739 F.Supp.3d 742
S.D. Iowa2024Background
- Plaintiffs Climbing Kites LLC and Field Day Brewing Co. sell hemp-derived THC beverages legal under federal and Iowa law after the 2018 Farm Bill and Iowa Hemp Act.
- In May 2024, Iowa passed House File 2605 (HF 2605) restricting THC potency in consumable hemp products and mandating new warning labels and other packaging rules effective July 1, 2024.
- Plaintiffs filed for a preliminary injunction to stop enforcement of HF 2605, asserting it is federally preempted and otherwise unlawful.
- The Iowa Department of Health and Human Services, led by Director Kelly Garcia, adopted guidance establishing a 12 oz. minimum serving size and a specific warning label, per legislative authorization.
- The federal district court expedited briefing and held a hearing on June 28, 2024; on July 2, it denied the preliminary injunction, explaining the reasons in this opinion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held (Court’s Ruling) |
|---|---|---|---|
| FDCA Preemption of HF 2605 | HF 2605’s potency/labeling rules are not identical to the FDCA; only FDA can regulate these areas. | Potency limit doesn't regulate labeling; warning is permitted—and expressly exempt from preemption by FDCA/NLEA. | Plaintiffs not likely to succeed; HF 2605 allowed by federal law; FDCA/NLEA does not preempt Iowa’s law. |
| Primary Jurisdiction (Stay Pending FDA) | Court should stay/enjoin HF 2605 pending potential FDA action on hemp-THC labeling/serving. | No authority to enjoin a state law solely based on primary jurisdiction; only possible to stay case, not law itself. | Court refused to enjoin state law based on this doctrine—no legal basis to do so. |
| Department’s Interpretive Authority | Department exceeded statutory authority in applying a 12 oz. serving size/minimum, ignoring proper rulemaking/Judicial review needed. | Department following FDA precedent for serving size and within authority; plaintiffs have state remedy under Iowa Administrative law. | Federal court lacks jurisdiction over state regulatory and APA claims; remedy is in state courts per Iowa statute, not federal court. |
| Irreparable Harm | Without injunction, products will be illegal, causing economic loss and potential criminal liability. | Failure on merits means harm/other factors can’t outweigh lack of legal basis for injunction. | No injunction—no likelihood of success on the merits, so balance of harms/public interest not reached in detail. |
Key Cases Cited
- Winter v. Nat’l Res. Def. Council, 555 U.S. 7 (2008) (sets standard for preliminary injunction, emphasizing likelihood of success and irreparable harm)
- Planned Parenthood Minn., N.D., S.D. v. Rounds, 530 F.3d 724 (8th Cir. 2008) (en banc) (heightened standard for enjoining statutes/regulations)
- Chamber of Commerce of U.S. v. Whiting, 563 U.S. 582 (2011) (emphasizes congressional intent as ultimate preemption touchstone)
- Sciortino v. PepsiCo, Inc., 108 F. Supp. 3d 780 (N.D. Cal. 2015) (NLEA preemption does not apply to state food safety warnings)