24-1343 Council for Responsible Nutrition v. James In the United States Court of Appeals for the Second Circuit
August Term 2024 Argued: January 24, 2025 Decided: November 13, 2025
No. 24-1343
COUNCIL FOR RESPONSIBLE NUTRITION, Plaintiff-Appellant, v. LETITIA JAMES, in her official capacity as New York Attorney General, Defendant-Appellee.
Appeal from the United States District Court for the Southern District of New York Docket No. 1:24-cv-1881, Andrew L. Carter, Jr., District Judge.
Before: CHIN, PÉREZ, and NATHAN, Circuit Judges.
Plaintiff-Appellant Council for Responsible Nutrition (“CRN”), a trade group representing the dietary-supplement industry, sued the New York Attorney General to enjoin enforcement of Section 391-oo of the New York General Business Law, which prohibits selling dietary supplements to anyone under eighteen years old if the supplement “is labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building.” N.Y. Gen. Bus. Law § 391-oo(1)(a). CRN alleges that the statute violates the First Amendment’s Free Speech Clause, is unconstitutionally vague, and is preempted by federal law. The District Court denied CRN’s motion for a preliminary injunction, finding that it was unlikely to succeed on the merits and had not established irreparable harm nor a favorable balance of the equities. This appeal followed.
We affirm, as the District Court did not abuse its direction in finding that CRN failed to show a likelihood of success on the merits, that CRN failed to demonstrate irreparable harm absent relief, and that the public interest weighs against preliminarily enjoining the law.
AFFIRMED.
TAMAR S. WISE, (Michael B. Leeuw, Arianna K. McLaughlin, on the briefs), Cozen O’Connor, New York, NY, for Plaintiff-Appellant.
GRACE X. ZHOU, Assistant Solicitor General, (Barbara D. Underwood, Solicitor General, Ester Murdukhayeva, Deputy Solicitor General, on the brief), for Letitia James, Attorney General of the State of New York, New York, NY, for Defendant-Appellee.
MYRNA PÉREZ, Circuit Judge:
Plaintiff-Appellant Council for Responsible Nutrition (“CRN”), a trade
group representing the dietary-supplement industry, sued the New York Attorney
General to enjoin enforcement of Section 391-oo of the New York General Business
Law, which prohibits selling dietary supplements to anyone under eighteen years
old if the supplement “is labeled, marketed, or otherwise represented for the
purpose of achieving weight loss or muscle building.” N.Y. Gen. Bus. Law
§ 391-oo(1)(a). CRN alleges that the statute violates the First Amendment’s Free
2 Speech Clause, is unconstitutionally vague, and is preempted by federal law. The
District Court denied CRN’s motion for a preliminary injunction, finding that it
was unlikely to succeed on the merits and had not established irreparable harm or
a favorable balance of the equities. This appeal followed.
We affirm, as the District Court did not abuse its direction in finding that
CRN failed to show a likelihood of success on the merits, that CRN failed to
demonstrate irreparable harm absent relief, and that the public interest weighs
against preliminarily enjoining the law.
BACKGROUND
I. Statutory Background
Responding to concerns that dietary supplements marketed for weight loss
and muscle building were causing serious medical problems among some youth,
the New York State Legislature in 2023 enacted Section 391-oo of the New York
General Business Law, which banned the sale of these supplements to minors.
Specifically, Section 391-oo provides that
[n]o person, firm, corporation, partnership, association, limited liability company, or other entity shall sell or offer to sell or give away, as either a retail or wholesale promotion, an over-the-counter diet pill or dietary supplement for weight loss or muscle building within this state to any person under eighteen years of age.
3 Retail establishments shall require proof of legal age for purchase of such products.
N.Y. Gen. Bus. Law § 391-oo(2).
“Dietary supplements for weight loss or muscle building” are defined as “a
class of dietary supplement,” excluding protein supplements, “that is labeled,
marketed, or otherwise represented for the purpose of achieving weight loss or
muscle building.” Id. § 391-oo(1)(a). 1
In the event of a violation of this statute, the Attorney General is authorized
to make an application to a state court to enjoin an alleged offender from
continuing the violation. Id. § 391-oo(5). Courts, in actions filed by the Attorney
General, are then tasked with deciding whether a particular supplement “is
labeled, marketed, or otherwise represented for the purpose of achieving weight
loss or muscle building.” Id. § 391-oo(6). The statute sets out nonexclusive factors
1 A “dietary supplement,” in turn, is defined as
(1) a product (other than tobacco) that is intended to supplement the diet and that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for the use by a person to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients; (2) intended for ingestion in pill, capsule, tablet, or liquid form; and (3) labeled as a “dietary supplement” pursuant to the federal Dietary Supplement Health and Education Act, 21 U.S.C. 321, as amended.
N.Y. Gen. Bus. Law § 831(2)(a); see also id. § 391-oo(1)(a) (incorporating this definition by reference). 4 for a court to consider, including how the retailer categorizes the supplement, how
it is labeled and marketed more broadly, and whether it contains certain
enumerated ingredients. Id.
Section 391-oo represents the Legislature’s second recent attempt to ban the
sale of these supplements to minors. In 2022, it passed Assembly Bill 431-C, which
would have charged the state’s Department of Health (“DOH”) with determining
which products were covered by the ban. But the Governor vetoed that bill,
finding that “DOH does not have the expertise necessary to analyze ingredients
used in countless products, a role that is traditionally played by the FDA.”
Governor Kathy Hochul, Veto Message No. 122 (Dec. 23, 2022). The Legislature
responded to that concern with Section 391-oo by targeting products based on how
they are represented and sold, leaving it to the courts to decide on a case-by-case
basis whether a particular product meets the statutory definition. See Mem. in
Support of Legis., A. 5610-D, 2023 State Assemb., Reg. Sess. (N.Y. 2023).
II. Procedural History
On March 13, 2024, CRN sued the Attorney General to enjoin enforcement
of the statute, which was set to go into effect on April 22 of that year. CRN moved
for a temporary restraining order and preliminary injunction on April 3, which the
5 District Court denied on April 19. Council for Responsible Nutrition v. James, No. 24-
CV-1881, 2024 WL 1700036, at *10 (S.D.N.Y. Apr. 19, 2024). CRN timely appealed.
On May 13, 2024, the District Court granted in part and denied in part the
Attorney General’s motion to dismiss, disposing of all but the First Amendment
claim. The court found that, though it had denied a preliminary injunction in part
because CRN was unlikely to succeed on its First Amendment claim, that claim
was nonetheless plausible and did not warrant dismissal under Rule 12(b)(6).
Council for Responsible Nutrition v. James, No. 24-CV-1881, 2024 WL 2137834, at *2–
4 (S.D.N.Y. May 13, 2024).
STANDARD OF REVIEW
Because CRN seeks to preliminarily enjoin “government action taken in the
public interest pursuant to a statutory . . . scheme,” it must show (1) irreparable
harm, (2) a likelihood of success on the merits, and (3) the injunction would serve
the public interest. Conn. State Police Union v. Rovella, 36 F.4th 54, 62 (2d Cir. 2022)
(quoting Bronx Household of Faith v. Bd. of Educ., 331 F.3d 342, 349 (2d Cir. 2003)).
We review a district court’s denial of a preliminary injunction for an abuse
of discretion. N. American Soccer League, LLC v. U.S. Soccer Fed’n, Inc., 883 F.3d 32,
36 (2d Cir. 2018). “A district court abuses its discretion when it rests its decision
6 on a clearly erroneous finding of fact or makes an error of law.” Id. (quoting
Almontaser v. N.Y.C. Dep’t of Educ., 519 F.3d 505, 508 (2d Cir. 2008)). We may affirm
the denial of a preliminary injunction on any basis supported by the record. Beal
v. Stern, 184 F.3d 117, 122 (2d Cir. 1999).
DISCUSSION
I. Jurisdiction
As an initial matter, we note that the parties dispute our appellate
jurisdiction to review the District Court’s denial of a preliminary injunction as to
CRN’s vagueness and preemption claims, because the District Court dismissed
those claims pursuant to Rule 12(b)(6) the day before this appeal was filed. See
Council for Responsible Nutrition, 2024 WL 2137834, at *3–4. The Attorney General
asserts that because those claims have been dismissed, that “portion of CRN’s
appeal is moot.” Appellee’s Br. 49. Not so.
We have jurisdiction to review the denial of a preliminary injunction
pursuant to 28 U.S.C. § 1292(a)(1). “A case becomes moot only when it is
impossible for a court to grant any effectual relief whatever to the prevailing
party.” Hassoun v. Searls, 976 F.3d 121, 128 (2d Cir. 2020) (quoting Knox v. Serv.
Emps. Int’l Union, Local 1000, 567 U.S. 298, 307 (2012)). Likewise, an appeal from
7 the denial of a preliminary injunction can be mooted by “the occurrence of the
action sought to be enjoined.” Fid. Partners, Inc. v. First Tr. Co., 142 F.3d 560, 565
(2d Cir. 1998) (quoting Bank of N.Y. Co. v. Ne. Bancorp, Inc., 9 F.3d 1065, 1067 (2d
Cir. 1993)); see also Irish Lesbian & Gay Org. v. Giuliani, 143 F.3d 638, 644 (2d Cir.
1998) (“The purpose of a preliminary injunction is merely to preserve the relative
positions of the parties until a trial on the merits can be held.” (quoting Univ. of
Tex. v. Camenisch, 451 U.S. 390, 395 (1981))).
CRN’s First Amendment claim remains live in the District Court, and there
is no indication that the Attorney General has declined to enforce Section 391-oo.
Cf. Catanzano v. Wing, 277 F.3d 99, 107 (2d Cir. 2001) (“Since . . . the State is no
longer implementing the fiscal assessment laws, and there is no reason to expect
that fiscal assessments are now occurring or that the legislature will reenact the
laws, no controversy now exists with respect to this claim and it is therefore
moot.”). Therefore, enjoining enforcement of the statute during the pendency of
the litigation as to the outstanding claim remains effectual relief as to all the claims,
and the sought preliminary injunction is not moot.
In any event, dismissal of claims without final judgment does not render
those claims moot in a preliminary injunction appeal. A preliminary injunction
8 appeal is mooted when all the claims underlying that injunction are dismissed via
a final judgment. See, e.g., Ruby v. Pan American World Airways, Inc., 360 F.2d 691,
691 (2d Cir. 1966) (per curiam); Pierce v. Woldenberg, 498 F. App’x 96, 97–98 (2d Cir.
2012) (summary order). That is because “[w]hen a district court enters a final
judgment in a case, interlocutory orders rendered in the case typically merge with
the judgment for purposes of appellate review.” Shannon v. Gen. Elec. Co., 186 F.3d
186, 192 (2d Cir. 1999). That merger extinguishes the availability of the interim
relief sought in a preliminary injunction, which is why the appeal of that
preliminary injunction is moot. So where there is no final judgment, interim relief
remains available, and the preliminary injunction appeal is not moot.
To illustrate, the District Court here did not dismiss all of CRN’s claims. See
Council for Responsible Nutrition, 2024 WL 2137834, at *2–4. The District Court
could thus revise its dismissal order to resurrect CRN’s preemption and vagueness
claims “at any time before the entry of a judgment adjudicating all the claims and
all the parties’ rights and liabilities.” Fed. R. Civ. P. 54(b). Furthermore, Rule 54(b)
also states that “the court may direct entry of a final judgment as to one or more,
but fewer than all, claims.” Accordingly, until there is a final judgment, whether
the District Court properly denied a preliminary injunction on CRN’s vagueness
9 and preemption claims remains a live controversy that we have jurisdiction to
review.
II. Likelihood of Success on the Merits
A. Burdens on Commercial Speech
CRN’s principal First Amendment claim is that Section 391-oo
unconstitutionally burdens the commercial speech of its members by limiting their
sales of dietary supplements based on that speech. For this claim to succeed,
Section 391-oo must constitute a (1) content-based regulation (2) of commercial
speech that (3) fails intermediate scrutiny. See Cent. Hudson Gas & Elec. Corp. v.
Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980). It does not. Even assuming that
Section 391-oo is a content-based regulation—which the parties contest—it would
nonetheless satisfy intermediate scrutiny under the Central Hudson test. See id. 2
Section 391-oo satisfies intermediate scrutiny under Central Hudson if “(1)
the speech restriction concerns lawful activity; (2) the [state]’s asserted interest is
substantial; (3) the prohibition ‘directly advances’ that interest; and (4) the
prohibition is no more extensive than necessary to serve that interest.” Vugo, Inc.
v. City of New York, 931 F.3d 42, 51 (2d Cir. 2019) (citing Cent. Hudson, 447 U.S. at
2 The parties agree—as do we—that the speech at issue is “commercial,” since it is “related solely to the economic interests of the speaker and its audience.” Cent. Hudson, 447 U.S. at 561. 10 566). As to the first prong, the parties agree that the speech implicated by the
statute concerns lawful activity. We thus address the remaining three prongs.
1. Substantial Governmental Interest
The Attorney General, on behalf of New York, asserts that “[t]he goal of
[Section] 391-oo is to protect the health of minors by limiting their access to weight-
loss and muscle-building supplements.” Appellee’s Br. 31. It is well established
that the state has a substantial interest in protecting the public’s health. See Rubin
v. Coors Brewing Co., 514 U.S. 476, 485 (1995) (“[T]he Government here has a
significant interest in protecting the health, safety, and welfare of its citizens by
preventing brewers from competing on the basis of alcohol strength, which could
lead to greater alcoholism and its attendant social costs.”). And when it comes to
“safeguarding the physical and psychological well-being of a minor,” that interest
is not only substantial, it is “compelling.” Globe Newspaper Co. v. Superior Ct., 457
U.S. 596, 607 (1982).
CRN argues that the state lacks a substantial interest in restricting the
disclosure of accurate information—namely, the weight-loss and muscle-building
benefits of certain supplements. By burdening the marketing of these benefits,
CRN argues, retailers and producers are less likely to make consumers aware of
11 them. But this Central Hudson prong is concerned with whether the state’s “asserted
interest is substantial.” Vugo, 931 F.3d at 51 (emphasis added); see also, e.g.,
Thompson v. W. States Med. Ctr., 535 U.S. 357, 368–69 (2002) (analyzing the asserted
interests as articulated by the government). The state’s asserted interest here is
not in restricting the flow of information to consumers, but in protecting the health
of minors. The question is not whether Section 391-oo is effective at achieving that
objective, nor whether its costs outweigh its benefits. CRN does not dispute—nor
could it reasonably—that the interest in protecting the health of minors is, at a
minimum, substantial.
2. Directly Advances the Asserted Interest
Under the third Central Hudson prong, the Attorney General must show (1)
that the asserted harms “are real” and (2) that Section 391-oo’s speech restrictions
“will in fact alleviate them to a material degree.” Vugo, 931 F.3d at 52 (quoting
Edenfield v. Fane, 507 U.S. 761, 771 (1993)). She can meet this burden “by reference
to studies and anecdotes” as well as “history, consensus, and ‘simple common
sense.’” Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 555 (2001) (quoting Fla. Bar v.
Went for It, Inc., 515 U.S. 618, 628 (1995)).
12 The record here contains sufficient evidence that (1) a significant number of
minors consume dietary supplements aimed at losing weight or building muscle
and that (2) these supplements can cause serious medical problems. In a letter to
the State Legislature, Dr. Jason Nagata, a pediatrician, summarized some of the
scientific literature on the issue:
Rigorous scientific study after study has shown that these types of supplements pose serious health risks to consumers. A recent study found that youth using weight-loss supplements were three times more likely than those using ordinary vitamins to experience severe medical harm, including hospitalization, disability, and even death. Studies have linked weight loss and muscle- building supplements to organ failure, heart attacks, stroke, and death. The CDC estimates that supplement use leads to 23,000 emergency room visits every year, with a quarter due to the weight-loss category alone.
J. App’x at 108 (footnotes and citations omitted). The scientific evidence in the
legislative record provided by Dr. Nagata and other experts certainly satisfies the
Attorney General’s burden to show that the asserted harms “are real.” Vugo, 931
F.3d at 52; cf. We the Patriots USA, Inc. v. Conn. Off. of Early Childhood Dev., 76 F.4th
130, 153–54 (2d Cir. 2023) (finding that the state legislature “reasonably judged”
the risk of harm based on data and expert testimony in drafting the law at issue).
While CRN takes issue with some studies linking supplement use to eating
13 disorders, it does not justify why that would discredit the broader body of
evidence demonstrating other health risks.
There is also sufficient indication that these adverse health effects will be
reduced materially by Section 391-oo’s use of marketing to identify the products
subject to its age restriction. To start, it is “simple common sense,” Lorillard
Tobacco, 533 U.S. at 555 (quoting Went for It, 515 U.S. at 628), that prohibiting
supplement sales to minors will reduce supplement consumption by minors. And
the category of products targeted by Section 391-oo—supplements that are
“labeled, marketed, or otherwise represented for the purpose of achieving weight
loss or muscle building,” N.Y. Gen. Bus. Law § 391-oo(1)(a)—is generally the same
category used in the cited literature to identify supplements that are especially
harmful. See, e.g., Andrew I. Geller et al., Emergency Department Visits for Adverse
Events Related to Dietary Supplements, 373 NEJM 1531, 1533–35 (2015) (cited in J.
App’x at 100, 108) (categorizing supplements by purpose, including “supplements
for weight loss”); Flora Or et al., Taking Stock of Dietary Supplements’ Harmful Effects
on Children, Adolescents, and Young Adults, 65 J. Adolescent Health 455, 456–58
(2019) (cited in J. App’x at 100, 108) (categorizing supplements by principal
advertised health claim). When a product’s marketed purpose is an indicator of
14 its risks, restricting sales of a product on that same basis—its marketed purpose—
will directly advance the goal of reducing those risks.
3. No More Extensive than Necessary
Lastly, the Attorney General must show that Section 391-oo does “not
burden substantially more speech than is necessary to further the government’s
legitimate interests.” Clear Channel Outdoor, Inc. v. City of New York, 594 F.3d 94,
104 (2d Cir. 2010) (quoting Bd. of Trs. v. Fox, 492 U.S. 469, 478 (1989)). She does not,
however, need to show that it is the least restrictive means of achieving its
objectives. Id. Rather, there must be a “reasonable” fit between the law and its
objectives, though that fit need not be “perfect.” Fox, 492 U.S. at 480. We will defer
to the Legislature’s reasonable judgment about how best to achieve those
objectives. See Clear Channel, 594 F.3d at 104.
CRN makes two arguments under this prong. First, it argues that the statute
is overinclusive because it could sweep in safe products, such as children’s
multivitamins, that tout certain weight or muscle benefits but do not pose the same
health risks. While it is certainly possible that Section 391-oo’s reach may extend
to less risky products, it does not appear from the record that it will “burden
substantially more speech than is necessary” to achieve its ends. Clear Channel, 594
15 F.3d at 104 (emphasis added) (quoting Fox, 492 U.S. at 478). Again, the fit need
only be “reasonable,” not “perfect.” Fox, 492 U.S. at 480.
Second, CRN argues that the Legislature could have restricted the sale of
products based on their ingredients rather than their marketing. It points to
Assembly Bill 431-C, which would have required the Department of Health to
determine which products were covered. But the Governor vetoed that bill, and
for a legitimate reason—the DOH lacked the expertise to effectively carry out the
bill’s objectives. The Legislature decided instead to use a product’s marketing as
a proxy, and we must defer to that reasonable judgment. See Clear Channel, 594
F.3d at 104; Vugo, 931 F.3d at 58–59. 3
B. Compelled Expression
In addition to prohibiting the sale of covered supplements to minors,
Section 391-oo requires that retailers verify the age of any purchaser who appears
younger than twenty-five. N.Y. Gen. Bus. Law § 391-oo(2). CRN argues that this
requirement unconstitutionally compels its members to communicate the message
that the age-restricted products are unsafe for minors. We disagree.
3 CRN’s claim that Section 391-oo exceeds the state’s police powers—to which it devotes two sentences of argument in a footnote—fails a fortiori. Because Section 391-oo satisfies intermediate scrutiny, it necessarily satisfies the rational-basis standard that applies to CRN’s police-powers claim. See United States v. Carolene Prods. Co., 304 U.S. 144, 152 (1938). 16 1. Not CRN’s or Its Members’ Own Expression
To succeed on this claim, CRN must show that Section 391-oo compels either
“speech,” New Hope Fam. Servs., Inc. v. Poole, 966 F.3d 145, 171 (2d Cir. 2020), or
“expressive conduct,” Emilee Carpenter, LLC v. James, 107 F.4th 92, 104 (2d Cir.
2024). In addition, CRN must show that Section 391-oo compels CRN’s or its
members’ “own speech” or “own expressive” conduct. Id. at 104–05 (emphasis
added).
As a threshold matter, we assume without deciding that age verification
procedures can constitute expressive activity. We also need not decide whether
age verification pursuant to Section 391-oo constitutes speech or conduct. Either
way, we conclude as a matter of law that on this record, CRN has failed to
demonstrate that the law affects its own expression. See id.; see also Rumsfeld v. F.
for Acad. & Inst. Rts., Inc., 547 U.S. 47, 63 (2006) (“The compelled-speech violation
in each of our prior cases . . . resulted from the fact that the complaining speaker’s
own message was affected . . . .” (emphasis added)). In assessing whether CRN’s
(or its members’) own message is affected by Section 391-oo, we may consider
whether the statute “interfere[s] with [their] choice not to propound a point of
view contrary to [their] beliefs,” “forc[es] . . . [them] to include other ideas within
17 [their] own speech that [they] would prefer not to include,” or whether an observer
would likely identify the compelled message with CRN or its members. Emilee
Carpenter, 107 F.4th at 105 (citation modified); Rumsfeld, 547 U.S. at 65.
Thus, in Hurley v. Irish-American Gay, Lesbian & Bisexual Group of Boston, the
Supreme Court deemed a state court order that required a private parade
organizer to allow a specific group to march in its parade to be an unlawful
compulsion of the parade organizers’ speech. 515 U.S. 557, 566 (1995). The
Supreme Court explained that “[p]arades are . . . a form of expression,” and “every
participating unit affects the message conveyed by the private organizers.” Id. at
568, 572. Hence, the order “essentially requir[ed] petitioners to alter the expressive
content of their parade.” Id. at 572–73.
By contrast, in Rumsfeld v. Forum for Academic and Institutional Rights, the
Supreme Court upheld a law that required law schools to permit equal access to
military recruiters on their campuses despite the schools’ disagreement with
military policy. 547 U.S. at 63–68. Likewise, in PruneYard Shopping Center v. Robins,
the Supreme Court sustained a statute which compelled a shopping center owner
to permit the gathering of signatures on its premises. 447 U.S. 74, 85–88 (1980).
The Supreme Court found that neither case involved a situation where “the
18 complaining speaker’s own message was affected by the speech it was forced to
accommodate.” Rumsfeld, 547 U.S. at 63–65 (emphasis added) (distinguishing
Hurley from itself and PruneYard). Rather, the purportedly expressive activities in
both cases were “not inherently expressive,” because “there was little likelihood
that the views of those engaging in the expressive activities would be identified
with the owner, who remained free to disassociate himself from those views and
who was ‘not . . . being compelled to affirm [a] belief in any governmentally
prescribed position or view.’” Rumsfeld, 547 U.S. at 65 (alterations in original)
(quoting PruneYard, 447 U.S. at 88); accord id. (“Nothing about recruiting suggests
that law schools agree with any speech by recruiters, and nothing in the [law]
restricts what the law schools may say about the military’s policies.”).
Applying these principles, we conclude that Section 391-oo does not compel
CRN’s or its members’ own expressive activity. At most, Section 391-oo requires
sellers to inform potential buyers that the product is age-restricted and request a
valid form of identification. To the extent this conveys a message to customers
that any products are unsafe for minors, there is little risk that this message would
be confused with CRN’s or its members’ own speech. Rather, “[r]equiring age
verification is common when a law draws lines based on age.” Free Speech Coal.,
19 Inc. v. Paxton, 606 U.S. 461, 479 (2025). Reasonable observers would not likely infer
that conducting age verification procedures is a retailer expressing a message at
all. As the Supreme Court observed in Paxton, state and federal laws require proof
of age to obtain alcohol, tobacco, lottery tickets, tattoos, body piercings, fireworks,
driver’s licenses, medications, and to vote, and to marry. Id. (collecting examples
and observing that “[i]n none of these contexts is the constitutionality of a
reasonable, bona fide age-verification requirement disputed”). An observer can
appreciate that the age verification requirement is a law or regulation, rather than
the views or speech of CRN or its members. Id. at 483 (“[A]dults have no First
Amendment right to avoid age verification, and the statute can readily be
understood as an effort to restrict minors’ access.”); Rumsfeld, 547 U.S. at 65 (“We
have held that high school students can appreciate the difference between speech
a school sponsors and speech the school permits because legally required to do
so . . . .”). Finally, Section 391-oo does not restrict how CRN or its members market
their products, including the content of that marketing or to whom it is directed.
Therefore, CRN and its members remain free to disassociate from any message
that the products are unsafe for minors while still complying with the law.
20 2. Any Burden on Expression Is Incidental
A separate reason that these age verification procedures are not
unconstitutional compulsions of expression is because here, any burden on
expression is incidental to an otherwise legitimate regulation. We have already
explained above that Section 391-oo is a constitutionally permissible regulation of
commercial speech under the Central Hudson test. See supra Section II.A. The age
verification procedures in question here are the mechanism by which that
regulation is implemented, and therefore its analysis folds into the same test of
intermediate scrutiny.
The Supreme Court’s decision in Lorillard Tobacco Company v. Reilly is
instructive. 533 U.S. 525 (2001). Lorillard Tobacco involved Massachusetts
regulations governing how tobacco products may be displayed to minors by
retailers. The Supreme Court found that the “communicative component” of the
regulations—there, the “placement of tobacco products”—was regulated “for
reasons unrelated to the communication of ideas.” Id. at 569. Applied here, while
Section 391-oo implicates commercial speech as to the manufacturers, the age
verification procedures themselves are unrelated to any communication of ideas—
once Section 391-oo determines the supplements subject to regulation, the age
21 verification procedures operate to restrict minors’ access to those supplements.
And here, as in Lorillard Tobacco, “retailers have other means of exercising any
cognizable speech interest in the presentation of their products.” Id. at 569–70. So
to the extent age verification procedures have a burden on expression, here that
burden is incidental at best.
And because the age verification procedures are an incidental burden on
expression, they are analyzed under intermediate scrutiny. Id.; see also Paxton, 606
U.S. at 483 (“Any burden experienced by adults is therefore only incidental to the
statute’s regulation of activity that is not protected by the First Amendment. That
fact makes intermediate scrutiny the appropriate standard under our precedents.”
(citing Boy Scouts of America v. Dale, 530 U.S. 640, 659 (2000))). For the same reasons
that Section 391-oo satisfies intermediate scrutiny discussed above, its chosen
mechanism of enforcement passes constitutional muster: the state has a substantial
interest in protecting minors from certain dietary supplements, restricting sales to
minors directly advances that interest, and such age restrictions are “well within
the State’s discretion under intermediate scrutiny.” Paxton, 606 U.S. at 497; see
Lorillard Tobacco, 533 U.S. at 570 (“The means chosen by the State are narrowly
tailored to prevent access to tobacco products by minors, are unrelated to
22 expression, and leave open alternative avenues for vendors to convey information
about products and for would-be customers to inspect products before
purchase.”).
C. Vagueness and Overbreadth
CRN claims that Section 391-oo’s scope—specifically, which products count
as being “labeled, marketed, or otherwise represented for the purpose of achieving
weight loss or muscle building,” N.Y. Gen. Bus. Law § 391-oo(1)(a)—is
unconstitutionally vague. We disagree.
A law is “vague” in the relevant sense when its scope—the factual situations
to which it applies—is uncertain. Because “we can never expect mathematical
certainty from our language,” Grayned v. City of Rockford, 408 U.S. 104, 110 (1972),
“[m]any statutes will have some inherent vagueness,” Rose v. Locke, 423 U.S. 48,
49–50 (1975).
Vagueness violates due process when the gray area between covered and
uncovered conduct is such that the law “fails to provide a person of ordinary
intelligence fair notice of what is prohibited, or is so standardless that it authorizes
or encourages seriously discriminatory enforcement.” FCC v. Fox Television
Stations, Inc., 567 U.S. 239, 253 (2012) (quoting United States v. Williams, 553 U.S.
23 285, 304 (2008)). This test is applied more or less strictly depending on what is at
stake. For example, “economic regulation is subject to a less strict vagueness test,”
as are “enactments with civil rather than criminal penalties.” Vill. of Hoffman Ests.
v. Flipside, Hoffman Ests., Inc., 455 U.S. 489, 498–99 (1982); see also Arriaga v. Mukasey,
521 F.3d 219, 223 (2d Cir. 2008) (“Laws with civil consequences receive less
exacting vagueness scrutiny.”). On the other hand, where a law “threatens to
inhibit the exercise of constitutionally protected rights”—for instance, if it
“interferes with the right of free speech”—then “a more stringent vagueness test
should apply.” Hoffman Ests., 455 U.S. at 499.
A facial vagueness challenge under the Due Process Clause, which CRN
brings here, “is ‘the most difficult challenge to mount successfully’ because, as a
general matter, ‘the challenger must establish that no set of circumstances exists
under which the [law] would be valid.’” Copeland v. Vance, 893 F.3d 101, 110 (2d
Cir. 2018) (quoting United States v. Salerno, 481 U.S. 739, 745 (1987)); see also United
States v. Requena, 980 F.3d 30, 39 (2d Cir. 2020). In other words, a facial challenger
must show that there is no situation in which a person could be sufficiently certain
that the law would apply to their conduct.
24 This heavy burden is lower, however, for First Amendment overbreadth
claims premised on a law’s vagueness. 4 In making such a claim, a challenger must
show that, due to the law’s vagueness, “it is unclear whether it regulates a
substantial amount of protected speech.” Williams, 553 U.S. at 304. This is a
distinct claim from a due process vagueness challenge, though, and it requires the
challenger to show that the potential regulation of speech violates the First
Amendment. See Vill. of Hoffman Ests., 455 U.S. at 495; Holder v. Humanitarian L.
Project, 561 U.S. 1, 20 (2010) (“[O]ur precedents make clear that a Fifth Amendment
vagueness challenge does not turn on whether a law applies to a substantial
amount of protected expression. Otherwise the doctrines would be substantially
redundant.” (citations omitted)).
CRN arguably makes both a due process vagueness challenge and a First
Amendment overbreadth challenge. Though it conflates the two claims, we
analyze them separately.
As for its vagueness claim under the Due Process Clause, CRN raises
ambiguities in Section 391-oo’s coverage and its failure to define terms such as
“represented.” Appellant’s Br. 50. But it falls far short of its burden to show, on a
4 This burden may also be lessened in certain other circumstances not relevant here. See Requena, 980 F.3d at 39–40. 25 facial challenge, “that no set of circumstances exists” for which the law’s
application would be unambiguous. Copeland, 893 F.3d at 110 (quoting Salerno,
481 U.S. at 745). 5 Those circumstances are readily apparent: a dietary supplement
is marketed as a weight-loss or muscle-building aid. CRN’s due process challenge
necessarily fails on that basis. 6
CRN’s First Amendment overbreadth claim fails because, as already
discussed, Section 391-oo’s effects on commercial speech satisfy intermediate
scrutiny. CRN points to no other speech that is implicated by the asserted
vagueness in the law. 7 It has thus failed to show that “a substantial amount of
protected speech” is infringed. Williams, 553 U.S. at 304.
5 Nor does CRN really attempt to meet that burden. Instead, it disputes that this burden applies to cases that implicate speech. But the Supreme Court has made clear that there is “no exception for conduct in the form of speech.” Humanitarian L. Project, 561 U.S. at 20. First Amendment challenges asserting overbreadth are subject to a less stringent standard in this respect, but CRN must still show that the law infringes on free speech, which CRN has failed to do here. Due process arguments unrelated to the infringement of free-speech rights cannot free-ride on this more lenient First Amendment standard.
6 If Section 391-oo opened CRN up to liability for speech by unrelated third parties without fair notice, it could be impermissibly vague in a substantial number of applications. But given the statute’s text and “stated purpose,” we construe the statute to apply only to the actions and statements of manufacturers and retailers. Cf. VIP of Berlin, LLC v. Town of Berlin, 593 F.3d 179, 187–89 (2d Cir. 2010). So any challenge premised on that hypothetical likewise fails.
7 To the extent CRN relies on hypothetical statements made by unaffiliated third parties, such as third parties on the internet, Section 391-oo does not reach speech by unregulated parties, and so there is no basis to think that third-party speech would be chilled or otherwise infringed. 26 D. Preemption
Finally, CRN argues that Section 391-oo violates the preemption provision
of the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 343-1(a), and thus the
Supremacy Clause. Section 343-1(a) provides that, with certain exceptions not
relevant here,
no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . (5) any requirement respecting any claim of the type described in section 343(r)(1) of this title made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title . . . .
Section 343(r)(1), in turn, prohibits health-related claims regarding a product’s
nutrients, while Section 343(r)(6) makes certain exceptions for dietary
supplements.
The question before us is whether Section 391-oo’s age restriction, by being
triggered by (among other things) a health claim made on a product label, is
therefore a “requirement respecting” such a health claim. We conclude that it is
not.
A “requirement” is “[s]omething that must be done because of a law or rule;
something legally imposed, called for, or demanded; an imperative command.”
27 Requirement, Black’s Law Dictionary (12th ed. 2024). While the reduction in sales
caused by Section 391-oo may lead some supplement makers to change the claims
made on their labels, that potential shift in economic balancing is far from a
“requirement,” as that word is ordinarily understood. Rather than regulating the
content of supplement labels, Section 391-oo uses the labels to identify products
subject to its sales restriction.
The Supreme Court reached a similar conclusion in Bates v. Dow Agrosciences
LLC, which involved a provision requiring that states “not impose or continue in
effect any requirements for labeling or packaging [pesticides] in addition to or
different from those required under” federal law. 544 U.S. 431, 436 (2005) (quoting
7 U.S.C. § 136v(b)). The Court rejected the argument that a state law that merely
induced a change in a product label—for example, by making actionable a breach
of a warranty appearing on the label—qualified as “a requirement ‘for labeling or
packaging.’” Id. at 445. This was because such a law “does not require the
manufacturer to make an express warranty, or in the event that the manufacturer
elects to do so, to say anything in particular in that warranty.” Id.; see also Cipollone
v. Liggett Grp., Inc., 505 U.S. 504, 522 (1992) (focusing on whether the “legal duty”
created by state law constituted a preempted “requirement”).
28 While the preemption provision here is different, the same logic applies.
Section 391-oo does not require a supplement maker to put anything in particular
on a product label. Rather, like a law enforcing warranties appearing on labels,
Section 391-oo imposes an independent legal obligation that is triggered by a
manufacturer’s choice to place something particular on a label. That obligation—
the duty not to sell the product to minors—is not a “requirement respecting any
claim” contained on the label. 21 U.S.C. § 343-1(a).
In any event, “where the text of a preemption clause is ambiguous or open
to more than one plausible reading, courts ‘have a duty to accept the reading that
disfavors pre-emption.’” N.Y. State Rest. Ass’n v. N.Y.C. Bd. of Health, 556 F.3d 114,
123 (2d Cir. 2009) (quoting Bates, 544 U.S. at 449). 8 Because Section 343-1(a) could
plausibly be read not to preempt Section 391-oo, we are bound to apply that
reading.
8 Citing our decision in Buono v. Tyco Fire Products., LP, 78 F.4th 490, 495 (2d Cir. 2023), which in turn relies on the Supreme Court’s decision in Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S. 115, 125 (2016), CRN asserts that no such presumption is applicable because the FDCA contains an express preemption provision. But that is only true insofar as the text of that provision is “plain.” Franklin, 579 U.S. at 125; Buono, 78 F.4th at 495. Where the preemptive force of the text is ambiguous—as it is here—we resolve that ambiguity against preemption. See Bates, 544 U.S. at 449 (applying that presumption to an ambiguous express-preemption provision). 29 III. Irreparable Harm
Beyond a likelihood of success on the merits, CRN must also establish that
it will likely face irreparable harm. CRN asserts in its brief two types of irreparable
harm suffered by its members: the per se irreparable injury to its members’ free-
speech rights, and the unrecoverable “costs expended to attempt to comply with
the Act’s vague mandates.” Appellant’s Br. 58.
The First Amendment basis for irreparable injury is insufficient given our
earlier analysis of CRN’s First Amendment claims. Because CRN is unlikely to
succeed on the merits of those claims, any irreparable injury premised on those
claims alone cannot justify a preliminary injunction. See We the Patriots USA, Inc.
v. Hochul, 17 F.4th 266, 294 (2d Cir. 2021) (“[B]ecause [Plaintiffs] have failed to
demonstrate a likelihood of success on their First Amendment or other
constitutional claims . . . Plaintiffs fail to meet the irreparable harm element simply
by alleging an impairment of their Free Exercise right.”).
With respect to the asserted economic injuries suffered by CRN’s members,
“ordinary compliance costs are typically insufficient to constitute irreparable
harm.” Freedom Holdings, Inc. v. Spitzer, 408 F.3d 112, 115 (2d Cir. 2005). The
compliance costs that CRN asserts—“time analyzing the Act’s potential
30 application to specific products,” “relabeling products,” “implementing age-
verification procedures through common carriers,” and “employing additional
age-verification procedures at point of sale,” Appellant’s Br. 17—fall into that
category.
Unrecoverable lost sales, however, can constitute irreparable harm. See
Warner Bros. v. Gay Toys, Inc., 658 F.2d 76, 79 (2d Cir. 1981). While the record before
us contains little more than conclusory and speculative predictions of lost sales,
one might reasonably assume that prohibiting sales to minors would reduce total
sales at least to some degree. Nevertheless, given that CRN’s claims are unlikely
to succeed on the merits, the minimal allegations of lost sales alone do not
demonstrate irreparable harm sufficient to warrant preliminary injunctive relief. 9
IV. Public Interest
Lastly, CRN must establish a favorable balance of the equities. The District
Court found that a preliminary injunction would not be in the public interest
because the “pecuniary interests, fear of the enforcement of civil penalties, and
speculative loss of revenue and sales” to CRN’s members “pale in comparison to
the State’s goal of protecting youth from products that unfettered access to dietary
9 For this reason, we need not address whether CRN’s five-month delay in seeking preliminary relief was an appropriate part of the District Court’s calculus. 31 supplements present.” Council for Responsible Nutrition, 2024 WL 1700036, at *10.
CRN’s arguments on this element—that the public interest requires adhering to
the First Amendment, and that Section 391-oo fails to address its target harms—
necessarily fall with its First Amendment claims. But even if its First Amendment
claims had likely merit, we cannot say that the District Court’s assessment of the
public interest in this case was an abuse of discretion.
CONCLUSION
We have considered CRN’s remaining arguments and conclude that they
are without merit. For the foregoing reasons, the order of the District Court
denying CRN’s motion for a preliminary injunction is AFFIRMED.