CRN’s lawyers have their work cut out in NY litigation—to put it mildly

A recent court opinion and order underscores that CRN has a tough road ahead to convince a judge to overturn a New York statute that restricts minors' access to certain dietary supplement products.

Josh Long, Associate editorial director, Natural Products Insider

April 23, 2024

7 Min Read

At a Glance

  • Judge Andrew Carter cited CRN's “substantial and inexcusable delay in moving for preliminary relief."
  • The judge determined that New York's statute regulates conduct, not speech, in a blow to CRN's First Amendment arguments.
  • There is a silver lining. Based on a finding that CRN has standing, the lawsuit remains alive.

On Friday, April 19, the Council for Responsible Nutrition (CRN) received word that its request for a preliminary injunction against a New York statute had been denied. There was a silver lining. U.S. District Judge Andrew L. Carter Jr. found CRN had standing to sue, meaning the Washington, D.C.-based trade association could continue to litigate the case in an effort to overturn New York Assembly Bill A5610.

Carter’s 25-page opinion/order underscores that CRN’s odds of overturning the statute based on the First Amendment are slim to none. And if the judge in a similar lawsuit brought by the Natural Products Association (NPA) reads Carter’s order, I feel she will be inclined to deny NPA’s forthcoming request for a preliminary injunction.

Beyond the issue of standing, none of this is stellar news for industry stakeholders concerned about the New York statute, which limits minors’ access to weight loss and muscle-building supplements. The Strategic Training Initiative for the Prevention of Eating Disorders (STRIPED), which has advocated strongly for laws like the one in New York that took effect this week, has probably already ordered the balloons, cake and fireworks for the celebration party.

Let’s begin to peel back this onion.

‘Inexcusable delay’

To convince the judge to issue a preliminary injunction, CRN had to show that the trade association would suffer “irreparable harm” without the relief, “a likelihood of success on the merits” of its legal claims and granting the injunction would serve the public interest. Carter found CRN met none of the three criteria.

Commenting on whether CRN would face irreparable harm absent the preliminary injunction, the judge observed that the trade group’s delay in filing the motion flew in the face of its request.

CRN’s “substantial and inexcusable delay in moving for preliminary relief five months after the [statute] was enacted in October 2023, erodes its claims of immediate, irreparable, and impending injury,” Carter wrote.

By similar reasoning, U.S. District Judge Joan M. Azrack could reach the same conclusion should NPA file a motion for a preliminary injunction. On April 1, the trade group had requested a pre-motion conference to discuss the filing of a motion for a preliminary injunction. Azrack recently stayed the court proceedings pending a decision by Carter.

Both lawsuits are pending in federal district court in New York but are before different judges in different districts.

A court’s denial of a request for a preliminary injunction is not the worst of the news, since obtaining one is a long shot. As the U.S. Court of Appeals for the Second Circuit noted in a 2007 opinion quoted by Carter, “[A] preliminary injunction is an extraordinary and drastic remedy, one that should not be granted unless the movant, by a clear showing, carries the burden of persuasion."

Commercial speech under First Amendment

On the issue of whether the New York statute unconstitutionally infringes on commercial speech under the First Amendment, Carter found the statute doesn’t even implicate the First Amendment, according to his determination.

“The statute regulates conduct, not speech,” the judge wrote. “It affects what sellers ‘must do,’ require proof of legal age to purchase over-the-counter dietary pills or dietary supplements for weight loss or muscle building. The statute does not regulate what these sellers ‘may or may not say.’ CRN member sellers are free to market, describe, or label their products however they so choose in accordance with federal and state statutory requirements regarding advertising.”

Carter did not reach this decision out of the blue. He turned to Lorillard Tobacco v. Reilly, a U.S. Supreme Court case decided in 2001. In that holding, the high court determined that certain tobacco regulations promulgated by the Massachusetts attorney general withstood scrutiny under the First Amendment. The state had prohibited displays that would allow a person to buy tobacco without having direct contact with a salesperson.

“Notably, the [Supreme Court] found that even though Massachusetts’ display-related sales provisions regulated conduct that may have had a ‘communicative component,’ the state sought to regulate the placement of tobacco products ‘for reasons unrelated to the communication of ideas,’” Carter remarked.

In a concurring opinion quoted by Carter, then-Associate Supreme Court Justice John Paul Stephens wrote, “However difficult that line may be to draw, it seems clear to me that laws requiring that stores maintain items behind counters and prohibiting self-service displays fall squarely on the conduct side of the line. Restrictions as to the accessibility of dangerous or legally restricted products are a common feature of the regulatory regime governing American retail stores. I see nothing the least bit constitutionally problematic in requiring individuals to ask for the assistance of a salesclerk in order to examine or purchase a handgun, a bottle of penicillin, or a package of cigarettes.”

The New York statute, Carter continued in his 25-page opinion, “targets the same conduct-based regulation by placing dietary supplements behind the proverbial counter and requiring age verification. The statute’s core purpose is to inhibit minors’ access to dietary supplements given the connection of unsupervised use to eating disorders.”

Carter concluded the New York statute doesn’t implicate the First Amendment, but he didn’t stop there. Even assuming that New York Assembly Bill A5610 regulates speech protected by the First Amendment, it most likely survives constitutional scrutiny. That's at least my reading of his opinion. He cited a four-factor test enumerated in a famous Supreme Court case on commercial speech. The 1980 decision — a must-read in law school — is known as Central Hudson Gas & Elec. Corp. v. Public Svcs. Comm.

The judge focused on the third and fourth prongs of Central Hudson, namely whether “the regulation directly advances the asserted government interest” and “is no more extensive than necessary to serve that interest.” He concluded both prongs were satisfied.

“Notably, this statute does not institute a complete ban on ‘the sale of dietary supplements that are labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building,’” Carter observed. “In fact, the statute carves out protein powders, protein drinks and foods marketed as containing protein (unless the product contains an ingredient that in isolation would constitute a dietary supplement for weight loss or muscle building). Because the statute also leaves ‘open alternative avenues for vendors to convey information about products,’ the restriction is not more extensive than necessary to serve the government’s interest.”

Judge: Other claims unlikely to succeed

CRN got eviscerated on its First Amendment arguments, but how does the judge view its other legal claims? I urge you to read the opinion for yourself, but the short answer is Carter found CRN failed to prove it will likely succeed on additional claims that the statute exceeds the state’s police powers, is preempted by federal law and is unconstitutionally vague on its face.

Of course, CRN’s lawsuit challenging the law isn’t dead. In an April 22 statement, CRN President and CEO Steve Mister said, “The announcement that we have standing is significant because it means that only CRN is positioned right now to go before the court on behalf of industry and argue the merits of what we believe is a strong case. As for the preliminary injunction, we knew that asking for such extraordinary relief was a longshot, although we respectfully disagree with the court. We will continue to pursue all available legal avenues to challenge this law and continue to believe it unfairly restricts consumer access to legitimate, beneficial health products and infringes upon the rights of businesses to engage in lawful commerce." (Judge Azrack, in the Eastern District of New York, hasn't made a ruling on whether or not NPA has standing).

But can CRN ultimately convince the U.S. District Court to overturn the statute? A reading of Carter’s opinion leads me to believe CRN’s lawyers at Cozen O’Connor have their work cut out for them — to put it mildly.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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