Claims for an allergy medication should be discontinued because they lack the necessary support, the National Advertising Division recently recommended, despite seemingly contrary findings in prior decisions that considered some of the studies at issue.
Bayer Healthcare, the maker of Claritin, challenged Chattem, Inc.’s claims that Xyzal Allergy 24 HR “WORKS TWICE AS FAST AS CLARITIN” and, unlike Claritin, Xyzal provides “relief that starts at hour 1 instead of hour 2.” Bayer argued the claims were false and misleading comparative claims that lacked adequate substantiation.
To support its claims, the advertiser pointed to prior NAD decisions involving Claritin. The self-regulatory body reviewed the same body of evidence in prior cases, Chattem said, and each time reached the same positive conclusion about the length of Claritin’s onset of action.
But the NAD rejected such reliance on prior decisions.
“While it is true that NAD has reviewed numerous studies concerning onset of action in submissions in prior proceedings, it was NAD’s sole task in those cases to determine whether the studies presented were sufficiently reliable to provide a reasonable basis for the case-specific onset of action advertising claims under the factual and procedural circumstances presented in those cases,” the NAD wrote. “To be clear, NAD did not make—and has not made—scientific ‘findings’ or ‘determinations’ as to the conclusiveness of clinical testing concerning the onset of action of Claritin for all purposes, under all circumstances, regardless of the comparative claims made. In each prior case, NAD reviewed specific advertising claims, in context, and whether the evidence offered to support (or dispute) those claims was sufficiently reliable.”
NAD’s prior determinations as to whether the evidence provided a reasonable basis for the claims with respect to Claritin’s onset of action are not controlling as to Chattem’s specific comparative onset of action claims in the current action, the self-regulatory body said.
Alternatively, the advertiser argued that two separate studies—one analyzing Xyzal and a second considering Claritin—when placed side by side, effectively tested the products head to head and supported the challenged claims.
Again, the NAD disagreed. “Head-to-head studies … are those that test two active ingredients and a placebo, simultaneously—i.e., at the same time, at the same facility, with the same technicians, with no room for variance as to the protocols and/or conditions with respect to the treatment of each ingredient,” according to the decision. “While head-to-head testing is not the sole way to provide support for comparative performance claims, the evidence presented must be sufficiently reliable to demonstrate that the advertiser’s claims are supported.”
The NAD did find that two other studies relied on by the advertiser were well-conducted and employed standard methodologies, but concluded that “the evidence provided by the challenger is stronger and more persuasive evidence warranting a different result—that while Xyzal may have a faster onset of action than Claritin, it is not unequivocally or necessarily ‘twice as fast.’ As such, NAD recommended that the advertiser discontinue its quantified claims that: ‘XYZAL WORKS TWICE AS FAST AS CLARITIN’ and that, unlike Claritin, Xyzal provides ‘relief that starts at hour 1 instead of hour 2.’”
To read the NAD’s press release about the decision, click here.
Why it matters: The NAD emphasized that conclusions formed about evidence are limited to the review of specific advertising claims in the context of the cases presented and do not apply under all circumstances.