08.08.19
A critical step in the EU regulatory approval process, the European Food Safety Authority (EFSA) issued a positive opinion of Nicotinamide Riboside (NR), commercially known as Niagen (from ChromaDex Corp.) at a daily serving of 300 mg in healthy adult populations.
“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, ChromaDex CEO.
“We are diligently working to complete the regulatory process to bring NR to the health-conscious people of the EU,” he said.
ChromaDex plans to launch its flagship consumer NR product, Tru Niagen, in the European Union once the regulatory process is completed. The process is now up to the European Commission for review.
Cells can use Niagen to create nicotinamide adenine dinucleotide (NAD), which is an essential molecule found in every living cell. NAD plays an essential role in cellular energy production and supporting cellular repair. Decreased NAD levels are associated with many age-related declines in overall health.
Niagen is the only commercially available NR which has twice been successfully reviewed under the U.S. Food & Drug Association’s New Dietary Ingredient (NDI) Notification requirement and has also been successfully notified to the FDA as Generally Recognized As Safe (GRAS).
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on its patent-protected NR and 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.
“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, ChromaDex CEO.
“We are diligently working to complete the regulatory process to bring NR to the health-conscious people of the EU,” he said.
ChromaDex plans to launch its flagship consumer NR product, Tru Niagen, in the European Union once the regulatory process is completed. The process is now up to the European Commission for review.
Cells can use Niagen to create nicotinamide adenine dinucleotide (NAD), which is an essential molecule found in every living cell. NAD plays an essential role in cellular energy production and supporting cellular repair. Decreased NAD levels are associated with many age-related declines in overall health.
Niagen is the only commercially available NR which has twice been successfully reviewed under the U.S. Food & Drug Association’s New Dietary Ingredient (NDI) Notification requirement and has also been successfully notified to the FDA as Generally Recognized As Safe (GRAS).
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on its patent-protected NR and 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.
