Lobbies the White House directly on peptide policy, and the opposition also lines up
Hims and Hers Health is the only publicly traded telehealth company directly lobbying the White House Office of Information and Regulatory Affairs (OIRA) on rule 0910-ZD94 (temporary compounding access for select peptides).
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This signals that peptides and longevity are a real product line, in contrast with the company's retreat in March from compounded GLP-1s to the Novo Nordisk brand. But the lobbying has shifted from pro-only to both sides. Consumer protection groups, evidence-based medicine groups and pharma lobbyists have all scheduled meetings for 27-28 Oct, and there are also a Safe Medication Coalition citizen petition and undercover materials on telehealth-prescribed injectable compounded peptides. The final policy may be narrowed (fewer peptides, more conditions) or delayed. Compliance risk is stacking up, as HIMS is also fighting an FTC suit and a securities class action. The core conflict is unchanged: 38% revenue growth against a gross margin compressed to 64%, an operating loss and rising compliance cost. The next check is Q3 earnings on 9 Nov after the close.
Key evidence
- Primary source: the reginfo.gov White House OIRA meeting registry, rule 0910-ZD94 (Temporary Access Policy for Select Peptide Compounding). Hims and Hers Health requested a meeting for 23 Oct at 2pm ET, with Sonya Elling as the applicant. The company initiated the meeting; it was not summoned.
- Other meetings on the same rule: the American Peptide Society on 21 Oct (pushing to open access). On 27 Oct, the American Pharmacy Compounding Alliance (a compounding industry trade group) and the Center for Science in the Public Interest (CSPI; consumer protection, generally against opening access). On 28 Oct, Faegre Drinker, representing the Evidence-Based Medicine Collaborative, and Carmen Group, representing Medivant Healthcare (pharma).
- Opposition action: on 16 Oct, the Safe Medication Coalition filed an FDA citizen petition demanding that BPC-157, KPV, TB-500, MOTS-c, Semax, epitalon and DSIP be banned from compounding in full, including under temporary enforcement discretion. It also challenged the July advisory committee vote on conflict-of-interest grounds. It published undercover materials from telehealth platforms selling injectable compounded peptides, and filed complaints with pharmacy regulators and the FDA Office of Criminal Investigations.
- The policy text is not yet public. The Executive Order 12866 review window is 90 days, extendable by 30 days.
- HIMS is the only publicly traded telehealth company directly lobbying on this rule. That signals peptides are a real product line, not just a mention on an earnings call. It contrasts with the March retreat from compounded weight loss to the Novo Nordisk brand: weight loss has retreated to the brand, while longevity and peptides are actively fighting for a compounding path.
- The lobbying field has shifted from pro-only to multi-sided, and the policy may be narrowed (fewer peptides, more conditions) or delayed. The 16 Oct note, that submission for review does not equal implementation, now carries concrete uncertainty.
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- The undercover materials target exactly the model of telehealth-prescribed injectable compounded peptides. HIMS is also fighting an FTC lawsuit and a securities class action. It is a compliance-sensitive period, and HIMS is pushing hardest in a category with weak efficacy evidence. Reputation risk is rising.
- Directionally positive (HIMS is positioning aggressively and its Menlo Park facility is ready), but the content of the meeting has not been disclosed and the outcome is not visible. The real catalyst is publication of the policy text and whether the peptide list is narrowed. The core conflict is unchanged: 38% revenue growth, against a 64% gross margin, an operating loss and rising compliance cost.
Catalysts to watch
- Publication of the policy text for rule 0910-ZD94: watch for a narrower peptide list or added conditions.
- Outcome of the opposition OIRA meetings on 27-28 Oct (American Pharmacy Compounding Alliance, CSPI, Evidence-Based Medicine Collaborative, Medivant).
- FDA response to the Safe Medication Coalition citizen petition (16 Oct).
- Q3 2026 earnings on 9 Nov after the close: revenue growth, gross margin, operating loss and compliance cost.
- Lead plaintiff deadline of 2 Nov in the 3 Sep securities class action.
- Any new 8-K after 7 Oct on policy or litigation developments.
Risks
- The final policy narrows the peptide list or adds conditions, limiting the runway for compounding.
- The policy is delayed beyond the review window of 90 days plus a 30-day extension.
- Compliance risks are stacking up: the FTC suit, the securities class action, the undercover telehealth peptide materials and the Office of Criminal Investigations complaint.
- Reputation risk from pushing hardest in a weak-efficacy category while facing several legal fronts.
- Gross margin compression to 64% persists, and the operating loss widens on compliance and marketing costs.
Sources (4)
- reginfo.gov OIRA meeting registry, rule 0910-ZD94
- Safe Medication Coalition FDA citizen petition, 16 Oct
- Executive Order 12866
- SEC EDGAR: latest HIMS 8-K dated 7 Oct, no new filing
A brief is a lead for our research, not a verified conclusion or advice.