The FDA has warned Evolus over an Instagram reel that made the “especially problematic” suggestion of blurred lines between a prescription product and consumer cosmetics.
Last week, Evolus received (PDF) an untitled letter setting out the agency’s concerns. In the letter, the FDA dissected an Instagram reel about Jeuveau, Evolus’ rival to AbbVie’s Botox. The reel was accompanied by a caption about how Evolus is “blurring the lines between what’s found in your beauty bag and what happens in the treatment room.” The caption included the emojis for syringe and lipstick.
The caption implied that Jeuveau “is comparable to an everyday beauty product or regimen and can simply be ordered from a cosmetic delivery service ... and incorporated as a part of a cosmetic routine, similar to a stick of lipstick being stored in ‘your beauty bag,’” the FDA said.
That implication triggered pushback from FDA officials. Likening Jeuveau to an everyday beauty product minimized the risks associated with a prescription drug with a boxed warning, the FDA said. The serious risks associated with Jeuveau informed the agency’s conclusion that the implication is “especially problematic.” The FDA gave Evolus 15 working days to respond to the letter, which it sent on Sept. 28.
Evolus’ positioning of Jeuveau as a beauty brand is a longstanding corporate strategy. In 2023, Evolus CEO David Moatazedi told Fierce that the company’s creative team “has no experience in healthcare.” The team developed branding that is “edgy” and designed to make consumers go “Wow, this is different. It feels like a beauty brand,” the CEO added.
The FDA’s untitled letter also tackled Evolus’ claims about the speed and magnitude of responses to the neurotoxin. The star of the reel, Josephine, expressed excitement about “getting rid of my lines” and surprise at “how quickly it’s kicking in.” The caption said, “Lines today. Blurred in as little as 2 days,” supported by a footnote stating that about 50% of patients begin showing improvement after two days.
Suggesting that Jeuveau will get “rid of” frown lines is misleading, the FDA said. Jeuveau is indicated for the temporary improvement of frown lines, and its pivotal program only assessed the proportion of people with no lines as an exploratory endpoint. The program’s primary endpoint tested the proportion of people with at least a two-point improvement on a frown line scale at Day 30.
The timing of the primary endpoint informed the FDA’s other concerns with the reel. Evolus assessed the effect of Jeuveau on frown lines at Day 2 as an exploratory endpoint. The limitations of the exploratory endpoint make “it difficult to interpret and draw reliable conclusions,” the FDA said, informing its view that the reel created a misleading impression.