Hims & Hers Is Alleged to Be Selling Non-FDA-Approved GLP-1 Injections From a Supplier Tied to a Federal Fraud Conviction

"The largest uncontrolled, unconsented human experiment of our lifetime." — obesity doctor quoted by Hunterbrook, on the broader compounded GLP-1 market

Note on timing: This is a summary of the original Hunterbrook Media report published on June 27, 2024 — not a current short call. Hunterbrook affiliate Hunterbrook Capital disclosed a short position in HIMS at the time of publication. Many of the issues raised have since evolved materially through FDA action, litigation, and corporate announcements. This summary reflects the evidence as presented in the original report.

Hims & Hers Health is a direct-to-consumer telehealth company historically known for selling hair loss treatments, sexual health products, and mental health services. On May 20, 2024, the company announced it would expand into weight loss by selling compounded versions of GLP-1 injectable drugs — the same class of medications as Novo Nordisk's Ozempic and Wegovy. Within weeks of that announcement, Hims executives including the CEO and Chief Legal Officer sold more than 1.7 million shares for approximately $26.4 million in net proceeds.

Hims does not manufacture its own GLP-1 drug, and the drug is not FDA-approved. Instead, the company relies on a narrow regulatory exception. When the FDA designates a drug as being in "shortage," compounding pharmacies are permitted under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act to produce their own versions of the branded drug. Hims contracts with BPI Labs — a compounding pharmacy — to manufacture its semaglutide injections, then sells them directly to consumers through its telehealth platform at a significant discount to branded alternatives. Hunterbrook argues the entire business line depends on two fragile pillars: the FDA continuing to list GLP-1 drugs as in shortage, and the company avoiding patent or safety litigation from the branded manufacturers. Compounded drugs differ from FDA-approved generics in a critical way — the FDA does not verify the safety, effectiveness, or quality of compounded drugs.

• 01

  Hims's sole GLP-1 supplier, BPI Labs, is wholly owned by Belcher Pharmaceuticals, whose former executives were convicted in what the Department of Justice called a "Nationwide Telemedicine Pharmacy Health Care Fraud Conspiracy." Mihir Taneja pleaded guilty in November 2020 to introduction of misbranded drugs into interstate commerce with intent to defraud and mislead, was sentenced to 10 months in prison, and was ordered to pay nearly $21 million. The scheme involved kickbacks to physicians and repackaging over-the-counter medicines and vitamins as prescription-only drugs. Supplier Risk

• 02

  A Hunterbrook reporter qualified for a compounded GLP-1 prescription after completing a four-minute online survey, without ever speaking to a physician or submitting medical records. This pattern was corroborated by conversations with multiple Hims patients. Hunterbrook argues this prescribing process falls well short of the standard of care for a drug class with significant side-effect profiles. Clinical Risk

• 03

  The entire Hims GLP-1 business exists only because of the FDA's "shortage" designation for semaglutide and tirzepatide. The shortage exception can be closed at any time, which would eliminate the regulatory basis for compounding pharmacies to produce copies of patented branded drugs. Once removed, Hims's compounded GLP-1 business becomes legally untenable overnight. Regulatory

• 04

  Hunterbrook's FDA legal expert warned that Hims could face patent litigation from Novo Nordisk or Eli Lilly regardless of the shortage exception. Both companies have already begun litigating against compounders producing unapproved knockoffs. A successful patent suit would be independent of the FDA's regulatory treatment. Patent Risk

• 05

  Hims executives including the CEO and Chief Legal Officer sold more than 1.7 million shares for approximately $26.4 million in net proceeds in the weeks following the May 20, 2024 announcement of the compounded GLP-1 business line — disposing of equity at elevated post-announcement prices before the risks associated with the new offering were publicly understood. Insider Activity

• 06

  An obesity physician quoted by Hunterbrook described mass-compounded GLP-1 drugs as "the largest uncontrolled, unconsented human experiment of our lifetime," citing concerns that compounded versions lack the rigorous testing and quality-control verification applied to FDA-approved drugs. Hunterbrook noted that injectables from compounding pharmacies have been linked to patient deaths in past cases. Safety

Hunterbrook Media concludes that the Hims compounded GLP-1 business rests on a regulatory loophole that could close at any time, depends on a supplier with a history of FDA scrutiny and fraud convictions among former executives, and operates through a prescribing process that appears to fall below clinical standards. Hunterbrook Capital disclosed a short position in HIMS at the time of publication.

IMPORTANT LEGAL DISCLAIMER: This summary is produced by Activ8 Insights and is based solely on the research report published by Hunterbrook Media on June 27, 2024. All allegations, findings, and conclusions are those of Hunterbrook Media and represent opinions, not statements of fact. Activ8 Insights holds no position in any security mentioned and does not endorse or verify the claims contained herein. Hunterbrook Capital, an affiliate of Hunterbrook Media, disclosed a short position in Hims & Hers Health (NYSE: HIMS) at the time of the original report's publication; positions may have changed since. This is not investment advice. You should do your own research and due diligence before making any investment decision with respect to the securities covered herein.