Making NAD, NAD+, NADH or NMN representations for listed medicines

This guidance applies to medicines listed on the Australian Register of Therapeutic Goods (ARTG) under section 26A of the Act. These types of listed medicines are not evaluated by the Therapeutic Goods Administration (TGA) prior to entry on the ARTG. Instead, sponsors certify that their listed medicine meets requirements in relation to quality, safety and efficacy. Sponsors of listed medicines are also required to ensure ongoing compliance with the applicable legislative requirements. To support this, the TGA uses a range of post‑market regulatory mechanisms to help ensure that listed medicines are of acceptable quality and can be used safely by consumers. These mechanisms include enforcing compliance with requirements relating to product presentation, advertising, permitted indications and permitted ingredients.

This guidance provides information for sponsors and advertisers of listed medicines about how nicotinamide adenine dinucleotide (NAD, NAD+, NADH) and nicotinamide mononucleotide (NMN) can be referred to, including in relation to ingredients, indications, statements and claims, names, advertising and presentation.

Although unapproved therapeutic goods are not included in the scope of this guidance, if you are advertising or supplying therapeutic goods that refer to NAD, NAD+, NADH, or NMN and these goods are not entered in the ARTG, nor otherwise subject to an exemption, approval or authority under the Act, you may be in breach of the Act. Such conduct may result in compliance or enforcement action by the TGA.

Listed medicines can only contain permitted ingredients that are specified in the Therapeutic Goods (Permissible Ingredients) Determination (the Ingredients Determination). Sponsors of listed medicines are reminded that NAD, NAD+, and NADH are currently not permitted ingredients.

NMN is a permitted ingredient, having been included in the Ingredients Determination on 10 December 2025. Sponsors must ensure that the use of NMN in listed medicines fully complies with all requirements that are specified in the Ingredients Determination.

The Ingredients Determination also includes several substances that may act as precursors to NMN, NAD, NAD+, and NADH, such as nicotinamide, nicotinamide ascorbate, nicotinamide riboside chloride and nicotinic acid (amongst others). This guidance should also be considered in relation to these ingredients, as applicable.

‘Indications’ are statements that describe the specific therapeutic use for a medicine.¹

To ensure that listed medicines remain low risk, they may only use low level indications that will not lead to their unsafe or inappropriate use. Indications permitted for use in listed medicines and requirements for their use are contained in the Therapeutic Goods (Permissible Indications) Determination (the Indications Determination).

Permitted indications have a consistent structure and terminology, with all permitted indications containing a therapeutic action and a therapeutic target as components, and some permitted indications additionally containing an action and/or a target qualifier.

Indications are an integral part of a medicine’s advertising and presentation and are one of the main factors influencing consumer self-selection of the medicine. As such, indications must be chosen and used with care to ensure that they are permitted indications, supported by appropriate evidence, and do not suggest therapeutic uses that the medicine does not have.

Currently, there are no permitted indications that reference NAD, NAD+, NADH, or NMN. Indications such as ‘Enhance/improve/promote/increase/boost NAD/NAD+/NADH/NMN levels’ and ‘Maintain/support NAD/NAD+/NADH/NMN levels’ are not permitted indications.

Sponsors or advertisers of listed medicines that use indications relating to NAD, NAD+, NADH, or NMN on their labels and/or in advertising may be in breach of the Act and may be subject to compliance or enforcement action by the TGA.

There are two types of statements or claims that can be made about a listed medicine:

• Type 1 is a statement or claim that does not contain a therapeutic use or indication, either expressly or by implication.
• Type 2 is a statement or claim that contains a therapeutic use or indication, either expressly or by implication.

Type 1 statements or claims

Type 1 statements or claims are those that do not contain a therapeutic use or indication.

For example:

• marketing or promotional statements (for example, “20% more tablets, same price”),
• directions for use (for example, “when taken three times a day”), or
• structure, function and/or mechanism‑of‑action statements that do not include the components of an indication, namely a therapeutic action and target, and do not imply a therapeutic use or indication (for example, “NAD+ is a coenzyme”).

Sponsors may use Type 1 statements and claims on product labels and/or in the advertising of their medicines provided they hold evidence to support those statements and claims.

Type 2 statements or claims

Type 2 statements or claims are those that contain a therapeutic use or indication, expressly or by implication, including instances where a structure, function or mechanism‑of‑action statement implies a therapeutic use but does not explicitly include all components of an indication.

Type 2 statements and claims require a permitted indication of similar intent to be included in the ARTG entry for the medicine and must be supported by appropriate evidence.

Statements or claims related to NAD, NAD+, NADH, or NMN which may be used in connection with permitted indications.

For example:

• ‘Maintains energy levels
  • This medicine contains NMN, a precursor of NAD. NAD is involved in cellular processes such as ATP production.'
  • This statement describes the NAD biochemical pathway and links it to the permitted ingredient (NMN) and the permitted indication “maintain/support energy levels”. Additionally, in this scenario, the indication is included in the ARTG entry for the medicine.
• ‘Maintains the body’s metabolism
  • NMN is a direct precursor to NAD, a molecule involved in several metabolic processes in the body.’
  • This statement describes the NAD biochemical pathway and links it to the permitted ingredient (NMN) and the permitted indication “maintain/support body metabolism/metabolic rate”. Additionally, in this scenario, the indication is included in the ARTG entry for the medicine.

The examples above are illustrative only. While such statements may, in some circumstances, align with permitted indications, the inclusion of the permitted indications does not in itself ensure compliance. The acceptability of any statement or claim depends on the overall presentation of the medicine.

Statements or claims related to NAD, NAD+, NADH, or NMN that imply an indication and are NOT permitted.

For example:

• ‘Maintaining NAD levels in the body is essential for your cellular function and vitality’
  • This statement does not contain permitted indications; however, a reasonable consumer may conclude that there is an implied therapeutic use that the medicine maintains NAD levels and through this maintenance, maintains or improves cellular function and vitality. Additionally, there are no permitted indications of similar intent that can be included in the ARTG for the medicine.
• ‘Declining NAD levels have been associated with abnormal DNA methylation. Supplementation with an NAD precursor may promote healthy methylation processes’
  • This statement does not contain permitted indications; however, a reasonable consumer2 may conclude that there is an implied therapeutic use that the medicine maintains NAD levels and supports or improves healthy methylation. Additionally, there are no permitted indications of similar intent that can be included in the ARTG for the medicine.

The name of a listed medicine forms a prominent part of the medicine’s advertisement and presentation and is one of the main label elements a consumer will consider.

Sponsors must ensure that the chosen name of their medicine does not cause a reasonable consumer² to associate it with ingredients or indications that are not permitted. Accordingly, the name must not state, suggest, imply, or otherwise indicate, either directly or indirectly, that the medicine has ingredients or indications that it does not have or that are not permitted.

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. Such expectations may be inaccurate or impermissible, as indications of this nature are not permitted for listed medicines at this time.

For example:

• The names ‘NAD’, ‘Bean’s NADH Supplement’, ‘NAD+ 50’, ‘NAD Booster’ or ‘NAD+ Enhance’ are all considered unacceptable.

'Advertise'³ in relation to therapeutic goods, includes making any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods. Whether a statement, pictorial representation or design is intended to promote the use or supply of the goods is determined not by the actual intentions of the person responsible for making or transmitting the content, but by whether the relevant content on its face appears to be designed or calculated to promote the supply or use of the relevant goods.

Advertisements for listed medicines must comply with the legislative and regulatory requirements found in the Act and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Advertising Code).

Examples of non-compliant advertising may include:

• Advertising a medicine as “the holy grail of longevity”, which may lead a reasonable consumer to believe the product is miraculous or infallible.
• Advertising that “NMN supplementation increases NAD+ concentration and could mitigate ageing-related disorders such as neurodegenerative diseases”, which may cause undue alarm in people that without the medicine, they are more likely to develop such a condition. Additionally, advertising a medicine for restricted representations, such as neurodegenerative diseases, is not allowed unless an approval or permission under the Act is in force.

You should be aware that these examples above are not exhaustive. Please refer to Applying the Advertising Code rules: general requirements for further information.

'Presentation'⁴ in relation to a medicine, means the way in which it is presented for supply. This includes matters relating to its name, labelling and packaging and any advertising or other informational material associated with the medicine. The presentation of a medicine as such includes, but is not limited to, all elements described above, namely:

• the medicine’s ARTG entry
• the medicine’s name;
• the medicine’s label, including symbols, pictures, logos, indications, directions for use, warning statements, claims, etc;
• the medicine’s packaging;
• the medicine’s dosage form;
• statements or claims made in connection with the medicine;
• advertising material, including websites, blogs or social media platforms, consumer reviews and testimonials, etc; and
• overall presentation.

The presentation of a medicine may be considered unacceptable if it suggests that the medicine has ingredients, components or characteristics that it does not have. The presentation must also ensure that the listed medicine remains within the bounds of the low-risk listed medicines framework, by being safe for consumer self-selection.

As listed medicines that refer to NAD, NAD+, NADH, or NMN are required to be safe for consumer self-selection, their presentation must not be misleading or confusing regarding the contents, correct usage, or identification of the medicine. Furthermore, the presentation must comply with all relevant legislation under the listed medicines framework, including the Ingredients Determination and the Indications Determination.

The following are hypothetical examples where a listed medicine’s overall presentation implies that it has ingredients, components or characteristics it does not have or is not permitted to have under the listed medicines regulatory framework.

Example - Overall presentation implies active ingredient is present when it is not

The name of a listed medicine is a primary label element and is typically the first aspect considered by consumers, playing a significant role in shaping their overall understanding of the medicine.

In circumstances where a medicine is named, for example, ‘NAD+ 500 mg’ and is accompanied by an image depicting the chemical structure of nicotinamide adenine dinucleotide (NAD+) on the main label, the primary message conveyed by the label is that NAD+ is an ingredient present in the medicine.

This impression is likely to be formed even though nicotinamide adenine dinucleotide is absent from the ingredient panel on the secondary label. Corrective information presented separately or less prominently does not overcome a misleading primary message generated by more prominent elements of the presentation.⁵

Example - Overall presentation implies potential use for serious conditions

In the following example, the website where the listed medicine is advertised is considered part of the medicine’s overall presentation.

A sponsor is advertising their medicine ‘Cell Energy Support’,⁶ which contains the active ingredient nicotinamide mononucleotide (NMN) on their website.

On the medicine’s webpage there is the following text:

‘NMN is a direct precursor to NAD+ and can support the body’s energy metabolism pathways.

NAD+ is a helper molecule that every cell in your body uses to stay alive and make energy. It helps turn the food you eat into fuel your cells can actually use. It also helps cells repair damage, communicate properly, and keep things running smoothly, especially in your muscles, brain, and organs. 

As you get older, your NAD+ levels naturally drop. When NAD+ levels are low, cells struggle to make enough energy, so you may feel tired, weak, or foggy because your muscles and brain aren’t being fuelled efficiently. Cells also become less able to repair DNA and handle stress, which can speed up cell damage and aging, including in your brain. Over time, low NAD+ is linked to slower metabolism, reduced muscle function, poorer brain health, weakened immune responses, and a higher risk of age‑related conditions such as Alzheimer’s disease because basic cell maintenance starts to break down.’

Under this text there is also a picture of an elderly person completing a memory test in a doctor’s office, that a consumer might understand to be a patient receiving diagnosis, treatment, or supervision for a cognitive-related medical condition.

Based on the overall presentation of this medicine, a consumer may infer that the medicine ‘Cell Energy Support’ may be suitable for age-related conditions that require diagnosis, treatment, or ongoing supervision by a qualified health professional. Reference to Alzheimer’s disease further suggests that this medicine can be used for cognitive-related medical conditions.⁷ Accordingly, the medicine’s overall presentation implies potential use for serious conditions that are not permitted under the listed medicines regulatory framework.

Example - Overall presentation implies potential use for an indication that is not permitted

In the following example, the website where the listed medicine is advertised is considered part of the medicine’s overall presentation.

A sponsor is advertising their medicine ‘NMN Pure High Strength 500’, which contains the active ingredient nicotinamide mononucleotide (NMN) on their website. 

On the medicine’s webpage there is an image of the medicine’s label which only refers to permitted indications or claims linked to permitted indications present on the medicine’s ARTG entry.⁸

On the medicine’s webpage there is the following text:

‘The role of NMN in cellular metabolism

Nicotinamide mononucleotide (NMN) is a naturally occurring molecule involved in the body’s cellular energy systems. It functions as a direct precursor to nicotinamide adenine dinucleotide (NAD⁺), a coenzyme that is required for a wide range of biochemical reactions within cells.

NAD⁺ plays a critical role in mitochondrial activity, where nutrients are converted into usable cellular energy. It is also involved in enzymatic processes linked to DNA maintenance, cellular signalling, and metabolic regulation. Because NAD⁺ is continuously consumed during these processes, the body relies on ongoing synthesis to maintain adequate levels.

NMN forms part of this renewal pathway. After ingestion or production within the body, NMN is converted into NAD⁺ through established cellular mechanisms.

NMN and its anti-ageing properties

Ageing is not only a matter of time, but of cellular function. Reduced energy production within cells is associated with many age‑related changes. NMN supports energy‑dependent cellular processes that aim to preserve longevity and combat and ward off signs of ageing. 

Based on the overall presentation of this medicine, a consumer may infer that the medicine ‘NMN Pure High Strength 500’ may be suitable for preserving longevity and anti-aging purposes. Accordingly, although the ingredient is linked to the mechanism of action, and the medicine’s label only contains permitted indications and claims, the medicine’s overall presentation implies potential use for indications that are not permitted under the listed medicines regulatory framework. 

For completeness, while the Indications Determination includes ‘Longevity tonic’, this indication must be supported by traditional evidence.⁹ Whereas, the information presented on the medicine’s webpage consists of scientific claims that must be supported by scientific evidence.

As a sponsor of listed medicines, it is your responsibility to consider the presentation of your medicine in a holistic manner, considering factors such as the medicine's name, ingredients, indications, statements and claims, names, advertisements and presentation, whether explicit or implied, and ensuring compliance with all applicable legislative requirements.

Carefully review the information in this guidance and:

1. Check that your medicine(s) comply with the applicable legislative requirements.
2. If relevant, make amendments to your medicine(s) (e.g. ARTG entry, label, advertising) in alignment with this guidance and applicable legislative requirements.
3. Stop the supply of any medicine(s) that do not meet these requirements.
4. Take steps to ensure future batches of your medicine(s) comply.

If you are unsure of your obligations under the Act, you should consider seeking independent regulatory or legal advice.

1. ‘Indications’ and ‘therapeutic use’ are defined in section 3 of the Therapeutic Goods Act 1989.

2. When considering the hypothetical response of a reasonable consumer, it is important to recognise that there may be multiple plausible responses. The key consideration is whether, among the range of reasonable responses, at least one could result in a consumer being misled, not whether it fails to deceive a more wary consumer. Thus, an advertisement may be misleading even if it fails to deceive wary readers.

3. ‘Advertise’ is defined in section 3 of the Therapeutic Goods Act 1989.

4. ‘Presentation’ is defined in section 3 of the Therapeutic Goods Act 1989. 

5. In Cat Media Pty Limited Carotino (Australia) Pty Limited Pharm-a-Care Laboratories Pty Limited and Minister for Health and Aged Care [2023] AATA 2792 Senior Member G. Lazanas found that a consumer is unlikely to engage in a detailed analysis of each constituent part of the label and ponder all their potential meanings. They are, instead, likely to form an overall impression based on the common thread running through the elements of the label.

6. In this example, the hypothetical sponsor for ‘Cell Energy Support’ has listed all the relevant permitted indications on the medicine’s ARTG entry and holds appropriate evidence to support the use of the medicine for these permitted indications.

7. A reference to Alzheimer’s disease is a restricted representation and can only be used in advertisements for therapeutic goods if the TGA has permitted or approved the use of that representation: Secretary, Department of Health v Oxymed Australia Pty Ltd [2021] FCA 1518.

8. In this example, the hypothetical sponsor for ‘NMN Pure High Strength 500’ has listed all the relevant permitted indications on the medicine’s ARTG entry and holds appropriate evidence to support the use of the medicine for these permitted indications.

9. ‘Traditional’ in relation to the type of evidence for an indication is defined in section 4 of the Therapeutic Goods (Permissible Indications) Determination to mean evidence of traditional use in a recognised paradigm outside modern conventional medicine, as described in the evidence guidelines published at www.tga.gov.au.