Hims House

In Hims House episode 60, Sam Koppelman (co-founder of Hunterbrook Media) joins Jonathan Stern to break down the renewed Hims x Novo Nordisk partnership that sent Hims' stock soaring. Koppelman argues CEO Andrew Dudum "wiped the floor" with Novo, essentially conceding nothing beyond dropping compounded GLP-1 ads. They dig into why Novo folded, how FDA enforcement under Marty Makary has been softer than expected, and whether compounded GLP-1s will survive 2026. The conversation also turns to peptides as Hims' next major growth lever, powered by its own manufacturing facility and coming regulatory changes under RFK. Koppelman also discusses Hims vs Ro, and discloses that Hunterbrook Capital is currently long $HIMS.00:00 - Sponsor: Mochi Health02:39 - Hims x Novo are back!07:40 - Why Dudum "wiped the floor" with Novo11:38 - The semaglutide pill controversy13:48 - Branded vs compounded GLP-1s 16:32 - Eli Lilly next?17:36 - FDA enforcement since Makary21:31 - Why peptides could be HUGE30:57 - Hims subscriber growth and outlook33:18 - Ro vs Hims35:45 - Hunterbrook’s current Hims position 👀Disclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.

Thanks to our partner, Mochi Health! https://JoinMochi.comSubscribe to Hims House:https://himshouse.com/subscribeFollow us:https://x.com/himshousehttps://x.com/jonathanrsternhttps://x.com/Raul_DSFJoin the Discord:https://discord.gg/tJqGgVhkEtIn this emergency episode of Hims House, Jonathan Stern is joined by Raul Shah, founder and CEO of DocShah Financial and a longtime HIMS shareholder, to unpack the new HIMS–Novo Nordisk partnership. They break down the deal terms, why Raul thinks it removes the biggest legal and regulatory overhangs and restores the platform thesis, and what both sides get out of it. From there they stress-test every major bear case, discuss margin impacts, future pharma partnerships, buybacks vs. dilution, the peptides opportunity, and long-term valuation math.00:00 - Sponsor: Mochi Health01:14 - Background on DocShah Financial04:12 - The Friday night Bloomberg rumor05:49 - Breaking down the actual deal terms07:48 - Why does this deal make sense for both sides?10:00 - Who won the deal?14:15 - Will the deal actually hold this time?16:50 - Margin impact and platform upside18:41 - Could Lilly or other pharma deals follow?21:47 - The remaining bear theses 23:45 - "Hims is too dependent on GLP-1s"25:30 - "The core business is dead"27:31 - "International expansion won't work"30:46 - "Subscriber growth slowing, CAC rising" 31:33 - Lifetime value vs. customer acquisition cost34:04 - Why did Raul hold through the 2025 drawdown37:22 - Buybacks and capital allocation40:18 - Peptides 42:57 - 2026 priorities44:04 - Does Hims actually have a moat?49:12 - Revenue targets and valuation55:57 - Peptides as a re-rating catalystDisclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.

In this episode of Hims House, Jonathan Stern sits down with Mark Mulhern (Manu Invests) to break down HIMS’ Q4 and full-year results: $2.35B in 2025 revenue, 59% Q4 growth, and $318M EBITDA—alongside subscriber growth that has slowed to ~flat sequentially. They unpack 2026 guidance of $2.7-$2.8B (excluding the pending Eucalyptus deal) and why total 2026 revenue could still land around ~$3B once Eucalyptus is included. The core debate is around what management didn’t address: the Novo Nordisk patent lawsuit, FDA/DOJ probes, an SEC investigation disclosed in the 10-K, plus the compounded semaglutide pill launch-and-pullback that triggered chaos. They also dig into competitive pressure (Ro and pharma price cuts), the pivot to international + labs as growth levers, the unanswered AI/ML product roadmap, and whether peptides are the next “GLP-1 moment” or just hype.00:00 Sponsor: Mochi Health 01:57 Q4 2025 earnings recap 05:22 2026 guidance & Eucalyptus impact09:34 Unanswered issues: Novo, FDA/DOJ, SEC14:06 Semaglutide pill chaos 19:49 International expansion23:38 U.S. core slowdown24:50 Why Mark still holds HIMS 27:44 Labs: acquisition and flywheel 31:14 Execution on new launches 34:55 Peptides 38:58 What is Hims’ new AI team building?! 41:30 Ranking risks: Novo vs. FDA vs. DOJ vs. SEC44:00 Hims x Lilly? 47:44 Sentiment drag54:48 Valuation and stock price 57:36 2026 predictions Disclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.

In Hims House episode 57, former quant Annanay Kapila (ex–Tower Research, Cambridge math) breaks down how high-frequency trading actually works and why retail investors shouldn't try to beat HFT firms at their own game. He breaks down QFEX, his new 24/7 exchange built with crypto-style efficiency for traditional markets, and the core case for nonstop trading. The conversation then turns to Hims' extraordinary short interest — roughly 76 million shares, around 44% of float — with Annanay pointing out that theoretically much of it *could* stem from long/short hedge fund mandates, risk-model offsets, and institutional groupthink rather than fundamental bets against the business. They also unpack what large disclosed stakes from firms like Jane Street and JP Morgan actually signal. The episode closes on Annanay’s essay “Prediction Market Paradox” - a dimmer view on prediction markets. 00:00 Sponsor: Mochi Health02:10 High-frequency trading 03:59 Background of a quant 12:47 Why Annanay left Tower to build QFEX 15:28 The case for 24/7 trading18:56 Does HFT “rig” the market?25:45 Why Is Hims so heavily shorted?34:25 How to read short disclosures correctly 37:14 What might trigger shorts to cover?40:15 Hims down 17 out of 18 weeks 🤯41:41 Convertible notes and the anti-squeeze 45:52 What a Jane Street stake really means52:11 Prediction markets Disclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.

In Episode 56 of Hims House, Jonathan Stern sits down with Myra Ahmad, founder and CEO of Mochi Health, to unpack where GLP-1s are headed - and how Mochi is building a broader telehealth marketplace around metabolic care. Myra explains Mochi’s pharmacy “marketplace” model and how she thinks about staying compliant with compounded GLP-1 pills amid increasing FDA scrutiny. They discuss oral vs. injectable GLP-1s, why pills may be an on-ramp but not a long-term winner for most patients, and what the Hims GLP-1 pill episode signals about enforcement and risk. Myra also outlines Mochi’s expansion beyond weight loss, including longevity and labs, and where AI can (and can’t) meaningfully replace humans in healthcare. The conversation closes with predictions on the next wave of GLP-1s.00:00 - Sponsor: Mochi Health 01:56 - Mochi's compounded semaglutide pill 04:27 - Oral vs. injectable GLP-1s11:25 - $HIMS GLP-1 pill blowback17:19 - FDA enforcement risk and what could change22:27 - Patents, “personalization,” and where compounders may get exposed24:05 - Mochi's growth story24:47 - Retatrutide31:32 - Why the U.S. could resemble Canada's system34:09 - AI in healthcare37:40 - Labs, GRAIL, and prevention41:01 - The next era of GLP-1sDisclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.

Thanks to our partner, Mochi Health! https://JoinMochi.comIn this episode of Hims House, Jonathan Stern is joined by patent attorney Gaston Kroub to break down Novo Nordisk’s Delaware lawsuit accusing Hims of infringing the semaglutide “343” patent (U.S. Patent No. 8,129,343). They discuss what Novo is actually asking the court for (a reasonable royalty, damages, and a permanent injunction), what Novo has to prove, and what levers Hims has to fight back. Gaston explains why Novo didn’t seek a preliminary injunction at filing, why that may be intentional, and how venue, jury dynamics, and Delaware court congestion may shape the case timeline. They also get into the downside scenarios for Hims, possible defenses and mitigation strategies (invalidity, damages limitations, indemnification), and how parallel FDA and DOJ pressure could influence the broader future of compounded GLP-1s.02:25 The lawsuit and what Novo is seeking: royalties, damages, injunction07:41 Why no preliminary injunction filed12:31 Why did Novo file now vs. 8-9 months ago? 24:04 Why did Novo file in Delaware? 29:21 Likely timelines, chances of settlement or dismissal 33:20 Worst-case scenarios 36:48 Indemnification and supplier liability? 45:01 FDA & DOJ pressure on compounded GLP-1s49:46 How Hims miscalculated the oral launch55:00 What to watch next Disclaimer: This podcast is for informational and entertainment purposes only. Nothing discussed should be considered financial, investment, or legal advice. Always consult with a qualified professional before making financial decisions.

Thanks to our partner, Mochi Health! https://JoinMochi.comSubscribe to Hims House:https://himshouse.com/subscribeFollow us:https://x.com/himshousehttps://x.com/jonathanrsternhttps://x.com/maxmarchioneJoin the Discord:https://discord.gg/tJqGgVhkEtIn this episode of Hims House, Jonathan Stern sits down with Max Marchione (Founder/CEO of Superpower) to break down what Hims' “rich people live longer” Super Bowl ad signals about the company’s ambitions beyond GLP-1s. They debate the path from DTC e-commerce to a true health platform -- membership, verticalized manufacturing, and “Pharma 2.0” wellness therapeutics -- then widen to the peptide boom, gray-market demand, and the “health super app” race. They close on labs pricing dynamics, AI hiring, and what could re-rate Hims’ valuation.00:00 – Sponsor: Mochi Health01:58 – Why Hims' Super Bowl ad works03:52 – Membership + manufacturing + pharma 2.006:33 – Superpower's approach10:19 – The peptide market explosion + retatrutide16:13 – Health "super-app" race: Hims, Whoop, Oura, Superpower19:50 – Deep dive into peptides and regulatory outlook27:50 – Superpower's product roadmap28:39 – Pharma 2.0 and consumer-driven wellness30:25 – Labs pricing strategies and market dynamics36:51 – AI and engineering: what is Hims building?! 42:25 – Hims valuation: 10x (or even 100x) potential 🤯47:27 – Future of GLP-1s  Not financial, legal, or medical advice

EMERGENCY EPISODE!!! Hims has launched a compounded oral semaglutide (GLP-1) pill, immediately triggering legal threats from Novo Nordisk. Jonathan Stern is joined by Cremieux, a bioinformatician and leading GLP-1 researcher, to break down what Hims actually released and why the drug-delivery mechanism matters. The conversation examines liposomal delivery vs. Novo’s proprietary SNAC technology, whether Hims’ product will work at all, and whether Novo will sue / how things might shake out if they do. The episode closes with a look at unit economics, next-gen GLP-1s, and what this gambit means for Hims, Novo, and the broader obesity drug market.00:00 Sponsor: Mochi Health02:24 Initial reaction to the news03:56 Science deep dive: liposomal delivery vs. SNAC06:02 Legal implications and possible lawsuit18:38 Future of the GLP-1 market (retatrutide, Viking, orforglipron)25:03 Final risk assessment and conclusionsNot financial, legal, or medical advice

Thanks to our partner, Mochi Health! https://JoinMochi.comIn this episode of Hims House, Jonathan Stern sits down with Sabina Hemmi (founder of GLP Winner), for the most comprehensive episode on GLP-1s that Hims House has done. They cover the compounding wars -- federal legislation, state-level crackdowns, and the lawsuits -- before diving into why tirzepatide dominates patient demand and what might be holding Hims back from offering it. The discussion spans oral GLP-1s, microdosing trends, and concludes with Sabina's skeptical take on peptides. 00:00 - Sponsor: Mochi Health02:59 - Video games → GLP-1s04:56 - GLP Winner Overview10:28 - Who does Hims actually compete with? 16:43 - Hims x Novo Relationship23:17 - Why tirzepatide is superior29:30 - The SAFE Drugs Act32:23 - State Bills: Indiana, Florida, Virginia40:43 - Adverse events43:09 - GLP-1 pill vs. injectables50:57 - Over-the-Counter GLP-1 coming soon? 52:55 - Peptides Not financial, legal, or medical adviceSubscribe to Hims House:https://himshouse.com/subscribeFollow Sabina:Tiktok: https://www.tiktok.com/@lawliepop Instagram: https://www.instagram.com/lawliepops Youtube: https://www.youtube.com/@lawliepop X/Twitter: https://x.com/lawliepop Substack: https://substack.com/@lawliepopLinkedin: https://www.linkedin.com/in/sabina-hemmiFollow us:https://x.com/himshousehttps://x.com/jonathanrsternJoin the Discord:https://discord.gg/tJqGgVhkEt

In episode 51 of Hims House, Bayside returns to the podcast to for year-end recap + 2026 predictions. The conversation covers Hims & Hers’ eventful 2025—international expansion, acquisitions, new product categories, partnerships and breakups—before pivoting to what investors should watch for in 2026. Bayside, who shifted to a more cautious stance mid-2025, explains his current thinking on valuation, growth rates, and the catalysts that could change the narrative. The episode closes with bold predictions about tirzepatide, a potential Super Bowl ad, and where the stock might trade heading into earnings.00:00 - Welcome back to Bayside01:10 - 2025 Recap: Labs, testosterone, menopause, international, acquisitions (Livewell, YourBio), $250M buyback, Deb Autor as Chief Policy Officer03:21 - Revenue concerns08:45 - Valuation framework11:30 - Is compounding still at risk?16:51 - The competitive landscape20:22 - Super Bowl Ad Speculation24:15 - Tirzepatide?!29:32 - Peptides Opportunity32:13 - Novo partnership “active talks”38:13 - 2026 predictions45:30 - Wearables?50:10 - Celebrity partnership gap Get full access to Hims House at himshouse.substack.com/subscribe

Shalin Shah is the founder & CEO of Marius Pharmaceuticals, the company that partnered with $HIMS to launch oral testosterone (KYZATREX). We discuss how the partnership came about, the benefits of teaming up with $HIMS, and the future of TRT.(00:41) Origin of the partnership(02:55) Benefits of partnering with $HIMS(04:14) Deal shape and exclusivity(06:51) How KYZATREX will sit alongside compounded meds on the $HIMS platform(09:22) Will KYZATREX be personalized? (16:07) TRT as a schedule 3 substance(21:39) Gearing up for 2026 launch of KYZATREX(22:40) Future of TRT market(27:29) Peptides(29:44) Testosterone for females Get full access to Hims House at himshouse.substack.com/subscribe

In episode 49 of Hims House, Jonathan Stern and Patrick Lester (Bayside) host Mark Mikhael and Joshua Fritzler from Olympia Pharmacy. Mark (CEO of Olympia), and Josh (CFO) discuss the evolution of their Orlando-based compounding pharmacy -- around GLP-1s and beyond. They dive into regulatory uncertainties, the impact of ongoing MFN negotiations involving Big Pharma, the role of compounded GLP-1s, and the burgeoning field of peptides. The conversation also touches on the concept of longevity through peptides and diagnostic testing, the broader implications of their work, and the role of Hims & Hers in the compounding industry.(00:48) Olympia Pharmacy(04:03) GLP-1s(10:10) MFN negotiations(20:45) Self-injection(24:20) MAHA PAC appointment and goals(31:43) Peptides peptides peptides(42:32) Longevity & diagnostic testing(45:56) Hims industry impact Get full access to Hims House at himshouse.substack.com/subscribe

In episode 48 of Hims House, Jonathan Stern and Patrick Lester (Bayside) are joined by Saad Alam, founder & CEO of Hone Health. The discussion dives into Saad’s personal health journey and the founding of Hone Health during the pandemic. Saad discusses the company’s focus on hormonal health, weight loss, thyroid medications, and new longevity medications. Saad shares insights into diagnostics, the future of primary care, implications of the Meta ad privacy policy changes and FDA advertising crackdown, and the future of the telehealth industry.00:43 Saad’s personal health journey02:34 Hone’s products, revenue, competitors04:29 Enclomiphene vs. clomiphene09:07 Testosterone market and demographics14:10 What longevity means19:25 Lab testing and biomarkers22:09 Why Hone hasn’t offered GLP-1s 25:14 “Everyone has a Chinese peptide dealer now”33:53 Which peptides should Hims start with35:38 Meta ads and the FDA crackdown on ads40:43 Is primary care in trouble?47:52 Why Saad is bullish on Hims Get full access to Hims House at himshouse.substack.com/subscribe

In Episode 47 of Hims House, Jonathan Stern and Patrick “Bayside” Lester talk to Lee Rosebush, chair of the Outsourcing Facilities Association (OFA), about what’s really going on with GLP-1 medications and peptide compounding. We the FDA warning letters over drug ads, what the new FDA “Green List” means for the future of compounding, and whether the DDC list (which could restrict what’s “too hard” to compound) or MFN drug-pricing might change the rules. We also touch on the MAHA PAC, recent patent challenges to sema and tirz, and what all this could mean for patient access in the near future.Note: Conversation includes legal/policy and financial analysis; none of it is legal or financial advice.(00:46) Lee’s Twitter comeback(02:09) FDA’s warning letters to drug advertisers(12:41) Lee on the Lilly vs. Willow/Mochi lawsuits(20:45) GLP-1 patents(25:12) FDA “Green List”(28:51) Is a compounded GLP-1 crackdown on the way?(32:11) The DDC List(36:48) MFN price negotiations(44:15) MAHA PAC(46:09) RFK on peptides and “patient access”(50:35) Thoughts on Hims Get full access to Hims House at himshouse.substack.com/subscribe

In Episode 46 of Hims House, Jonathan Stern and Patrick Lester (Bayside) sit down with Rob Leclerc, founder of AgFunder and one of TIME Magazine’s Top 100 VCs. Rob explains why he believes Hims is a category-defining company -- comparing it to Nvidia in 2016 -- and weighs in on the company’s high-profile engineering/AI hires from Cruise. The discussion covers Rob’s own experience as a Hims customer, Hims’ push into AI and tech leadership, the ZAVA acquisition and global expansion, and emerging frontiers like testosterone, diagnostics, and wearables. They also dig into public-market pressures, regulatory challenges, and how Hims might stack new S-curves to fuel growth over the next decade.00:00 Intro01:15 Rob’s background + AgFunder02:21 Why Hims?03:37 Rob as a Hims customer06:55 Ex-Cruise tech leadership11:04 AI, robotics & safety mindset16:46 Is AI a bubble?21:41 Core growth slowdown27:45 Acquisition of ZAVA: how to evaluate28:56 The $1B raise31:17 Diagnostics, wearables, & home testing35:12 Emerging healthcare trends39:10 Regulation and patents44:37 Public markets50:27 Valuation Get full access to Hims House at himshouse.substack.com/subscribe

In Episode 45 of Hims House, hosts Jonathan Stern and Patrick Lester (aka Bayside) welcome Scott Brunner, CEO of the Alliance for Pharmacy Compounding, for a conversation on the future of compounding. They cover the surge in GLP-1 demand, lawsuits involving Eli Lilly and Novo Nordisk, FDA policies, and the regulatory pressures shaping 503A and 503B pharmacies. Brunner also unpacks the challenges around the demonstrably difficult to compound list, compounded hormone therapy, and peptides, while sharing insights into congressional actions and the MAHA movement’s role in protecting patient access to compounded medications.00:00 - Introduction01:02 - The Role of the Alliance for Pharmacy Compounding01:51 - 503Bs Ramping Production? Rumors vs Realities07:55 - Lawsuits Involving Eli Lilly and Novo Nordisk11:58 - Patents15:51 - Policy Negotiations and the MFN Debate25:06 - Lawmaker Letter to FDA28:04 - What’s in the APC Blueprint28:51 - The 5% Rule and MOU Requirements33:42 - The Demonstrably Difficult to Compound List41:00 - Compounded Hormone Therapy43:21 - Peptides Get full access to Hims House at himshouse.substack.com/subscribe

In Episode 44 of Hims House, hosts Jonathan Stern and Patrick Lester (Bayside) sit down with Geoff Cook, CEO of Noom. Noom is one of Hims' competitors and is best known for its behavioral health platform and recent expansion into GLP-1 microdosing and hormone replacement therapy. Geoff discusses Noom’s evolution, the shift in revenue from behavioral programs to medicated plans, and the company’s vision for democratizing longevity medicine. The conversation covers the business of GLP-1s, regulatory and legal challenges, the impact of tariffs and partnerships, and the future of personalized healthcare. The episode closes with predictions for the next decade in health tech and reflections on human flourishing.Link to the article about the "high-priced drug list": https://www.mmm-online.com/news/noom-wsj-ad-policy-changes-compounded-glp-100:00 - Introduction01:11 - Noom’s background and evolution05:17 - Noom's revenue breakdown: behavioral vs. medicated programs07:22 - Launch of GLP-1 microdosing17:44 - Geoff’s personal experience with microdosing21:12 - Policy and regulatory landscape for GLP-1s24:19 - Compounding, MFN pricing, and drug shortages28:38 - Noom's WSJ ad for high-priced drug list31:36 - Supply chain and tariffs on APIs34:10 - Partnerships with pharma (Lilly, Novo)37:11 - Legal risks and the future of healthcare “front doors”40:36 - Hims' core business slowdown: competition and ad policy45:21 - Noom’s strategy for growth... free tier?46:06 - Looking ahead: AI, peptides, and the future of health tech53:52 - Reflections on human flourishing Get full access to Hims House at himshouse.substack.com/subscribe

In Episode 43 of Hims House, hosts Jonathan Stern and Patrick Lester (Bayside) sit down with Dr. William Seeds, a board-certified orthopedic surgeon and pioneer in peptide therapy. Dr. Seeds shares how a personal tragedy led him to explore the power of peptides and why he believes they will redefine the future of medicine. The conversation covers the fundamentals of peptides, why they are often called "magical" drugs, and the skepticism they sometimes face. The trio also explores why the U.S. lags behind Europe and Asia in adoption, and the historical influence of Big Pharma. The episode closes with Dr. Seeds sharing predictions on how Hims could legally enter the peptide market, what products they may launch first, and how the field will evolve over the next decade.00:00 - Introduction01:31 - Dr. Seeds’ personal journey into peptides05:28 - Peptides 10113:44 - Legal & Regulatory Barriers17:00 - Response to Eric Topol's recent article25:29 - The U.S. legal landscape35:56 - Potential FDA crackdown bad actors36:29 - Risks facing physicians and vendors37:19 - What’s next in peptide policy38:43 - Patents40:51 - How Big Pharma shapes regulation44:37 - Peptide adoption worldwide47:06 - How will Hims enter the market?56:45 - The two, five and ten-year outlook01:02:55 - Final takeaways Get full access to Hims House at himshouse.substack.com/subscribe

In Episode 42 of Hims House, Jonathan Stern and Patrick Lester (Bayside) sit down with Shaun Noorian, founder & CEO of Empower Pharmacy, the world’s largest compounding pharmacy. We dig into why rumors about 503Bs “ramping up GLP-1s” may be misleading, how Empower is challenging Eli Lilly on tirzepatide patents, and the broader fight over compounding. We also how Trump’s new administration - RFK Jr. at HHS, and Marty Makary at FDA - could reshape the industry. We close with the MFN pricing backdrop under the new administration. All along the way, Noorian makes the case that compounding is not a loophole but a critical, highly regulated part of healthcare, and looks ahead to its future in hormone therapy, peptides, longevity medicine, and sleep health.00:00 – Intro00:52 – Empower’s mission: personalized medicine at scale03:07 – GLP-1 rumors: are 503Bs ramping? What’s actually legal09:21 – 503A vs. 503B compliance19:14 – The Eli Lilly v. Empower lawsuit27:04 – MFN pricing, EO chatter & compounding33:11 – Hims’ impact on the industry: awareness, lobbying & demand37:15 – HRT, peptides, longevity39:59 – Sermorelin explained41:32 – Bad actors vs. legitimate compounders43:08 – Odds: percent chance of FDA action against compounders Get full access to Hims House at himshouse.substack.com/subscribe

In this episode of Hims House, Jonathan Stern and Patrick Lester (“Bayside”) sit down with Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) and former FDA Associate Commissioner. Pitts recently authored a paper arguing that the FDA has failed to enforce existing limits on GLP-1 compounding, creating major public-health risks. They explore how CMPI operates and who funds it (big pharma), whether compounders are breaking the law or simply skirting its intent, and why the FDA’s resource constraints may explain its lack of action. The discussion digs into the dangers of unregulated foreign API supply chains, Pitts’ critique of “phony personalization” schemes, and how aggressive advertising complicates oversight. They also look at the enforcement tools available—from the 5% rule to “too difficult to compound” lists—and debate whether we’ll see targeted crackdowns or blanket bans.00:00 – Intro01:14 – Background on Pitts & CMPI03:08 – Initial Views on Hims05:43 – Are Compounders Breaking the Law or Just the Spirit of the Law?10:58 – FDA Enforcement Gaps & Compounding Loopholes18:33 – Unregulated Foreign API and Supply Chain Risks23:53 – “Phony Personalization Schemes”25:05 – Should Dosing Be Individualized?25:30 – FDA’s Role in Dosing Oversight26:11 – Why Pitts Thinks "Personalization" Claims Fall Short32:11 – Where GLP-1 Regulation May Be Headed35:11 – Odds that the FDA and/or Congress Will Crack Down Get full access to Hims House at himshouse.substack.com/subscribe