Natural Products Association v. James

CourtDistrict Court, E.D. New York
DecidedJune 13, 2024
Docket2:23-cv-08912
StatusUnknown

This text of Natural Products Association v. James (Natural Products Association v. James) is published on Counsel Stack Legal Research, covering District Court, E.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Natural Products Association v. James, (E.D.N.Y. 2024).

Opinion

EASTERN DISTRICT OF NEW YORK ----------------------------------------------------------------------X NATIONAL PRODUCTS ASSOCIATION,

Plaintiff, MEMORANDUM & ORDER 23-cv-08912 (JMA) (LGD) -against- FILED CLERK LETITIA JAMES, in her official capacity as, 3:19 pm, Jun 13, 2024 New York Attorney General, U.S. DISTRICT COURT

EASTERN DISTRICT OF NEW YORK Defendants. LONG ISLAND OFFICE ----------------------------------------------------------------------X AZRACK, United States District Judge: Plaintiff National Products Association—a nonprofit trade organization allegedly representing over 700 members that sell, manufacture, and distribute dietary supplements—brings a pre-enforcement, facial challenge to New York’s Assembly Bill A5610, codified at NY Gen. Bus. Law § 391-oo (collectively, “Statute”), which restricts the sale of certain dietary supplements used for weight loss and muscle building to minors. (ECF No. 30.) Seeking to prevent enforcement of the Statute, Plaintiff filed the instant Motion for a Preliminary Injunction against Defendant Letitia James in her official capacity as New York Attorney General. (ECF No. 37.) For the following reasons, Plaintiff’s motion for a preliminary injunction is DENIED, and this action is DISMISSED without prejudice for lack of subject-matter jurisdiction.1 A. Statutory Background Starting in 2020, the New York State Legislature sought to address the growing “serious

public health problem” of eating disorders that is purportedly “affecting youth and adults of all races, ages, and genders.” Sponsor’s Mem. in Support for A10138 (2020), at 1 (see Hingerton Decl., Ex. B, ECF No. 37-3); accord Sponsor’s Mem. in Support, in Bill Jacket for Ch. 558 (2023), at 1–2 (see Hingerton Decl., Ex. A, ECF No. 37-2). The chief concern for the Legislature was that eating disorders are a mental health condition that may be identified and diagnosed based on “the presence of what clinicians call unhealthy weight control behaviors”—one of which is the use (or misuse) of dietary aids to promote weight loss or to build muscle. Sponsor’s Mem. in Support, in Bill Jacket for Ch. 558 (2023), at 1–2. A second concern for the Legislature was that weight loss or muscle building dietary supplements were readily available for purchase “alongside multivitamins and other supplements largely regarded as safe,” despite several reported instances

of death and serious harms resulting from their essentially unregulated use. (Id.) On December 23, 2022, Governor Kathy Hochul vetoed Assembly Bill 431-C. (See Ex. B, SAC.) The Governor first noted that “she share[d] the concerns of the sponsors of this bill” and “desired to address the marketing of … diet pills and dietary supplements to minors.” (Id.) Citing the United States Food and Drug Administration’s lack of “oversight over the safety and efficacy” of diet pills and dietary supplements, Governor Hochul acknowledged “concerns … about dangerous ingredients and the links to eating disorders” that these products allegedly cause—

2 This Memorandum and Order draws its facts from Plaintiff’s Second Amended Complaint (ECF No. 30 (“SAC”)); Plaintiff’s Memorandum of Law in Support of its Motion for a Preliminary Injunction (ECF No. 36-1 (“Pl. Mot.”)); Plaintiff’s Affidavits in Support of its Motion for a Preliminary Injunction (ECF Nos. 36-2 (“Dr. Fabricant Aff.”), 36-3 (“Emme Aff.”)); Defendant’s Memorandum of Law in Opposition to Plaintiff’s Motion for a Preliminary Injunction (ECF No. 37 (“Def. Opp.”)); Defendant’s Declaration in Support of its Opposition to Plaintiff’s Motion for a Preliminary Injunction (ECF No. 37-1-5 (“Hingerton Decl.”)); and Plaintiff’s Reply Memorandum of Law in Support of its Motion for a Preliminary Injunction (ECF No. 39 (“Pl. Rep.”).) Department of Health (DOH) to determine what products should be limited under this new law.”

(Id.) Without “the expertise necessary to analyze ingredients used in countless products,” Governor Hochul concluded that the DOH was “not equipped to create a list of restricted products.” (Id.) For this principal reason—among others—Governor Hochul was “constrained to veto th[e] bill” and thus “disapproved” it.3 (Id.) Following several rounds of revisions, the Legislature enacted A5610 on October 25, 2023—the Statute at the heart of this action. See Ch. 558, 2023 N.Y. Laws. The Statute provides that no person, company “or other entity shall sell or offer to sell or give away, as either a retail or wholesale promotion, ... [a] dietary supplement for weight loss or muscle building within this state

to any person under eighteen years of age.” Ch. 558, § 1, 2023 N.Y. Laws (codified at N.Y. Gen. Bus. Law § 391-oo(2)). A “dietary supplement4 for weight loss or muscle building” is defined as “a class of dietary supplement as defined in section three hundred ninety-one-o of this article that is labeled, marketed, or otherwise represented for the purpose of achieving weight loss or muscle building.” Gen. Bus. Law § 391-oo(l)(a). Exempted from the Statute’s age-based sales restriction are “protein powders, protein drinks and foods marketed as containing protein unless the protein powder, protein drink or food ... contains an ingredient other than protein which would, considered alone, constitute a dietary supplement for weight loss or muscle building.” Id. The Statute also contains provisions clarifying its scope and guiding its enforcement. In

particular, the Statute clarifies that a supplement is “labeled, marketed, or otherwise represented

3 Governor Hochul also stated: [i]t would … be unfair to expect retailers to determine which products they can and cannot sell over the counter to minors, particularly while facing the threat of civil penalties.” (Id.)

4 “Dietary supplement” is defined, in relevant part, as an ingestible product that “contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid ...” and which is labeled as a “dietary supplement” under federal law. See Gen. Bus. Law § 831 (renumbered from Gen. Bus. Law § 391-o). statements or images that express or imply that the product will help ... modify, maintain, or reduce

body weight, fat, appetite, overall metabolism, or the process by which nutrients are metabolized” or “maintain or increase muscle or strength.” Id. § 391-oo(6)(b)(i)–(ii). The Statute also directs courts in enforcement proceedings to consider––among other factors––whether a dietary supplement contains certain ingredients, as the inclusion of such ingredients commonly associated with weight loss or muscle building may make it more likely to bring a product within the Statute’s restrictions. Id. § 391-oo(6)(a)(i)–(iii). Such ingredients include: (1) steroids; (2) “creatine, green tea extract, raspberry ketone, garcinia cambogia, green coffee bean extract;” or (3) “an ingredient approved by the federal Food and Drug Administration for weight loss or muscle building.” Id. Further, the Statute provides that a dietary supplement may be subject to the age-based sales

restriction through the actions of a retailer by: “placing signs, categorizing, or tagging the supplement with statements” suggesting that the supplement will impact weight, fat, appetite, metabolism, muscle or strength, or by “grouping the supplements with other weight loss or muscle building products in a display, advertisement, webpage, or area of the store.” Id. § 391-oo(6)(d)(i)– (iii). The Statute requires brick-and-mortar retailers who directly sell covered products to the public to comply with its age-based sales restriction. See id. § 391-oo(2).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Havens Realty Corp. v. Coleman
455 U.S. 363 (Supreme Court, 1982)
Lujan v. National Wildlife Federation
497 U.S. 871 (Supreme Court, 1990)
Lujan v. Defenders of Wildlife
504 U.S. 555 (Supreme Court, 1992)
Munaf v. Geren
553 U.S. 674 (Supreme Court, 2008)
Carver v. City of New York
621 F.3d 221 (Second Circuit, 2010)
Cacchillo v. Insmed, Inc.
638 F.3d 401 (Second Circuit, 2011)
Shain v. Ellison
356 F.3d 211 (Second Circuit, 2004)
Clapper v. Amnesty International USA
133 S. Ct. 1138 (Supreme Court, 2013)
National Organization for Marriage, Inc. v. Walsh
714 F.3d 682 (Second Circuit, 2013)
Cave v. East Meadow Union Free School District
514 F.3d 240 (Second Circuit, 2008)
Pietsch v. Bush
755 F. Supp. 62 (E.D. New York, 1991)
Knife Rights, Inc. v. Vance
802 F.3d 377 (Second Circuit, 2015)
Carter v. HealthPort Technologies, LLC
822 F.3d 47 (Second Circuit, 2016)
Chevron Corp. v. Donziger
833 F.3d 74 (Second Circuit, 2016)
Carney v. Adams
592 U.S. 53 (Supreme Court, 2020)
Grand River Enterprises v. Boughton
988 F.3d 114 (Second Circuit, 2021)
LaFleur v. Whitman
300 F.3d 256 (Second Circuit, 2002)
Parker Madison Partners v. Airbnb, Inc.
283 F. Supp. 3d 174 (S.D. Illinois, 2017)

Cite This Page — Counsel Stack

Bluebook (online)
Natural Products Association v. James, Counsel Stack Legal Research, https://law.counselstack.com/opinion/natural-products-association-v-james-nyed-2024.