Hims & Hers Health, Inc.

The FDA expressly named Hims & Hers among businesses marketing unapproved compounded GLP-1 products and announced enforcement intentions. Hims also disclosed an HHS official’s stated referral to the DOJ, which alone does not establish criminal charges.

State of the evidence

FDA and company disclosures document scrutiny but not any adjudicated violation.

Legal status — source text

Regulatory scrutiny and a reported referral, with no proven criminal disposition.

Attribution

Marketing and supply of unapproved compounded GLP-1 products.

Hims & Hers disclosed a February letter from the SEC Enforcement Division opening an investigation and requesting preservation of records about compounded semaglutide statements and business relationships. Its November filing did not report a final enforcement outcome.

State of the evidence

The inquiry is confirmed by the company’s SEC filing; wrongdoing has not been established.

Legal status — source text

SEC investigation disclosed, with no final sanctions verified.

Attribution

Potentially misleading semaglutide and commercial-relationship disclosures.

Novo Nordisk sued Hims & Hers in February 2026 alleging infringement of a semaglutide patent. Novo Nordisk voluntarily dismissed the case without prejudice on March 9; the case was closed, with a possible future refiling.

State of the evidence

The company’s SEC filing confirms the filing and withdrawal.

Legal status — source text

Civil case voluntarily dismissed without prejudice and without a merits ruling.

Attribution

Alleged infringement of Novo Nordisk’s semaglutide patent.

Consumers filed Doe v. Hims & Hers following the FTC action, alleging breaches of federal and California communication and medical privacy laws. The claims substantially overlap the government case.

State of the evidence

The SEC filing confirms the suit; its allegations remain unproven.

Legal status — source text

Putative civil class action with no verified final ruling.

Attribution

Allegedly unlawful collection and sharing of health data.

Investors allege Hims & Hers made misleading statements about its business outlook and Novo Nordisk partnership, covering parts of April to June 2025.

State of the evidence

The SEC filing confirms the lawsuit, not the allegations.

Legal status — source text

Pending civil securities class action without a final merits ruling.

Attribution

Allegedly misleading disclosures about the Novo Nordisk relationship.

A shareholder class action, Velanki v. Hims & Hers, was filed September 1, alleging misleading privacy and billing disclosures related to the FTC case. It remained pending in November.

State of the evidence

The SEC filing documents the case and its link to the FTC allegations.

Legal status — source text

Pending shareholder civil complaint with no final judgment identified.

Attribution

Allegedly misleading privacy and subscription-related public disclosures.

The FDA issued a warning letter stating that Hims & Hers marketed compounded semaglutide using misleading comparisons with approved medicines. The letter records the regulator’s position, not a criminal conviction.

State of the evidence

The FDA letter documents the regulatory findings, not a court judgment.

Legal status — source text

An administrative FDA warning was issued; no criminal conviction is identified.

Attribution

Allegedly misleading promotion of compounded semaglutide products.