Is NMN Legal in US Supplements? The FDA Timeline From 2022 to Today

This company white paper from Mt. Angel Vitamins, which is not peer-reviewed, traces NMN's US legal status through primary FDA documents. FDA excluded NMN from the dietary supplement definition in 2022 and 2023, then reversed that position in a letter dated September 29, 2025. The reversal is a legal reading. FDA does not approve supplements, NMN still requires a new dietary ingredient notification, and FDA's letter says nothing about whether NMN is safe or effective.

If you're not a researcher

• The answer: Under FDA's latest stated position, NMN can be sold as a dietary supplement in the US. FDA reversed its 2022 position in a letter dated September 29, 2025.
• The strength of the evidence: This is a legal record, not a study. The sources are FDA's own letters and filings, and we opened the ones that carry the key dates.
• What the reversal did not decide: FDA does not approve supplements. The reversal says nothing about whether NMN is safe or works.
• The rule that still applies: NMN is a new dietary ingredient, so a notification must reach FDA at least 75 days before a product is sold.
• The dose question: FDA does not limit serving sizes. The manufacturer sets the amount. The dose comparison shows what the human trials used.
• What to do today: Check the Supplement Facts panel, ask which notification covers the NMN, and ask for the lot's certificate of analysis. The label-check checklist lists the questions.
• Related: The NMN monograph is the research companion to this page.

Short answer

Yes, under FDA's latest stated position. In a letter dated September 29, 2025, FDA said NMN is not excluded from the dietary supplement definition. That reverses its October 2022 position. The surprise is in FDA's own reasoning. The agency found evidence that NMN was sold as a dietary supplement in the United States as early as 2017, before NMN was authorized for investigation as a new drug.

Two limits matter as much as the answer. FDA does not approve dietary supplements, so this is a legal reading, not an approval. And NMN is still a new dietary ingredient, which means a notification must reach FDA at least 75 days before a product containing it is sold.

What the drug exclusion says

FDA's consumer Q&A states the rule this way. Dietary supplements exclude ingredients that are approved as new drugs, licensed as biologics, or authorized for clinical investigation under an investigational new drug application (IND) that has gone into effect. The exception is that the ingredient was marketed as a supplement or food first. For an ingredient under an IND, the exclusion applies only when "substantial clinical investigations" have been instituted and the existence of those investigations has been made public.

Two dates decide most of this story. One is when NMN was first marketed as a supplement or food in the United States. The other is when it was authorized for drug investigation. FDA says it can state whether the first date came before or after the second. It says it cannot give the authorization date.

What a new dietary ingredient notification requires

A new dietary ingredient (NDI) is one not marketed in the United States before October 15, 1994. A supplement containing an NDI needs a notification to FDA at least 75 days before it is introduced into interstate commerce. The notification must include the safety information the company relies on.

FDA treats the filing itself as procedural. Its May 2022 acknowledgment to SyncoZymes says acceptance "does not constitute a finding by FDA that the new dietary ingredient or supplement that contains the new dietary ingredient is safe." FDA also rejected the argument that NMN's self-affirmed GRAS status makes the notification requirement disappear.

Timeline

2022: why FDA excluded NMN

FDA's first exclusion letter went to Inner Mongolia Kingdomway on October 11, 2022. FDA later summarized its conclusion as follows: NMN "was not marketed as a dietary supplement, except unlawfully without an NDI notification, or as a food before FDA authorized it for investigation as a new drug." FDA says it sent similar letters to every company that had filed an NMN notification.

The reasoning rested on trials of MIB-626, an investigational drug. FDA's 2025 letter says that information was available when it acknowledged the SyncoZymes filing in May 2022. It also says "it was not readily clear to the staff reviewing the NDIN that MIB-626 referred to NMN," so the information was overlooked. FDA states that NMN and MIB-626 have the same chemical structure.

The November 4, 2022 supplemental letter gave two more points. FDA could not disclose the date NMN was authorized for investigation, because of legal limits on investigational drug information. And marketing in Japan did not satisfy the US notification requirement, because dietary supplements are not part of the "food supply" under the statute.

FDA's January 18, 2023 letter to Effepharm repeated the conclusion. It cited three ClinicalTrials.gov registrations for MIB-626 as the substantial clinical investigations. Those registrations are NCT05038488 (COVID-19 with early kidney injury), NCT05040321 (Alzheimer's disease), and NCT04817111 (Friedreich's ataxia). Each lists a start date in 2021.

2023 to 2025: the petition, the lawsuit, and the stay

NPA and the Alliance for Natural Health USA filed a citizen petition dated March 7, 2023. They amended it on December 24, 2024. FDA's 2025 letter identifies both documents under docket FDA-2023-P-0872.

NPA sued FDA, HHS, and their officials in the US District Court for the District of Columbia in August 2024. The complaint asks for a declaration that the drug exclusion does not apply to NMN.

On October 24, 2024, NPA, FDA, and the Department of Justice filed a joint motion asking the court to pause the case while FDA considered the petition. Judge Paul L. Friedman granted the stay in late October. According to SupplySide Supplement Journal, the motion said FDA "does not intend to prioritize enforcement action" against NMN-labeled supplements that would be lawful if NMN were not excluded. It also said FDA would need to reevaluate if it became aware of new safety concerns. We have not opened the motion itself, so that wording comes from SupplySide's report. The same day, Metro International Biotech, which develops MIB-626, moved to join the suit.

September 2025: what FDA changed

FDA's letter grants the petition in part and denies it in part. It says NMN "was authorized for investigation as a new drug and substantial clinical investigations of NMN have been instituted and made public," but "NMN was marketed as a dietary supplement in the United States before such authorization."

FDA also changed how it reads the phrase "marketed as a dietary supplement or as a food." It no longer requires that the earlier marketing have been lawful. It says it is aware of evidence of US marketing "as early as 2017," which preceded the drug authorization.

Some things did not change. NMN is still a new dietary ingredient, so notification is still required. FDA rejected the petition's argument that NMN should be treated as a supplement on the basis of self-affirmed GRAS status. And the letter does not evaluate NMN's safety or effects. It answers a question about the statute.

NPA says its petition and lawsuit produced the reversal, and that it is pursuing a legislative fix to the drug exclusion. Venable LLP notes that courts no longer defer to agency interpretations after the Supreme Court's Loper Bright decision, so a court could still review the reversal.

December 2025 and 2026 filings

NPA and NutraIngredients report that FDA sent letters dated December 2, 2025 to SyncoZymes and Inner Mongolia Kingdomway confirming that NMN is no longer excluded. We did not open those letters.

FDA's NDI list is the primary record for later filings. It shows NDIN 1444, submitted November 17, 2025 by Effepharm, Ltd. for beta-NMN, with a recorded FDA response of January 28, 2026. It shows NDIN 1451, submitted February 11, 2026 by Effepharm (Shanghai) Co., Ltd. for a reduced beta-NMN calcium salt, with a recorded response of April 17, 2026. The list records dates, not conclusions. The response letters themselves are not on this page.

What is established, what is proposed, and what would settle it

Established. FDA's letter dates and positions, as cited above. The 2017 US marketing evidence that FDA describes. The continuing notification requirement for NMN. FDA's lack of authority to approve supplements before they are sold.

Proposed. That the drug exclusion no longer bars NMN. This is FDA's current reading. We found no court ruling that adopts it, and we could not confirm the lawsuit's status after September 2025.

What would settle it. A court ruling on the drug exclusion clause. Public release of the date FDA used for NMN's drug authorization. A statute or rule change, which NPA says it is pursuing. Or a new FDA safety finding, which FDA says would prompt a review of its enforcement priorities.

What to check on an NMN label

FDA's Q&A lists what a supplement label must show. That includes a "dietary supplement" statement, the manufacturer's name and address, a Supplement Facts panel with serving size, servings per container, and the amount of each dietary ingredient per serving, a list of other ingredients, the net quantity, and a domestic address or phone number for serious adverse event reports. FDA does not test supplements before they reach shelves, so the label and the company's records are where a shopper starts.

For NMN, add three checks. Look for the NMN amount per serving, not only the bottle total. Ask which NDI notification covers the NMN, then look it up on FDA's list. Ask for the certificate of analysis for the lot you are buying. The label-check checklist lists the questions to ask any brand.

FDA does not set serving limits. The Q&A says no law limits the serving size of a supplement or the amount of a dietary ingredient in a serving. The manufacturer decides, and FDA does not approve that decision. For how doses compare with the human trials, see the dose comparison. NR has its own regulatory history, covered in the NR monograph.

Where to check the FDA record yourself

Start with FDA's public NDI list. It links to a downloadable list of notifications from 1995 to the present, and each entry links to its docket on regulations.gov. The NMN notifications and letters sit in docket FDA-2022-S-0023. The citizen petition and FDA's September 2025 response sit in docket FDA-2023-P-0872. FDA's Questions and Answers page explains the definitions in plain language.

The lawsuit is in the federal district court for the District of Columbia. Search PACER or CourtListener for Natural Products Association v. Food and Drug Administration. The complaint copy we read does not show a case number, so use the party names.

Our product, for context

This section is commercial and separate from the legal record above. Mt. Angel Vitamins sells an NMN + NR capsule formula. On the live product page, checked October 20, 2026, each 2-capsule serving provides 500 mg beta-NMN and 200 mg NR, along with resveratrol, TMG, BioPerine, and zinc. A 60-capsule bottle holds 30 servings. At $59.99, the price works out to $2.00 per day. The product page links a lot-specific certificate of analysis.

View the product page. The page does not name the NMN supplier or the notification that covers it. Ask us that question with the checklist above. For a wider view of NMN and NR products, see the buying guide.

Limits of this review

We opened the FDA letters of May 16, 2022, January 18, 2023, and September 29, 2025 (NPA-hosted copies), the FDA NDI list, the FDA Q&A page, the NPA complaint copy, and the three ClinicalTrials.gov records. We did not open the October 11 and November 4, 2022 letters, the December 2, 2025 letters, the January 28, 2026 response to NDIN 1444, or the joint motion and stay order. Those items appear here only as FDA or secondary sources describe them. One text copy of the September 2025 letter reads "September 29, 2029" in its date line. The 2025 date comes from Venable, NPA, and NutraIngredients, and should be checked against the regulations.gov original. This is a company white paper, not a peer-reviewed study. It makes no health claims, so it cites no PubMed records.

Glossary

• New dietary ingredient (NDI): an ingredient not marketed in the United States before October 15, 1994.
• NDI notification (NDIN): the premarket filing FDA requires at least 75 days before a supplement containing an NDI is sold.
• Drug exclusion clause: 21 U.S.C. 321(ff)(3)(B)(ii), which removes certain drug-investigated ingredients from the supplement definition.
• Race-to-market clause: FDA's name for the same provision, which turns on whether drug authorization or supplement marketing came first.
• Investigational new drug (IND): the FDA authorization that lets a drug be tested in people.
• Substantial clinical investigations: drug trials that have been instituted and made public, one condition of the exclusion.
• MIB-626: an investigational drug that FDA's 2025 letter says is the same molecule as NMN.
• Citizen petition: a formal request asking FDA to change a position, filed in a public docket.
• Docket: FDA's public file for a petition or notification, hosted on regulations.gov.
• Acknowledgment letter: FDA's notice that a notification was filed. It is not a safety finding.
• Enforcement discretion: a decision not to prioritize action against a category of product.
• Declaratory judgment: a court ruling on what the law means, without ordering a specific act.
• Supplement Facts panel: the required label box listing dietary ingredients and amounts per serving.
• Self-affirmed GRAS: a company's own conclusion that an ingredient is generally recognized as safe. FDA says it does not replace an NDI notification for NMN.

References

1. FDA, letter to the Natural Products Association and Alliance for Natural Health USA responding to citizen petition, docket FDA-2023-P-0872, dated September 29, 2025. Copy hosted by NPA. https://www.npanational.org/wp-content/uploads/2026/10/FDA-Response.pdf
2. FDA, letter to Effepharm, Ltd. regarding NDI 1267, January 18, 2023. Copy hosted by NPA. https://www.npanational.org/wp-content/uploads/2023/04/FDA-Letter-to-Effepharm.pdf
3. FDA, acknowledgment letter regarding NDI 1247 (beta-NMN), May 16, 2022. Copy hosted by NPA. https://www.npanational.org/wp-content/uploads/2023/04/NDI-1247-AKL-%CE%B2-NMN-FDA-acknowledgement-letter-LO-220516.pdf
4. FDA, Submitted 75-Day Premarket Notifications for New Dietary Ingredients, content current July 10, 2026. https://www.fda.gov/food/new-dietary-ingredient-ndi-notification-process/submitted-75-day-premarket-notifications-new-dietary-ingredients
5. FDA, Questions and Answers on Dietary Supplements, content current August 27, 2026. https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
6. Natural Products Association v. FDA, complaint for declaratory and injunctive relief, US District Court for the District of Columbia, filed August 2024. Copy hosted by NPA; case number blank on copy. https://www.npanational.org/wp-content/uploads/2024/08/01-Complaint-NPA-v-FDA.pdf
7. ClinicalTrials.gov, NCT05038488. https://clinicaltrials.gov/study/NCT05038488
8. ClinicalTrials.gov, NCT05040321. https://clinicaltrials.gov/study/NCT05040321
9. ClinicalTrials.gov, NCT04817111. https://clinicaltrials.gov/study/NCT04817111
10. Keller and Heckman, "FDA Letter States that beta-Nicotinamide Mononucleotide is Not Lawful Dietary Supplement," National Law Review, December 13, 2022. Secondary. https://natlawreview.com/article/fda-letter-states-nicotinamide-mononucleotide-not-lawful-dietary-supplement
11. Venable LLP, "FDA Declares Nicotinamide Mononucleotide Is a Dietary Supplement," October 2, 2025. Secondary. https://www.venable.com/insights/publications/2025/10/fda-declares-nicotinamide-mononucleotide-is
12. Stephen Daniells, "FDA reinstates NDI status of NMN with new letters to ingredient players," NutraIngredients, December 9, 2025. Secondary. https://www.nutraingredients.com/Article/2025/12/09/fda-reinstates-ndi-status-of-nmn-with-new-letters-to-ingredient-players/
13. Josh Long, "FDA telegraphs enforcement strategy against NMN supplements amid NPA lawsuit," SupplySide Supplement Journal, October 25, 2024. Secondary; quotes the joint motion. https://www.supplysidesj.com/supplement-regulations/fda-telegraphs-enforcement-strategy-against-nmn-supplements-amid-npa-lawsuit
14. Natural Products Association, "Nicotinamide Mononucleotide (NMN)," advocacy page. Secondary. https://www.npanational.org/nicotinamide-mononucleotide-nmn/
15. Mt. Angel Vitamins, NMN + NR with Resveratrol and TMG product page, checked October 20, 2026. https://mtangelvitamins.com/products/nmn-nr-cellular-wellness-supplement

Next reads

• The NMN monograph covers what the human studies measured, graded by outcome. Read it for the research behind the ingredient.
• NMN vs NR: which NAD+ precursor to take explains how the two compounds differ and where they overlap.
• NAD+ and cellular energy: the complete guide is the pillar page for this topic, covering the NAD+ pathway and the evidence around it.
• The buying guide for NMN and NR products puts the label checks into practice across the products on the market.

Related reading

• Trial registry census of NMN, NR and urolithin A trials
• Who funds the NAD+ precursor trials
• what the human NMN and NR trials recorded about safety

More on NAD+ and Cellular Energy: The Complete Guide