ChromaDex has received approval for nicotinamide riboside chloride as an ingredient for complementary medicines from the Australian Therapeutic Goods Administration (TGA). This approval means ChromaDex’s patented ingredient in Australia will receive market exclusivity for two years.
With this approval, ChromaDex will be listing their final product as a complementary medicine on the Australian Register of Therapeutic Goods (ARTG).
“This is an important milestone as we expand our presence in the Asia-Pacific region,” said ChromaDex CEO, Rob Fried.
Cells can use NR 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.
Regulations worldwide
Niagen is the only commercially available NR, which has twice been successfully reviewed under US FDA’s new dietary ingredient (NDI) notification requirement and has also been successfully notified to the FDA as generally recognised as safe (GRAS). In August, the European Food Safety Authority (EFSA) issued a positive opinion on Nicotinamide Riboside (NR) as a novel food ingredient for use in a food supplement; in November, the European Commission voted in favor of listing nicotinamide riboside chloride as a novel food.
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on its NR ingredient 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.
