A strand of Merz Pharmaceuticals’ star-studded promotion of the anti-wrinkle drug Xeomin has landed it a reprimand from the FDA. The agency sent an untitled letter after finding fault with how the company and one of its celebrity spokespeople handled the risks and benefits of the drug in an Instagram reel.
Merz has put stars and influencers at the heart of its recent efforts to carve out a space in a market that is synonymous with AbbVie’s Botox. Nate Berkus, an interior designer and TV personality with 1.9 million followers on Instagram, is one of the many people Merz has enlisted to spread the word about Xeomin. A short-form Instagram video shared by Berkus and Merz caught the attention of the FDA.
The video shows Berkus dancing to music as he is getting “ready for a big night out.” In the FDA’s view, the ad misleadingly suggests Xeomin provides faster or more rapid results than have been demonstrated.
Berkus shared his routine for getting ready to go out, explaining that keeping his dermatologist on speed dial is his “secret weapon for looking fresh.” A caption said “my pro-tips for getting ready for a night out; tuxedo at the ready, fries and Xeomin.” The FDA said the ad suggests the “surprise appearance” of frown lines during preparation for a same-day event can be resolved in time for a “big night out.”
The FDA challenged Merx to submit data to support such a fast onset of action. The trials that supported FDA approval of Xeomin for the temporary improvement of wrinkles used efficacy at Day 30 as primary endpoints. Composite endpoint treatment success wasn’t evaluated before Day 7, the FDA said.
Onset of action was one of two benefit claims challenged by the FDA. The other claim related to Berkus’ framing of Merz’s Xeomin as “a double-filtered smart tox that smooths the looks of frown lines with only the ingredients that you need for treatment” and use of the hashtag #SmartTox.
“These claims misleadingly suggest that due to its manufacturing process and formulation, Xeomin offers benefits over other botulinum toxin products, when this has not been demonstrated,” the FDA said. The agency acknowledged product information that says the active Xeomin neurotoxin is “without accessory proteins” but said it was unaware of evidence that the formulation has benefits over rival products.
The FDA’s challenge touches on a central pillar of Merz’s promotion of Xeomin. On the Xeomin website, Merz says “other toxins contain unnecessary ingredients that can lead to treatment resistance over time (when you end up needing more units over time to get the same results).” Merz’s “purified injectable” is different, according to the company, although it notes the lack of head-to-head studies in a footnote.
The FDA found other issues with the presentation of risks. The agency ruled the post is misleading because it “fails to present information relating to side effects and contraindications associated with the drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug.”
Berkus spends about 40 seconds talking about the role Xeomin plays in his routine. Throughout that time, the indication and use statement for Xeomin are shown in static text at the bottom of the reel. Risk information is only presented after Berkus says “see you guys at the next big event,” walks away and the screen goes black for three seconds.
When the risk information is displayed, it is presented “using fast-paced, scrolling font that is small and difficult to read, which is unlikely to draw the viewer’s attention,” the FDA said. The overall effect of the presentation “undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Xeomin,” according to the agency.