“Blockbuster ingredient”: ChromaDex receives EFSA approval for nicotinamide riboside chloride
22 Nov 2019 --- This week, nutraceutical company ChromaDex received European Commission approval for listing nicotinamide riboside chloride (NR) as a novel food ingredient. The decision follows a positive opinion issued by the European Food Safety Authority (EFSA) in August. NR helps maintain healthy aging by supporting nicotinamide adenine dinucleotide (NAD) levels in the body, which in turn equip the body’s cells cope with physical stresses such as poor diet, immune system challenges and physical and mental stress.
“Achieving formal regulatory acceptance of a novel food or ingredient can be a long and challenging process, particularly where firms lack the scientific and regulatory expertise or if there are large gaps in the data supporting the ingredient. As we know, an EFSA positive opinion is perhaps the most critical milestone to achieve in the EU novel foods process. This success in terms of regulatory acceptance is a direct result of the quality of our dossiers and the data we’ve provided to regulators,” Andrew Shao, Vice President of Regulatory and Scientific Affairs at ChromaDex, tells NutritionInsight.
The company first established NR’s regulatory acceptance in the North American market, with approvals from both the US Food and Drug Administration (FDA) in 2017 and Health Canada in 2018. This allowed the ChromaDex to launch its flagship consumer brand, Tru Niagen, containing NR as the sole active ingredient of the product. Following this regulatory momentum, the company turned to markets outside North America, starting with the EU. In August, it received a positive opinion from the EFSA on the safety of NR as a novel food.
The company affirms that this EC decision is not just important for its own business, but also for global researchers studying NR.Health benefits
The company’s flagship ingredient is suitable at a daily serving of 300 mg for the healthy adult population, helping reduce tiredness and fatigue as well as maintain normal skin. It is suitable for a wide variety of adults, from athletes to career-focused working people to seniors seeking support with healthy aging. These categories fall under a newer trend called “cellular health,” which is addressing and helping to bolster damage repair at the cellular level, says Shao.
Decreased NAD levels have been associated with many age-related declines in overall health. Tru Niagen is a dietary supplement clinically proven to increase bodily NAD levels, which stimulate cellular energy production and support cellular repair.
“Our bodies face a variety of stresses every day – poor diet, immune system challenges, physical and mental stress at work, and so on. These stresses manifest themselves as damage down to the cellular level, which accumulates over time, resulting in more rapid aging and decline in some basic body functions. NR enters each and every cell in our body to boost NAD, which declines as the stresses of life wear on your body and its trillions of cells,” he explains.
What’s next?
ChromaDex is currently conducting research, which targets specific endpoints throughout the human body at different doses. The company is keen on discovering what this research has in store, as NR has been the subject of rigorous preclinical safety and toxicology studies laying the groundwork for the published clinical studies that demonstrate safety and efficacy.
“Right now, we know that NAD declines with metabolic stress over time and Tru Niagen is a presently available solution. There are presently 43 human clinical trials involving NR registered and six have already published. At present, our consumer product is marketed for both cellular health and healthy aging as we wait for additional clinical trials to complete, ” says Shao.
To date, ChromaDex has invested millions of dollars in safety and human clinical trials on Tru Niagen and has entered research agreements with more than 170 US-based research institutions, including Dartmouth, the National Institutes of Health, University of Iowa and the Scripps Research Institute.
By Anni Schleicher
