National Advertising Division Refers Advertising for PLx Pharma's Vazalore to FTC After Compliance Review

NEW YORK, Dec. 22, 2021 /PRNewswire/ -- The National Advertising Division (NAD) of BBB National Programs has referred advertising claims made by PLx Pharma, Inc. to the Federal Trade Commission (FTC) for review and possible enforcement action after the company declined to accept NAD's recommendations to modify certain claims for its Vazalore immediate-release aspirin product.

In Case #6912, NAD recommended, among other things, that PLx Pharma:

• Modify the claim "Vazalore has up to 5X greater absorption than enteric coated aspirin" to avoid conveying the message that the claimed difference in absorption related to superior clinical efficacy and disclose that the reported results were limited to diabetic, obese subjects.
• Discontinue the claim "The Miracles of Aspirin Fully Realized."
• Discontinue the claim "Better gastrointestinal safety" (or modify it to convey the limited message that Vazalore causes fewer erosions and ulcers in the first week of treatment than traditional immediate release aspirin).

In PLx Pharma's advertiser's statement it agreed to comply with NAD's recommendations and incorporate them in updates to its company website and development of Vazalore's marketing campaign.

Thereafter, the challenger, Bayer Healthcare LLC, asked NAD to open a compliance inquiry based on concerns about advertising on PLx Pharma's website directed to healthcare professionals (HCP) and a television commercial. In a compliance matter, NAD must determine whether the advertiser has made a bona fide, good-faith effort to comply with NAD's recommendations.

Although NAD determined that some new advertising claims were not appropriate for review in a compliance matter because they were not previously reviewed by NAD or were monadic performance claims, a few others were substantially similar to claims challenged in the underlying proceeding. Therefore, NAD considered whether these new claims fully comply with NAD's recommendations.

Television Commercial

Regarding PLx Pharma's television commercial, NAD determined that, in context, the claim "Aspirin Made Amazing" was substantially similar to the claim NAD recommended be discontinued in the underlying challenge, "The Miracles of Aspirin Fully Realized." NAD noted that both phrases reasonably convey the unsupported message that Vazalore provides superior cardiovascular benefits or gastrointestinal safety. Therefore, NAD recommended that Vazalore modify its commercial to avoid conveying this message.

Consistent with the underlying decision, NAD noted that nothing precludes PLx Pharma from:

• Making a properly limited claim based on the clinical study results that the Vazalore 325 mg aspirin causes fewer erosions and ulcers in the first week of treatment than traditional immediate release aspirin or from touting that it provides a new delivery system; or
• Using the "Aspirin Made Amazing" tagline to highlight truthful attributes that make Vazalore different from other products provided, however, the context does not overstate its performance benefits.

Advertising Directed to Healthcare Professionals

NAD noted that it appreciates PLx Pharma's efforts to create a gated site for HCPs separate from its consumer-facing website.

In the underlying decision, NAD recommended that the advertiser modify the claim "Vazalore has up to 5x greater absorption than enteric coated aspirin" to avoid conveying the message that the claimed difference in absorption related to superior clinical efficacy and disclose that the reported results were from a limited study population, diabetic, obese subjects. In the compliance inquiry, NAD considered whether the advertiser's disclosure of the limitations of its clinical study, as referenced on its HCP-facing website, namely the title of the study, its characteristics including the study's population, and finally the results, complied with this recommendation. NAD determined that it did not and, therefore, recommended that the disclosure concerning the 5x absorption claim clearly and conspicuously reference the limited population of the clinical study.

Further, NAD determined that claims on PLx Pharma's "Features and Benefits" page convey a comparative safety message as to competing traditional release aspirin. Consequently, NAD recommended that the advertiser modify this advertising to make clear the limitations of its study (i.e., that Vazalore causes fewer erosions and ulcers in the first week of treatment than traditional immediate release aspirin).

While the advertiser made modifications following the original challenge, they have declined to make additional modifications as NAD requested. As a result, NAD is referring this matter to the appropriate government agencies for review and possible law enforcement action.

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.

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 Division: The National Advertising Division (NAD) of BBB National Programs provides independent self-regulation and dispute resolution services, guiding the truthfulness of advertising across the U.S. NAD reviews national advertising in all media and its decisions set consistent standards for advertising truth and accuracy, delivering meaningful protection to consumers and leveling the playing field for business.

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