State Regulatory Landscape: A Representative Survey (6 of 50 States)

State law cannot legalize an FDA-unapproved biologic drug. This page explains federal preemption and summarizes six representative state statutes — disclosure laws, physician-conduct laws, and a smaller group of more aggressive authorization laws — and how each interacts with, but does not override, FDA's authority. This is a partial survey, not a complete 50-state review; see the scope note below.

The legal baseline

21 U.S.C. § 321(g) defines "drug" broadly enough to sweep in most cell and biologic products intended to treat, cure, mitigate, or prevent disease. 42 U.S.C. § 262(i) (PHS Act §351) governs biologics licensure. Federal courts have repeatedly confirmed this framework applies regardless of state authorization: in October 2024, the Ninth Circuit held that certain stem cell (stromal vascular fraction) products require FDA premarket approval, rejecting arguments that minimal-processing, same-day procedures escape drug regulation; the U.S. Supreme Court denied certiorari, leaving that ruling in place (reported October 2025).

FDA operated a 36-month "enforcement discretion" period (announced November 2017, extended for COVID-19) during which it generally did not enforce IND/premarket requirements against certain HCT/Ps that raised no reported safety concerns. That period expired May 31, 2021. Several of the more aggressive state statutes below were enacted after that enforcement-discretion window closed — i.e., after FDA had already re-asserted active enforcement.

A representative sample of state approaches (6 of 50 states)

State statutes in this space generally fall into three categories: (1) disclosure/consumer-protection statutes that assume FDA's regulatory line and add notice requirements; (2) practitioner-conduct statutes that limit state licensing-board discipline for compliant physicians, without purporting to change the product's federal status; and (3) a smaller, more recent group of statutes that attempt to authorize clinical marketing of specific unapproved product categories outright — which legal commentary consistently describes as being in direct tension with federal law.

California — disclosure model (Cal. Bus. & Prof. Code § 684)

Requires a practitioner performing a non-FDA-approved "stem cell therapy" (defined by direct reference to the 21 CFR §§ 1271.3/1271.10/1271.15 HCT/P criteria) to post and provide a specific written notice that the therapy is not FDA-approved, before the first treatment. Violations are subject to licensing-board citation/fine. The statute does not purport to authorize marketing of unapproved products — it assumes FDA's regulatory line and layers disclosure on top of it. It does not apply where the practitioner already holds FDA IND/IDE approval.

Texas — physician-conduct model (Health & Safety Code Ch. 1003, "Charlie's Law")

Permits a licensed physician to administer an investigational adult stem cell treatment to a patient with a severe chronic or terminal illness who has exhausted approved options, with written informed consent, physician certification, and IRB oversight, and limits Texas Medical Board discipline for compliant physicians. Legal commentary at passage noted this creates potential state-federal tension, since "state laws are subordinate to federal FDA rules" — the statute limits state licensing consequences; it does not exempt the underlying product from FDA premarket requirements.

Florida — broader authorization model (Fla. Stat. § 458.3245, effective July 2025)

Allows a physician to perform non-FDA-approved "stem cell therapy" (including certain perinatal/placental HCT/Ps) within orthopedics, wound care, or pain management, subject to sourcing, advertising-disclosure, informed-consent, and cGMP-reference requirements, and excludes anyone who already holds FDA IND/IDE approval. Legal commentary characterizes this as one of the more aggressive state statutes, explicitly noting it attempts to "provide leeway" for treatment outside FDA approval — a leeway that does not bind FDA itself.

Utah — placental tissue model (SB 199, 2024)

Permits a broad category of licensed health care providers to perform non-FDA-approved placental/perinatal stem cell therapy with written notice and informed consent. Widely reported (Science/AAAS headline: "Utah flouts FDA with law greenlighting placental stem cell therapies") as one of the clearest examples of a state statute in direct tension with federal authority.

Montana — licensed "Experimental Treatment Center" model (SB 535, 2025)

Creates a state licensing framework for facilities that may administer, for compensation, Phase-1-completed investigational drugs/biologics/devices to patients with any condition (not limited to terminal illness) — described by commentators as unusually broad among right-to-try-style statutes, and explicitly flagged in coverage as covering stem cell and peptide therapies. It creates a parallel state licensing regime; it does not and cannot exempt a manufacturer from federal drug/biologic requirements.

Louisiana — board policy reinforcing federal control

The Louisiana State Board of Medical Examiners' 2013 policy on non-FDA-approved stem cell products directs physicians to ensure compliance with federal law and generally avoid use absent FDA approval, an approved IND with enrolled-patient status, or an applicable FDA exemption — a useful contrast to the more permissive statutes above. Louisiana separately enacted an "Individualized Treatments Act" (HB 899/Act 750, 2024) that expressly excludes embryonic-stem-cell-derived products from its expanded right-to-try mechanism.

"Right to Try 2.0" / Individualized Treatments Acts (multi-state trend)

A newer category of state statute, broader than the original state and federal right-to-try models, permits access to investigational products that have not completed Phase 1. Advocacy-sourced tracking lists roughly 17 states as having enacted some version of this model as of 2026. Unverified as a complete list Only Texas, Louisiana, Nevada, and Montana were independently corroborated with primary or near-primary sourcing in this research pass; the remainder should be verified state-by-state before being asserted as fact.

State medical board and enforcement examples