TRecently, the U.S. Food and Drug Administration (FDA) reminded compounders that food-grade NAD⁺ should not be used for IVs due to contamination risks and reported adverse events. The agency emphasized using only ingredients suitable for sterile compounding. See the FDA reminder here: https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-use-ingredients-suitable-sterile-compounding.
This article explains the FDA’s concern, clarifies the difference between food-grade and pharmaceutical-grade material, and outlines how options like pharmaceutical-grade Niagen® IV (nicotinamide riboside chloride, NRCl) address safety and quality.
What the FDA Warned About
In its recent reminder, FDA cautioned against food-grade NAD⁺ for IV use and underscored that IV solutions must be prepared with sterile, pharmaceutical-grade ingredients. Non-sterile inputs are more likely to carry microbes and endotoxins, which can trigger reactions ranging from chills and vomiting to systemic inflammatory responses requiring medical care.
Food-Grade vs. Pharmaceutical-Grade: The Key Difference
“Food-grade” sounds reassuring, but it’s formulated for oral ingestion (dietary supplements), not injection. Standards focus on purity for swallowing—not sterility for the bloodstream.
Pharmaceutical-grade ingredients for IVs are manufactured and tested to be sterile and free of endotoxins.
Per the U.S. Pharmacopeia (USP), medications administered by injection or IV are among those required to be sterile. That’s the core reason “pharmaceutical-grade” is non-negotiable for IV therapy.
Why Sterility Is Non-Negotiable
Think of the difference like contact lenses and tap water: drinking water may be fine, but it can harbor microorganisms unsafe for your eyes. Similarly, a substance acceptable to swallow may be unsafe to inject. Endotoxin-contaminated infusions have caused documented harm.
A Safer Alternative: Pharmaceutical-Grade Niagen® IV (NRCl)
Because of inconsistent quality seen with some NAD⁺ IVs, practitioners are turning to options designed for clinical use. Niagen® IV uses nicotinamide riboside chloride (NRCl)—a precursor to NAD⁺—prepared to pharmaceutical-grade specifications and mixed with bacteriostatic or sterile water prior to administration by qualified, licensed clinicians.
Quality is supported through partnership with an FDA-registered 503B outsourcing facility and adherence to relevant USP standards (e.g., <797>, <788>, <85>). The manufacturing process includes multi-step checks (17 total) to verify sterility and endotoxin limits—aimed at delivering a product that’s consistent, controlled, and clinic-ready.
Early clinical work suggests practical advantages: in a pilot study, Niagen® IV infusions were faster to administer, better tolerated, and raised NAD⁺ more rapidly than NAD⁺ IVs—supporting its role as a well-tolerated alternative.
How to Vet an NAD⁺ IV for Safety
Before receiving an infusion, ask:
- Is the product pharmaceutical-grade and sterile?
- What documentation confirms it’s endotoxin-free and contaminant-free?
- Where is it sourced and compounded? (503B outsourcing facility or a state-registered 503A pharmacy)
Red flags to avoid:
- Vague or no statement about pharmaceutical-grade sterility
- Unwillingness to share source and quality documentation
- No medical supervision or trained healthcare professional administering IVs
- Missing compounding credentials (USP/PCAB standards, etc.)
- Prices that seem too good to be true (often a warning sign for quality shortcuts)
Your safety is worth the questions.
Bottom Line: Choose Pharmaceutical-Grade
For IV therapy, sterility is paramount. Do not use food-grade NAD⁺ for IV infusions. Niagen® IV (NRCl) is built for clinical use, backed by stringent quality controls and appropriate compounding partnerships—offering a pharmaceutical-grade pathway to support NAD⁺ levels without compromising on safety.
If you’re considering an infusion, verify the source, sterility, and documentation—and choose a provider that meets pharmaceutical standards from end to end.
References
- Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019;9(1):9772. doi:10.1038/s41598-019-46120-z
- Hawkins J, Idoine R, Kwon J, et al. Randomized, placebo-controlled, pilot clinical study evaluating acute Niagen®+ IV and NAD+ IV in healthy adults. (Preprint bioRxiv). https://doi.org/10.1101/2024.06.06.24308565
- Johnstone T, Quinn E, Tobin S, et al. Seven cases of probable endotoxin poisoning related to contaminated glutathione infusions. Epidemiol Infect. 2018;146(7):931-934. doi:10.1017/S0950268818000420
- Mehmel M, Jovanović N, Spitz U. Nicotinamide Riboside—The Current State of Research and Therapeutic Uses. Nutrients. 2020;12(6):1616. doi:10.3390/nu12061616
- U.S. Environmental Protection Agency (2024). The Danger of Using Tap Water with Contact Lenses. https://www.epa.gov/sdwa/danger-using-tap-water-contact-lenses
- U.S. Food & Drug Administration (2024). FDA reminds compounders to use ingredients suitable for sterile compounding. https://www.fda.gov/drugs/human-drug-compounding/fda-reminds-compounders-use-ingredients-suitable-sterile-compounding
This content is educational, not medical advice. IV therapies should be administered by licensed professionals following applicable regulations and standards.
