to] help patients with discomfort associated with dry mouth”
  • “Specially formulated with soothing natural enzymes and a gentle, plant-derived mouth-watering natural salivary enhancer that tingles and quickly moisturizes the mouth that releases saliva in the mouth”
  • “This professional formula helps quickly moisturize the mouth with soothing natural enzymes and a gentle plant-derived mouth-watering natural salivary enhancer that releases saliva into the mouth”
  • “Dentist Developed [or Dentist Formulated]”
  • “Satisfaction Guaranteed or Your Money Back.”

NAD also considered the following claims, made on packaging for the advertiser’s lozenges:

  • “Helps relieve dry mouth symptoms”
  • “natural salivary enhancer
  • ” “Helps revive natural mouth moisture”
  • “Contains a gentle plant-derived mouth-watering natural salivary enhancer that tinges and moisturizes the mouth”
  • “Dentist Developed [or Dentist Formulated]”
  • “Satisfaction Guaranteed or Your Money Back.”

The advertiser in this case relied primarily on consumer-use surveys and studies on certain ingredients as support for its health-performance claims. NAD took issue with certain features of the consumer-use surveys, including a failure to properly determine whether survey respondents displayed symptoms of dry mouth. NAD determined the advertiser did not submit sufficient evidence that the products at issue in the ingredient studies it provided had active ingredients in the same dosage and formulation as TheraBreath products.

Following its review, NAD determined that the evidence in the record was sufficient to support the advertiser’s “Dentist Developed [or Formulated]” and “Satisfaction Guaranteed or Your Money Back” claims.

NAD recommended the advertiser discontinue the remaining challenged health-performance claims.

In its advertiser’s statement, the company noted that its “strongly disagrees with the NAD’s adverse findings and conclusions … with regard to the symptoms relief claims made for the TheraBreath Dry Mouth Oral Rinse and Lozenges. Katz believes the substantiation analysis in the decision rests on a faulty legal premise and is conceptually incorrect, particularly its finding that the appropriate level of evidence required to substantiate health claims ‘generally means randomized, placebo-controlled studies on human beings that reach statistical significance and also yield clinically meaningful results.’”

While Katz “certainly respects the NAD’s authority and views, it intends to appeal the decision,” the company said.

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.