NMN and NR Legal & Patent Challenges: What the FDA Regulatory Field Means for You

Is NMN legal to sell as a supplement today?

Yes. In its response letter posted to the citizen petition docket on 29 September 2025, FDA's Human Foods Program concluded that NMN is not excluded from the dietary supplement definition [1]. The regulations.gov record type for that letter is 'Partial Petition Approval and Denial' [1]. FDA found evidence that NMN was marketed as a dietary supplement in the US before it was authorized for investigation as a new drug [1].

What happened in 2022

In late 2022 FDA told two NMN ingredient makers, SyncoZymes and Inner Mongolia Kingdomway, that NMN could not be marketed as a dietary supplement [2]. The ground was the drug exclusion clause in section 201(ff)(3)(B) of the FD&C Act: NMN had been authorized for investigation as a new drug (Metro International Biotech's MIB-626) before it was marketed as a supplement [2]. Reports of those 2022 communications come from trade press, not from a public FDA document [2].

The Natural Products Association and the Alliance for Natural Health USA filed a citizen petition in March 2023 (docket FDA-2023-P-0872, posted 9 March 2023), and FDA sent an interim 'no decision yet' response on 30 August 2023 [2]. The September 2025 letter responded to that petition and reversed the exclusion position [1].

What followed the reversal

Trade press reports FDA sent follow-up letters on 2 December 2025 to the two ingredient makers saying NMN is no longer treated as excluded; the SyncoZymes letter reinstated a May 2022 'no objection' response to its NDI notification [2]. The Natural Products Association's lawsuit against FDA, filed in August 2024 and stayed while FDA considered the petition, was reported dismissed without prejudice on 29 December 2025 [2]. Those later steps are trade-press reports and were not verified on fda.gov [2].

The 'FDA banned NMN' claim

Widely repeated and out of date. FDA's 2022 position concerned whether NMN was excluded from the dietary supplement definition under the drug-exclusion clause [2]. That position has been reversed, and NMN is treated as lawful in dietary supplements [1]. NMN is not banned or illegal.

What NMN sellers still have to do

NMN remains 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 of the September 2025 letter say FDA did not define what counts as 'substantial clinical investigations' [1].

Is NR legal to sell as a supplement?

Yes. NR is sold in the US as an oral dietary supplement and is not an FDA-approved drug [1]. FDA's 2016 response on NR was a GRAS notice letter: GRN 000635, submitted on behalf of ChromaDex, was answered with a 'no questions at this time' letter dated 3 August 2016, and FDA stated that it had not made its own GRAS determination [3].

The notice covered NR 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, and stated it was not intended for foods under USDA jurisdiction or for foods intended for infants and toddlers [3]. That is a food-use notice, not an FDA approval of NR supplements.

Does a supplement label mean FDA approved it?

No. Under DSHEA, supplement manufacturers and distributors are prohibited from marketing adulterated or misbranded products and are responsible for evaluating the safety and labeling of their products before marketing; FDA's authority to act against an adulterated or misbranded product applies after it reaches the market [5]. FDA does not approve dietary supplements for safety or effectiveness before sale.

What about injectable NAD+?

Injectable or IV NAD+ is a compounded product, not an FDA-approved drug [4]. FDA has not approved any NAD+-precursor product to treat aging or disease [1]. Compounded drugs are not reviewed by FDA for safety, effectiveness or quality before they reach patients [6].

Does legal status tell you whether NMN or NR work?

No. Oral NMN and NR do raise blood NAD+ in randomized trials: NMN 250 mg/day for 12 weeks raised whole-blood NAD+ in 30 healthy adults, and NMN 300, 600 or 900 mg/day for 60 days raised blood NAD in 80 middle-aged adults [7][8]. Clinical benefit is less settled. A 2025 meta-analysis of 12 trials with 513 participants found blood NAD rose but most metabolic outcomes were not significantly different from control [9], and a 2025 systematic review in older adults found NMN had no significant effect on skeletal muscle index, handgrip strength, gait speed or the five-times chair stand [10].

Human trials were short and small, with 12 to 140 participants, and long-term safety data beyond about 12 weeks are lacking [11].