National Advertising Review Board Recommends PLx Pharma Either Discontinue or Modify “Clinically Shown” Claim for its Vazalore Aspirin Product

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New York, NY – January 13, 2022 – A panel of the National Advertising Review Board (NARB), the appellate advertising law body of BBB National Programs, has recommended that PLx Pharma Inc. either discontinue use of the claim that Vazalore “is the first liquid-filled aspirin capsule clinically shown to cause fewer ulcers than plain aspirin” or modify it to disclose as part of the main claim that the clinical evidence is based on a seven-day study comparing a 325mg dose of Vazalore to a 325mg dose of immediate release aspirin. 

The advertising at issue, which appeared in a television commercial, had been challenged by Bayer Healthcare, LLC before the National Advertising Division (NAD) as part of NAD’s Fast Track SWIFT expedited challenge process, designed for single-issue advertising cases. Following NAD’s decision (Case No. 7058), PLx Pharma appealed NAD’s recommendations.

There was no dispute that PLx Pharma’s support for its clinically shown claim is based on a study comparing Vazalore 325 against 325mg of immediate release aspirin with results measured after testing for seven days.

After reviewing the challenged advertisements, the NARB panel agreed with the position of NAD and the challenger that the “clinically shown” claim could lead reasonable consumers to interpret it as applying to an 81mg dose of Vazalore as well as a 325mg dose. Further, the panel found that the comparison to “plain aspirin” could reasonably be interpreted by consumers as testing against enteric-coated aspirin, which is an accepted dosage form for aspirin therapy.

The panel also concluded that the current disclosure in the challenged commercial is neither clear nor conspicuous and does not cure the concerns that NAD had with the message. Therefore, the panel further agreed with NAD that additional necessary disclosures should be clearly and conspicuously disclosed as part of the “main message.” 

With respect to the disclaimer that was used in the challenged commercial (“In a clinical study, compared to 325mg immediate release aspirin after seven days of treatment”), the panel concluded that “after seven days of treatment” is ambiguous in that it could convey the unsupported message that the GI benefit continues after seven days.

For these reasons, the panel recommended that the claim that Vazalore “is the first liquid-filled aspirin capsule clinically shown to cause fewer ulcers than plain aspirin” be either discontinued or modified to disclose as part of the main claim that the clinical evidence was based on a seven-day study comparing a 325mg dose of Vazalore to a 325mg dose of immediate release aspirin. 

PLx Pharma stated that “even though it respectfully disagrees with the decision, PLx Pharma will nevertheless modify the disclosure in its television advertising of the study parameters supporting the Vazalore 325 mg clinical study as recommended by NARB.”

All BBB National Programs case decision summaries can be found in the case decision library. For the full text of NAD, NARB, and CARU decisions, subscribe to the online archive.

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About BBB National Programs: BBB National Programs is where businesses turn to enhance consumer trust and consumers are heard. The non-profit organization creates a fairer playing field for businesses and a better experience for consumers through the development and delivery of effective third-party accountability and dispute resolution programs. Embracing its role as an independent organization since the restructuring of the Council of Better Business Bureaus in June 2019, BBB National Programs today oversees more than a dozen leading national industry self-regulation programs, and continues to evolve its work and grow its impact by providing business guidance and fostering best practices in arenas such as advertising, child-directed marketing, and privacy. To learn more, visit bbbprograms.org.

About the National Advertising Review Board (NARB): The National Advertising Review Board (NARB) is the appellate body for BBB National Programs’ advertising self-regulatory programs. NARB’s panel members include 85 distinguished volunteer professionals from the national advertising industry, agencies, and public members, such as academics and former members of the public sector. NARB serves as a layer of independent industry peer review that helps engender trust and compliance in NAD, CARU, and DSSRC matters.