FDA admonishes Evolus for ‘false and misleading’ social media claims
The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Evolus for exaggerating efficacy claims for its drug Jeuveau (prabotulinumtoxinA-xvfs) and for “blurring the lines” between prescription products and consumer cosmetics on Instagram.
Jeuveau is an FDA-approved prescription injection that temporarily improves the appearance of moderate to severe frown lines between the eyebrows in adults. Its main competitor is AbbVie's Botox.
The untitled letter focuses on an Instagram reel posted by Evolus that features a patient named Josephine, who sits down for an interview where she expresses her excitement about getting rid of her lines with Jeuveau. The scene includes a video clip showing her before the treatment and another clip after the treatment. In the voiceover following the treatment, Josephine states that she feels “really good” and is “really surprised” by how quickly the treatment is working and feels “like the line between my eyebrows is gone.”
The ad also states that about 50% of patients will start to improve after two days, and around 69% of patients “will achieve complete results by day 30.”
FDA said that “these claims and presentations are misleading for multiple reasons. First, the claims and presentations misleadingly suggest that treatment with Jeuveau will get ‘rid of’ of frown lines, patients will experience ‘complete results,’ and frown lines will be ‘gone’ indefinitely, when this is not the case.”
The prescribing information for Jeuveau specifies that it is intended only for the temporary treatment of moderate to severe frown lines and is not designed as a permanent treatment.
The company also overstated the effectiveness claims for the drug. The data used to approve the drug did not assess whether frown lines were eliminated or whether patients achieved “complete” results.
FDA also objected to the advertisement’s claim that “in 2026, we’re blurring the lines between what’s found in your beauty bag and what happens in the treatment room.”
“The totality of these claims and presentations is misleading because it likens the use of an injectable prescription product with an everyday beauty product, oversimplifies the important dosage and administration instructions of Jeuveau and minimizes the risks associated with a prescription drug product with a boxed warning,” stated FDA. “Specifically, the claims and presentations imply that the use of Jeuveau, a prescription injectable product intended to be administered by a healthcare provider, is comparable to an everyday beauty product or regimen and can simply be ordered from a cosmetic delivery service such as IPSY and incorporated as a part of a cosmetic routine, similar to a stick of lipstick being stored in “your beauty bag.” IPSY is a personalized beauty subscription service.
The agency also noted that the risk information appears at the end of the reel, where it is less likely to capture the viewer's attention.
FDA noted that similar concerns about misleading claims were raised by an advisory committee in November 2019. The agency expressed worry that Evolus is not accurately representing the benefits of Jeuveau, despite previous concerns raised by OPDP.
The company has 15 working days to respond to the letter.
