NAD+

Identity and nomenclature

INN

Not verified

Synonyms

nicotinamide adenine dinucleotide, NAD, beta-nicotinamide adenine dinucleotide

Development codes

Not verified

Mechanism

Nicotinamide adenine dinucleotide is a pyridine dinucleotide coenzyme that participates in cellular redox reactions, cycling between an oxidised form and a reduced form. Nicotinamide mononucleotide and nicotinamide riboside are biosynthetic precursors of it.

The relationship between the precursor forms and the parent cofactor is the reason the three are discussed together in a supply context. It is not a statement about what any of them does when administered, and no such statement is made here.

The published human research literature on precursor supplementation was not verified in this review pass, so no findings from it are reported. The research literature section records that absence rather than summarising work that has not been read.

Analytical and manufacturing profile

Research literature

The published human literature on precursor supplementation reports one reproducible finding — a rise in whole blood or peripheral blood mononuclear cell NAD+ concentration — alongside a consistent failure of that rise to translate into measured clinical outcomes. Trials are predominantly small, short, and conducted in relatively healthy adults, and a substantial proportion are funded by manufacturers of the material studied. Two independent author groups have used the language of exaggeration to describe how findings in this field are reported.

• human · n=140

  The study reported dose-dependent increases in whole blood NAD+ within two weeks that were sustained through the study, with corresponding increases in plasma and urinary metabolites. It reported no serious adverse events, no flushing, no between-group difference in adverse event type, incidence or severity, and no elevation of LDL cholesterol or plasma homocysteine.

  Randomised, double-blind, placebo-controlled parallel trial of nicotinamide riboside chloride in healthy overweight adults aged 40 to 60, 8 weeks after a 2-week run-in, with vital signs, haematology, clinical chemistry including homocysteine and lipids, and coded adverse event diaries

  Limitations: This is the largest dedicated safety trial located for this material. It was funded by the manufacturer, two authors were employees of that manufacturer, and one author is an inventor on licensed intellectual property and chief scientific adviser.

• human · n=58

  The study reported that NAD+ rose 2.6 to 3.1-fold within 5 to 10 weeks and remained elevated at 20 weeks, while reporting no significant between-group difference on any cognitive outcome or on fatigue, sleep, anxiety or depression.

  Randomised, double-blind, placebo-controlled trial of nicotinamide riboside in adults with long COVID, 2:1 randomisation with a placebo lead-in, 24 weeks total, with prespecified cognitive, fatigue, sleep, anxiety and depression outcomes

  Limitations: The dissociation between the biomarker response and the clinical outcomes is the central observation. Improvements were reported only in post-hoc within-group analyses combining all exposed participants, after null between-group results. Two authors hold equity in the funding company.

• human · n=40

  The study reported no improvement in insulin sensitivity, glucose production, disposal or oxidation, resting energy expenditure, lipolysis, lipid oxidation or body composition. It reported no serious adverse events and normal safety parameters.

  Randomised, double-blind, placebo-controlled parallel trial of nicotinamide riboside in sedentary men with obesity aged 40 to 70, 12 weeks, with hyperinsulinaemic-euglycaemic clamp, tracer-based indirect calorimetry, dual-energy X-ray absorptiometry and magnetic resonance imaging

  Limitations: An independently funded trial reporting null metabolic findings. A companion analysis from the same group reported that the skeletal muscle NAD+ metabolome was not significantly altered, and that mitochondrial respiratory capacity, content and morphology were unchanged.

• human · n=80

  The study reported that blood NAD significantly increased in all active groups at 30 and 60 days relative to both placebo and baseline, and reported improvements in walking distance and quality-of-life scores.

  Randomised, multicentre, double-blind, placebo-controlled, parallel-group trial of nicotinamide mononucleotide in healthy middle-aged adults with three ascending exposure levels against placebo, 60 days

  Limitations: Funded by two commercial entities, with the lead author an employee of one of them. A later systematic review assessing this literature rated no included trial of this material at low risk of bias.

• review

  The review reported that pooled estimates were non-significant across every muscle outcome assessed, and concluded that current evidence does not support supplementation for preserving muscle mass and function in this population. It also noted lower physical performance battery scores and slower chair-stand performance with nicotinamide riboside in participants with mild cognitive impairment.

  Systematic review and meta-analysis of 10 randomised controlled trials of nicotinamide mononucleotide and nicotinamide riboside in adults of mean age over 60, pooling skeletal muscle index, handgrip strength, gait speed and chair-stand performance

  Limitations: The authors name few available trials, unmonitored physical activity and diet, heterogeneous populations and possibly insufficient durations as limitations. A separate review of overlapping trials reported a significant gait-speed benefit; that contradiction is unreconciled.

• review

  The review reported an overall significant effect on blood NAD concentration, while reporting that most clinically relevant outcomes did not differ significantly between supplementation and control.

  Systematic review with meta-analysis of 12 randomised controlled trials of nicotinamide mononucleotide covering 513 participants, assessing glucose and lipid metabolism outcomes

  Limitations: The risk-of-bias assessment rated seven included studies as raising some concerns and five as high risk, with no study rated at low risk. The authors state that an exaggeration of the benefits may exist in this field.

• human · n=11

  The study reported no change in plasma NAD+ or its metabolites until after two hours, with significant increases at six hours, and increased urinary excretion. It reported no adverse events in either arm.

  Randomised, saline-controlled pilot study of a six-hour intravenous infusion of NAD+ in healthy males aged 30 to 55, with plasma and urine metabolite quantification by tandem mass spectrometry

  Limitations: This single small pilot constitutes the entire published human pharmacokinetic basis for intravenous administration. It was not described as blinded. A separate retrospective review of 14 records reported that all six recipients of intravenous NAD+ experienced moderate to severe gastrointestinal and cardiorespiratory symptoms during infusion, resolving on completion; that review had no control arm and its authors were employed by the entity whose records were reviewed.

What the literature does not establish

• The reproducible finding across trials is a rise in circulating NAD+ concentration. This is a surrogate biomarker, not a clinical endpoint, and three independent meta-analyses report that it does not translate into measured metabolic or muscle outcomes.
• Tissue uptake is unresolved. One trial reported the skeletal muscle NAD+ metabolome was not significantly altered; a commentary notes that nicotinamide mononucleotide did not raise muscle NAD+ in a trial that reported a muscle insulin-sensitivity effect; and cerebral NAD increases have been reported as significant but variable.
• Sample sizes are small. Most frequently cited trials enrolled between 8 and 40 participants; the largest located are 140, 90 and 80.
• Durations are short, typically 4 to 12 weeks. No completed and published randomised trial of 12 months or longer was located, so long-term safety data do not exist.
• There is no large definitive phase 3 evidence. The largest registered trial located, with 410 participants, has no posted results and no publication.
• Published systematic reviews contradict one another on muscle and gait outcomes across overlapping trial sets, and one risk-of-bias assessment rated no included trial at low risk.
• Industry funding is pervasive. Independently funded trials produced a notably higher proportion of null metabolic findings than manufacturer-funded ones.
• A published commentary argues that one influential trial was not effectively randomised, on the basis of a marked baseline imbalance between arms. The original authors dispute this. Both positions are on the record.
• The published human literature on parenteral administration comprises four studies, only one of which is a randomised placebo-controlled trial, and a 2026 systematic review states that no eligible outcomes trial has evaluated intravenous or intramuscular NAD+ for anti-ageing or wellness indications.

Open classification questions

• May nicotinamide mononucleotide lawfully be marketed as a dietary supplement ingredient in the United States?

  The FDA reversed its earlier position on 29 September 2025. Responding to a citizen petition, it concluded that NMN is not excluded from the definition of dietary supplement under section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act. The reversal turns on a single element of statutory interpretation: the agency previously read the race-to-market clause as requiring that prior marketing as a food or supplement had been lawful, and now holds that the marketed product must have been a dietary supplement or food but need not have been lawfully marketed. On that reading, NMN was marketed as a dietary supplement in the United States before it was authorised for investigation as a new drug. The agency states it is aware of evidence of such marketing as early as 2017.

  Unresolved: Not being excluded is not a clearance. The FDA maintains that NMN remains a new dietary ingredient requiring a notification under section 413, that a supplement containing it may still be adulterated, and that it may act to remove an adulterated product from the market. The two notification responses reinstated in December 2025 were acknowledgements with objections on safety grounds, so reinstatement restored an objection rather than a clearance. Marketability therefore turns on whether an individual firm holds an adequate, unobjected notification for its own ingredient and conditions of use. Related litigation in the United States District Court for the District of Columbia has a docket visible to November 2025, and its final disposition has not been verified.

  FDA Response to Citizen Petition, Docket FDA-2023-P-0872, regarding the regulatory status of beta-nicotinamide mononucleotide · verified 2026-07-30

• What was the FDA position on nicotinamide mononucleotide before September 2025, and what exactly changed?

  In October and November 2022 the FDA notified firms that NMN is excluded from the dietary supplement definition because it had been authorised for investigation as a new drug, substantial clinical investigations had been instituted and made public, and it had not been marketed as a dietary supplement or food before that authorisation other than unlawfully. In December 2025 the agency set those superseding letters aside, which reinstated its earlier responses to the affected notifications.

  Unresolved: Several elements of the 2022 analysis were expressly not changed. The relevant date remains the date the investigational new drug application took effect rather than the date investigations were made public; marketing still means marketing in the United States, so evidence of sale in other territories does not count; and the agency declined to narrow what counts as substantial clinical investigations. The agency also retains authority to reverse its own notification responses.

  FDA Response to Citizen Petition, Docket FDA-2023-P-0872 — discussion of the 2022 position · verified 2026-07-30

• What is the United States status of nicotinamide riboside as a food and supplement ingredient?

  Nicotinamide riboside chloride is the subject of GRAS Notice 635, filed in March 2016 and closed in August 2016, to which the FDA responded that it had no questions. The notified use is as a source of vitamin B3 in specified food categories at a maximum level of 0.0057 per cent by weight as consumed, excluding products under Department of Agriculture jurisdiction and infant and toddler foods. Two new dietary ingredient notifications were also acknowledged, the later of which the agency acknowledged in March 2018.

  Unresolved: A no-questions response to a GRAS notice is an acknowledgement that the notifier’s conclusion has not been challenged on the notified conditions of use. It is neither an approval nor a finding that extends beyond those conditions.

  Agency Response Letter, GRAS Notice No. GRN 000635, nicotinamide riboside chloride · verified 2026-07-30

• Is nicotinamide riboside chloride authorised as a novel food in the European Union, and on what conditions?

  Yes. Commission Implementing Regulation (EU) 2020/16 of 10 January 2020 authorised the placing on the market of nicotinamide riboside chloride as a novel food and entered it in the Union list, on application by ChromaDex Inc. Commission Implementing Regulation (EU) 2022/1160 of 5 July 2022 extended the conditions of use. The current entry covers food supplements, foods for special medical purposes, total diet replacement for weight control, and meal replacements, with the latter three restricted to adults excluding pregnant and lactating women. The Union list also carries a full compositional specification, including a purity requirement of at least 90 per cent predominantly in the beta form, water content, residual solvent, reaction by-product, heavy metal and microbiological limits.

  Unresolved: Two things a reader should not conflate. First, a favourable scientific opinion is not an authorisation: the 2019 opinion was adopted in July 2019 and marketing became lawful only with the January 2020 implementing regulation. Second, the Commission did not simply adopt the scientific conclusion. The 2021 opinion held that safety was not established for meal replacements and for nutritional drink mixes; the Commission authorised meal replacements anyway, restricted to adults, and did not authorise nutritional drink mixes. The Union list is therefore broader than the opinion in one respect and narrower in another. The five-year data protection granted to the applicant has expired.

  Commission Implementing Regulation (EU) 2022/1160 amending the conditions of use and specifications of nicotinamide riboside chloride · verified 2026-07-30

• Is beta-nicotinamide mononucleotide authorised as a novel food in the European Union?

  No. NMN is absent from the consolidated Union list of novel foods, and no Commission implementing regulation authorising it exists. Placing it on the market as a food or food supplement is therefore contrary to Article 6 of Regulation (EU) 2015/2283. The Novel Food Status Catalogue records it as novel, following a determination by the Czech competent authority that it was not consumed in the European Union to a significant degree before 15 May 1997. Enforcement is active rather than merely notional: Rapid Alert System notifications from Poland and Sweden record a sales ban, withdrawal from the market in Finland, and withdrawal from recipients.

  Unresolved: The position is unauthorised today and unresolved tomorrow. The EFSA Panel adopted a favourable opinion on 4 March 2026, published 11 May 2026, concluding on an application by EffePharm that the material is safe under the proposed conditions of use and is a bioavailable source of niacin. The Commission has not acted on it as at 30 July 2026. A separate application from a different applicant using an enzymatic rather than chemical synthesis route is also open, and because Union list entries bind to the specifications and production process assessed, an authorisation founded on one applicant’s dossier would not automatically cover another’s material. Several further dossiers are under assessment with clockstops running into 2027, and an earlier authorisation procedure was terminated by the Commission on 31 March 2022 without the reasons being published.

  Consolidated Union list of novel foods — NMN absent from the authorised list · verified 2026-07-30

• What status does the European Union assign to nicotinamide adenine dinucleotide itself?

  NAD+ is absent from the Union list of authorised novel foods. The Novel Food Status Catalogue records it as not novel in food supplements, on the basis that it was used in food supplements in the European Union before 15 May 1997, and states that its use in food supplements is therefore not subject to pre-market authorisation. The same entry states that any other food use may be considered novel and may require authorisation.

  Unresolved: This produces a counter-intuitive asymmetry: the parent cofactor is catalogued as not novel in supplements, while its precursor NMN is catalogued as novel and unauthorised, and the other precursor required a full novel food authorisation. The difference rests on documented history of consumption, not on pharmacology. Several caveats limit what the entry supports. The catalogue is expressly non-binding and non-exhaustive; the burden of proving consumption before 15 May 1997 rests on the food business operator rather than on the catalogue; the status is limited to food supplements; other European Union or national legislation may still restrict placing on the market; and unlike the NMN entry, the NAD+ entry carries no purity, specification or source qualification at all. It should not be treated as clearance for a particular material.

  EU Novel Food Status Catalogue · verified 2026-07-30

• What is the regulatory position on intravenous and injectable preparations of nicotinamide adenine dinucleotide?

  No marketing authorisation exists for an injectable preparation in the United States, the European Union, the United Kingdom, Australia or Canada. Searches of the FDA approved-application database, the EU Union Register, the MHRA substance index, the Australian Register of Therapeutic Goods and the Health Canada Drug Product Database each returned no authorised injectable product. The FDA has described repackaged NAD+ injection in writing as an unapproved new drug, and has separately warned that food-grade material is not suitable for sterile compounding because of microbial and endotoxin contamination risk, reporting adverse events including severe chills, shaking, vomiting and fatigue, some requiring medical treatment. In one enforcement action the agency recorded three patients developing symptoms during or shortly after administration and an unopened vial from the same lot containing bacterial endotoxin at 3,360 endotoxin units per millilitre, concluding the product was adulterated.

  Unresolved: Unapproved is not the same as prohibited, and the two should not be conflated. In the United States the substance sits in the category of bulk drug substances under evaluation for compounding, not in the category the FDA identifies as raising significant safety risks; it is absent from the section 503A list and from the section 503B list, and a 2019 proposed rule recommending against its inclusion has never been finalised. In Canada the injectable route is structurally foreclosed from the natural health product regime, because the regulations exclude any substance administered by puncturing the dermis, so such a product falls to be regulated as a drug. In Australia the register entries that do exist are export-only oral products expressly barred from domestic sale, and the substance is unscheduled in the Poisons Standard, which is notable given that the same instrument does schedule a comparable substance for parenteral use. Separately, a 2026 systematic review states that no eligible outcomes trial has evaluated intravenous or intramuscular NAD+ for anti-ageing or wellness indications, and the total published human literature on parenteral administration comprises four studies, only one of which is randomised and placebo-controlled.

  FDA reminds compounders to use ingredients suitable for sterile compounding · verified 2026-07-30

Related forms

• beta-Nicotinamide mononucleotide (NMN)

  A biosynthetic precursor of nicotinamide adenine dinucleotide. Its United States status changed materially on 29 September 2025, while in the European Union it remains an unauthorised novel food notwithstanding a favourable scientific opinion adopted in 2026. Identity data here is taken from that opinion’s own characterisation table.

  Molecular formula

  C11H15N2O8P

  Molecular weight

  334.221 g/mol

  CAS number

  1094-61-7

• Nicotinamide riboside chloride (NR chloride)

  A biosynthetic precursor of nicotinamide adenine dinucleotide, and the only form in this group authorised as a novel food in the European Union and in Great Britain. Identity data and compositional specifications are published in the Union list itself, which makes this the best-specified form of the three.

  Molecular formula

  C11H15N2O5Cl

  Molecular weight

  290.7 g/mol

  CAS number

  23111-00-4

Regulatory status by jurisdiction

• United States

  FDA
  ○No established classification

  No settled classification has been verified for nicotinamide adenine dinucleotide itself. The FDA has taken enforcement action against products containing it, but on the basis of disease claims made for those products rather than on the ingredient status of the compound.

  FDA and FTC Warning Letter, Alive By Nature Inc., MARCS-CMS 607435Verified 2026-07-30

• Australia

  TGA
  ○No established classification

  The Therapeutic Goods Administration states that NAD, NAD+ and NADH are not permitted ingredients in listed medicines in Australia, that products making therapeutic claims without an ARTG number may be unapproved or illegally supplied, and that compounded medicines are not evaluated for safety, quality or efficacy. A compliance review resulted in nine ARTG cancellations and two recalls.

  NAD, NAD+, NADH or NMN medicines sold in Australia — safety alertVerified 2026-07-30

• European Union

  European Commission
  ◆Food supplement ingredient

  Nicotinamide adenine dinucleotide is absent from the Union list of authorised novel foods, and the Novel Food Status Catalogue records it as not novel in food supplements on the basis of use before 15 May 1997, meaning its use in supplements does not require pre-market authorisation. The catalogue is expressly non-binding, and the evidential burden rests on the food business operator.

  EU Novel Food Status CatalogueVerified 2026-07-30

• United Kingdom

  Food Standards Agency
  ○No established classification

  No published position on nicotinamide adenine dinucleotide. Searches of the Food Standards Agency register of novel food authorisations and of the regulated product applications register return no result for it. Great Britain operates a novel food regime separate from the European Union one, and has not followed the 2022 European extension of use for the authorised precursor.

  FSA Register of Novel Food Authorisations, entry NOVEL-96 nicotinamide riboside chlorideVerified 2026-07-30

Supply classification and permitted use

Nicotinamide adenine dinucleotide and its precursors have no settled regulatory classification across major jurisdictions, and their classification varies by form and by route. Material is supplied to businesses for research and manufacturing purposes only. No medicinal claims are made for any form.

• The classification of a precursor does not transfer to the parent compound, and the classification of an orally administered form does not transfer to an injectable one. These are distinct regulatory questions.
• The status of injectable and intravenous preparations was not verified in this review pass and must not be inferred from the position recorded here for oral ingredient forms.
• A favourable scientific opinion from a food safety authority is a risk assessment, not an authorisation. In the European Union, authorisation requires a Commission implementing regulation adding the food to the Union list.

How supply classifications work · Documented safety signals

References

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