Earlier this week, FDA posted numerous warning letters and untitled letters to the manufacturers and telehealth companies for their marketing practices that are harming our young adult patient community. Among these companies targeted were those marketing unapproved compounded GLP-1s, with FDA labeling their products as misbranded. FDA also sent warning letters to manufacturers of approved GLP-1s who have been engaging in misleading and deceptive advertising practices, warning manufacturers that if they fail to correct these advertisements, they will also be labeled as misbranded. In addition to GLP-1 enforcement, FDA sent 40 untitled letters to other manufacturers engaging in deceptive marketing practices.
The companies facing this enforcement included Hims & Hers, which has been heavily marketing their compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. While semaglutide was added to FDA’s drug shortage list in 2022, allowing for manufacturers to create and market compounded versions of the drug, FDA announced that the semaglutide shortage was resolved in February of this year. Since this announcement, FDA has repeatedly told manufacturers to stop marketing these compounded GLP-1s and has warned patients of the high risks associated with taking unapproved medications. Yet, companies like Hims & Hers continued to aggressively market these unapproved products, especially on social media sites run by Meta and TikTok, which are heavily frequented by our young adult patient community. FDA has given these companies 15 days to submit a response, or they will move forward with penalties.
“Labeling compounded GLP-1s as misbranded is an important step that allows FDA to initiate a seizure of these unapproved products from the market, along with other serious legal penalties for companies if they continue to push these unsafe products onto patients.” Alexander Naum, JD, Policy Manager at Generation Patient.
In addition, FDA also went after Eli Lilly and Novo Nordisk for deceptive promotional practices for their approved GLP-1’s including Ozempic, Wegovy, Mounjaro, and Zepbound. Including, their use of paid consultants on a recent Oprah Winfrey Special featured on ABC. On the Oprah Special, they heavily promoted the efficacy of these GLP-1 products and failed to adequately discuss the risks associated with these products. Even more unsettling, they downplayed the risk of pancreatitis, gallbladder complications, and thyroid cancer resulting from the use of these products, which are warnings that must be included in their promotional materials. FDA has requested that they submit a comprehensive plan to correct past and prevent future misleading communications on these products.
Finally, FDA issued a total of 40 untitled letters to other pharmaceutical manufacturers that engaged in various deceptive marketing practices. These deceptive marketing practices were employed across various media, including print, television, websites, and influencer promotions on social media. For example, FDA sent an untitled letter to Kaleo for their social media promotions for their injectable, Auvi-Q. Kaleo paid social media influencer Brittany Mahomes to make a post endorsing the efficacy of Auvi-Q, without including key safety information. FDA found the post to be false or misleading for failing to include the product’s risk information, giving Kaleo 15 days to respond before proceeding with further actions. Brittany Mahomes has an Instagram following of over 2 million, many of whom are young adult patients who trust her product endorsements, but unfortunately, many were misled.
“These letters are a positive and exciting first step. We look forward to seeing increased staff capacity and resources go toward FDA’s enforcement of penalties.” Sneha Dave, Executive Director at Generation Patient