U.S. regulatory status
NAD+
Also known as Nicotinamide adenine dinucleotide, NAD, β-NAD
Is NAD+ legal right now?
In the United States, NAD+ sits in an unresolved regulatory zone rather than a clearly permitted or clearly banned one.
It was nominated for the 503A list, but the advisory committee recommended against inclusion (2017) and the FDA’s September 2019 proposed rule listed NAD among substances it proposed not to add; no final rule has definitively placed it on the list. It is not an FDA-approved drug, yet there is no formal federal ban: oral NAD+ is sold as a dietary supplement, and pharmacies continue to prepare NAD+ injections and IV infusions in a gray area.
Recent FDA activity has focused on ingredient-quality reminders and product-specific recalls rather than scheduling the substance itself.
In limbo: Moved on paper - nominated, removed from a restricted list, or recommended by an FDA committee - but not added to the 503A list. The headline implies a change; the legal status has not moved.
Verified Sep 22, 2026 (ET) · status held since Sep 5, 2019
Where it sits in the process
- Nominated (stalled here - not advancing)
- Under review (not reached)
- Rulemaking (not reached)
- Compounding-legal (not reached)
Not on a path to the 503A list right now. The process stalled or reversed at this stage - read the status above. Sitting at an earlier step is not a sign it will advance.
What changed last
No recorded changes yet - this entry has held one status since it was added.
Status elsewhere
| Jurisdiction | Status | Note |
|---|---|---|
| United States (FDA) | In limbo | Proposed for non-inclusion (2019); no final rule and no ban; oral sold as a supplement; injectable compounded in a gray area. |
| Australia (TGA) | Restricted | Per an April 2025 TGA safety alert, NAD/NAD+/NADH are not permitted ingredients in listed medicines. |
| United Kingdom (MHRA) | Restricted | No UK marketing authorisation; injectable NAD+ is supplied only as an unlicensed ‘special’ on a prescriber’s order, while oral NAD+ is sold under food-supplement rules. |
| European Union (EMA) | Restricted | No EU marketing authorisation; injectable NAD+ cannot be marketed as a medicine EU-wide, with enforcement handled at member-state level; oral NAD+ circulates under food-supplement law. |
| Canada (Health Canada) | Restricted | No approved injectable NAD+ in the Drug Product Database; an April 2026 Health Canada advisory lists NAD+ among unauthorized injectable drugs illegal to sell; oral NAD+ is regulated as a natural health product. |
| Sport / anti-doping (WADA) | Unscheduled | Not named on the Prohibited List, but IV infusions over 100 mL per 12 hours are prohibited as a method (M2.2). |
The U.S. status is watched by automation every six hours. Statuses elsewhere change less often and are covered by a monthly wide-net sweep, then re-verified whenever a lead surfaces - this entry’s last-verified date covers every row above. How we track it
Sources & transparency
Sources for this entry
- Federal Register - 2019 proposed rule, 503A bulk drug substances Federal Register · primaryProposes not to include a set of nominated substances on the 503A list.
- eCFR - 21 CFR 216.23 (503A bulk drug substances lists) Government · primaryThe codified 503A lists; NAD does not appear on the finalized ‘will not include’ list - the 2019 proposed rule was never finalized, which is why NAD sits in limbo.
- Health Canada public advisory - Think twice before injecting peptides bought online (Apr 9, 2026) Health Canada · primaryBasis for the Canada (Health Canada) status row.
- EMA - Medicines search (no entry for nicotinamide adenine dinucleotide) EU · primaryBasis for the European Union (EMA) status row.
- BSCG - NAD+ rules, risks and testing AnalysisOral NAD+ is a dietary supplement; injectable is not FDA-approved; WADA IV-volume limit.
- Partnership for Safe Medicines - FDA sterile-compounding reminder AnalysisFDA reminder on ingredient suitability for sterile compounding of NAD+.
- MHRA - The supply of unlicensed medicinal products (‘specials’), gov.uk AnalysisBasis for the United Kingdom (MHRA) status row.
- Last verified by a human
- Sep 22, 2026 (ET) · how we verify
- Who runs this
- Peptlas Research Team - independent. About us.
- What we sell
- Nothing. No products, no affiliates, no sponsored placements.
This page reports publicly available regulatory status for information only. It is not medical or legal advice and makes no health claim. See our full disclaimer.
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