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NARB Finds Supported the Claims that Aleve is “Proven Better On Pain” than Tylenol Extra Strength For First Six Hours After Ingestion

For Immediate Release
Contact: Saveeta Dhanai, NARB Coordinator, 212.705.0115 / sdhanai@bbbnp.org

 

New York, NY – April 6, 2020 – A panel of the National Advertising Review Board (“NARB”) has determined that Bayer Healthcare LLC has properly supported the claims that Aleve is “Proven Better on Pain than Tylenol Extra Strength” and “Proven Better on Pain than Tylenol,” but has recommended that the advertiser modify such claims by adding a clear and conspicuous disclosure that the asserted pain-relief superiority is based on clinical data from the first six hours after initial dosing. 


NARB is the appellate unit of the advertising industry’s system of self-regulation. The advertising at issue had been challenged by Johnson & Johnson Consumer Inc., the maker of Tylenol products, before the National Advertising Division (“NAD”).  NAD is an investigative unit of the advertising industry’s system of self-regulation.  Following NAD’s decision, Bayer appealed NAD’s findings. 

The active ingredients in Aleve and Tylenol are naproxen sodium and acetaminophen, respectively. Aleve and Tylenol have different dosing regimens, but both products are labeled for the same over-the-counter indications of use.

In support of Bayer’s strong comparative superiority “establishment” claims, it relied on the data generated in six clinical trials. Four of these tested Aleve head-to-head with Tylenol Extra Strength – three dental pain studies from the early 1990s and one recently conducted cross-over menstrual pain study. In addition, Aleve was evaluated against Tylenol 8HR Arthritis Pain (a time-release version of regular-strength Tylenol) in two studies, one dental pain and one menstrual pain.  The NARB panel noted that there was no dispute that all of Bayer’s clinical studies were well designed and properly executed. Rather, the dispute centered on whether the data generated in those studies support the Bayer pain-relief superiority claims set forth in the challenged advertising.

After closely evaluating Bayer’s evidence, the NARB panel concluded that Bayer provided reasonable, competent and reliable scientific support for the pain-relief superiority of Aleve compared to Tylenol Extra Strength (and consequently, the lower dose regular-strength Tylenol), for the first six hours after an initial dose. 

However, the NARB panel expressed concern that as currently stated, the two challenged claims are potentially misleading to consumers. The panel noted that for some consumers re-medication with Tylenol Extra Strength at six hours reflects real-world usage, but there was no such re-medication in the clinicals comparing Aleve with Tylenol Extra Strength. Nor did either party offer evidence considering the incidence of re-dosing by Tylenol Extra Strength users at that point. Therefore, the panel recommended that the advertiser modify the two challenged claims with a clear and conspicuous disclosure that the asserted pain-relief superiority is based on clinical data from the first six hours after initial dosing.

Bayer stated that it “will comply with the NARB’s recommendation” and that it “appreciates the NARB’s consideration of its advertising, respects the NAD, and supports the self-regulatory review process.”

###

About the National Advertising Review Board (NARB): NARB is the appellate body for advertising industry self-regulation. NARB’s membership is composed of 87 professionals from three different categories: national advertisers (49 members), advertising agencies (26 members), and public members (12) made up of academics and former members of the public sector. 

About BBB National Programs: BBB National Programs (BBB NP) fosters trust, innovation, and competition in the marketplace through the development and delivery of cost-effective, third-party self-regulation, dispute resolution and other programs. The programs were formerly administered by the Council of Better Business Bureaus. BBB NP is the home of industry self-regulatory and dispute resolution programs that include the National Advertising Division (NAD), National Advertising Review Board (NARB), BBB EU Privacy Shield, BBB AUTO LINE, Children’s Advertising Review Unit (CARU), Children’s Food and Beverage Advertising Initiative (CFBAI), Children’s Confection Advertising Initiative (CCAI), Direct Selling Self-Regulatory Council (DSSRC), Digital Advertising Accountability Program (Accountability Program), and the Coalition for Better Advertising Dispute Resolution Program (CBA DRM). The programs are designed to resolve business issues and advance shared objectives by responding to marketplace concerns to create a better customer experience. To learn more about industry self-regulation, please visit: BBBNP.org. 

 

NARB Finds Supported the Claims that Aleve is “Proven Better On Pain” than Tylenol Extra Strength For First Six Hours After Ingestion

For Immediate Release
Contact: Saveeta Dhanai, NARB Coordinator, 212.705.0115 / sdhanai@bbbnp.org

 

New York, NY – April 6, 2020 – A panel of the National Advertising Review Board (“NARB”) has determined that Bayer Healthcare LLC has properly supported the claims that Aleve is “Proven Better on Pain than Tylenol Extra Strength” and “Proven Better on Pain than Tylenol,” but has recommended that the advertiser modify such claims by adding a clear and conspicuous disclosure that the asserted pain-relief superiority is based on clinical data from the first six hours after initial dosing. 


NARB is the appellate unit of the advertising industry’s system of self-regulation. The advertising at issue had been challenged by Johnson & Johnson Consumer Inc., the maker of Tylenol products, before the National Advertising Division (“NAD”).  NAD is an investigative unit of the advertising industry’s system of self-regulation.  Following NAD’s decision, Bayer appealed NAD’s findings. 

The active ingredients in Aleve and Tylenol are naproxen sodium and acetaminophen, respectively. Aleve and Tylenol have different dosing regimens, but both products are labeled for the same over-the-counter indications of use.

In support of Bayer’s strong comparative superiority “establishment” claims, it relied on the data generated in six clinical trials. Four of these tested Aleve head-to-head with Tylenol Extra Strength – three dental pain studies from the early 1990s and one recently conducted cross-over menstrual pain study. In addition, Aleve was evaluated against Tylenol 8HR Arthritis Pain (a time-release version of regular-strength Tylenol) in two studies, one dental pain and one menstrual pain.  The NARB panel noted that there was no dispute that all of Bayer’s clinical studies were well designed and properly executed. Rather, the dispute centered on whether the data generated in those studies support the Bayer pain-relief superiority claims set forth in the challenged advertising.

After closely evaluating Bayer’s evidence, the NARB panel concluded that Bayer provided reasonable, competent and reliable scientific support for the pain-relief superiority of Aleve compared to Tylenol Extra Strength (and consequently, the lower dose regular-strength Tylenol), for the first six hours after an initial dose. 

However, the NARB panel expressed concern that as currently stated, the two challenged claims are potentially misleading to consumers. The panel noted that for some consumers re-medication with Tylenol Extra Strength at six hours reflects real-world usage, but there was no such re-medication in the clinicals comparing Aleve with Tylenol Extra Strength. Nor did either party offer evidence considering the incidence of re-dosing by Tylenol Extra Strength users at that point. Therefore, the panel recommended that the advertiser modify the two challenged claims with a clear and conspicuous disclosure that the asserted pain-relief superiority is based on clinical data from the first six hours after initial dosing.

Bayer stated that it “will comply with the NARB’s recommendation” and that it “appreciates the NARB’s consideration of its advertising, respects the NAD, and supports the self-regulatory review process.”

###

About the National Advertising Review Board (NARB): NARB is the appellate body for advertising industry self-regulation. NARB’s membership is composed of 87 professionals from three different categories: national advertisers (49 members), advertising agencies (26 members), and public members (12) made up of academics and former members of the public sector. 

About BBB National Programs: BBB National Programs (BBB NP) fosters trust, innovation, and competition in the marketplace through the development and delivery of cost-effective, third-party self-regulation, dispute resolution and other programs. The programs were formerly administered by the Council of Better Business Bureaus. BBB NP is the home of industry self-regulatory and dispute resolution programs that include the National Advertising Division (NAD), National Advertising Review Board (NARB), BBB EU Privacy Shield, BBB AUTO LINE, Children’s Advertising Review Unit (CARU), Children’s Food and Beverage Advertising Initiative (CFBAI), Children’s Confection Advertising Initiative (CCAI), Direct Selling Self-Regulatory Council (DSSRC), Digital Advertising Accountability Program (Accountability Program), and the Coalition for Better Advertising Dispute Resolution Program (CBA DRM). The programs are designed to resolve business issues and advance shared objectives by responding to marketplace concerns to create a better customer experience. To learn more about industry self-regulation, please visit: BBBNP.org. 

 

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