Natural Products Association SUES New York Over Supplement Restrictions (Updated 2/8/24)

On December 4, 2023, the Natural Products Association (NPA) filed a lawsuit against the State of New York — specifically Attorney General Letitia James — arguing that the state’s recently-enacted law that prohibits and restricts dietary supplement purchases is unconstitutional.[1]

This article explains the law, summarizes the lawsuit, provides a quote from the Natural Products Association (New York has not yet commented), and will be updated as major news occurs.

Article/Lawsuit Updates:

  • January 31, 2024 – New York’s Attorney General office has responded with a “Motion for Pre-Motion Conference”, explaining to the judge their criticisms against this suit and that they plan to file a motion to dismiss. See the Motion for Pre-Motion Conference section for a link.
  • February 7, 2024 – The NPA has responded to the above letter with points as to why this case should continue. See the Motion for Pre-Motion Conference Response section.

To take action: readers can head to the NPA’s Action Center and leave a comment to New York.

About The New York Supplement Restriction Law

The bill was titled Assembly Bill A5610D[2] and was signed into law on October 25, 2023 by Governor Kathy Hochul.[3] It’s set to be enacted as NY General Business Law § 391-oo on April 22, 2024.[4]

Natural Products Association vs. New York: Lawsuit over Supplement Restriction Law

The Natural Products Association (NPA) has sued the State of New York (specifically attorney general Letitia James, not pictured here) over the state’s unconstitutional restrictive dietary supplement law

The law minimizes public access to dietary supplements and, in certain situations, requires a prescription to access some products. Retailers’ failure to comply would result in fines for each infraction.

Proof of age for weight loss or muscle building dietary supplements

More specifically, the law focuses on “dietary supplements for weight loss or muscle building”.

It excludes protein powders, protein drinks, and foods marketed as containing protein — unless it contains an ingredient other than protein that’s considered a weight loss or muscle-building supplement.

Stores may not sell these supplements to any person under 18 years of age, and retail establishments must require proof of age for them. It also requires deliveries of such products to be signed for by adults with proof of ID.

Determination of products in these categories will be based upon several factors, such as if it implies reduced body weight, fat, appetite, or overall metabolism. It also specifically calls out any products with creatine, green tea extract, raspberry ketone, garcinia cambogia, and green coffee bean extract.[4]

Key points of the NPA’s New York lawsuit

The case, filed in the Eastern District of New York, specifically names New York Attorney General Letitia James, since she’s delegated as the authority of enforcing this law.[1] It begins by justifying the jurisdiction and validity of the lawsuit, as it seeks to redress the deprivation of rights of NPA’s member parties.

The Federal Law that Preempts a State’s Ability to Enforce This Law

It then provides background facts, explaining that dietary supplement manufacturing, use, and sales are regulated by the Food, Drug, & Cosmetic Act (FDCA).[1] It shows federal laws such as:

NPA vs. New York Lawsuit

Does the state of New York have the ability to define dietary supplement categories and how they’re sold, or is that exclusively reserved for the federal government?[1]

  1. 21 USC § 343-1(a)(5), which preempts state laws from requiring claims that different from FDCA’s requirements.[5]
  2. 21 USC § 337(a), which prohibits the private enforcement of any of the provisions of FDCA“all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.”[6]

So NPA is arguing that New York’s law violates the federal government’s exclusive enforcement authority on matters relating to the Food, Drug, & Cosmetic Act.

The NPA also argues that New York’s Law is in conflict with other parts of the FDCA that define dietary supplements because the law attempts to make product definitions that conflict with the FDCA. Additionally, prescription and over-the-counter drugs could also be included in this law’s enforcement, and those are not dietary supplements.

Further, the law attempts to define what constitutes “weight loss” and “muscle-building” supplements, but such definitions are also the responsibility of the federal government, not the states. This can lead to “improper arbitrary and capricious application of the law”.[1]

An unconstitutional law

In short, point 39 quickly summarizes this for us:

“Since the FDCA and the Act are in direct conflict, the FDCA preempts the Act and the Act is unconstitutional.”[1]

Seeking declaratory judgment and order of restraint

As such, in the lawsuit’s prayer for relief section, the NPA seeks a declaratory judgment that the Act is unconstitutional on its face, and requests an order restraining the state from enforcing the law. They also request attorneys’ fees.

Case Updates (through February 2, 2024)

  1. January 31, 2024: NY AG Files Motion for Pre-Motion Conference

    After requesting an extension until February 1, 2024,[7] Patricia M. Hingerton, New York’s Assistant Attorney General, filed a request to have a pre-motion conference.[8] Inside, they stated that they’re anticipating to file a motion to dismiss the case, and provided a few points of dissention with the lawsuit:[8]

    1. The lawsuit doesn’t list members that will be harmed
    2. The suit is premature — the harm hasn’t (yet) taken place
    3. The law doesn’t actually change labeling requirements per FDCA
    4. The law is not “impermissibly vague”, which is a requirement from past case law.

    The NPA stated that they were not suprised by these comments, and their response is updated below.

    These points will either be debated in a meeting with the judge present, or through formal filings, but it shows us that a great way to get discourse started is sadly through a lawsuit like this.

  2. February 7, 2024: NPA Files Response to NY’s Motion for Pre-Motion Conference

    Kevin Bell, counsel for the NPA, submitted a response to the judge regarding the above letter, explaining why the case should move forward.[9]

    NPA vs. New York: Response to Motion for Pre-Motion Conference

    The NPA’s counsel has responded to New York, stating this case does have standing, so let’s go!

    Using case law, he argues the following points:[9]

    • NPA claims it does have standing, since their member organizations will immediately be affected by the law and are in the relevant market. They also argue that they don’t have to “name names” of its members to satisfy requirements for standing.
    • NPA states that the FDCA does preempt the Act because the Act would create a new category of dietary supplements, departing from FDCA. They later argue that it doesn’t appropriately define “weight loss” or “muscle building”.
    • NPA insists that the act is vague and improper, especially in that it would improperly favor enforcement upon brick-and-mortar locations compared to online retailers. Online retailers, meanwhile, would have to submit to exorbitant delivery costs, and NPA alleges that there aren’t good systems in place to ensure 18+.

    Finally, the NPA objects to the 45-day timeline proposed by the NY AG, since that would cause harm to their members in the interim while waiting.

    The judge’s response is expected within a week or so – stay tuned to PricePlow.

Case updates to be reported in this article

The Natural Products Association has promised to keep us in the loop with major updates as the case develops. You can sign up for alerts on PricePlow’s Natural Products Association news page or in the widget at the bottom of this page.

Take Action Now!

Natural Products Association

The Natural Products Association (NPA) is the nation’s leading trade association for dietary supplements and natural health products. See the NPA’s Action Center

To take action, readers can share this article and then head to the NPA’s Action Center and leave a comment to New York. You can also share this image to your Instagram story and link to this page.

Join the NPA

Additionally, brands, manufacturers, and retailers can look to join the Natural Products Association to receive support from the leading trade association for dietary supplements and natural health products.

The industry is going to need to get used to these suits, as more states are looking to pass similar laws.

NPA’s Dan Fabricant speaks out

Dan Fabricant, the Natural Products Association’s President and CEO, released the following statement:

“Governor Hochul’s decision to flip-flop and cave to anti-supplement charlatans is evidence she cares more about politics than New Yorkers ability to stay healthy.

Dan Fabricant: NPA's 2023 Washington DC Fly-In Day for Episode #100 on the PricePlow Podcast

Team PricePlow flew into Washington DC for the Natural Products Association’s 2023 Fly-In Day, recording a great tell-all podcast with NPA’s CEO, Dan Fabricant, who tells us in PricePlow Podcast Episode #100 why we should be involved in our industry’s politics.

Not only is this unconstitutional, but this prohibition is a bad policy threatening the ability of nearly 80% of Americans to access wellness products they’ve relied on for their health routines. It also violates the U.S. Constitution because it hands the state’s executive branch unfettered discretion to restrict access to dietary supplements and relies on an absurd enforcement mechanism to enforce compliance. We believe the court will recognize the serious concerns raised and declare it unconstitutional.”

— Dan Fabricant, NPA President & CEO

You can learn more about Dan Fabricant in Episode #100 of the PricePlow Podcast, where he explains why everyone needs to get involved in their industry’s political matters.

Request for comment out for Letitia James

We have reached out to the office of Letitia James for further comment, and will update this article if we receive one.

The background and basis of the law

The New York legislators who created this bill argued that these supplements lead to eating disorders. This has never been established — not through correlation nor causation. There is zero data showing the likelihood of developing an eating disorder as a result of using weight loss products.

Natural Products Association vs. Dick Durbin S.4090

Previously on the PricePlow Podcast, the NPA successfully defeated a bill (S.4090) introduced by Senator Dick Durbin that would have required pre-approval from the FDA for all dietary supplements. Listen to it in Episode #067.

The lawsuit argues that such situations would be filed as adverse events (for which there have been none), and that, too, is under the purview of the federal government, not the states.

Instead, the argument that “fat burners lead to eating disorders” has seemingly been pushed for political grandstanding and headline-worthy clickbait. If we come across any research indicating a correlation or causation between supplements and eating disorders, we will post updates here.

The lawsuit was served by Kevin Bell and Matthew Zapadka of Arnall Golden Gregory (AGG),[10-12] one of NPA’s Washington DC Law Firms. Their New York representation is Aaron Zerykier of Polsinelli PC. It has a case number of 2:2023-cv-08912. The presiding judge is Hon. Joan M. Azrack.

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About the Author: Mike Roberto

Mike Roberto

Mike Roberto is a research scientist and water sports athlete who founded PricePlow. He is an n=1 diet experimenter with extensive experience in supplementation and dietary modification, whose personal expertise stems from several experiments done on himself while sharing lab tests.

Mike's goal is to bridge the gap between nutritional research scientists and non-academics who seek to better their health in a system that has catastrophically failed the public.

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References

  1. “Complaint for Declaratory Judgment and Injunctive Relief.” Natural Products Association v. Letitia James, New York Attorney General. United States District Court for the Eastern District of New York. 2:2023-cv-08912. 04 Dec 2023; https://blog.priceplow.com/wp-content/uploads/npa-vs-new-york-20231204-complaint.pdf
  2. New York State Senate. “Assembly Bill A5610D”. 2023-2024 Legislative Session. 17 Mar. 2023. https://www.nysenate.gov/legislation/bills/2023/A5610/amendment/D
  3. New York State Assembly. “A05610D”. 17 Mar. 2023. https://assembly.state.ny.us/leg/?bn=A5610&Summary=Y&Actions=Y&Text=Y
  4. New York State Senate. “SECTION 391-OO: Sale of over-the-counter diet pills and dietary supplements for weight loss or muscle building”. 27 Oct 2023. https://www.nysenate.gov/legislation/laws/GBS/391-OO
  5. United States Code; “21 USC § 343-1: National uniform nutrition labeling”; Food, Drug, & Cosmetic Act Section 403; Amended 23 Mar 2010; https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-prelim-title21-section343-1#:~:text=no%20State%20or%20political%20subdivision%20of%20a%20State%20may%20directly%20or%20indirectly%20establish%20under%20any%20authority%20or%20continue%20in%20effect%20as%20to%20any%20food%20in%20interstate%20commerce
  6. United States Code; “21 USC § 337: Proceedings in name of United States; provision as to subpoenas”; Food, Drug, & Cosmetic Act Section 310; Amended 13 May 1992; https://uscode.house.gov/view.xhtml?hl=false&edition=prelim&req=granuleid%3AUSC-prelim-title21-section337#:~:text=all%20such%20proceedings%20for%20the%20enforcement%2C%20or%20to%20restrain%20violations%2C%20of%20this%20chapter%20shall%20be%20by%20and%20in%20the%20name%20of%20the%20United%20States
  7. Request for Extension. Natural Products Association v. Letitia James, New York Attorney General. United States District Court for the Eastern District of New York. 2:2023-cv-08912-JMA-LGD. 20 Dec 2023; https://blog.priceplow.com/wp-content/uploads/npa-vs-new-york-20231220-request-for-extension.pdf
  8. Hingerton, Patricia M. “Motion for Pre Motion Conference”. State of New York Office of the Attorney General. United States District Court for the Eastern District of New York. 2:2023-cv-08912-JMA-LGD. 31 Jan. 2024. https://blog.priceplow.com/wp-content/uploads/npa-vs-new-york-20240131-motion-for-pre-motion-conference.pdf
  9. https://blog.priceplow.com/wp-content/uploads/npa-vs-new-york-20240207-npa-pre-motion-conference-response.pdf
  10. Kevin Bell. Co-Chair of the Intellectual Property Practice at Arnall Golden Gregory LLP. https://www.linkedin.com/in/kevinmbell/
  11. Matthew Zapadka. Partner at Arnall Golden Gregory LLP. https://www.linkedin.com/in/mzapadka/
  12. Arnall Golden Gregory LLP. https://www.agg.com/

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