Judge must decide motion to dismiss CRN’s lawsuit challenging NY law

With time winding down before a New York law takes effect restricting minors’ access to certain dietary supplement products, a judge may rule in the coming days on a request for a preliminary injunction filed by the Council for Responsible Nutrition and a separate motion to dismiss filed by the New York attorney general.

Josh Long, Associate editorial director, Natural Products Insider

April 16, 2024

6 Min Read

The Council for Responsible Nutrition (CRN) and the New York attorney general filed opposing papers with a U.S. District Court over whether a lawsuit should be dismissed, as time winds down before a controversial law is set to go into effect on April 22.

New York Assembly Bill A5610, which prohibits minors’ access to certain dietary supplement products, is the subject of lawsuits filed by CRN and the Natural Products Association (NPA).

On April 12, in the Southern District of New York, the state attorney general filed a motion to dismiss CRN’s amended complaint with prejudice. Three days later, CRN contested the motion, leaving the decision to U.S. District Judge Andrew Carter.

Carter also must rule on CRN’s request for a preliminary injunction to prevent enforcement of the law, until the trade association’s lawsuit is resolved.

Federal courts may go several months before ruling on motions to dismiss, but considering CRN’s request for a preliminary injunction and that the law is set to take effect in a week, the judge may issue rulings in the coming days.

During a recent court hearing, “the judge appeared to appreciate the gravity and the immediacy of this situation,” CRN President and CEO Steve Mister told Natural Products Insider.

New York Assembly Bill A5610 establishes restrictions on the sale of over-the-counter diet pills and dietary supplements marketed for weight loss or muscle building. Industry lawyers, however, maintain the bill is vague and potentially captures far more products than those marketed for weight loss or muscle building.

Related:‘Vague’ NY law looms for The Vitamin Shoppe, other supplement retailers

CRN has alleged the law is “void for vagueness” under the First and 14th amendments of the U.S. Constitution, infringes on constitutionally protected speech under the First Amendment and exceeds the state’s police powers. CRN also claimed the law violates the U.S. Constitution’s supremacy clause, which invalidates state laws contrary to federal statutes.

Spat over ‘standing’

The state attorney general has argued the lawsuit should be dismissed because CRN “lacks standing” and its “claims uniformly fail as a matter of law.” On the standing issue, the state attorney general maintained the court lacks “jurisdiction” or authority to review the case.

First, the state attorney general argued the prohibitions in the new law “only apply to persons or entities who sell covered products directly to consumers, and not to the manufacturers or distributors who provide the products to retailers or wholesalers, so long as the latter do not transact with consumers directly.”

Of nine CRN members who provided declarations to the federal court, only four are from companies that sell products directly to consumers, according to the motion to dismiss. The other companies that produce or manufacture supplements “do not face any possibility of enforcement under the statute, and thus their imaginary fears of harm are insufficient,” argued the state attorney for why CRN lacks standing.

“Even as to plaintiff’s seller members, their declarations fail to demonstrate, with any level of specificity, that they have ‘concrete plans to perform, in the near future, the conduct that officials would consider illegal,’” the state attorney general’s motion added. The government brief cited a court case determining there was no standing to assert a pre-enforcement challenge where a plaintiff didn’t provide the court information concerning his intentions.

“A number of plaintiff’s members aver that the companies purportedly must choose between ‘facing the risk of an enforcement action’ or ‘overwhelmingly erring on the side of caution with respect to both the marketing and sale of dietary supplements.’ But the declarations do not provide any specifics as to what the members actually intend to do,” the state AG asserted. “Nor do they identify a single product that plaintiff’s members intend to continue selling, subject to the statute’s age restrictions, or any product the members intend to continue selling without the restrictions that they believe may expose them to enforcement.”

In a brief filed April 15, CRN countered it has alleged sufficient facts to show “both associational and organizational standing.” The state attorney general has failed to “address standing based on incurred compliance costs,” CRN’s lawyers wrote. They quoted a decision in 2021 in which the U.S. Court of Appeals for the Second Circuit ruled “[a] regulated entity may plead an ‘injury in fact’ by plausibly alleging compliance costs associated with an increased regulatory burden.”

Further, the brief claimed CRN’s “members face a credible threat of an enforcement action due to the Act’s vague language.”

“Critically, CRN is not required to demonstrate a statute will certainly be interpreted in a way that could lead to enforcement; rather, it only needs to allege a ‘reasonable enough’ interpretation such that a CRN member ‘legitimately fear[s] that it will face enforcement,’” according to CRN’s brief.

Finally, CRN argued it met the standing requirement by alleging the New York statute has “chilled” its members’ speech.

Substantive claims: State police powers

Beyond the “standing” issue, the litigants argued over whether CRN’s substantive claims challenging the law should be dismissed immediately.

For instance, the state attorney general maintained the New York statute is a proper exercise of the state’s police powers. “In short, a statute must be upheld as long as its rationality is ‘at least debatable,’” according to the the motion to dismiss, which asserted the statute meets this requirement.

“It was plainly reasonable for the Legislature to restrict the ability of teenagers and children to buy dietary supplements identified as promoting weight loss or muscle building as a means of protecting the public health and raising awareness of the health risks attendant to the unfettered access of these substances by a vulnerable population,” the state attorney general asserted in the motion. “It cannot be seriously disputed that a restriction preventing minors from directly purchasing certain dietary supplements is a rational means of reducing the unsupervised use of those products by minors — products which plaintiff’s own members warn are ‘[n]ot intended for use by persons under the age of 18.’”

CRN countered, “There is no ‘reasonable relationship’ between, on one hand, a law that age-restricts purchases based on marketing and, on the other hand, eating disorders in minors.”

“The Act does nothing to prevent minors from accessing products with inherently dangerous ingredients that do get abused for purposes of eating disorders (i.e., laxatives and caffeine), while simultaneously and irrationally prohibiting the sale of products that are perfectly safe but have associated marketing with the wrong ‘buzzwords,’” CRN’s brief maintained. “Given the disconnect between the marketing of a product and the goal of curbing eating disorders, it should come as no surprise that none of the scientific support offered in support of the Act relates in any way to the marketing or labeling of dietary supplements, the relationship between dietary supplements and eating disorders, or the prevalence of eating disorders in adolescents that consume dietary supplements. To date, the legislature has not offered any such scientific support.”

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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