NPA wants to prevent the New York AG “from enforcing or otherwise requiring compliance” with a state law limiting minors' access to dietary supplement products until the case in federal court is resolved.

Josh Long, Associate editorial director, Natural Products Insider

April 3, 2024

4 Min Read

At a Glance

  • On April 1, NPA lawyer wrote to Federal Judge Joan Azrack.
  • NPA's letter expressed interest in filing a motion for a preliminary injunction.
  • To obtain a preliminary injunction, NPA must show "irreparable harm."

The Natural Products Association (NPA) intends to file a motion for a preliminary injunction to block the New York attorney general from enforcing a law that restricts minors’ access to dietary supplement products marketed for weight loss or muscle building.

The law, passed as New York Assembly Bill A5610, takes effect on April 22.

In an April 1 letter to Federal Judge Joan Azrack, NPA requested a pre-motion conference to discuss the filing of a motion for a preliminary injunction to enjoin the state AG from “from enforcing or otherwise requiring compliance” with the law until the case is resolved.

Kevin Bell, an attorney in the nation’s capital who represents NPA, said in the letter that he conferred with Assistant Attorney General Patricia M. Hingerton. Bell requested the state AG “reconsider enforcing the Act until the resolution of this case, but, as of the date of this letter, defendant has not reconsidered and presumably intends to enforce the Act as soon as it goes into effect on April 22, 2024.”

NPA, which was granted permission this week to file a second amended complaint, has alleged the law (enacted as NY Gen. Bus. Law § 391-oo) violates several provisions of the U.S. Constitution, including the so-called dormant Commerce Clause. The most recent version of the lawsuit identifies some NPA members who will be directly harmed by the law: NOW Foods and The Vitamin Shoppe.

Related:NY law targeting dietary supplements mired in CRN, NPA litigation

To prevail on a motion for a preliminary injunction, NPA must establish “(a) a threat of irreparable injury, (b) a likelihood of success on the merits and (c) that the balance of the equities tip in their favor and the injunction is in the public interest,” according to Bell’s letter to Azrack, who presides in the U.S. District Court for the Eastern District of New York.

Members of NPA will “suffer irreparable injury due to (a) the potential prosecution and imposition of monetary fines under the Act, if in the defendant’s discretion, it is determined a product sold by such member should be considered an ‘over-the-counter diet pill[s] or dietary supplement[s] for weight loss or muscle building’ (‘regulated product’), despite the members’ good faith efforts to understand what constitutes a regulated product under the Act, and/or (b) lost profits (or complete loss of business) as a result of the unavailability of the type of age verification services required under the Act and/or due to the significant increase in delivery costs associated with in-person hand-delivery,” Bell wrote.

New Jersey-based industry attorney Theodora McCormick maintained the lawsuits challenging the law and filed by NPA in December and the Council for Responsible Nutrition (CRN) in March contain “really strong” legal arguments.

Related:NPA, New York AG spar over ‘standing’ issue in lawsuit

“The statute is really really vague, and as a result, I think that [NPA] can show likelihood of success on the merits,” McCormick, a member of the law firm Epstein Becker & Green P.C., said in an interview. “To me, it’s going to come down to, can they convince the court that there’s a risk of irreparable harm here and persuade the court to enter an injunction?”

The state AG has not responded to requests for comment on NPA’s complaint or implementation of the new law.

According to the lawsuits and several industry lawyers, it’s not clear what products fall within the definition of a weight loss or muscle building supplement under the legislation.

The law specifies certain factors a court may consider but also says the court is not limited to examining those factors. One of the factors is “whether the product's labeling or marketing bears statements or images that express or imply that the product will help: (i) modify, maintain, or reduce body weight, fat, appetite, overall metabolism, or the process by which nutrients are metabolized.”

Steven Shapiro of Rivkin Radler LLP, who has been practicing food law since 1988, said there are many unanswered questions about the scope of the law, including whether it covers products targeting the elderly for maintaining healthy weight or muscular structure.

“When you start to look at products that discuss metabolism, a lot of companies have B vitamins that talk about metabolism,” he added in an interview. “Products that have black pepper extract discuss the benefit of that ingredient helping nutrients to be metabolized or digested. Does that fall within the scope of the law?”

As companies go through the exercise of determining which dietary supplement products are subject to the new restrictions, the impact of the law is proving “far broader than anybody ever imagined,” Shapiro concluded.

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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