National Advertising Division Recommends Galderma Modify or Discontinue Certain Claims for Nemluvio
New York, NY – December 8, 2025 – Following a challenge from Sanofi S.A., BBB National Programs’ National Advertising Division recommended Galderma Laboratories, L.P. modify or discontinue claims regarding its prescription drug Nemluvio’s uniqueness, superiority, and certain efficacy and performance benefits.
Sanofi and Galderma are multinational pharmaceutical companies that each market injectable monoclonal antibody drugs to treat moderate-to-severe eczema.
The challenged claims appear in two television commercials and an Instagram ad highlighting Nemluvio’s effects on eczema, including relief of itch, reduction of inflammation, and improvement in skin appearance. At issue for the National Advertising Division (NAD) was whether the claims regarding Nemluvio’s efficacy and treatment benefits were supported by competent and reliable evidence.
NAD found that the record did not support the claims that Nemluvio treats the underlying cause of eczema or that it is the only FDA-approved drug to do so.
NAD also found that the claim that Nemluvio delivers superior efficacy compared to all other FDA-approved eczema treatments was unsupported.
NAD recommended that Galderma discontinue the claims “works like nothing before, treating eczema at its core,” “treating eczema at its core,” and “get to the root of your eczema.” NAD also recommended that Galderma modify its advertising to avoid conveying the message that Nemluvio is the one and only FDA approved drug that treats eczema at its core or that it has superior efficacy compared to all other FDA approved eczema treatments and discontinue or modify the claim “works like nothing before.”
Calms the Nerves That Make You Itch
Although NAD noted that Nemluvio blocks IL 31 signaling, which indirectly reduces itch, there was insufficient evidence in the record to support the claim that it directly calms nerve activity. Therefore, NAD recommended discontinuing the claim.
Soothes Inflammation
NAD also noted that Nemluvio soothes skin inflammation, but there was insufficient support for broader claims regarding other types of inflammation. Therefore, NAD recommended modifying the claim to clearly and conspicuously specify that it refers to skin inflammation.
Restores Skin Barrier
NAD determined that the submitted clinical studies were not designed to demonstrate restoration of the skin barrier and that Galderma’s expert statements were speculative and unsupported. NAD also found that improved skin appearance alone is not indicative of skin barrier restoration. Therefore, NAD recommended discontinuing the claim.
Therefore, NAD recommended discontinuing the claim and modifying advertising to avoid conveying that all eczema lesions will completely resolve.
NAD found both messages unsupported and recommended that Galderma discontinue the claim “skin can finally heal” or modify it to avoid conveying that all skin lesions associated with a patient’s eczema will completely resolve after using Nemluvio or that Nemluvio is superior to other eczema treatments.
In its advertiser statement, Galderma stated that although it “believes that NAD has misinterpreted most of the claims challenged in this matter, Galderma will comply with its recommendations.”
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. Per NAD/NARB Procedures, this release may not be used for promotional purposes.
Sanofi and Galderma are multinational pharmaceutical companies that each market injectable monoclonal antibody drugs to treat moderate-to-severe eczema.
The challenged claims appear in two television commercials and an Instagram ad highlighting Nemluvio’s effects on eczema, including relief of itch, reduction of inflammation, and improvement in skin appearance. At issue for the National Advertising Division (NAD) was whether the claims regarding Nemluvio’s efficacy and treatment benefits were supported by competent and reliable evidence.
“Works Like Nothing Before, Treating Eczema at Its Core” and “Get to the Root of Your Eczema”
NAD found that the use of the word “core” in the context of the challenged advertising suggests that there is a single core or root that causes eczema and that Nemluvio treats that core or root. NAD found that “works like nothing before” is a uniqueness claim tied to efficacy, which communicates comparative superiority. In the Instagram ad, NAD found the ad conveys the message that Nemluvio not only treats the root cause of eczema, but that it is the only product that does so, thereby communicating an implied superiority claim.NAD found that the record did not support the claims that Nemluvio treats the underlying cause of eczema or that it is the only FDA-approved drug to do so.
NAD also found that the claim that Nemluvio delivers superior efficacy compared to all other FDA-approved eczema treatments was unsupported.
NAD recommended that Galderma discontinue the claims “works like nothing before, treating eczema at its core,” “treating eczema at its core,” and “get to the root of your eczema.” NAD also recommended that Galderma modify its advertising to avoid conveying the message that Nemluvio is the one and only FDA approved drug that treats eczema at its core or that it has superior efficacy compared to all other FDA approved eczema treatments and discontinue or modify the claim “works like nothing before.”
“It’s the First Treatment of Its Kind That Calms the Nerves That Make You Itch, Soothes Inflammation, and Restores Skin Barrier”
NAD determined that the challenged claim tied “first treatment of its kind” directly to calming nerves, soothing inflammation, and restoring the skin barrier, conveying unique efficacy and superiority. NAD found that the record did not support the claim and recommended that Galderma discontinue the full claim, discontinue or modify the standalone “first treatment of its kind” claim, and modify its advertising to avoid conveying that Nemluvio is the first and only treatment of its kind to provide the claimed benefits.Calms the Nerves That Make You Itch
Although NAD noted that Nemluvio blocks IL 31 signaling, which indirectly reduces itch, there was insufficient evidence in the record to support the claim that it directly calms nerve activity. Therefore, NAD recommended discontinuing the claim.
Soothes Inflammation
NAD also noted that Nemluvio soothes skin inflammation, but there was insufficient support for broader claims regarding other types of inflammation. Therefore, NAD recommended modifying the claim to clearly and conspicuously specify that it refers to skin inflammation.
Restores Skin Barrier
NAD determined that the submitted clinical studies were not designed to demonstrate restoration of the skin barrier and that Galderma’s expert statements were speculative and unsupported. NAD also found that improved skin appearance alone is not indicative of skin barrier restoration. Therefore, NAD recommended discontinuing the claim.
“Clear Skin That Lasts”
NAD determined that consumers are likely to interpret the statement “clear skin that lasts” in the television commercials as promising completely clear skin, reinforced by the voiceover and visuals. NAD found that such performance claims for a prescription drug reasonably convey typical results, a claim not supported by the record.Therefore, NAD recommended discontinuing the claim and modifying advertising to avoid conveying that all eczema lesions will completely resolve.
“Skin Can Finally Heal”
Although NAD found the phrase “skin can finally heal” does not, in isolation, communicate product superiority, NAD found that, in the context in which the claim appears, it conveys two messages: that all eczema lesions will completely resolve after using Nemluvio and that Nemluvio enables a level of skin healing that other treatments do not, thereby conveying comparative superiority.NAD found both messages unsupported and recommended that Galderma discontinue the claim “skin can finally heal” or modify it to avoid conveying that all skin lesions associated with a patient’s eczema will completely resolve after using Nemluvio or that Nemluvio is superior to other eczema treatments.
In its advertiser statement, Galderma stated that although it “believes that NAD has misinterpreted most of the claims challenged in this matter, Galderma will comply with its recommendations.”
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. Per NAD/NARB Procedures, this release may not be used for promotional purposes.