By: Caitlin A. Koppenhaver, Attorney with Florida Healthcare Law Firm and Chief Industry Advisor to APA.
If you felt like the compounded oral semaglutide headlines were changing by the hour, you weren’t imagining it. Within days, the narrative shifted from a consumer-facing launch to heightened FDA attention and legal escalation, ending with a rapid withdrawal.
How This Unfolded—Fast
On Thursday, February 5, Hims & Hers announced it was expanding its weight-loss portfolio with access to compounded semaglutide pills, promoted as having “the same active ingredient as Wegovy®”, and marketed with introductory pricing starting at $49 (with pricing that varies by plan). The announcement immediately landed in the middle of the broader “compounded GLP-1” conversation, namely, whether these offerings fit within narrow, patient-specific compounding exceptions permitted under the Federal Food, Drug, and Cosmetic Act (FDCA), or whether they were being positioned as scaled substitutes for FDA-approved products, which is where FDA scrutiny and branded manufacturer enforcement tend to converge.
That same day, Novo Nordisk’s CEO publicly questioned whether a compounded oral semaglutide pill would work as consumers expect, reportedly describing it as a “waste of money” because it lacks the SNAC absorption technology used in Novo’s FDA-approved oral Wegovy formulation. “SNAC” is a proprietary excipient that helps semaglutide survive the stomach and be absorbed into the bloodstream when taken orally. Without it, semaglutide is largely degraded by stomach acid and enzymes, meaning the active peptide may not reach the bloodstream in meaningful amounts. Novo’s point, anchored in its public comments at an investor meeting on Feb. 5, 2026, is that an oral semaglutide pill without this type of enhancer is unlikely to perform clinically like an FDA-approved product.
By Friday, February 6, the FDA publicly escalated its position. In a formal statement, the agency said it intends 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 action was framed around consumer protection and the agency’s inability to verify quality, safety, or efficacy for compounded formulations.
The business impact was almost immediate. On Saturday, February 7, reporting confirmed Hims stopped offering access to the compounded semaglutide pill after what it described as “constructive conversations with stakeholders across the industry”, in the wake of FDA’s statements and the broader regulatory scrutiny.
And on Monday, February 9, Novo Nordisk formally escalated to litigation, filing suit against Hims & Hers alleging patent infringement tied to compounded semaglutide products and seeking injunctive relief and damages. As stated by their CEO, “Novo Nordisk is asking the court to permanently ban Hims from selling unapproved, compounded drugs that infringe our patents, and is seeking to recover damages”.
One point worth flagging, because it helps explain the speed of the escalation, is how Novo framed the moment. In public comments, Novo suggested Hims was the “tipping point,” in the sense that a highly visible, consumer-facing rollout drew immediate attention and prompted a faster, more public response.
What This Means for Industry Participants
While this week in no way settled the compounded GLP-1 debate, it did, however, show how quickly the conversation can accelerate when FDA signaling and branded manufacturer enforcement converge in a high-demand category. It also highlights a few practical realities compounding pharmacies and their partners should keep in mind right now.
For compounders, the risk often turns on posture and messaging: tightly patient-specific, pharmacy-controlled dispensing tends to be viewed differently than marketing that reads like a substitute for an FDA-approved drug.
For telehealth platforms, scale and consumer marketing amplify everything. Even if a licensed pharmacy is dispensing, a national rollout can draw immediate attention from regulators and brand manufacturers.
And for both, transparency matters, not just from an FDA standpoint. From an FTC risk standpoint, regulators look at the overall takeaway a reasonable consumer would get from the ad, not just whether each sentence is technically defensible. If the headline, pricing, visuals, or phrasing leaves consumers thinking “FDA-approved” or “equivalent to Wegovy,” disclaimers buried later may not cure the overall net impression.