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February 12, 2024
The Natural Products Association (NPA) has “standing” to challenge a New York law restricting minors’ access to dietary supplements, according to its counsel in a letter filed last week in Federal District Court.
New York Assembly Bill A5610 prohibits the sale of an OTC diet pill or dietary supplement for weight loss or muscle building to an individual under the age of 18. The legislation is set to take effect in April, or 180 days after it was signed by Gov. Kathy Hochul.
NPA in December filed a lawsuit challenging the constitutionality of AB A5610. In late January, a lawyer in the office of New York Attorney General Letitia James disclosed plans to file a motion to dismiss NPA’s lawsuit.
Among the arguments raised in a Jan. 31 letter, New York Assistant Attorney General Patricia M. Hingerton claimed NPA does not have “standing to sue.”
NPA has failed to “sufficiently identify at least one member who has suffered or would suffer harm as a consequence of the Act or any action by AG James,” thereby lacking “associational standing,” Hingerton wrote in the three-page letter to Federal Judge Joan M. Azrack. “Relatedly, plaintiff has not sufficiently alleged an injury that is certainly impending or substantially likely to occur so as to constitute the requisite injury-in-fact.”
Kevin Bell, an attorney in the nation’s capital with Arnall Golden Gregory LLP, who represents NPA in its lawsuit, responded to Hingerton’s letter. NPA has standing to sue, he argued in a Feb. 7 letter, because its complaint alleged AB A5610 “will imminently and directly affect members of NPA that sell and market supplements in New York on a daily basis.”
Hingerton’s letter cited a federal appeals court’s decision in 2021 affirming the dismissal of a lawsuit because the membership association filing the complaint against New York University did not identify members who suffered the requisite harm.
While the plaintiff in that case “failed to allege when and if its members were participating in the conduct subject to regulation, NPA’s complaint sufficiently alleges that its members are in the relevant market and are actively selling dietary supplements to the general public every single day,” Bell wrote to Azrack.
To satisfy the standing requirement, NPA is not required to identify the names of its members, according to his three-page letter.
“Moreover, since NPA’s members are already engaged in the conduct sought to be regulated by the Act (i.e., the sale of dietary supplements), if NPA’s members do not change the way they currently conduct their business (i.e., by implementing age-verification systems for both in-store purchases and online purchases), they will necessarily be subject to prosecution under the Act, as the Act specifically grants defendant the power to prosecute anyone who sells dietary supplements or diet pills to anyone under the age of eighteen," Bell wrote.
His letter further laid out arguments to demonstrate New York’s law is preempted by the Federal Food, Drug & Cosmetic Act (FDCA), violates the Dormant Commerce Clause of the U.S. Constitution and is “void for vagueness.”
For instance, on the issue of preemption, Bell noted AB A5610 identifies several factors to be considered by New York courts in determining whether an OTC diet pill or supplement is labeled, marketed or otherwise represented to achieve weight loss or build muscle.
“By creating this new definition, the Act effectively creates a new category of dietary supplement under New York law, which establishes particular requirements related to the covered supplements and departs from the expressly mandated boundaries of FDCA,” Bell stated. “In New York, this means that a product could be regulated differently based on the product’s label or marketing depending upon whether it is marketed in New York or outside of it.”
Before the judge is Hingerton’s request for a pre-motion conference regarding the anticipated filing of a motion to dismiss NPA’s lawsuit. Hingerton alternatively requested a briefing schedule providing at least 45 days to file her motion.
Bell requested the court deny the request for a formal briefing schedule, and he objected to the 45-day proposed timeline.
NPA’s lawsuit, 2:23-cv-08912, is pending in the U.S. District Court for the Eastern District of New York.
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.
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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