NARB Panel Recommends Bayer Modify, Discontinue Certain Claims for Claritin-D

New York, NY – Oct. 28, 2015  – A five-member panel of the National Advertising Review Board (NARB) has recommended that Bayer HealthCare, LLC  discontinue the advertising claim that nothing works faster than Claritin-D and qualify the claim that Claritin-D starts to work on allergies in 30 minutes.

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

Advertising claims made by Bayer for Claritin and Claritin-D were initially challenged by Chattem, Inc., the maker of competing allergy medications Nasacort and Allegra, before the National Advertising Division (NAD) an investigative unit of the advertising industry’s system of self-regulation.

The challenged claims included the following express claims:

  • “Claritin-D … starts to work on allergies in 30 minutes.”
  • “Nothing works faster than Claritin-D.”

The NAD determined that Bayer did not provide a reasonable basis to support its claim that “Nothing works faster than Claritin-D,” and recommended that the claim be discontinued. Bayer appealed that determination to the NARB. NAD also determined that Bayer provided a reasonable basis for its claim that Claritin-D starts to work on allergies in 30 minutes. Chattem appealed that finding to NARB.

In support of its claim that Claritin-D starts to work on allergies in 30 minutes, Bayer provided a study that tested 593 subjects in five different outdoor parks. All test participants were pre-screened for sensitivity to the pollen present at the test sites. The study included three randomized, double-blinded groups – a group that was given Claritin-D, a group that was given another drug that is no longer available in the United States, and a placebo group. Individual allergy symptom scores were measured at 15 minute intervals for the first two hours after dosing, and the total symptom score was evaluated for each measurement interval.

The panel noted in its decision that the study was reliable and well-conducted. However, following its review, the panel found that given the variability in the study’s findings with respect to the effectiveness of Claritin-D at study sites with higher levels of pollen, and the fact that the study was the sole support relied on by Bayer for its 30-minute onset of action claim for Claritin-D, an unqualified “starts to work on allergies in 30 minutes” claim was not reasonably supported. The panel recommended that Bayer qualify any onset of action claim to avoid conveying the unsupported message that Claritin-D will start to work for all consumers within the first 30 minutes.  For example, the panel noted, Bayer could qualify the claim by stating that Claritin starts to work on allergies “in as little as” 30 minutes.

Bayer submitted multiple tests in support of its “nothing works faster” claim, including tests that examined the onset of action time for competing products. The panel noted, however, that such claims are best supported by head-to-head testing against at least 85 percent of the relevant marketplace.  The advertiser has the burden of providing a reasonable basis, through competent and reliable scientific evidence, to support a “nothing works faster” claim as made in the challenged advertising. The panel found that Bayer did not meet its burden in this case.

Bayer took issue with certain of NARB’s findings, but said in its advertiser’s statement that it “supports the self-regulatory process and is therefore willing to comply with the NARB decision on this point.”

 

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