A recent warning from the U.S. Food and Drug Administration (FDA) is serving as a caution to businesses promoting prescription products on social media: Claims about benefits, results, and risks must remain consistent with approved labeling.
The agency has issued an untitled letter to Evolus, the maker of the prescription neurotoxin Jeuveau, saying an Instagram Reel about the treatment gave consumers a misleading impression of what the product can do, how quickly it works, and that it minimized associated risks.
According to the FDA, the Instagram video featured a patient describing her results with Jeuveau and, among other claims, said it could produce “complete results” and “get rid of” frown lines. The FDA-approved injectable is indicated for only temporary cosmetic improvement, the agency pointed out.
The agency said those claims overstated what has been demonstrated in clinical research. The studies used to support approval primarily evaluated results 30 days after treatment, and the FDA said the promotional material created an inaccurate impression of both the speed and extent of improvement consumers can expect.
The federal agency also objected to language in the post that described the company as “blurring the lines” between products found in a beauty bag and treatments performed in a medical setting. Regulators said this comparison minimized the fact that Jeuveau is a prescription drug that must be administered by a healthcare professional and carries important safety risks.
The FDA also noted that risk information appeared late in the video and was not presented as prominently as the product’s benefits.
The agency has asked Evolus to stop or correct the promotional claims and explain how it plans to prevent similar issues in future advertising.