Currently, only one nicotinamide mononucleotide (NMN) ingredient is approved for use in complementary medicines sold in Australia.
Aside from NMN, nicotinamide and nicotinamide riboside chloride (NR), other ingredients related to the nicotinamide adenine dinucleotide (NAD+) conversion chain, such as NAD, NAD+ itself and NADH, are not yet permitted for use in complementary medicines sold in Australia.
A search on the Australian Register of Therapeutic Goods (ARTG) database, however, returns more than 50 complementary medicines containing terms such as NAD+ or NAD in their product name.
In the guidance document published on Aug. 12, the TGA stated using these terms in product names was unacceptable, highlighting “NAD”, “Bean’s NADH Supplement”, “NAD+ 50″, “NAD Booster” and “NAD+ Enhance” as examples of unacceptable cases.
This is because such product names may imply the presence of NAD+ or NAD as ingredients in the product, which is not the case, since these ingredients are not yet permitted for use in complementary medicines in Australia.
“Medicine names that include terms such as ‘NAD’, ‘NAD+’, ‘NADH’ or ‘NMN’, even when combined with other words or numbers, may reasonably lead consumers to expect that the medicine either contains those ingredients or be interpreted as indications for the medicine,” the TGA wrote. “Such expectations may be inaccurate or impermissible, as indications of this nature are not permitted for listed medicines at this time.”
The TGA guidance also listed details on product claims, advertising and presentation.
Symptoms of a post-market surveillance system
Rhiona Robertson, general manager at product development and regulatory agency Healthcare Product Specialists, explained that products containing NAD, NAD+ and NADH in their names remain on the ARTG because Australia operates a post-market surveillance system.
As such, companies are free to list products with NAD, NAD+ and NADH as part of the product name in the database, while the TGA uses targeted post-market compliance reviews to identify non-compliant products for further review and enforcement action.
If a product is found to have not met its conditions of listing, such as using a name that the guidance defines as non-compliant, the TGA can issue a cancellation notice and remove the product from the ARTG in the worst-case scenario.
“The presence of these names on the ARTG does not mean they are allowed,” Robertson said. “It is a symptom of the post-market surveillance system not having caught up or an open dialogue with the TGA. There are several systems and processes in place for brands to engage with the TGA during this process, meaning that an update such as the one seen in the guidance does not equate to an immediate cancellation of a product.”
She added that because guidance documents are not equivalent to legislation, there is greater scope for interpretation and consideration before a final determination is made.
This also means that complementary medicines with non-compliant names may remain on the ARTG while brands and the TGA work together to determine whether they can be brought into compliance before a decision is made on whether to retain or cancel their listing.
Impact on businesses
Robertson believes that the issue also highlights how regulatory developments can lag behind industry trends.
NAD+ precursor ingredients have seen rapid growth across the Asia-Pacific region, particularly in China, where they have gained popularity since 2020 amid growing interest in anti-aging and longevity claims.
Before the approval of the popular NAD+ precursor ingredient, in this case, NMN, by the TGA last year, Australian consumers had to purchase their products through cross-border e-commerce, also known as the personal importation scheme in Australia.
Although NMN was eventually approved last December, the TGA only released the guidance document about eight months later, which Robertson noted has posed challenges for the industry.
“This meant that brands were left to launch using overseas competitors to set their product narrative in an exceptionally competitive market, importantly without clear direction from the TGA,” she said.
This could be gleaned from the fact that several brands highlighted the term “NAD” or “NAD+” in their product names, as increasing NAD+ levels through NMN or other NAD+ precursor supplementation is a common benefit claim overseas and Australian consumers have become well-acquainted with this concept.
“Fast forward to more than six months after the ingredient was approved for use; the guidance is now published, and one of the toughest regulatory markets in the world is now finding out what the TGA will accept and won’t accept in terms of claims, product names and overall product presentation.”
The delayed guidance, she said, could leave businesses that have already invested in product development, packaging and marketing having to make costly changes.
“The impact of these updates is being felt across the industry,” she said. “Businesses have invested heavily in product development, packaging, stock and marketing based on their understanding of the requirements and the information available to them at the time.
“It is important that the TGA and the industry at large recognize the impact this is having on those businesses, rather than treating the issue as though every affected brand has deliberately ignored the requirements, as this is not the case.”
One area where the regulator could improve is by looking beyond initial ingredient approval to consider how ingredients are ultimately used, marketed and packaged.
Robertson noted that when the broader context is not considered from the outset, businesses may have to make significant decisions without sufficient practical clarity, only to face regulatory changes and commercial consequences later.
“A clearer position from the beginning would help create better outcomes for all stakeholders,” she said.
Not a level playing field for Australian brands
Since consumers could still purchase NAD+, NAD and NADH supplements through the cross-border e-commerce (CBEC) channel, Robertson said regulatory restrictions, being applied only to products sold in Australia, meant that local brands could not compete on a level playing field as overseas brands sold in Australia via CBEC.
This is also one of the greatest challenges for local Australian brands.
“Australian brands operate within strict requirements around ingredients, claims, labelling and advertising, while international competitors may market similar products using claims and terminology that would not be acceptable for an Australian Listed medicine,” she said.
“This means Australian businesses are not always competing on a level playing field. They can invest significantly in regulatory compliance, Australian manufacturing, packaging and marketing, while competing for the same consumer against imported products operating under very different regulatory requirements.”
What can businesses do now?
Robertson has advised brands to reassess whether their product names or claims could mislead consumers or fall outside the TGA’s requirements.
In addition to product names and health claims, consumers also rely on product labels and pictures to learn more about products. As such, brands would need to consider whether the entire product label, when read together, could be interpreted as misleading to consumers.
“Would a reasonable consumer take away from reading ‘NAD+’ as a product name, with a product byline in the same field of vision stating ‘Contains NMN, known to support NAD+ levels in the body’, that the product contains NAD+?” she asked.
She urged brands to seek regulatory advice early and throughout the product development process, noting that doing so can help achieve successful outcomes and avoid enforcement action.
“In my experience, brands are rarely non-compliant on purpose,” she added. “More often, issues arise from a genuine difference of opinion or interpretation of the legislation, or from guidance that may be difficult to interpret in practice.”
