Australia's TGA Reiterates NMN as Illegal Ingredient

On April 7, 2025, the Therapeutic Goods Administration (TGA) of Australia released an official alert addressing concerns over the sale and promotion of medicines that claim to contain or influence levels of nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN).

The TGA reminded sponsors, manufacturers, and retailers that all therapeutic goods sold, imported, or exported in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) unless otherwise exempt or authorised. Currently, NAD and NMN are not permitted ingredients in listed medicines.

What is NMN and How is it Regulated in Australia?

Nicotinamide mononucleotide (NMN) is a naturally occurring molecule found in human cells. It serves as a precursor to NAD+, a vital compound involved in energy production, DNA repair, immune system function, and cellular stress resistance. However, NAD+ levels decline with age, which has driven interest in NMN as a potential supplement to support healthy aging.

Despite global interest, the sale of NMN supplements is not legal within Australia. All NMN products listed in the ARTG are approved as 'export only' medicines, meaning they can be manufactured in Australia but cannot be sold domestically. Australian-based consumers are allowed to obtain NMN only through personal importation from overseas suppliers.

Under the Personal Importation Scheme, individuals may import a 3-month supply per order for personal or immediate family use, with a maximum limit of 15 months’ supply over a 12-month period. It is illegal to resell or distribute these goods within Australia. Import quantities exceeding these limits, or intended for commercial sale, may be considered unlawful under the Therapeutic Goods Act 1989.

The TGA strongly advises consumers to only purchase NMN products from reputable overseas sources, as internet-bought supplements may not meet Australian standards for quality or safety.

Warning to Sponsors and Consumers

According to the alert, sponsors of listed medicines must ensure their products comply with regulatory requirements. Any reference to NAD or NMN in a product's name, label, or advertising, especially if such ingredients are not approved, could be a breach of Australian law. The TGA emphasized that enforcement actions may be taken against non-compliant sponsors, including the removal of unlawful advertising and stopping supply of unapproved goods.

The agency also urged consumers to remain cautious. Approved medicines must carry an AUST L, AUST L(A), or AUST R number, indicating their listing in the ARTG. Products that lack these identifiers and promote NAD, NMN, or related substances may be unapproved and potentially unsafe.

Regulatory Measures Ahead

The TGA reaffirmed its commitment to consumer safety and regulatory compliance. While initial steps may involve working with responsible entities to educate and guide them toward compliance, repeated or serious breaches may lead to escalated enforcement actions. This alert serves as a clear signal of the TGA's stance on unauthorized therapeutic products and its ongoing efforts to uphold health standards in Australia.