The ingredient, often associated with anti-aging and longevity, was added to the TGA’s Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2025 on Dec. 10.
With this approval, dietary supplement manufacturers in Australia can now formulate NMN into their products for sale within Australia.
Prior to this, NMN dietary supplements could be made in Australia, but only for exports.
Australia is one of the few countries to approve NMN’s use as an ingredient in oral supplements.
In Japan, NMN use is already approved by the Consumer Affairs Agency (CAA) for use in Foods with Function Claims (FFC).
In Canada, NMN is also listed in the Natural Health Products Ingredients Database and can be made into supplements for adults.
The U.S. Food and Drug Administration (FDA) also declared NMN as lawful for use in dietary supplements in late September and recently sent letters to specific NMN ingredient suppliers to confirm that NMN is no longer excluded from the dietary supplement definition.
The approved NMN
The NMN ingredient approved by the TGA was sourced from Australian biotechnology company Longevity Life Sciences Pty Ltd and manufactured by Shanghai-based SyncoZymes.
Commercially available as CellVive NMN, the ingredient will initially be sold in Australia.
Longevity Life Sciences has also developed a finished product containing the ingredient, which is slated for launch in Australia, Singapore, and Hong Kong via e-commerce next March, CEO Sally Panton told NutraIngredients.
The product, named Elevate Cellvive NMN Advance, is also listed on the Australian Register of Therapeutic Goods (ARTG) database as of Dec. 11.
This is a single-ingredient product, with each capsule containing 250 mg of NMN. Based on information listed on the ARTG, the product is permitted to make indications such as “reduce free radicals formed in the body”, “maintain/support energy production”, and “maintain/support general health and well-being.”
Panton explained that the dual ingredient and product strategy demonstrates the end-to-end regulatory capability of the company’s NMN from ingredient approval through to finished product compliance.
“It also allows the company to set a benchmark for quality, formulation, and responsible claims in the emerging NMN category,” she said.
SyncoZymes was one of the NMN ingredient manufacturers that received the U.S. FDA’s letter confirming that NMN is no longer excluded from the dietary supplement definition.
The process
Panton told NI that her company, founded about three years ago, had undergone a multi-year regulatory process to secure the permissible ingredient status from the TGA.
The process required a comprehensive safety dossier, including toxicology, human clinical data, and historical exposure evidence, as well as full chemical characterization and manufacturing controls, demonstrating pharmaceutical-grade quality, consistency, and stability.
Another aspect is ensuring a clear differentiation from food and dietary supplement pathways used in other jurisdictions, positioning NMN appropriately within Australia’s therapeutic framework.
“One of the key challenges was navigating NMN’s global regulatory ambiguity—where it has been treated differently across food, supplement, and investigational drug frameworks internationally," Panton said.
“Australia’s process demanded a higher evidentiary and quality threshold, consistent with medicines regulation rather than food law.
“Ultimately, the TGA’s decision reflects confidence in both the safety profile of NMN and the robustness of the supporting scientific and manufacturing data. Australia has now become the first country globally to formally permit NMN for use in listed therapeutic medicines, establishing a clear regulatory benchmark."
Lucy Canny, co-founder and chief operating officer at Longevity Life Sciences, added that the regulatory approval would pave the way for NMN market transparency.
Before the approval, Australian consumers who wanted NMN supplements were getting them from overseas or from domestic suppliers who were breaching local regulations.
“This decision paves the way for NMN to enter the market transparently and with greater safety mechanisms, giving consumers and our industry partners confidence in the ingredient’s quality and evidence base,” said Canny.
Clinical trial and other plans
The company is partnering with the University of Sydney to conduct a human clinical study using its NMN ingredient next year.
It is also working with Australian research institutions in formulation-specific and indication-focused research designed for clinically meaningful applications of NMN across metabolic, cognitive, and inflammatory health domains.
At the same time, the company is seeking regulatory approvals for NMN in Europe through the novel foods pathway.
Before diving into the longevity health space, Panton co-founded the rapid diagnostic products and testing solutions company Pantonic Health.
“Longevity Life Sciences was born out of a great passion for prevention over treatment, and my background at Pantonic Health has pioneered a lot of that preventative testing in Australia,” she said.
“We had great experiences working with the TGA in bringing preventative health diagnostics through their strict regulatory framework, and when we saw the potential of NMN as an ingredient, we decided to form an entity that would allow us to bring longevity-related compounds through the ARTG,” she said.
Aside from NMN, the company is also working on other ingredients in the preventative health space that show promise in supporting healthy aging and longevity.
