In brief
For the first time, the FDA has issued warnings to telehealth companies for advertising unofficial versions of prescription drugs, including popular weight loss medications. Hims & Hers received a cease-and-desist letter for making misleading claims about the ingredients in its custom drugs compared to FDA-approved options like Wegovy and Ozempic. This crackdown is part of the Trump administration's directive to ensure pharmaceutical ads are truthful and compliant, responding to growing concerns about misleading healthcare messaging.
WASHINGTON (AP) — Federal health officials are taking unprecedented action against telehealth companies for promoting unofficial versions of prescription drugs, primarily targeting weight loss medications. This initiative follows the Trump administration’s crackdown on misleading pharmaceutical advertising.
The Food and Drug Administration (FDA) has sent out more than 100 letters to drug and online prescribing companies, including Hims & Hers, which has thrived by offering lower-cost versions of commonly used obesity injections.
The FDA letter drawn attention to “false and misleading” claims on Hims' website, specifically the assertion that their products contain “the same active ingredient” as FDA-approved drugs Wegovy and Ozempic. These formulations, created by compounding pharmacies, lack FDA review, raising safety concerns.
“Your claims imply that your products are the same as an FDA-approved product when they are not,” the warning letter stated.
This action represents the FDA's first direct intervention in regulating telehealth platforms, which have historically maintained a stance that drug advertising regulations do not pertain to them.
A recent presidential memo from Donald Trump called on FDA officials, including Health Secretary Robert F. Kennedy Jr., to ensure that all pharmaceutical advertising across TV, social media, and the web remains “truthful and non-misleading.” This initiative led to the FDA outlining its intention to issue 100 letters addressing deceptive advertisements.
Each letter contains explicit “cease and desist” language, marking a notable shift from the FDA's usual bureaucratic communication style.
The scrutiny of Hims intensified earlier this year following a controversial Super Bowl advertisement, which highlighted the benefits of weight-loss drugs while neglecting to mention potential side effects or harms, contradicting FDA regulations requiring a balanced portrayal of drug risks.
Hims launched as a provider of affordable generic versions of pharmaceuticals targeting conditions like hair loss and erectile dysfunction but has shifted towards offering budget-friendly alternatives to popular obesity treatments in the wake of increased public demand.
FDA regulations allow for compounded prescriptions only when recognized shortages exist, but an exception is made for customized formulations for patients. The FDA's recent ruling stated that GLP-1 drugs are no longer in shortage, potentially limiting the use of compounding.
The letters released on Tuesday originated from the FDA's drug center, as concerns grow regarding the ethical implications of telehealth companies understating or misrepresenting medical risks in pursuit of profit.
As the debate over pharmaceutical advertising continues, the FDA faces growing scrutiny regarding its efficacy in protecting consumers from potentially misleading healthcare messaging.
