NMN and NR FDA Approval History: What the Regulatory Record Actually Shows

Has FDA ever approved NMN or NR?

No. Neither nicotinamide mononucleotide (NMN) nor nicotinamide riboside (NR) is an FDA-approved drug, and no NAD+ precursor product is approved by FDA to treat aging or any disease [1]. Both are sold in the United States as oral dietary supplements [1].

That part has not changed. What changed between 2022 and 2025 was whether NMN could be sold as a supplement at all.

The NMN timeline

2022: FDA told two ingredient suppliers no. Under the drug exclusion clause of the Federal Food, Drug, and Cosmetic Act, section 201(ff)(3)(B), a substance cannot be marketed as a dietary supplement if it was authorized for investigation as a new drug before it was marketed as a supplement. Trade press reported that in late 2022 FDA told two NMN ingredient makers, SyncoZymes and Inner Mongolia Kingdomway, that NMN could not be marketed as a dietary supplement under that clause, citing Metro International Biotech's investigational drug MIB-626 [3].

March 2023: a citizen petition. The Natural Products Association and the Alliance for Natural Health USA filed a citizen petition in docket FDA-2023-P-0872, posted 2023-03-09. FDA sent an interim no-decision response on 2023-08-30 [3].

September 2025: FDA reversed itself. On 2025-09-29 FDA's Human Foods Program posted its response letter in the docket, recorded as a Partial Petition Approval and Denial. Law-firm and trade reports of the letter say FDA concluded that NMN is not excluded from the dietary supplement definition, having found evidence that NMN was marketed as a supplement in the United States before it was authorized for drug investigation [1].

December 2025: letters to the suppliers. Trade press reported that FDA sent follow-up letters on 2025-12-02 to the same two ingredient makers saying NMN was no longer treated as excluded; the SyncoZymes letter reinstated a May 2022 no-objection response to its NDI notification. The association's lawsuit against FDA, filed in August 2024 and stayed while the petition was pending, was reported dismissed without prejudice on 2025-12-29. These letters have been reported in the trade press only [3].

What the reversal did not settle

NMN is still a new dietary ingredient for FDA purposes, so a maker must file an NDI notification, or rely on a prior notification covering that supplier's ingredient, before selling it [1]. Trade reports say FDA's letter did not define what counts as substantial clinical investigations [1].

NMN is not banned or illegal as a supplement. FDA's 2022 position was that NMN was excluded from the supplement definition, and that position has since been reversed [1][3].

NR: what the 2016 letter says

NR's FDA record is shorter. FDA answered ChromaDex's GRAS notice GRN 000635 with a no-questions-at-this-time letter dated 2016-08-03, and stated that it had not made its own GRAS determination [2]. The notice covered nicotinamide riboside chloride as a source of vitamin B3 in vitamin waters, protein shakes, nutrition bars, gum, chews and powdered beverages, at a maximum of 0.0057% by weight as consumed [2].

That is a food-use GRAS notice, not a drug approval. The letter shows only that FDA had no questions about the company's own safety conclusion [2].

Injectable and IV NAD+

Injectable or IV NAD+ is a compounded product, not an FDA-approved drug, and no NAD+ drug is FDA-approved for aging or wellness [1]. FDA's page on bulk drug substances for compounding describes which substances state-licensed physicians and pharmacists may compound with, and the conditions attached; it does not confirm a compounding category for NAD+ [4].

What human trials show

Randomized trials show that oral NMN and NR raise blood NAD+ or related metabolites [5][6][7]. Clinical benefit is much less certain.

A 2025 meta-analysis of 12 studies with 513 participants found NMN significantly raised blood NAD, but most clinical outcomes (fasting glucose, triglycerides, total cholesterol, LDL-C, HDL-C) were not significantly different from control. The authors suggested the benefits of NMN may be exaggerated, and rated risk of bias as high in 5 of the 12 studies and of some concern in 7 [9]. A 2025 systematic review in older adults, mean ages 60.9 to 83, found NMN had no significant effect on skeletal muscle index, handgrip strength, gait speed or the 5-times chair stand [8].

A 10-week randomized trial in postmenopausal women with prediabetes who were overweight or obese reported increased insulin-stimulated glucose disposal with NMN 250 mg/day, with no change on placebo. It was small (25 completers) and single-center, and a published comment disputed its analysis [10].

Safety studies have been short and small. NMN 1,250 mg once daily for up to 4 weeks in 31 healthy adults aged 20-65 produced no severe adverse events and no changes beyond physiological variation in hematology, biochemistry, urine or body composition [11]. Human safety data beyond about 12 weeks are lacking [12].

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