National Advertising Review Board Recommends Bausch + Lomb Discontinue or Modify Certain Claims for INFUSE Contact Lenses

NEW YORK, April 7, 2022 /PRNewswire/ -- A panel of the National Advertising Review Board (NARB), the appellate advertising law body of BBB National Programs, has recommended that Bausch Health US, LLC discontinue or modify certain claims for its Bausch + Lomb INFUSE brand of silicone hydrogel daily contact lenses, including:

• "Most Moisture" and "Lowest Modulus" claims;
• Implied superior comfort claim;
• "Maintains 96% of its moisture for a full 16 hours – more than the leading silicone hydrogel daily disposable";
• Unsurpassed overall vision and comfort claim;
• Vision, irritation, and dryness-related percentage agreement claims; and
• Aspheric optics claim.

The advertising at issue had been challenged before the National Advertising Division (NAD) by Alcon Vision, LLC, manufacturer of competing DAILIES TOTAL1 (DT1) contact lenses (Case No. 6951). After NAD's decision was rendered, Bausch + Lomb appealed to NARB as part of the advertising industry's self-regulatory process. The principal challenged claims, many of which are technical in nature and based on clinical testing of the products, had appeared in an INFUSE contact lens brochure distributed by Bausch+ Lomb to eye care professionals (ECPs).

"Most Moisture" and "Lowest Modulus" Claims

The NARB panel concluded that the evidence in the record shows that the advertiser and challenger use different technical approaches to try to minimize the disruption to homeostasis caused by wearing contact lenses. Referring to the INFUSE lens as monophasic and the DT1 lens as biphasic represent reasonably accurate descriptions of the technology.

In agreement with NAD, the panel recommended that Bausch + Lomb modify its "lowest modulus" and "most moisture" claims to clearly disclose the material distinction between the products (e.g., monophasic vs. biphasic) in a manner that is understandable to ECPs.

Implied Superior Comfort Claim

The NARB panel found that the focus of the Bausch + Lomb INFUSE brochure was to present Bausch + Lomb INFUSE lenses as a preferred option in terms of reducing discomfort and that one message reasonably communicated to ECPs by the "most moisture," "lowest modulus," and "high oxygen" references in context is one of greater comfort when the INFUSE lenses are worn. Thus, the panel agreed with NAD and concluded that the Bausch + Lomb INFUSE brochure communicates to ECPs the implied message that INFUSE lenses provide greater eye comfort than competitive daily lenses, a message not supported by the record.

The panel recommended, therefore, that Bausch + Lomb modify its advertising to avoid conveying the implied message that the physical properties of its Bausch + Lomb INFUSE lenses ("most moisture," "lowest modulus," and "high oxygen") lead to superior consumer relevant benefits versus competing lenses, including DT1 lenses.

16-Hour Moisture Claim

The NARB panel agreed with NAD that the claim that Bausch + Lomb INFUSE "Maintains 96% of its moisture for a full 16 hours – more than the leading silicone hydrogel daily disposable" is not properly supported because the advertiser failed to show that the claimed moisture retention differential is material. Thus, the panel recommended that the claim be discontinued.

Unsurpassed Overall Vision and Comfort Claims and Percentage Agreement Claims

In support of its parity claim, as well as several percentage agreement claims, Bausch + Lomb relied on the results of its 893 Clinical Study. The NARB panel agreed with NAD that the 893 Study did not provide proper support for the advertiser's unsurpassed claim (a comparative establishment claim) because there are methodological deficiencies directly relevant to this analysis, the most important being limiting the enrollment in the study to wearers of standard, not daily, contact lenses.

Therefore, the panel recommended that Bausch discontinue the claim that Bausch + Lomb INFUSE has "unsurpassed overall comfort and vision compared to Dailies Total1."

The NARB panel concluded that Bausch + Lomb's four percentage agreement claims are monadic in nature, and accordingly the substantiation can be evaluated under a less rigorous standard. The panel found that the methodological shortcomings of the 893 Study are not disqualifying, but recommended modifications to the following claims:

• "89% of patients agreed Bausch + Lomb INFUSE reduces halos and glare even in low light conditions."
• "84% agreed Bausch + Lomb INFUSE reduced irritation and discomfort."
• "73% agreed Bausch + Lomb INFUSE helped minimize symptoms of contact lens dryness."

The NARB panel recommended that the 84% claim and the 73% claim either be discontinued or modified to match the language in the survey (e.g., "protect against irritation" rather than "reduced irritation") to which agreement was expressed. Further, the panel recommended that Bausch + Lomb discontinue the 89%, 84%, and 73% claims or disclose the stated percentages of those who indicated that they "slightly agree."

Finally, the NARB panel recommended that Bausch + Lomb discontinue the claim that "95% of patients agreed Bausch + Lomb INFUSE provides clear vision even when driving at night" because the 893 Study did not determine which subjects, if any, drove at night during the study period. The panel concluded that it was not appropriate for the 893 Study to use passenger data as support for a claim about drivers.

Aspheric Optics Claim

In agreement with NAD, the NARB panel recommended that Bausch + Lomb modify the chart in the INFUSE brochure accompanying the claim "Compared to leading silicone hydrogel daily disposables, only Bausch + Lomb INFUSE is designed with aspheric optics to reduce spherical aberration across the entire power range" to indicate that the lens property being compared is "Spherical Aberration Control Across the Entire Power Range." 

In its advertiser's statement, Bausch + Lomb stated that it "will comply with NARB's decision." The advertiser further stated that it "appreciates NARB's finding that Bausch+ Lomb's 893 Study supports its monadic percentage agreement claims, as modified according to NARB's decision." Although the advertiser noted that it "respectfully disagrees" with some of NARB's findings which "misstate some of Bausch+ Lomb's positions and arguments," it stated that it "is a strong supporter of the self-regulatory process and will consider NAD's and NARB's recommendations with respect to its advertising going forward."

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 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. 

SOURCE BBB National Programs