By Ginika Igboke
Telehealth company Hims & Hers said it will stop offering customers pills made with compounded semaglutide, a drug used for weight loss and diabetes management, according to a Feb. 7 post by the company on X.
Compounded drugs are medications prepared by licensed pharmacists or physicians by combining or altering ingredients. These drugs are not approved by the Food and Drug Administration, meaning their safety, quality, and effectiveness are not independently verified by the agency. Semaglutide is the active ingredient in FDA-approved medications such as Ozempic and Wegovy, which belong to the GLP-1 class of drugs used to treat diabetes and obesity.
On Feb. 5, Hims & Hers announced it had begun offering compounded semaglutide pills, describing the product as a “specialized formulation” designed to protect the active ingredient during digestion and support absorption. The company offered introductory plans starting at $49 for the first month as part of a five-month program.
Hims & Hers said at the time that it complied with all federal and state compounding standards and that the active pharmaceutical ingredients used in its products were sourced from FDA-registered facilities.
That same day, FDA Commissioner Dr. Marty Makary warned on X that the agency would take “swift action” against companies mass-marketing copycat drugs that claim similarity to FDA-approved products.
“The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,” Makary said.
Following what it described as “constructive conversations” with industry stakeholders, Hims & Hers said it decided to discontinue access to the compounded semaglutide pill.
“We remain committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care,” the company said.
On Feb. 6, Mike Stuart, general counsel for the Department of Health and Human Services, said the department’s Office of General Counsel had referred Hims & Hers to the Justice Department for potential violations of the Federal Food, Drug, and Cosmetic Act and federal criminal statutes.
Novo Nordisk Files Patent Lawsuit
On Feb. 9, Novo Nordisk, the manufacturer of Ozempic and Wegovy, announced it had filed a lawsuit against Hims & Hers, alleging infringement of its U.S. patent rights.
“Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, misleading consumers and healthcare professionals about the clinical benefits and safety of these unapproved drugs,” Novo Nordisk said in a statement.
The company pointed to Hims & Hers’ recent launch and rapid discontinuation of its “Compounded GLP-1 Pill,” which followed Novo Nordisk’s introduction of a Wegovy pill—the first FDA-approved oral GLP-1 medication for weight loss. Novo Nordisk also alleged that Hims & Hers continues to mass compound injectable versions using inauthentic active ingredients, which it said pose risks to patient health.
In response, a Hims & Hers spokesperson said the lawsuit challenges a long-standing component of U.S. pharmacy practice that has improved patient care across a range of conditions, from obesity to cancer. In a separate statement, the company criticized what it described as a recurring narrative from large pharmaceutical firms opposing alternative healthcare delivery models.
FDA Steps Up Enforcement on Compounded GLP-1 Drugs
The FDA said on Feb. 6 that it plans to take action against non-approved compounded GLP-1 drugs sold by Hims & Hers and other compounding pharmacies.
“The FDA will use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns,” the agency said, warning that violations could lead to seizures, injunctions, or other legal action.
The agency also said it is targeting misleading advertising, including claims that compounded products are generic versions of FDA-approved drugs. Companies will be prohibited from stating that their compounded medications contain the same active ingredients as approved products, the FDA added.
Hims & Hers’ announcement about offering semaglutide at a starting price of $49 coincided with President Donald Trump’s launch of the TrumpRx website, which advertises steep discounts on prescription drugs. The site currently lists Ozempic at discounts of up to 81 percent, or about $199 per month, and Wegovy pills at discounts of up to 89 percent, or about $149 per month.
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