United States of America

FEDERAL TRADE COMMISSION

Washington, D.C. 20580

Division of Advertising Practices

February 24, 2022

Via Electronic Mail (lbrett@bbbnp.org)

Laura Brett, Esq.

Vice President

National Advertising Division

112 Madison Avenue, 3rd Floor

New York, NY 10016

Re: Advertising by PLx Pharma Inc. for Vazalore aspirin product

Dear Ms. Brett:

Thank you for your November 30, 2021 letter referring an NAD Decision involving 

advertising claims by PLx Pharma Inc. (“PLx”) for its Vazalore aspirin product, a liquid-filled 

immediate release aspirin that bypasses the stomach and is sold in various doses. The NAD 

proceedings first began with a March 2020 NAD Challenge filed by a competitor, Bayer 

Healthcare LLC (“Bayer”). Although the procedural history is fairly complex, the core claims at 

issue are PLx’s representations that Vazalore confers (1) superior gastrointestinal safety than 

uncoated aspirin and (2) superior absorption and antiplatelet activity than enteric-coated aspirin. 

These claims appeared on PLx’s Vazalore website and in a television commercial.1 In 

November 2021, NAD issued a Compliance Decision recommending that PLx modify its 

television and online advertising to clearly convey the limitations of the clinical studies 

underlying its claims. In its Advertiser’s Statement, PLx stated it would not comply with NAD’s 

recommendations. Accordingly, NAD referred this matter to the FTC.

2

 

1 The advertiser’s “pin ball” commercial, which first aired after the initial NAD Challenge was filed, became the 

subject of a September 2021 Fast-Track SWIFT Challenge also filed by Bayer. In December 2021, NAD issued its 

Decision recommending that PLx modify the commercial to explicate the limited duration of the clinical study 

referenced, and NARB affirmed on appeal. 2 After FTC had already started reviewing NAD’s referral, PLx’s counsel notified NAD in writing that PLx had 

decided to accept NAD’s recommendations set forth in its Compliance Decision. Letter from Andrew B. Lustigman 

to Laura Brett and Annie Ugurlayan re: PLx Pharma Inc. (Jan. 27, 2022).
Laura Brett, Esq.

February 24, 2022

Page 2

After reviewing the NAD case record, we had discussions with PLx’s counsel regarding 

the claims at issue. Subsequently, PLx agreed to make significant modifications to the television 

and online advertising at issue, including revising its television ad and adding more prominent 

disclosures regarding the limited population and duration of the clinical studies on which it relies 

on its website. Accordingly, we have determined not to take additional action at this time. In 

coming to this conclusion, we considered a number of factors related to resource allocation and 

enforcement priorities, as well as the nature of any FTC Act violation and the type and severity 

of any consumer injury. 

The Commission reserves the right to take such further action as the public interest may 

require. We appreciate your referral and the opportunity to support the NAD’s self-regulatory 

process.

Very truly yours,

s/ Carolyn L. Hann

Carolyn L. Hann 

Chief of Staff for Advertising Practices 

cc: Andrew B. Lustigman, Olshan Frome Wolosky LLP