HIMS putting on a masterclass on how to destroy a company

They somehow think that rules don't apply to them. Turns out that you can't just revolutionize the medical industry. Who knew?!

It's been fascinating to watch.

A little summary:

Hims & Hers Health, a telehealth company specializing in direct-to-consumer medications, has demonstrated significant naivety in its aggressive push to sell compounded versions of popular GLP-1 weight-loss drugs (like semaglutide, mimicking Ozempic and Wegovy). This stems from their apparent underestimation of regulatory risks, including FDA restrictions on compounding once drug shortages end, intellectual property conflicts with pharma giants like Novo Nordisk, and the potential for misleading marketing to trigger lawsuits and enforcement.

By prioritizing low-cost access and high-profile advertising (e.g., Super Bowl spots) over rigorous compliance, they've repeatedly courted controversy, assuming "personalization" loopholes would shield them from scrutiny. This approach ignores historical FDA crackdowns on unapproved drugs, patient safety concerns (e.g., untested foreign-sourced ingredients), and the power of Big Pharma lobbying, leading to a pattern of short-lived initiatives, stock volatility, and legal entanglements that could have been mitigated with more cautious vetting.

Here's an outline of the key troubles Hims & Hers has faced over the last year (roughly February 2025 to February 2026), based on regulatory actions, lawsuits, and market fallout:

February 2025: Super Bowl Ad Controversy – Their ad during Super Bowl LIX promoted compounded GLP-1s, sparking allegations of violating FDA rules on drug advertising by downplaying the unapproved status and lack of clinical trials. This drew criticism from regulators, senators, and consumer groups for misleading consumers about safety and efficacy.

April-June 2025: Partnership with Novo Nordisk Collapses – Announced a collaboration with Novo to sell FDA-approved Wegovy in April, but Novo terminated it in June, accusing Hims of "deceptive promotion" of illegitimate knockoffs using unsafe foreign ingredients. This led to public sparring and immediate stock drops.

July 2025: Securities Class Action Lawsuit Initiated – Investors sued (Sookdeo v. Hims & Hers) alleging misleading statements about the Novo deal and risks of selling knockoffs, claiming executives hyped approved drugs while pushing unapproved versions.


September 2025: FDA Warning Letter for Unapproved Drugs – FDA issued a warning for unlawful sale of misbranded compounded semaglutide, citing false claims like "same active ingredient as Ozempic/Wegovy." This was part of a broader crackdown with over 100 letters to telehealth firms.


November 2025-January 2026: Securities Lawsuit Advances – Court appointed lead plaintiff and counsel in November; amended complaint filed in January, expanding claims of investor deception regarding regulatory compliance and partnerships.


February 2026: Launch and Rapid Halt of $49 Compounded Pill – Launched an oral compounded semaglutide pill on February 5 at $49/month, undercutting branded options. Novo threatened and filed a lawsuit for patent infringement and deceptive marketing, seeking a permanent sales ban. FDA announced restrictions on GLP-1 ingredients, citing safety/quality issues, and HHS referred Hims to DOJ for potential federal violations. Hims halted sales by February 7 amid backlash, with shares plunging up to 16%.


Ongoing 2026 Super Bowl Concerns – Ahead of the 2026 Super Bowl, consumer alerts highlighted risks in their ads promoting "personalized" compounded GLP-1s with untested additions (e.g., B vitamins), potentially leading to dosing errors and side effects.


Social media buzz amplified scrutiny, with users and analysts criticizing the company's "dangerous and deceptive" practices.

These issues have compounded financial pressures, with repeated stock tumbles and ongoing legal costs, highlighting the perils of challenging established pharma regulations without robust safeguards.

Is this over the various GLP peptides? I thought you couldn't patent a peptide. Or was HIMS copying something of NVO that was under patent?

So big pharma using their might to crush the little guy. A tale as old as time.

What? Hims is publicly listed, and "the big guy" in compounding these drugs. The compounding places that can still sell it are small and not publicly listed.