The Second Circuit dealt a blow to the dietary supplement industry last month as it affirmed a lower court’s decision not to temporarily pause enforcement of New York’s new restrictions on sales of certain dietary supplements to minors as legal challenges continue to proceed through the court system.
On November 13, 2025, the Second Circuit affirmed a District Court’s decision not to grant a preliminary injunction in a lawsuit filed by the Council for Responsible Nutrition (“CRN”) challenging New York Business Law Section 391-oo (“the Statute”), which prohibits the sale of dietary supplements marketed for weight loss or muscle building to anyone under the age of 18.[1]
As EBG previously reported, this type of legislation is part of a growing trend of states attempting to prohibit the sale of dietary supplements that target weight loss and muscle building to minors. States such as Colorado, New Jersey, and Michigan have also enacted or proposed similar legislation, creating a movement through law-making that will negatively impact the dietary supplement industry, both reputationally and financially.
We explore the court’s decision, and the threat such legislation poses for the dietary supplement industry, in more detail below.
Background and Procedural History
In 2023, the New York legislature passed a Statute prohibiting the sale of weight loss or muscle building dietary supplements to minors. This Statute is the New York legislature’s second attempt at banning such sales – in 2022 the legislature passed Assembly Bill 431-C, but it was vetoed by New York Governor, Kathy Hochul, due to concerns that the New York Department of Health, charged with determining which dietary supplements would be limited by the proposed law, lacked the necessary expertise to properly analyze dietary supplement ingredients to make such a determination.[2] The current Statute succeeded in avoiding a similar veto by focusing on the sale of dietary supplements and using labeling as the distinguishing characteristic: supplements that are “labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building” are considered “dietary supplements for weight loss or muscle building” and cannot be sold to minors below the age of 18. The Statute also mandates that retail establishments require proof of legal age for the purchase of such supplements.
On March 13, 2024, the CRN sued New York Attorney General Letitia James (“James”) to enjoin the Statute. CRN alleged that the Statute: (1) violated the First Amendment by burdening commercial speech and compelling expression; (2) violated the Due Process Clause by being unconstitutionally vague; and (3) was preempted by the Federal Food Drug and Cosmetic Act (“FDCA”). The District Court denied CRN’s motion for a temporary restraining order and preliminary injunction and subsequently granted James’ motion to dismiss on all but the First Amendment Claims. A three-judge panel of the Second Circuit heard CRN’s appeal.
To prevail on preliminarily enjoining the Statute, CRN had to show: 1) a likelihood of success on the merits; 2) irreparable harm; and 3) that the injunction would serve the public interest. The latter two requirements were dealt with by the Second Circuit relatively briefly: while there may be some irreparable harm for lost sales, a preliminary injunction could not be said to serve the public interest. The bulk of the court’s ruling, as reflected in this blog post, was dedicated to discussing the underlying claims brought by CRN.
Unlikely to Succeed on First Amendment Claims
The Second Circuit separately analyzed the two First Amendment claims: burden on commercial speech and compelled expression. The court held that James, not CRN, was likely to succeed on the merits to show that the Statute does not unconstitutionally burden commercial speech. In reaching this decision, the court considered whether the prohibition satisfied intermediate scrutiny through conducting a commercial speech analysis pursuant to Central Hudson.[3] Under Central Hudson, a restriction on commercial speech satisfies intermediate scrutiny if: (1) the restriction on speech concerns lawful activity; (2) the state’s asserted interest is substantial; (3) the prohibition directly advances that substantial interest; and (4) the prohibition is no more extensive than necessary to serve that interest. The court addressed the latter three prongs, as both CRN and James agreed that the Statute restricted lawful activity.
The court found that New York’s interest in protecting the health of minors was of substantial government interest and was directly advanced by the Statute, as evidenced by alleged misuse of weight loss and muscle building supplements among minors despite CRN’s concerns about potential flaws in the scientific studies offered in support of the Statute.
CRN attempted to show that the Statute was more substantially burdensome than necessary to protect the health of minors, highlighting the Statute’s potential to ban the sale of even children’s multivitamins to minors based solely on packaging. However, the court found that the potential overinclusion still did not substantially burden more speech than necessary. The court also emphasized that intermediate scrutiny does not require the least restrictive means of achieving a goal, but instead a “reasonable fit between the law and its objectives,” with wide deference to the New York Legislature to use “reasonable judgment” to find such a reasonable fit. Despite CRN’s arguments that an ingredients-based approach would present a more reasonable solution to protecting the health of minors, the court determined that the New York Legislature’s use of marketing as a proxy demonstrated “reasonable judgment” because it prevented reliance on state analysis of ingredients which had caused Governor Hochul to veto Assembly Bill 431-C. Since the court found that the Statute met all prongs of the Central Hudson test, the court concluded that the Statute satisfied intermediate scrutiny and thus did not unconstitutionally burden speech.
The Second Circuit also held that CRN was unlikely to succeed on the merits of its claim that the Statute’s age verification requirement unconstitutionally compelled expression. To succeed, CRN needed to demonstrate that the age verification requirement compelled CRN’s own speech or expression such that the views would be identified with CRN or that CRN was forced to affirm belief in a governmentally prescribed position. The court rejected CRN’s assertions that the age verification process would force it to communicate that the age-restricted products were unsafe for minors, because reasonable observers were not only unlikely to confuse the age verification process for CRN’s own speech, but also unlikely to infer any message from it at all.
Not Unconstitutionally Vague or Overbroad
The Second Circuit also rejected CRN’s claim that the Statute’s scope was unconstitutionally vague or overbroad. An unconstitutionally vague law is facially vague when there is no situation in which a person could be sufficiently certain that the Statute would apply to them. The Second Circuit found that using marketing as a weight loss or muscle building aid as a benchmark for whether the law would apply made the Statute’s application to a given supplement “readily apparent,” and thus agreed with the District Court that the Statute was not unconstitutionally vague.
The court similarly determined that the Statute was not impermissibly overbroad in violation of the First Amendment. A law is overbroad under the First Amendment when it is unclear whether the Statute regulates a substantial amount of protected speech, though a law that satisfies intermediate scrutiny will not be found impermissibly overbroad. Due to the court’s conclusion that the Statute satisfied intermediate scrutiny, as explained above, the court easily? concluded that the Statute was not impermissibly overbroad.
Not Preempted by FDCA
The FDCA provides that state law may not directly or indirectly establish any requirement respecting any health-related claims regarding a product’s nutrients.[4] CRN alleged that prompting age restriction as a result of the supplement’s packaging was therefore plainly preempted by the FDCA. However, the Second Circuit disagreed, distinguishing a requirement triggered by a health claim from a requirement as to the contents of a product label, and finding that only the latter would be preempted by the FDCA. Citing Bates v. Dow Agrosciences LLC,[5] a Supreme Court decision rejecting an argument that merely inducing a change in a product label did not constitute a requirement preempted by the FDCA, the court acknowledged that the Statute may induce dietary supplement manufacturers to change their packaging but concluded that the Statute merely imposed an independent legal obligation triggered by a supplement’s health claims. The court noted that it was deferring to this “plausible” reading of the FDCA, even if the FDCA could otherwise be read to preempt the Statute.
Implications
The Second Circuit’s decision not only upholds the New York Statute but may empower additional states to similarly regulate the sale of dietary supplements to minors based not on what the supplements contain, but on labeling, marketing, and representations. The proliferation of similar laws would present substantial implications for revenue reduction within the dietary supplement industry, of which the youth market represents a sizeable source of revenue. Additionally, these bans create a fear for the industry that states might pass even more stringent laws, potentially extending age restrictions to 21, which would drastically affect the military market, and other consumers, similar to the restrictions on the sale of alcohol to minors.
Banning dietary supplements based on how they are marketed, rather than their contents, raises legitimate concerns of regulatory overreach that fails to actually protect the health of minors. As the Second Circuit acknowledged, bans focused on advertising cast a broad, indiscriminate net that encompasses even supplements commonly understood to benefit the health of minors, like children’s multivitamins. Moreover, the court easily brushed past concerns about inaccurate science underlying the Statute, instead generally referencing a “broader body of evidence demonstrating other health risks” and relying heavily on “simple common sense.” As the court noted, the Statute’s use of health claims to determine which products are subject to the ban originated, at least in part, as a proxy to avoid legal challenges. If state laws rely on convenient proxies, like advertising, rather than scientific-backed reasoning, well-intentioned laws could cause harm to the health of minors that they were meant to protect.
It is worth noting that this case is still not over. CRN plans to seek a full court (en banc) review by the Second Circuit, arguing that its original decision lowers the constitutional protections for truthful commercial speech. Additionally, the First Amendment claims in the original District Court case remain live. There are still opportunities for the courts to redirect this regulatory trend to ensure that state laws are properly tailored to safeguard the health of minors, rather than reaching for a convenient (and inaccurate) proxy.
Endnotes
[1] Council for Responsible Nutrition v. James, No. 24-1343 (2d Cir. Nov. 13, 2025).
[2] Governor Kathy Hochul, Veto Message No. 122 (Dec. 23, 2022).
[3] Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 US. 557 (1980).
[4] FDCA § 343(r)(1).
[5] 544 U.S. 431, 436 (2005).
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