Marketing-Triggered Age Restrictions on Dietary Supplements Survive Central Hudson and Avoid FDCA Preemption: Second Circuit Affirms Denial of Preliminary Injunction in CRN v. James

Introduction

This appeal presented a modern test case at the intersection of commercial speech, public health, and federal preemption. The Council for Responsible Nutrition (CRN), a trade association for the dietary-supplement industry, sought to preliminarily enjoin New York General Business Law § 391-oo. The statute bars the sale of “dietary supplements for weight loss or muscle building” to persons under eighteen, defining covered products by how they are “labeled, marketed, or otherwise represented” for those purposes, and requires age verification for purchasers appearing under twenty-five. Protein supplements are expressly excluded.

After the district court denied preliminary relief, CRN appealed, pressing First Amendment (commercial and compelled speech), vagueness and overbreadth, and FDCA preemption challenges. The Second Circuit (Judges Chin, Pérez, and Nathan; opinion by Judge Pérez) affirmed. In doing so, the court clarified multiple doctrinal points: (1) a state may use a product’s marketing purpose as a proxy to target age-restricted sales under intermediate scrutiny; (2) age verification requirements do not compel a seller’s “own speech” and at most impose an incidental burden on expression; (3) the statute is not facially vague; and (4) FDCA § 343-1(a) does not preempt a sales restriction merely because label claims trigger its application. The court also addressed appellate jurisdiction over preliminary injunction denials following partial Rule 12(b)(6) dismissal.

Summary of the Opinion

Jurisdiction: The court held the appeal was not moot despite the district court’s intervening dismissal of CRN’s vagueness and preemption counts. Without a final judgment, interim relief remains effectual; interlocutory orders have not merged with a final judgment. Rule 54(b) permits revision before final judgment, preserving a live controversy.
First Amendment—Commercial Speech: Assuming arguendo the statute is content-based, the court applied Central Hudson’s intermediate scrutiny and found: New York’s interest in protecting minors’ health is substantial; restricting minors’ access to supplements marketed for weight loss/muscle building directly advances that interest; and using marketing as the regulatory trigger is a reasonable fit, not more extensive than necessary.
First Amendment—Compelled Expression: The age-verification mandate does not compel CRN members’ “own” speech or expressive conduct. Any expressive burden is incidental to a lawful regime regulating minors’ access and is permissible under intermediate scrutiny, consistent with the Supreme Court’s recent decision in Free Speech Coalition v. Paxton (2025).
Vagueness and Overbreadth: The facial vagueness challenge fails because there are obvious, clear applications (e.g., supplements explicitly marketed for weight loss). The First Amendment overbreadth theory also fails because the statute’s effect on commercial speech survives intermediate scrutiny, and the law is construed to regulate manufacturer and retailer representations, not unaffiliated third-party speech.
FDCA Preemption: The sales restriction is not a “requirement respecting any claim” within 21 U.S.C. § 343-1(a). It does not regulate label content but uses label/marketing claims to identify covered products. Under Bates v. Dow, inducements to change labeling are not the same as state-labeling “requirements.” Any ambiguity is resolved against preemption.
Irreparable Harm and Public Interest: CRN did not demonstrate irreparable harm. Compliance costs are ordinary and compensable. Assertions of lost sales were speculative and, in any event, could not justify a preliminary injunction given the low likelihood of success. The equities and public interest favor protecting minors’ health.

Analysis

Precedents Cited and Their Influence

Central Hudson Gas & Electric Corp. v. Public Service Commission (447 U.S. 557): Provides the four-part test for commercial speech. The panel accepted that the speech concerns lawful activity, then found (1) a substantial governmental interest (protecting minors’ health), (2) a direct advancement of that interest, and (3) a reasonable fit.
Vugo, Inc. v. City of New York (2d Cir. 2019): Clarifies application of Central Hudson elements in this Circuit, including the “direct advancement” requirement and permissible reliance on studies, history, and common sense.
Rubin v. Coors Brewing Co. and Globe Newspaper Co. v. Superior Court: Establish that protecting public health is significant, and safeguarding minors is compelling; these authorities undergird the state’s interest.
Edenfield v. Fane and Lorillard Tobacco Co. v. Reilly: Frame the evidentiary burden for “direct advancement” (real harms; material alleviation) and recognize permissible reliance on evidence, consensus, and common sense. Lorillard also supports treating non-communicative aspects of retail presentation and access as incidental to expression.
Board of Trustees v. Fox and Clear Channel Outdoor, Inc. v. City of New York: Articulate the “reasonable fit” standard—no least-restrictive-means requirement—and judicial deference to legislative judgments within intermediate scrutiny.
Hurley v. Irish-American GLB Group, Rumsfeld v. FAIR, and PruneYard Shopping Center v. Robins: Define when a law compels the speaker’s “own” message (Hurley) versus when it merely requires accommodating others’ speech without altering the speaker’s own message (Rumsfeld, PruneYard). The panel used these to reject CRN’s compelled-speech theory.
Emilee Carpenter, LLC v. James and New Hope Family Services, Inc. v. Poole: Second Circuit decisions clarifying “own speech” and expressive conduct in the compelled-speech context; applied to show age verification does not alter CRN members’ own message.
Free Speech Coalition v. Paxton (2025): The Supreme Court recognized age-verification regimes as commonplace and constitutional; any burden on adults is incidental to regulating minors’ access. The panel leans on Paxton to uphold age checks here.
Grayned v. City of Rockford, FCC v. Fox Television Stations, Village of Hoffman Estates v. Flipside, Copeland v. Vance, United States v. Salerno: Provide the vagueness framework—fair notice and no undue discretion, with a higher bar for facial challenges—and carve out less exacting review for civil/economic regulations absent a substantial chill of protected expression.
Holder v. Humanitarian Law Project and United States v. Williams: Distinguish due process vagueness from First Amendment overbreadth; the latter turns on whether a law regulates a substantial amount of protected speech.
VIP of Berlin, LLC v. Town of Berlin: Supports narrowing constructions that confine a statute to regulated parties’ speech to avoid vagueness concerns related to third-party communications.
Bates v. Dow Agrosciences and Cipollone v. Liggett Group: Teach that “requirements for labeling” preemption does not extend to state laws that merely induce label changes or impose independent obligations triggered by label content; the panel analogizes to conclude § 391-oo is not preempted by FDCA § 343-1(a).
New York State Restaurant Ass’n v. NYC Board of Health, Buono v. Tyco Fire Products, and Puerto Rico v. Franklin California Tax-Free Trust: Address express preemption and canons; where text is ambiguous, courts prefer the reading that disfavors preemption.
Freedom Holdings, Inc. v. Spitzer and Warner Bros. v. Gay Toys: Set standards for irreparable harm—compliance costs are ordinary; unrecoverable lost sales can sometimes suffice, but not on sparse proof and weak merits.

Legal Reasoning

1) Commercial Speech: Marketing as a Risk Proxy Satisfies Central Hudson

The court assumed, without deciding, that the law is content-based and proceeded under Central Hudson. Three features drove its analysis:

Substantial interest: Protecting minors’ physical and psychological health is at least substantial and often compelling.
Direct advancement: The legislative record included pediatric and public health evidence linking youth use of weight-loss/muscle-building supplements to serious adverse events. The court accepted both empirical materials and “simple common sense” to conclude that banning sales to minors would materially reduce harms. Critically, the risk category used by researchers—supplements marketed for weight loss or muscle building—matches the statute’s trigger, making the regulatory fit empirically grounded.
No more extensive than necessary: The statute need not be the least restrictive means. Using marketing claims as the gate is a reasonable fit, especially after the Governor vetoed an earlier ingredient-based scheme for lack of agency expertise. While the law might capture some lower-risk products, reasonable overbreadth does not defeat intermediate scrutiny.

2) Compelled Expression: Age Verification Is Not the Seller’s “Own Speech” and Any Burden Is Incidental

CRN argued that checking IDs communicates the message that covered supplements are unsafe for minors, compelling their speech. The court rejected that view for two independent reasons:

No compulsion of “own” speech or expressive conduct: Requiring ID checks is not akin to forcing a speaker to include an unwanted message (Hurley). Rather, as in Rumsfeld and PruneYard, retailers remain free to disavow any messages and to market as they wish. Reasonable observers will attribute the ID-check requirement to law, not to the retailer’s own views—an understanding reinforced by Paxton’s recognition that age verification is ubiquitous for regulated goods and activities.
At most an incidental burden on expression: The ID-check requirement implements a lawful age-based access restriction. Under Lorillard and Paxton, such implementation measures are evaluated under intermediate scrutiny and pass for essentially the same reasons the underlying sales restriction does.

3) Vagueness and Overbreadth: Clear Core Applications; Narrowing Construction

The facial vagueness challenge failed because there are undisputedly clear cases (e.g., products overtly marketed for weight loss). A facial challenger must show “no set of circumstances” in which the law is clear; CRN could not do so. The court further construed the law to reach the representations of manufacturers and retailers, not unaffiliated third parties, to avoid speculation about liability for outside speech.

The First Amendment overbreadth claim also failed because the only implicated speech is commercial speech that survives Central Hudson. CRN did not identify any “substantial amount of protected speech” chilled by indeterminacy.

4) FDCA Preemption: Labels as Triggers, Not Targets

FDCA § 343-1(a) preempts non-identical state “requirements respecting” certain label claims. New York’s statute does not regulate what labels must or must not say. It imposes an independent sales restriction and uses labeling/marketing as a trigger to identify covered products, much like tort or warranty laws that may induce label changes but do not themselves constitute labeling “requirements.” Under Bates and Cipollone, that is not preempted. To the extent there is ambiguity, the court applied the canon favoring non-preemption.

5) Procedural Points: Jurisdiction, Irreparable Harm, and Public Interest

Jurisdiction over PI appeal after partial dismissal: The denial of a preliminary injunction remained reviewable because no final judgment had entered and interim relief remained possible. Interlocutory orders had not merged into a final judgment (Rule 54(b) analysis).
Irreparable harm: First Amendment per se injury failed with the merits. Compliance costs are ordinary. The thin showing of lost sales, combined with a weak merits case, did not justify preliminary relief.
Public interest: The equities favor minors’ health protection over speculative industry losses, especially where the speech regulation is constitutional.

Impact

For State Legislatures and Regulators

Blueprint for age-based access laws: The decision confirms that states may condition minors’ access to products on how those products are “labeled, marketed, or represented,” provided there is evidence tying the marketing-defined category to the risk the law seeks to mitigate.
Deference to reasonable implementation choices: Legislatures may reject ingredient-by-ingredient schemes in favor of marketing proxies when agency capacity is lacking, so long as the proxy is reasonably related to the harm and the law passes intermediate scrutiny.
Preemption-safe design: A statute that uses label claims as a trigger for a separate sales restriction will generally avoid FDCA preemption, which targets state label-content mandates, not independent obligations keyed to labels.

For the Dietary Supplement Industry

Marketing equals coverage: How a product is presented—on the label, online, in-store, or by the retailer—can place it within a minors’ sales ban. “Weight loss” and “muscle building” claims are especially sensitive. Protein supplements are excluded by statute, but adjacent claims may invite scrutiny.
Age verification is here to stay: Post-Paxton and this decision, bona fide age checks for regulated goods face a strong constitutional footing. Retailers should standardize ID policies for in-person and delivery sales.
Litigation risk at the margins: Edge cases (e.g., multivitamins that hint at energy or body composition) may still be contested, but the statute’s factors, including retailer categorization and enumerated ingredients, allow case-by-case adjudication in state enforcement actions.

For First Amendment Doctrine

Central Hudson remains central: Even assuming content-based regulation of commercial speech, the court applied Central Hudson rather than any purported “heightened scrutiny” beyond it. Evidence plus common sense can suffice to show direct advancement.
Compelled speech narrowed: The “own speech” requirement, fortified by Rumsfeld, PruneYard, and Paxton, limits compelled-speech challenges to situations where the state alters a speaker’s message. Compliance mechanisms like age verification are treated as incidental burdens.
Vagueness vs. overbreadth clarity: The court separated the two doctrines, applying the stringent facial vagueness standard to a civil economic regulation and rejecting overbreadth where Central Hudson is satisfied.

Complex Concepts Simplified

Commercial speech: Advertising and other speech about a product or service, tied to economic interests. It receives intermediate (not strict) scrutiny.
Central Hudson test: A four-part inquiry for commercial speech restrictions: (1) lawful, non-misleading speech; (2) substantial government interest; (3) regulation directly advances that interest; (4) regulation is not more extensive than necessary (reasonable fit; not least restrictive means).
Content-based regulation (of commercial speech): A law that turns on the topic or subject of speech. In the commercial context, courts still apply Central Hudson’s intermediate scrutiny.
Compelled speech vs. incidental burden: Compelled speech forces a speaker to convey the government’s message or another’s message as their own. An incidental burden arises when a neutral rule (e.g., age verification) affects expressive activity only as a byproduct of regulating conduct.
Age-verification requirement: A rule obliging sellers to confirm a buyer’s age. Courts treat it as a standard implementation tool for lawful age-based access restrictions, not as compelled speech.
Vagueness (Due Process): A law is unconstitutionally vague if people cannot tell what it covers or if it invites arbitrary enforcement. Facial challenges must usually show no clear applications.
Overbreadth (First Amendment): A law is invalid if it restricts a substantial amount of protected speech relative to its legitimate sweep. It is distinct from vagueness.
FDCA preemption (21 U.S.C. § 343-1(a)): States may not impose labeling requirements “not identical” to federal ones, but independent state obligations keyed to label content (e.g., sales restrictions) are not automatically preempted.
“Requirement respecting any claim”: In FDCA parlance, a state-law mandate that governs what claims the label may make. A sales ban that uses claims as triggers is not itself a labeling requirement.
Merger doctrine and Rule 54(b): Interlocutory orders (like PI denials) typically merge into the final judgment for appeal, but before final judgment—and absent a Rule 54(b) certification—interim appeals remain live.

Conclusion

Council for Responsible Nutrition v. James establishes a clear and consequential rule in the Second Circuit: States may lawfully restrict minors’ access to categories of products defined by their marketing representations where the evidentiary record ties those representations to the harms addressed. Such marketing-triggered sales bans survive Central Hudson’s intermediate scrutiny, and implementation through age verification neither compels the retailer’s “own” speech nor exceeds incidental burdens on expression. The panel also delineates the limits of FDCA preemption, confirming that sales restrictions keyed to labels are not label-content “requirements,” and clarifies procedural doctrine preserving appellate review of preliminary injunction denials after partial dismissals.

Practically, the decision provides a defensible blueprint for public health age-gating that is sensitive to agency capacity and federal preemption constraints. Doctrinally, it underscores the vitality of Central Hudson, cabins compelled-speech claims to genuine alterations of a speaker’s message, and reinforces the strict standards for facial vagueness challenges in civil economic regulation. As litigation proceeds on the merits in the district court, this opinion will likely guide future state efforts to address youth risks through marketing-proxy regulations beyond the supplement context.