Council for Responsible Nutrition v. James

Council for Responsible Nutrition · United States Court of Appeals for the Second Circuit · November 13, 2025 · No. No. 24-1343

Summary

The Second Circuit affirmed the denial of the Council for Responsible Nutrition’s motion for a preliminary injunction against enforcement of New York General Business Law § 391-oo, which restricts the sale of certain weight-loss and muscle-building dietary supplements to minors. The court held that the statute likely satisfies intermediate scrutiny under the Central Hudson test and rejected the plaintiff’s compelled-expression arguments concerning age verification. The court also concluded that the appeal concerning the dismissed vagueness and preemption claims was not moot because no final judgment had been entered and effective interim relief remained available.

Court
United States Court of Appeals for the Second Circuit
Writing for the Court
Myrna Pérez; Chin; Pérez; Nathan
Jurisdiction
United States Court of Appeals for the Second Circuit
Decision date
November 13, 2025
Docket number
No. 24-1343
Procedural posture
Appeal from the denial of a motion for a temporary restraining order and preliminary injunction seeking to enjoin enforcement of New York General Business Law § 391-oo.
Standard of review
Denial of a preliminary injunction is reviewed for abuse of discretion. A district court abuses its discretion when its decision rests on a clearly erroneous factual finding or an error of law. The appellate court may affirm on any basis supported by the record.
Precedential value
published and precedential
Parties
Council for Responsible Nutrition v. Letitia James, in her official capacity as New York Attorney General
Disposition
affirmed

Topics

intermediate scrutinyfree speechpreemptionappellate jurisdictionprocedural due process

Practice areas

constitutional lawhealth lawappellate procedureremediesstatutory interpretation

Questions Presented

  1. Whether the Second Circuit had appellate jurisdiction to review the denial of preliminary injunctive relief concerning claims that had been dismissed under Rule 12(b)(6) but not resolved by a final judgment.
  2. Whether § 391-oo likely violates the First Amendment by regulating commercial speech concerning supplements marketed for weight loss or muscle building.
  3. Whether § 391-oo's age-verification requirement unconstitutionally compels CRN or its members' speech or expressive conduct.
  4. Whether § 391-oo is unconstitutionally vague or overbroad.
  5. Whether § 391-oo is preempted by the Food, Drug, and Cosmetic Act.
  6. Whether CRN established irreparable harm and that preliminary relief would serve the public interest.

Holdings

  1. An appeal from the denial of a preliminary injunction is not moot merely because some underlying claims were dismissed under Rule 12(b)(6) when no final judgment has been entered and at least one claim remains pending; interim injunctive relief remains available.
  2. Section 391-oo satisfies intermediate scrutiny under the Central Hudson test and therefore does not likely violate the First Amendment by restricting sales based on the marketing or representation of covered dietary supplements.
  3. Section 391-oo's age-verification procedures do not compel CRN or its members' own speech or expressive conduct, and any burden on expression is incidental to a permissible regulation of commercial activity.
  4. CRN failed to establish that § 391-oo is facially vague under the Due Process Clause or facially overbroad under the First Amendment.
  5. Section 391-oo is not preempted by 21 U.S.C. § 343-1(a) because it does not impose a requirement respecting a claim on a supplement label; it imposes an independent sales restriction triggered by the manufacturer's labeling or marketing choice.

Key quotations

We have jurisdiction to review the denial of a preliminary injunction pursuant to 28 U.S.C. § 1292(a)(1). (9)
Again, the fit need only be “reasonable,” not “perfect.” (15)
That obligation— the duty not to sell the product to minors—is not a “requirement respecting any claim” contained on the label. (29)

Factual background

New York General Business Law § 391-oo prohibits selling or giving away to persons under eighteen certain over-the-counter diet pills and dietary supplements marketed or represented for weight loss or muscle building, and requires age verification for purchasers who appear younger than twenty-five. The statute was enacted in response to evidence that minors use these supplements and that some supplements pose serious health risks. CRN, a trade association representing the dietary-supplement industry, challenged the law based on alleged burdens on commercial speech, compelled speech, vagueness, and federal preemption.

Procedural history

CRN sued the New York Attorney General before the statute's effective date, alleging violations of the First Amendment, vagueness principles, and federal preemption. The Southern District of New York denied CRN's request for a temporary restraining order and preliminary injunction. It later dismissed the vagueness and preemption claims under Rule 12(b)(6) but allowed the First Amendment claim to proceed. The Second Circuit held that the preliminary-injunction appeal remained justiciable because no final judgment had been entered and affirmed the denial of preliminary relief.

Court Document

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