EC confirms Chromadex’s anti-ageing ingredient is a Novel Food.
The EC’s vote of confidence for the ingredient and its makers, ChromaDex follows approvals from the US Food and Drug Administration (FDA) in 2017, where it is marketed under the brand, Tru Niagen.
The ruling leaves the way clear for ChromaDex to target Europe, in which professor John Walker, member of the ChromaDex Scientific Advisory Board (SAB) describes the EC’s decision as a “meaningful occasion for researchers around the world studying nicotinamide riboside”.
Under the EC’s instructions a daily serving of 300 milligrams (mg) for the healthy adult population is permitted for NR, which is said to increase NAD (nicotinamide adenine dinucleotide) levels in the body stimulating cellular energy production and support cellular repair.
Decreased NAD levels have been associated with many age-related declines in overall health, say the Californian-based company, who also point to a number of published clinical studies that demonstrate its safety and efficacy.
Nestlé agreement
The ingredient’s potential caught the eye of Swiss giants Nestlé, who last year secured the “exclusive right” to include Tru Niagen in its branded medical nutrition products.
The deal gave Nestlé Health Science “co-exclusive rights to include Tru Niagen in certain products within the consumer health category,” according to a press release.
Under the terms, Nestlé will make an upfront payment of €3.6m ($4m). ChromaDex will receive certain commercial milestone payments related to the sale of its branded NR Tru Niagen to Nestlé as well as tiered royalties.
Speaking at this year’s Food Matters Summit in London, Dr Charles Brenner, ChromaDex’s chief scientific advisor echoed professor Walker’s comments adding, “This is a celebratory occasion for researchers around the globe who understand the great potential of nicotinamide riboside and its important role in raising NAD levels.”
To date, ChromaDex has entered research agreements with more than 170 leading research institutions, including Dartmouth, the National Institutes of Health, University of Iowa, and the Scripps Research Institute.
According to the European Food Safety Authority’s (EFSA) positive opinion issued back in August 2019, the ingredient’s production process, composition, specifications, batch‐to‐batch variability and stability of the Novel Food did not raise safety concerns.
“Animal and human data indicate that the Novel Food contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns,” the opinion added.
Additional evidence
EFSA’s Panel on Nutrition, Novel foods and Food allergens (NDA) confirmed these observations with the help of supporting evidence supplied by ChromaDex that included an in vitro study evaluating the metabolism of nicotinamide riboside in blood.
The Panel noted these results indicated the NR could 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 milligrams (mg) for one day up to 2000 mg/day for up to 12 weeks, did 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 adds.
“The Panel also concludes that nicotinamide riboside chloride is a source from which NAM, which is a form of niacin, is bioavailable.”
