Oral Semaglutide and the GLP-1 Compounding Reckoning: From Regulatory Ambiguity to FDA Enforcement, DOJ Referrals, and Novo Nordisk’s Case Against Hims & Hers

What unfolded around Hims & Hers Health and its short-lived oral semaglutide offering did not occur in a single regulatory moment. It unfolded over time. The company’s 2024 experiment with a compounded oral GLP-1 tablet marked the beginning of a broader reckoning—one that moved from regulatory ambiguity and manufacturer pressure to coordinated federal enforcement by 2025 and early 2026.

Understanding that arc matters. In 2024, the legal landscape was unsettled. By 2026, it was not. What changed—and how quickly—explains why Hims’ oral semaglutide initiative was ultimately unsustainable and why the GLP-1 compounding environment today bears little resemblance to the one that existed just two years earlier.

2024: The GLP-1 Market, Shortages and Regulatory Gray Space

By 2024, GLP-1 receptor agonists had transformed obesity and diabetes care. Semaglutide and tirzepatide produced consistent, clinically meaningful weight loss and significant cardiometabolic benefits. Demand exploded. Supply lagged. Patients faced prolonged shortages, injection aversion prices exceeding $1,000 per month.

During this period, the FDA continued to list certain GLP-1 products as being in shortage. That designation mattered. It allowed compounding pharmacies, under Sections 503A and 503B of the Federal Food, Drug and Cosmetic Act, to prepare compounded versions of otherwise approved drugs when commercial supply could not meet patient need.

But even in 2024, the legal flexibility was limited. Compounding was never intended to function as a substitute manufacturing pathway or a consumer-scale distribution model. It existed as a narrow exception, contingent on shortage status and patient-specific medical necessity.

Hims & Hers Tests the Outer Boundary

Against that backdrop, Hims & Hers Health expanded into GLP-1 therapy. The company’s early 2024 offering of compounded injectable semaglutide, supplied by partner pharmacies, reflected a broader telehealth trend: leveraging the shortage period to meet patient demand at lower price points.

The inflection point came when Hims introduced a compounded oral semaglutide tablet for weight loss. That product did not exist in FDA-approved form at obesity-level dosing. Oral peptide delivery presents well-documented scientific challenges and Novo Nordisk had spent years developing proprietary technology and clinical data to bring oral semaglutide to market for diabetes.

In 2024, there was no FDA guidance squarely prohibiting oral compounded GLP-1s. But the risk profile was obvious. An unapproved dosage form, consumer-facing marketing and direct competition with a branded manufacturer placed the product at the far edge of regulatory tolerance.

Manufacturer Pressure Precedes Formal Enforcement

Novo Nordisk did not wait for regulatory clarity to respond. Throughout 2024, the company applied sustained pressure across multiple fronts—raising concerns with regulators about compounded GLP-1 safety, stability and bioavailability, particularly for oral formulations lacking proprietary absorption mechanisms.

At the same time, Novo signaled its willingness to escalate beyond traditional civil remedies. While formal DOJ involvement was not yet public in 2024, the prospect of criminal referral began to loom. The message to compounders and telehealth platforms was unmistakable: continued expansion would not be met with passive tolerance.

This phase—manufacturer pressure without fully articulated federal enforcement—defined much of 2024. The legal risk was asymmetric. Telehealth platforms bore an existential downside, while manufacturers could escalate incrementally.

2025: The FDA Draws Bright Lines

That ambiguity did not last. In late 2024 and into 2025, the FDA began formally declaring GLP-1 shortages resolved. Those determinations carried legal consequences. Once the shortage predicate disappeared, so did the statutory basis for routine compounding.

By spring 2025, most GLP-1 compounding outside narrow, documented medical necessity became presumptively unlawful. The FDA made clear that affordability, convenience, or patient preference were insufficient justifications. Compounded products that were “essentially copies” of FDA-approved drugs were no longer tolerated.

Enforcement followed. In September 2025, the Food and Drug Administration, working with HHS, issued dozens of warning letters targeting compounding pharmacies, telehealth platforms and manufacturers marketing GLP-1 products. The focus was not only on compounding practices, but on marketing conduct—claims suggesting equivalence, predictability of outcomes, or parity with FDA-approved drugs.

Early 2026: Clarification, Not Retreat

That enforcement posture culminated in February 2026, when the FDA publicly stated its intent to take action against non-FDA-approved GLP-1 drugs. The announcement triggered widespread concern among patients and providers relying on compounded therapies.

Subsequent clarification made an important distinction. The agency did not signal a blanket prohibition on lawful, patient-specific compounding by state-licensed pharmacies. Instead, it identified clear enforcement priorities: compounding without documented medical necessity, unlicensed manufacturing, misleading marketing, improper storage and shipping, poor API sourcing and the use of research-grade ingredients not intended for human use.

The clarification did not reopen the door to broad GLP-1 compounding. It confirmed that the remaining pathway is narrow, technical and heavily scrutinized.

Why Hims’ Retreat Was Inevitable

Viewed through this timeline, Hims’ decision to discontinue its oral semaglutide product was not a reaction to a single regulatory action. It was a rational response to an evolving enforcement environment. By late 2024, the oral formulation carried disproportionate risk: scientific uncertainty, heightened regulatory exposure and the certainty of manufacturer opposition.

As enforcement hardened in 2025 and federal alignment became explicit in early 2026, including confirmed DOJ involvement, the decision looked less strategic and more unavoidable.

What This Means Going Forward

The GLP-1 compounding landscape today is not the one that existed in 2024. What began as regulatory gray space has narrowed into a tightly policed corridor. Innovation alone does not create legal protection. Marketing conduct now drives enforcement risk as much as formulation technique.

For pharmacies and digital health platforms, the message is clear. Compounding must be supported by documented, patient-specific medical necessity. Advertising must be conservative. Supply chains must be validated. Compliance systems must be real, not aspirational.

Conclusion

The Hims oral semaglutide episode is best understood as an early signal, not an anomaly. It marked the point at which regulatory tolerance began to collapse under manufacturer pressure and federal scrutiny. By 2026, that collapse was complete.

Those still operating in the GLP-1 space must recognize that the ground has shifted and that acting as if it has not is no longer aggressive innovation. It is regulatory exposure.