NAD Recommends Chattem Discontinue ‘Smart’ Design, Formulation Claims for Xyzal Allergy Medication

New York, NY – Jan. 25, 2018 – The National Advertising Division has recommended that Chattem, Inc., the maker of Xyzal Allergy 24HR  medication, discontinue claims that convey the message that the product’s “smart” or “wise” design confers a clinically meaningful benefit compared to Johnson & Johnson Consumer Inc.’s Zyrtec.

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

J&J challenged express claims that included:

• “A Smart Formulation is NOW a Wise OTC Choice for Allergy Sufferers.”
• “Wisely Designed to be Different.”
• “Active enantiomer of Zyrtec with no dextrocetirizine.”
• “See why a Smart Molecule matters.”
• “Delivers Potency With a Smart Design.”
• “Potent proof that not all OTC oral histamines are built the same.”
• “Xyzal is the active enantiomer of Zyrtec, delivering 2x the binding affinity with none of the dextrocetirizine.”
• “2X GREATER BINDING AFFINITY THAN ZYRTEC.”
• “Xyzal contains no dextrocetirizine, which has a 5.5x higher distribution across the blood-brain barrier than levocetirizine.”
• “Xyzal works differently from other oral antihistamines.”
• Xyzal has “Stronger H1 receptor binding” than other OTC oral antihistamines, including Zyrtec.”
• “POTENT H1 BLOCKER.”
• “Xyzal delivers efficacy in a 5mg tablet.”
• “Xyzal Allergy 24HR provides the same relief as Zyrtec, with half the medicine.”

NAD also considered whether the advertising at issue implied that Xyzal offers a product performance benefit over Zyrtec and other OTC oral antihistamines or that Xyzal has the same efficacy as Zyrtec with half the medicine.

The challenged advertisements appear on Chattem’s HCP website and feature the image of an owl in a labcoat, alongside a blackboard, with scientific drawings, a comparison chart and references to various aspects of Xyzal Allergy 24HR’s pharmacological makeup as compared to that of Zyrtec which were characterized as being “wise” and “smart.”

NAD noted in its decision that, “notwithstanding the lighthearted images of the owl in the lab coat and the ‘wise’ references, playing off of the owl,” certain of the challenged claims conveyed the message that “Xyzal is better or more efficacious than Zyrtec because of its pharmacological design.  The use of a ‘wise’ owl and the advertising’s emphasis on a ‘smart design’ help convey the message that Xyzal is superior to Zyrtec in a meaningful way.   Chattem is  not merely informing healthcare providers about the design differences in the products – its advertising  conveys the message that Xyzal is superior to Zyrtec so that healthcare providers will recommend Xyzal Allergy 24HR instead of competing OTC oral antihistamines (including Zyrtec) to their patients.  While advertisers are free to highlight meaningful differences between their product and a competing product, the highlighted differences should be truthful and provide meaningful benefits.”

Following its review of the evidence in the record, NAD recommended that Chattem discontinue the following claims:

• A Smart Formulation is NOW a Wise OTC Choice for Allergy Sufferers”
• “See why a Smart Molecule matters”
• “Delivers Potency With a Smart Design”
• “Potent proof that not all OTC oral antihistamines are built the same.”

NAD further recommended that Chattem discontinue the claims “Xyzal Allergy 24HR provides the same relief as Zyrtec, with half the medicine” and Xyzal has the same efficacy as Zyrtec with half the medicine, but determined that the advertiser provided a reasonable basis to support the stand-alone claim “Xyzal delivers efficacy in a 5mg tablet.”

NAD noted that nothing in its decision prevents the advertiser from stating that Xyzal contains half the medicine of Zyrtec if it is administered to children ages 6-11.

With respect to claims that describe the pharmacological design of the product including claims that “Xyzal is the active enantiomer of Zyrtec, delivering 2x the binding affinity with none of the dextrocetirizine”; “2X GREATER BINDING AFFINITY THAN ZYRTEC”; “Xyzal contains no dextrocetirizine, which has a 5.5x higher distribution across the blood-brain barrier than levocetirizine,” Xyzal has “Stronger H1 receptor binding” than other OTC oral antihistamines, including Zyrtec,” NAD recommended that these claims be modified to avoid conveying a message that the pharmacological design confers a clinically meaningful benefit over Zyrtec.

NAD determined the following challenged claims are monadic product descriptions and were supported:

• “Xyzal works differently from other oral antihistamines”
• “Active enantiomer of Zyrtec with no dextrocetirizine”
• “POTENT H1 BLOCKER”

NAD noted that Chattem can highlight pharmacological differences between oral antihistamines which may cause them to differ from a potential toxicity perspective for individuals in certain risk groups and which may not be included in OTC labeling, but cautioned Chattem to avoid making any express or implied claims about Xyzal – including comparative claims – that are clinically irrelevant.

During the course of the proceeding, Chattem advised NAD in writing that instead of submitting substantiating evidence it had elected to permanently discontinue patient satisfaction claims initially challenged by JJCI. In reliance on the advertiser’s representation that these claims have been permanently discontinued, NAD did not review these 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.

Chattem, in its advertiser’s statement, said the company “agrees to comply with NAD’s recommendations” although it noted that it “disagrees with NAD’s position that health care practitioners or consumers would be misled by Chattem’s other advertising, but, out of respect for NAD, will take the decision into consideration in future advertising.”

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.