FDA Drug Label Status for NAD IV
No, there is no official FDA drug label for intravenous NAD (nicotinamide adenine dinucleotide). The FDA has not approved NAD for intravenous administration as a therapeutic drug, and any FDA labeling that exists lists only cosmetic uses, not therapeutic medical indications 1.
Current Regulatory Status
- The American Academy of Physical Medicine and Rehabilitation explicitly does not recommend NAD patches due to lack of clinical evidence, and this lack of evidence extends to intravenous formulations 1.
- NAD IV is not recognized by major medical societies or regulatory bodies as having established therapeutic indications 1.
- The absence of FDA approval means NAD IV lacks standardized dosing protocols, safety monitoring requirements, or quality control standards that accompany approved medications 2.
What IS FDA-Approved
The FDA has established guidelines only for NAD precursors in oral/enteral forms:
- Niacin (vitamin B3) has established daily intake recommendations: 16 mg/day for adult males, 14 mg/day for adult females, 18 mg/day for pregnant women 2.
- Parenteral nutrition formulations containing niacin are approved at 40 mg/day, but this refers to niacin precursors, not NAD itself 2, 1.
- Upper safety limits exist for nicotinic acid (10 mg/day) and nicotinamide (900 mg/day for adults) 2.
Clinical Implications
For patients inquiring about NAD infusion, the evidence-based approach is to recommend dietary sources of niacin (meat, poultry, fish, nuts, legumes) as the first-line intervention 1.
When NAD Supplementation May Be Considered:
- If deficiency is suspected: Measure blood or tissue NAD levels in the presence of pellagra symptoms (diarrhea, dermatitis, dementia) 1.
- If deficiency is confirmed: Use oral nicotinic acid (15-20 mg/day) or nicotinamide (300 mg/day) for pellagra treatment 1.
- Avoid NAD infusion for therapeutic purposes outside of research protocols, given the lack of guideline support, poor pharmacokinetics, and absence of proven clinical benefit 1.
Safety Concerns with Unapproved NAD IV
High doses of nicotinic acid can cause:
- Flushing, nausea, vomiting 1
- Liver toxicity 1
- Blurred vision and impaired glucose tolerance 1
- Potential concerns about NAD(P)H oxidase activity in anthracycline-induced cardiotoxicity 1
Common Pitfalls to Avoid
- Do not assume that because oral NAD precursors are safe, intravenous NAD is equally safe – the pharmacokinetics and safety profiles differ substantially 1.
- Do not confuse NAD precursors (NMN, NR, nicotinamide) with NAD itself – these are distinct compounds with different regulatory statuses 2, 3.
- Beware of clinics offering "NAD IV therapy" – these operate outside FDA oversight and lack evidence-based protocols 1.