Federal health officials have issued warnings to telehealth companies and drugmakers over their advertising of prescription drugs, including weight loss medications. The Food and Drug Administration (FDA) on Tuesday posted more than 100 letters addressed to various drugmakers and online prescribing companies such as Hims & Hers. The agency’s action is part of the Trump administration’s efforts to tighten oversight of pharmaceutical advertising.
Hims & Hers, a company known for selling lower-cost versions of popular obesity injections, was among those warned by the FDA. The regulator told the company to remove promotional statements from its website that suggest its customized products contain “the same active ingredient” as FDA-approved drugs Wegovy and Ozempic. According to the warning letter dated September 9, these formulations are made by specialty compounding pharmacies and have not been reviewed by the FDA.
“Your claims imply that your products are the same as an FDA-approved product when they are not,” the letter stated.
In response, Hims said it “looks forward to engaging with the FDA.” The company added in a statement: “Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA.”
This marks the first time the FDA has taken direct steps to oversee online platforms like Hims regarding drug advertising rules. Previously, such companies maintained they were not subject to traditional regulations.
The FDA also sent separate warning letters concerning GLP-1 drugs after reviewing a 2024 infomercial featuring Oprah Winfrey produced by Eli Lilly and Novo Nordisk. Regulators said this 42-minute TV segment gave a “misleading impression” about safety risks associated with Zepbound, Wegovy, and similar drugs.
Health Secretary Robert F. Kennedy Jr., who has criticized both pharmaceutical companies and GLP-1 drugs in particular, previously suggested Americans could address obesity through diet and exercise alone.
A memo signed last week by President Donald Trump directed Kennedy and the FDA to ensure all pharmaceutical ads across TV, social media, and websites are “truthful and non-misleading.”
The new round of letters from the agency included explicit “cease and desist” instructions—a shift from past practice where language was more technical or regulatory in nature.
Hims has faced scrutiny before. Earlier this year, one of its Super Bowl ads promoted weight-loss medications but did not mention potential side effects or harms—an omission that runs afoul of FDA requirements for balanced risk-benefit information in advertisements.
Makary highlighted this ad in last week’s Journal of the American Medical Association as an example of how advertising contributes to an overreliance on pharmaceuticals for health management in America.
Initially focused on generic treatments for hair loss or erectile dysfunction, Hims later expanded into selling less expensive copies of obesity medications amid growing demand.
Compounding—or customized production—is allowed by the FDA when there is a shortage of officially approved medication versions. However, regulators recently determined that GLP-1 drugs no longer meet criteria for shortage status; compounding remains permitted only when prescriptions are tailored for individual patients’ needs.
Companies like Hims continue offering personalized dosages for certain patients while claiming additional benefits from these custom formulations.
Following news of these warnings, shares in San Francisco-based Hims & Hers Health Inc. dropped more than 6.47% during Tuesday trading (https://www.nasdaq.com/market-activity/stocks/hims).
The recent batch of warning letters came from FDA’s drug center. In addition, last week another letter from its vaccine division criticized AstraZeneca’s FluMist vaccine TV ad for using distracting music and visuals that overshadowed information about side effects; this letter was signed by Dr. Vinay Prasad at the agency’s vaccine division.
Researchers and consumer advocates have often raised concerns about television ads showing upbeat images while downplaying potential side effects.
