National Advertising Division Finds Certain Bausch + Lomb Claims for INFUSE Contact Lenses Supported; Advertiser Appeals Other Findings

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New York, NY – December 1, 2021 – The National Advertising Division (NAD) of BBB National Programs has determined that Bausch Health US, LLC (B+L) provided a reasonable basis for claims that its INFUSE brand of silicone hydrogel (SiHy) daily contact lenses are a “next-generation material infused with ProBalance Technology” providing a balanced ocular environment to “reduce contact lens dryness and discomfort.” NAD also found that certain lens property claims were supported.

However, NAD recommended other challenged claims be modified or discontinued, including the advertiser’s: 

• Unsurpassed overall comfort and vision claims;
• Vision, irritation, and dryness-related percentage agreement claims; and
• Certain lens property claims.

The claims, which appeared in an INFUSE contact lens brochure directed to Eye Care Professionals (ECPs), along with substantially similar claims appearing on a video (on an ECP-facing website) and on a consumer-facing website, were challenged by Alcon Vision, LLC, manufacturer of competing DAILIES TOTAL1 (DT1) contact lenses. B+L will appeal NAD’s decision. 

This case was handled by NAD through its Complex Track process, a case track designed for truth-in-advertising issues that require complex claim substantiation.

Unsurpassed Overall Comfort and Vision Claims and Percentage Agreement Claims

In support of its parity claim, as well as several percentage agreement claims, the advertiser relied on the results of its 893 Clinical Study. NAD determined that this study is not a good fit to support these challenged claims and recommended that B+L discontinue the claim that INFUSE has “unsurpassed overall comfort and vision compared to Dailies Total1,” as well as its vision, irritation, and dryness-related percentage agreement claims: 

• “95% of patients agreed Bausch + Lomb INFUSE provides clear vision even when driving at night” 
• “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”

NAD identified several areas of concern relating to B+L’s use of the 893 Clinical Study as the basis for supporting its advertising claims, including:

• Subjects’ experience with the lenses may be caused by factors other than the product itself; 
• The study was not double-blinded to the sponsor of the study or with respect to the subjects’ treatment groups; and
• The survey suffered from several methodological flaws that cast doubt on the reliability of the subjects’ responses.

Homeostasis, Dryness, and Comfort Claims

NAD considered the messages reasonably conveyed by several sections of B+L’s brochure pertaining to “ocular homeostasis,” but was not persuaded by the challenger’s argument that ECPs would take away a comparative message that INFUSE lenses are superior to other SiHy lenses in maintaining ocular surface homeostasis or in reducing contact-lens related dryness and discomfort. 

Rather, NAD determined that the brochure communicates monadic claims about INFUSE lens material with ProBalance Technology by explaining that its properties will help reduce or minimize the symptoms of contact lens dryness and discomfort that result from the disruption to ocular surface impact inherent in using contact lenses. Further, NAD found that B+L’s evidence provided a reasonable basis for claims that its “next-generation material infused with ProBalance Technology” provides a balanced ocular environment to “reduce contact lens dryness and discomfort.”

Lens Property Claims 

NAD determined that at least one reasonable interpretation of the challenged lens property claims (“most moisture,” “lowest modulus,” and “high oxygen”), in context, is that B+L infuse lenses are better able to reduce the impact on the ocular surface and improve comfort and moisture than DT1 lenses because of these touted lens properties. NAD noted that the basis for B+L’s “most moisture” and “lowest modulus” claims is in vitro testing of the lenses’ physical properties. However, B+L did not provide any evidence to show that there are clinically meaningful differences between INFUSE and DT1 in terms of their impact on ocular homeostasis and comfort. 

Therefore, NAD recommended that B+L modify its advertising to avoid conveying the message that the physical properties of its INFUSE lenses lead to superior consumer-relevant benefits versus competing lenses, including DT1 lenses. NAD noted that nothing in its decision prevents the advertiser from presenting the chart data in a manner that does not suggest superiority (e.g., simply comparing the properties of its lenses to those of its competitors).

Further, NAD determined that B+L provided a reasonable basis for the claim that “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.” However, NAD recommended that the advertiser modify the accompanying chart to indicate that the lens property being compared is “Spherical Aberration Control Across the Entire Power Range.”

Regarding the “lowest modulus” and “most moisture” claims, NAD determined that these claims do not reasonably convey any message about DT1 lenses’ surface properties, nor would a reasonable ECP take away this message. However, NAD noted that because the advertiser seeks to compare the lens properties of its monophasic INFUSE lenses with Alcon’s biphasic DT1 lenses, this is an “apples-to-oranges” comparison. Therefore, NAD recommended that the advertiser modify its advertising to clearly disclose the material distinction between the products (monophasic vs. biphasic) in a manner that is understandable to ECPs.

Finally, NAD recommended that B+L discontinue its comparative claim that INFUSE “Maintains 96% of its moisture for a full 16 hours – more than leading silicone hydrogel daily disposables.” NAD noted that B+L did not present any evidence that the claimed moisture retention differential is material to the consumer experience.  

In its advertiser statement, B+L stated that it “disagrees with NAD’s recommendations to the extent they direct Bausch to modify or discontinue its claims, including its recommendation that Bausch modify its advertising when comparing lens properties to disclose that INFUSE lenses are monophasic and DT1 lenses are biphasic, and will appeal those aspects of NAD’s decision.” Such appeals of NAD decisions are made to the BBB National Programs’ National Advertising Review Board (NARB), the appellate-level truth-in-advertising body of BBB National Programs.

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 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.