ChromaDex’s nicotinamide riboside chloride receives Australia’s TGA ingredient approval

By Guan Yu Lim contact

- Last updated on GMT

ChromaDex receives approval from Australian TGA for its nicotinamide ribosome chloride (NR) in listed complementary medicines in the country ©TruNiagen
ChromaDex receives approval from Australian TGA for its nicotinamide ribosome chloride (NR) in listed complementary medicines in the country ©TruNiagen

Related tags: Chromadex, Nr, Australia, TGA, Complementary medicines

ChromaDex has received approval from the Australian Therapeutic Goods Administration (TGA) for use of its patented nicotinamide ribosome chloride (NR) in listed complementary medicines in the country.

With this regulatory approval, the firm can exclusively market NR for two years in Australia until December 2, 2021.

According to Rob Fried, ChromaDex’s CEO, NR is currently only listed as an ingredient for complementary medicine. Its flagship product, Tru Niagen is not yet approved for sale in Australia, but the firm is in the process of listing it.

NR is the key ingredient in Tru Niagen, which is said to have anti-ageing benefits. It has been clinically tested in five studies in North America, with 40 additional studies underway in the US, EU, and Canada collectively. Findings have suggested its safety and effectiveness in increasing NAD+ in humans.

In one study​, the higher the intake of NR, the greater the blood levels of NAD+ in healthy but overweight adults. Dosages at 100mg, 300mg, and 1000mg raised NAD+ levels by 22%, 51%, and 142% respectively.

In another study​, chronic supplementation with NR ingredient is also effective at raising NAD+ levels by 60% in lean and healthy adults.

According to Fried: “NR is perhaps the most important healthy-ageing solution to come along in a very long time, supporting health and energy to help people remain active, energetic, and feeling as good as possible as they age or experience stress in the body​.”

How it works

NR is part of the vitamin B3 family. The firm explained its mechanism: “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. Many scientists have speculated that declining NAD+ levels has been associated with many age-related declines in overall health.

NAD+ enables cells to generate cellular energy from the food that we eat. It is also an important substrate for a variety of NAD+-consuming enzymes (including PARPs and sirtuins)​,” the firm said.

NR has been authorised by the European Food Safety Authority (EFSA) as a novel food ingredient for use in a food supplement in August this year, and in November, the European Commission voted in favour of listing NR as a novel food.

NR is FDA-approved and holds the generally recognised as safe (GRAS) status.

APAC strategy

Fried said the approval by Australia’s TGA in December was “an important milestone as we expand our presence in the Asia-Pacific region​.”

Besides having a presence in Hong Kong, Singapore and New Zealand for its Tru Niagen product, the firm is planning for a broader APAC strategy.

Fried told NutraIngredients-Asia​: “We’ve developed a cross-border sales business into mainland China, Japan and South Korea, and also offer Tru Niagen cross-border through e-commerce from New Zealand into Australia, through our partner Matakana Health (MHL)​.”

The firm most recently expanded its retail partnership with MHL until 2023, to boost sales in the Oceania region. MHL is a supplement manufacturer and distributor in New Zealand with national and Australian distribution in both online and offline channels.

According to Fried, over 50% of health foods are consumed by the middle-aged and geriatric populations in Asia. In the West, supplement consumption was also highest among the middle-aged population.

He said as both regions were experiencing rising health consciousness, growing interest in sports activities and increasing trend for plant-based diets, this has boosted demand for supplements in the coming years.

Fried told us the next focus for the firm is, “bringing Tru Niagen to consumers around the globe, so as many people as possible can reap the benefits of healthy ageing​.”

Last month, the firm reported its Q3 2019 net sales of US$12.1 million, which was up 48% compared to US$8.1 million in the corresponding period last year. The increase in Q3 2019 revenues was driven by growth in sales of Tru Niagen.

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