Telehealth business Hims & Hers will stop offering customers pills made of compounded semaglutide, which is used for weight loss and diabetes control, the company said in a Feb. 7 post on X.
Compounded drugs are medications created by licensed pharmacists or physicians by mixing and combining the various ingredients of a drug. These are not approved by the Food and Drug Administration, as a result of which their safety, quality, and effectiveness remain suspect. Semaglutide is the active ingredient of medications such as Ozempic and Wegovy, which are GLP-1 drugs used to treat diabetes and weight loss.
On Feb. 5, Hims & Hers announced it was offering compounded semaglutide to customers.
“This new option features a specialized formulation that is engineered to protect the active ingredient through digestion and support absorption,” it said.
The company offered introductory plans beginning at $49 from the first month, with a 5-month plan. Hims & Hers claimed it adhered to “all federal and state standards for compounding.” Moreover, all active pharmaceutical ingredients used in the compounded drugs are exclusively sourced from facilities registered with the FDA, according to the company.
In a Feb. 5 post on X, FDA Commissioner Dr. Marty Makary said the agency would take “swift action” against companies that mass-market copycat drugs with a claim that they are similar to FDA-approved products.
“The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,” Makary wrote.
In its post, Hims & Hers said it has had “constructive conversations” with stakeholders across the industry since launching the compounded semaglutide pill.
“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,” the company said.
Mike Stuart, general counsel of the Department of Health and Human Services, said in a Feb. 6 post on X that the department’s Office of General Counsel has referred the company to the Justice Department for potential violation of the Federal Food, Drug, and Cosmetic Act and Title 18 of the U.S. Code that deals with various crimes.
Novo Nordisk Lawsuit
In a Feb. 9 statement, Novo Nordisk, the company that manufactures Wegovy and Ozempic, announced that it had filed a lawsuit against Hims & Hers for infringing the pharma company’s patent rights in the United States.
“Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs,” the company said.
“This includes Hims’ recent launch, and two days later, abrupt discontinuance of its ‘Compounded GLP-1 Pill,’ which came on the heels of Novo Nordisk’s introduction of the Wegovy pill, the first and only FDA-approved GLP-1 pill for weight loss. Hims continues to unlawfully mass compound injectable versions, made with inauthentic API, and these knock-offs are putting patient health and wellbeing at risk.”
In a statement to The Epoch Times, a Hims & Hers spokesperson said, “This lawsuit attacks more than just one medication or company—it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer.”
In a previous statement, a Hims & Hers spokesperson said: “This is not the first time—nor will it be the last time—a big pharma company has suggested taking an accessible, customer-first approach to healthcare is dangerous, illegal, or bad for the marketplace. This narrative is as predictable as it is outdated and false.”
Unapproved Semaglutide
The FDA said on Feb. 6 that it intends to take action against non-FDA-approved GLP-1 compounded drugs sold in the market 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.
“Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.”
The FDA said it was taking steps to combat misleading consumer ads, including claims by companies that the non-FDA-approved compounded products are generic versions of drugs approved by the agency.
Companies will also be prohibited from claiming that their compounded drugs use the same active ingredient as FDA-approved medications, the agency said.
Hims & Hers’ Feb. 5 announcement regarding the sale of semaglutide at a starting price of $49 came the same day as President Donald Trump announced the launch of the TrumpRx website, which offers medicines, including Ozempic and Wegovy, at high discounts.
“This launch represents the largest reduction in prescription drug prices in history by many, many times,” Trump said.
The website currently lists Ozempic Pen at up to 51–81 percent discount, at $199 per month. Wegovy pills are listed at 78–89 percent off at $149 per month.
Rob Sabo contributed to this report.