FDA Cracks Down on Hims, Other Telehealth Companies Over Drug Ads

WEDNESDAY, Sept. 17, 2025 (HealthDay News) — Federal health officials are cracking down on telehealth companies’ promotion of unapproved versions of prescription drugs, including popular weight loss medications.

On Tuesday, the U.S. Food and Drug Administration (FDA) released more than 100 warning letters aimed at both drugmakers and online health companies. Among them: Hims & Hers, a telehealth platform that has made a name by selling lower-cost versions of well-known drugs, The Associated Press said.

The agency said Hims crossed the line by telling customers its compounded products contained “the same active ingredient” as Ozempic and Wegovy, even though Hims’ versions are mixed by compounding pharmacies and never reviewed by the FDA.

“Your claims imply that your products are the same as an FDA-approved product when they are not,” the warning letter said.

In response, Hims said it told consumers that compounded medicines aren’t FDA-approved and that it “looks forward to engaging” with the agency.

Compounding is the process of combining, mixing or altering ingredients to create a medication tailored to a patient’s needs, according to the National Library of Medicine.

This is the first time the FDA has targeted online platforms such as Hims directly. The company has long argued that traditional drug advertising rules don’t apply to them. 

The move follows an order from President Donald Trump directing federal agencies to ensure drug ads on TV and social media are accurate.

The agency’s concerns go beyond Hims. Regulators also sent letters to Eli Lilly and Novo Nordisk, criticizing a 2024 infomercial with Oprah Winfrey that the FDA said gave a “misleading impression” of weight loss injections such as Wegovy and Zepbound, The AP reported.

While compounding drugs is sometimes allowed when FDA-approved versions are scarce, regulators recently said these drugs no longer qualify as in shortage.

Despite that, some companies continue selling “customized” doses. Hims has defended this, because it is potentially beneficial for certain patients.

More information

Learn more about the U.S. Food and Drug Administration's drug advertisement reforms.

SOURCE: The Associated Press, Sept. 16, 2025

What This Means For You

Compounded weight loss drugs aren’t government-reviewed for safety or effectiveness.