The National Advertising Review Board recommended that Bayer HealthCare discontinue two express claims for Claritin-D, finding that the advertiser lacked a reasonable basis to support one of the claims and that the other needed qualification to avoid conveying an unsupported message.

Chattem, the maker of Nasacort and Allegra, challenged two claims made by Bayer for Claritin-D: “Claritin-D … starts to work on allergies in 30 minutes” and “Nothing works faster than Claritin-D.” The National Advertising Division determined that Bayer provided a qualified approval for the onset of action claim, but failed to provide a reasonable basis for the “nothing works faster” claim. Both parties appealed.

The NARB first considered the onset of action claim. In support, Bayer provided a study that tested 593 subjects in five different outdoor parks. The study included three randomized, double-blind groups: a group given Claritin-D, a group given another drug, 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 overall findings at 30 minutes for the combined sites showed statistically significant improvement in total symptom score for the Claritin-D group as compared to the placebo group. But when results for individual sites were analyzed, the Claritin-D group demonstrated statistically significant improvement in total symptom score only at sites with a lower pollen count.

The study was reliable and well-conducted, the NARB said, but did not reasonably support the unqualified “starts to work on allergies in 30 minutes” claim. “Given the variability in [the study’s] findings with respect to the higher and lower pollen sites, and the fact that [the study] is the sole study relied on by Bayer for its 30 minute onset of action claim for Claritin-D, the panel believes that any onset of action claim should be qualified to avoid conveying the unsupported message that Claritin-D will start to work for all consumers within the first 30 minutes.”

Bayer could qualify the claim by stating that Claritin-D starts to work on allergies “in as little as 30 minutes,” the NARB suggested.

Considering the “nothing works faster” claim, the panel found that the advertiser failed to meet its burden to substantiate the claim. Bayer argued that a combination of factors provided support, including the study relied upon for the onset of action claim, the clinical studies establishing the onset of action time for competitor allergy medications at more than 30 minutes, claims by competitor manufacturers as to when their allergy medications start to work, all of which indicated a time greater than 30 minutes, and prior NAD cases evaluating onset of action claims for competitors.

“The panel agrees with the NAD that unsurpassed claims such as ‘nothing works faster’ are best supported by head-to-head testing against at least 85 percent of the relevant marketplace,” the NARB wrote. While other testing and scientific evidence may properly support an unsurpassed claim (such as multiple monadic studies), the multiple tests offered by Bayer were not sufficiently similar to permit a valid comparison with its study.

“The panel agrees with the NAD that manufacturer claims as to when their allergy medications start to work do not reasonably establish that the claimed times represent the fastest onset of action for these medications for purposes of supporting an unsurpassed claim,” the panel said. “Similarly, the panel agrees with the NAD that prior NAD cases which substantiated an onset of action greater than 30 minutes do not reasonably establish that is the fastest onset of action time for those medications.”

It is well established that the advertiser has the burden of providing a reasonable basis to support a “nothing work faster” claim through competent and reliable scientific evidence, the panel wrote. “Bayer has not met its burden in this case,” the NARB concluded.

To read the press release about the decision, click here.

Why it matters: The panel determined that Bayer failed to substantiate either of the challenged claims for Claritin-D. While the study relied upon to support the onset of action claim was reliable and well-conducted, the NARB found the results were not statistically significant enough to support an unqualified claim. As for the “nothing works faster” claim, the panel said the combination of factors put forth by the advertiser—including claims and studies from competitors and prior NAD cases—was insufficient support.