Hims & Hers Lawsuit Says Compounded Semaglutide Does Not Have Same Active Ingredient as Ozempic, Wegovy as Advertised

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A proposed class action lawsuit alleges that Hims & Hers has falsely advertised that its injectable compounded semaglutide product contains the same active ingredient as Ozempic and Wegovy.

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The 37-page false advertising lawsuit contends that the active ingredient in Hims & Hers’ purported “knock-off” GLP-1 product is made using a “fundamentally different process”—one that, per the lawsuit, has never been meaningfully tested for safety or effectiveness, or evaluated by the FDA—that produces an entirely different active ingredient.

Although the Hims & Hers product at issue contains the same semaglutide peptide molecule as Ozempic and Wegovy, the class action lawsuit says that the Hims & Hers GLP-1 treatment nevertheless contains a different active ingredient made with “little to no oversight.”

“Consumers do not want to inject substances into their body without reasonable assurances that the substance is safe and effective,” the filing stresses, arguing that if Hims & Hers “told consumers the truth,” then they would not buy the product, or would pay far less for it.

According to the filing, Hims & Hers “heavily” advertises its GLP-1 medication on “nearly all media channels,” and the company additionally promotes the product through paid influencers on platforms such as Facebook, TikTok, Instagram and YouTube.

This “massive media blitz,” the lawsuit says, is intended to “funnel” consumers to either the Hims or Hers website, which the complaint alleges both misleadingly represent that the compounded GLP-1 medication is made with “the same active ingredients as Ozempic and Wegovy.”

The case points to language found on both the Hims and Hers websites that says the product only “differs from brand-name weight-loss injections” because it does not come in a “preloaded injection pen.”

These claims are manifestly false, the lawsuit insists. Per the case, Novo Nordisk, which manufactures both Ozempic and Wegovy, uses a biological process that alters yeast cells to produce the peptide GLP-1, a naturally occurring hormone that triggers the body’s satiety signals. The suit states that this process yields “extremely pure” semaglutide peptides that, when injected, can reduce appetite, promote satiety, and support weight loss.

The lawsuit asserts that Hims & Hers does not use this biological method to create the active ingredients in its GLP-1 medication; instead, the company allegedly uses a cheaper “synthetic chemical process” whereby amino acids are added to a chain one by one to create a “compounded semaglutide.”  This method is used to produce semaglutide peptides but also creates peptides that are “different than semaglutide, having missing [sic] amino acids, extra amino acids, and/or truncated amino acid sequences,” the lawsuit says.

As a result, the suit states, the imperfect semaglutide peptides can have “serious” side effects, including a consumer’s potential immune response to the foreign, “novel” amino acids. An immune response can lead to dangerous symptoms such as a rash, flu-like symptoms, inflammation, and anaphylactic shock, “among others,” the lawsuit states.

Moreover, an immune system response to Hims & Hers’ compounded GLP-1 medication could potentially lead to cross-reactions with other GLP-1 medications and even a consumer’s own naturally occurring GLP-1 peptide hormones, with “serious health consequences.”

Hims & Hers compounded semaglutide additionally contains benzyl alcohol, an ingredient that has not yet been studied for potential negative interactions with the manufactured active ingredients in the product, the complaint adds.

The lawsuit says that Novo Nordisk has responded to Hims & Hers’ marketing of its compounded semaglutide, saying that the chemically synthesized active ingredients are “meaningfully different” from biologically produced semaglutide. Novo Nordisk further petitioned that semaglutide be added to the FDA’s list of drugs that present “demonstrable difficulties” for compounding, due to a significant difference in the active ingredients produced by both processes.

Additionally, the case says that in the pharmaceutical industry, “[i]t is well established that, particularly with biological molecules like peptides and proteins, ‘the process defines the product.’”

Testing of Hims & Hers’ GLP-1 medication has indicated that it contains both a different active ingredient that is not found in Ozempic or Wegovy and semaglutide peptides, the filing states.

The plaintiffs purchased “compounded semaglutide” from the Hims and Hers websites, respectively, in reasonable reliance on the claims that the product contained the same active ingredients as Ozempic and Wegovy, the case states. Had they been aware of the meaningful difference in the amino acid makeup of the GLP-1 medication, the suit says, they would have paid significantly less for the product or not purchased it at all.

Furthermore, the case says that the plaintiffs never spoke to a licensed medical provider at any point in the process – a conversation that may have revealed the differences between “compounded” GLP-1 medications and Ozempic or Wegovy.

The Hims & Hers class action lawsuit seeks to cover all individuals in the United States who purchased the telehealth company’s “compounded semaglutide.”

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