BBB National Programs Archive

NARB PANEL RECOMMENDS NOVARTIS DISCONTINUE CLAIMS THAT EXCEDRIN STARTS RELIEVING HEADACHE PAIN FASTER THAN ADVIL Claims at Issue Challenged by Pfizer Consumer Healthcare

New York, New York – Jan. 24,  2012 – A National Advertising Review Board (NARB) panel has recommended that Novartis Consumer Health, Inc., discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil. The claims at issue were initially challenged before the National Advertising Division (NAD) of the Council of Better Business Bureaus by Pfizer Consumer Healthcare, the maker of
Advil.

NAD determined that Novartis did not provide a reasonable basis to support claims that Excedrin starts to relieve headache pain faster than Advil. NAD recommended that the challenged claims be discontinued. Novartis appealed NAD’s findings to the NARB. The challenged advertising appeared in television,  website and in-store shelf display
advertising and included the following claims:

  • “Excedrin starts relieving headaches faster than extra strength Tylenol and Advil.”
  • “Excedrin Extra Strength starts RELIEVING HEADACHE PAIN FASTER than … Advil*”
    • *“Based on clinical trials of Excedrin Extra Strength Tablets versus Advil tablets.”
  • “Excedrin Extra Strength starts RELIEVING HEADACHE PAIN FASTER than the top two pain reliever brands*”
    • “Based on clinical trials versus Advil tablets”.
  • Pfizer argued that the challenged advertising conveyed to consumers the following
  • messages:
    • Excedrin tablets start relieving headache pain faster than Advil tablets – a tablet-to-tablet claim.
    • All Excedrin products start relieving headache pain faster than all Advil products – a product line claim.

NARB noted in its decision that when efficacy claims are made for pain-relief medication, “those claims must be supported by at least one adequate and well-controlled scientific study that measures efficacy in treating the type of pain for which efficacy is claimed, e.g., substantiation for claims involving relief of tension headache pain should include at least one scientific study that evaluates efficacy in treating tension headache pain.”

In this case, the advertiser offered as support for its claims studies related to migraine and dental pain, as well as one study – the “201” study – which evaluated speed of relief in treating tension headaches.

The panel noted that the 201 study focused on the following “four analgesic variables”
during the first hour after ingestion of the test medication:

  • Time to at least half relieved pain
  • Time to complete pain relief
  • Weighted sum of pain intensity difference scores • Time to meaningful pain relief

The study found no statistically significant differences between subjects who received Excedrin and subjects who received Advil with respect to the first three variables. While a statistically significant difference of 5.1 minutes was arguably found in looking at median time to achieve meaningful pain relief within the first hour, no statistically significant differences were found at any of the 10 minute measurements except for the 40 minute
measurement.

Following its review, the panel determined that the study’s results did not provide a reasonable basis for the general onset superiority  claims and recommended that Novartis discontinue the challenged claims that Excedrin starts relieving headache pain faster than Advil.

Novartis, in its advertiser’s statement, said the company “disagrees with the NAD and NARB conclusions regarding the scientific substantiation in issue, but will comply with the recommendations made. Novartis Consumer Health, Inc. supports, and appreciates the opportunity to participate in, the self-regulatory process.”
 
 
NAD’s inquiry was conducted under NAD/CARU/NARB Procedures for the Voluntary Self-Regulation of National Advertising.  Details of the initial inquiry, NAD’s decision, and the advertiser’s response will be included in the next NAD/CARU Case Report.

About Advertising Industry Self-Regulation: The National Advertising Review Council (NARC) was formed in 1971. NARC establishes the policies and procedures for the National Advertising Division (NAD) of the Council of Better Business Bureaus, the CBBB’s Children’s Advertising Review Unit (CARU), the National Advertising Review Board (NARB) and the Electronic Retailing Self-Regulation Program (ERSP).

The NARC Board of Directors is composed of representatives of the American Advertising Federation, Inc. (AAF), American Association of Advertising Agencies, Inc., (AAAA), the Association of National Advertisers, Inc. (ANA), Council of Better Business Bureaus, Inc. (CBBB), Direct Marketing Association (DMA), Electronic Retailing Association (ERA) and Interactive Advertising Bureau (IAB).  Its purpose is to foster truth and accuracy in national advertising through voluntary self-regulation.

NAD, CARU and ERSP are the investigative arms of the advertising industry’s voluntary self-regulation program. Their casework results from competitive challenges  from other advertisers, and also from self-monitoring traditional and new media. NARB, the appeals body, is a peer group from which ad-hoc panels are selected to adjudicate NAD/CARU cases that are not resolved at the NAD/CARU level. This unique, self-regulatory system is funded entirely by the business community; CARU is  financed by the children’s advertising industry, while NAD/NARC/NARB’s primary source of funding is derived from membership fees paid to the CBBB. ERSP’s funding is derived from membership in the Electronic Retailing Association. For more information about advertising industry self-regulation, please visit www.narcpartners.org.