Writing in EFSA’s official journal, the ruling states the NR is safe at levels up to 300 milligrams per day (mg/day), for the healthy adult population, excluding pregnant and lactating women.
The Panel also conclude that an intake of up to 230 mg/day is safe for pregnant and lactating women.
“Safety is paramount for ChromaDex and this positive opinion from EFSA underscores our depth of science, and is the latest in a consistently positive series of reviews of NR by authoritative bodies,” said Rob Fried CEO of ChromaDex, the US-based applicant.
“We are diligently working to complete the regulatory process to bring NR to the health-conscious people of the EU.”
Once the regulatory process is completed, ChromaDex plan to launch its flagship consumer NR product, Tru Niagen in the EU.
The product is currently available in the US in capsule form with each capsule containing 150mg of nicotinamide riboside chloride (Niagen). Tru Niagen is certified vegetarian, gluten-, nut- and caffeine-free.
Studies suggest cells can use NR to create nicotinamide adenine dinucleotide (NAD), which is an essential molecule found in every living cell.
NAD plays a role in cellular energy production and supporting cellular repair. Decreased NAD levels are associated with many age-related declines in overall health.
EFSA’s Panel on Nutrition, Novel foods and Food allergens (NDA) confirm these observations as it acknowledges the supporting evidence supplied by ChromaDex that includes an in vitro study evaluating the metabolism of nicotinamide riboside in blood.
The Panel notes that these results indicate that the NR can be metabolised to NAM in a cellular component of whole blood.
Other available human studies on the NR, conducted in healthy adult subjects with dosages from 100 mg for 1 day up to 2000 mg/day for up to 12 weeks, do not raise safety concerns particularly to vital signs, haematology and clinical chemistry.
“Information provided on the production process, composition, specifications, batch‐to‐batch variability and stability of the NR is sufficient and does not raise concerns about the safety of the NR,” EFSA conclude.
“The Panel also concludes that nicotinamide riboside chloride is a source from which NAM, which is a form of niacin, is bioavailable.”