Federal regulators have turned their sights on one of the nation's fastest‑growing telehealth companies, sending Hims & Hers a warning letter that accuses the firm of promoting compounded semaglutide products with “false or misleading claims.” The letter, one of dozens dispatched this month to drugmakers and sellers, demanded prompt corrections and underscored the Food and Drug Administration’s heightened vigilance after a White House directive aimed at tightening oversight of direct‑to‑consumer drug advertising.

Semaglutide, sold under brand names such as Ozempic for diabetes and Wegovy for weight management, belongs to a class of medications known as GLP‑1 receptor agonists. The drugs have driven a surge in demand for weight‑loss treatments, prompting some providers and compounding pharmacies to offer home‑delivered, compounded versions that are not approved by the FDA. The agency warned that such products can carry risks including inconsistent potency, contamination and lack of demonstrated safety and efficacy.

“Hims & Hers was sent a letter regarding its compounded semaglutide products,” Forbes reported. The FDA’s correspondence, according to the letter text cited in media accounts, directs companies to correct promotional statements it deems inaccurate. The agency declined to provide additional comment by deadline; Hims & Hers also did not respond to requests for comment.

The enforcement action arrives amid growing scrutiny of how telehealth platforms market prescription drugs directly to consumers. President Donald Trump signed an executive order earlier this month designed to clamp down on what regulators and critics describe as aggressive advertising practices that may mislead patients about risks or overpromise benefits. Regulators say the orders and letters are meant to protect patients encountering an expanding and often confusing array of online treatment options.

Industry analysts say the letters could have broad implications. Telehealth firms have leaned on convenience and direct outreach to capture patients seeking weight‑loss therapies, sometimes facilitating prescriptions for compounded or off‑label formulations when branded alternatives are scarce or costly. “Compounded products occupy a regulatory gray area and can undermine clinical safeguards,” said a regulatory consultant who requested anonymity to speak candidly about ongoing industry negotiations. “We are likely to see companies either tighten marketing claims or face enforcement and reputational risk.”

Physicians and safety advocates have warned that compounded semaglutide lacks the rigorous manufacturing controls and clinical trial evidence tied to FDA‑approved products. That raises concerns for patients who may substitute compounded versions for approved therapies or obtain them without adequate screening and monitoring. Insurers and state boards are also watching supply and liability questions, which could affect coverage and prescribing practices.

For Hims & Hers, the letter is a reputational challenge for a company that has built its brand on accessible telehealth. For consumers, it is a reminder that not all treatments offered online have the same regulatory scrutiny as branded prescription drugs. The FDA’s campaign, observers say, aims to force clearer distinctions in marketing and to shore up patient protections as demand for GLP‑1 drugs continues to reshape primary care and the weight‑loss market. Forbes reported it had reached out to both the FDA and Hims & Hers for comment; neither had replied by publication.