After a controversial product launch, Hims & Hers announced plans to remove access to its compounded semaglutide pill following regulatory warnings from FDA and legal pressure from Novo Nordisk.

The reversal comes just two days after the company announced its launch and highlights the intensifying scrutiny surrounding compounded glucagon-like peptide-1 (GLP-1) therapies as both regulators and branded manufacturers continue to push back against copycat alternatives marketed alongside FDA-approved drugs.

Why did Hims & Hers remove access to its new drug?

In a statement shared on X, the telehealth platform said, “Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment. We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.”

How did FDA affect Hims & Hers decision?

Shortly following Hims & Hers reveal of its new compounded semaglutide, the FDA announced plans to take stronger enforcement measures against companies’ mass-marketing compounded products positioned as alternatives to approved therapies, directly naming Hims & Hers in its statement.²

“Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers and other compounding pharmacies, as similar alternatives to FDA-approved drugs.” The agency said the actions are intended “to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.”

The agency also emphasized ongoing concerns around promotional claims and direct-to-consumer messaging, building on the letters the agency previously sent to several pharmaceutical companies, including Hims & Hers.

“The FDA is also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025,” the agency said.

The statement continued to add that companies “cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA” and cannot state that compounded products use the same active ingredient or are clinically proven to produce patient results.²

The FDA’s official statement builds on Commissioner Marty Makary’s X post from February 5^th, saying that the agency would move against copycat drugs marketed as comparable to approved therapies, warning that regulators “will take swift action against companies’ mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products. The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”³

Did Novo Nordisk affect Hims & Hers decision?

Novo Nordisk, the manufacturer of Wegovy, responded strongly to the initial launch of Hims & Hers’ compounded semaglutide pill, releasing a company statement describing the product as an “unlawful mass compounding,” signaling potential legal action.⁴

The company argued that compounded semaglutide products posed safety risks and undermined the established drug approval framework.⁴ This argument reinforces an increasingly assertive stance by branded manufacturers seeking to protect intellectual property and regulatory standards as demand for GLP-1 therapies continues to surge.⁴

Sources

1. Hims & Hers Comms X February 7, 2026 https://x.com/HimsHersComms/status/2020207947645911214?s=20
2. FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs U.S. Food and Drug Administration February 6, 2026 https://www.fda.gov/news-events/press-announcements/fda-intends-take-action-against-non-fda-approved-glp-1-drugs
3. Dr. Marty Makary X, X February 5, 2026 https://x.com/DrMakaryFDA/status/2019552255310020616?s=20
4. Novo Nordisk issues statement on illegal mass compounding and deceptive advertising by Hims & Hers Novo Nordisk February 5, 2026 https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=916489