NMN & the FDA: What You Should Know Ahead of the July Ruling
June 2025 Update
Dear ProHealth Customer,
As many of you know, the legal status of NMN (Nicotinamide Mononucleotide) as a dietary supplement in the United States has been under review by the FDA. A final decision is expected by July 31, 2025, and we want to ensure you have the facts—both public and behind the scenes—about what’s happening and what it may mean for continued access to NMN.
A Timeline of Key Developments
May–August 2022:
The FDA issued “no objection” (or “good day”) letters in response to New Dietary Ingredient (NDI) submissions, effectively permitting NMN to be sold as a dietary supplement in the U.S.
November 2022:
The FDA reversed course, stating that those letters were issued in error and that NMN is not eligible as a dietary supplement due to its prior investigation as a pharmaceutical.
2023–2024:
Although the FDA had declared NMN ineligible as a dietary ingredient, it chose not to enforce this position, creating a gray area. However, it also declined to formally commit to a policy of non-enforcement.
December 2023:
A Citizen Petition was submitted by the Natural Products Association (NPA), urging the FDA to reverse its position and reinstate NMN as a lawful dietary ingredient.
March 2024:
The NPA filed a lawsuit against the FDA to compel a response to the Citizen Petition.
April 2024:
The FDA and the NPA agreed to pause the litigation. As part of that agreement, the FDA committed to respond to the petition by July 31, 2025, and to delay enforcement actions against NMN in the meantime.
Recent Developments at ProHealth
In February 2025, one of our U.S.-based NMN shipments was placed under FDA quarantine. The agency requested documentation proving that NMN is currently legal for sale. Our legal team presented the stay-of-enforcement agreement tied to the ongoing litigation. As a result, the FDA agent released the product from quarantine and informed us that he would see us again in July.
In anticipation of the upcoming decision, we paused most new NMN production earlier this year. Our goal is to responsibly manufacture just enough inventory for our customers but no safety stock or inventory for the future in case a ban is enforced and inventory is seized.
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What Happens Next?
While no one can predict the outcome of the FDA’s decision, there are three likely scenarios:
- NMN remains permanently available as a dietary supplement in the U.S. through a reversal of the ban.
- NMN remains temporarily available as a dietary supplement in the U.S. because the FDA is unable to respond by July 31st as required.
- NMN is formally banned, and all domestic sales would be prohibited shortly thereafter.
We’ll continue offering NMN in the U.S. as long as it remains legal. In parallel, we’ve begun manufacturing NMN in Canada to ensure continuity for international customers and to preserve long-term access if U.S. restrictions are enforced.
Looking Ahead
Regardless of the outcome, our commitment to longevity science and product innovation remains unchanged. We’ve spent the past year accelerating the development of next-generation NAD+ boosters as well as a diverse set of innovative longevity interventions—including prescription NAD+ therapies, prescription Sermorelin, prescription GLP-1’s, BPC-157, NMNH, NR Capsules and Powders, Molecular Hydrogen, Methylene Blue, Full Spectrum Urolithin A, Full Spectrum Adaptogens, and a Sirtuin 6 Activator.
We’ll continue to provide updates as we learn more. In the meantime, thank you for your trust, your patience, and your continued support of our mission to deliver the most effective longevity tools available.
If you have questions, we’re here to help.
Warm regards,
Dan Obegi
Chief Executive Officer
ProHealth Longevity