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Approved names for herbal ingredients
TGA approved terminology for therapeutic goods
This guidance provides information on approved names for herbal ingredients in therapeutic goods.
Most medicines that contain herbal ingredients are regulated as complementary medicines. Further information is available in the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).
Herbal ingredient name categories
There are different categories of approved names for herbal ingredients:
- Approved Herbal Name (AHN) refers to a species name expressed as its Latin binomial, for example, 'Hypericum perforatum' and includes fungi, algae and yeasts. AHNs are used in conjunction with information on the plant part and preparation to make a complete name such as 'Vaccinium macrocarpon fruit powder'. This approach is used for both active ingredients and excipients.
- Approved Herbal Substance name (AHS) refers to a single herbal substance that is defined by a pharmacopoeial monograph, for example, 'St John's Wort herb dry'.
- Approved Ingredient Name (AIN) refers to an ingredient derived from a plant that is highly refined but is not a pure chemical. AINs will be described by a default standard (an individual or specific monograph in the BP, EP or USP) or by a TGA compositional guideline. Requests cannot be made for an AIN, they are determined by the TGA.
- Approved Food Name (AFN) refers to a food name, for example, 'blueberry'. These can only be used to identify excipients.
All herbal ingredient names must be 'complete'. See section 8 for more information on how to make complete names.
Searching the list of approved herbal names
The Ingredients Table on the TGA Business Services website contains all approved names for ingredients used in therapeutic goods.
For more information on how to search for ingredients, refer to Appendix 3.1.1.
The inclusion of a herbal ingredient name in the Ingredients Table:
- indicates that the name is approved as the descriptor of the substance
- does not imply that the substance has been approved for use in therapeutic goods.
If a herbal name is not on the Approved List
If there is no approved herbal name to describe a new ingredient:
- follow the process for proposing a new ingredient name
- review section 9.2: Proposing a new herbal ingredient name
- use the form - Proposed Approved Herbal Name.
Using common names for herbal species
Common names do not unambiguously identify herbal species. Generally, the scientific species name must be used as the approved name.
In some cases, it might be appropriate to also include the common name for a plant in other documentation, including the medicine label. This might be appropriate where there are closely related species, subspecies, varieties and cultivars.
For example, Brassica oleracea, has several subspecies including cabbage, broccoli, Brussel sprouts, kale and cauliflower. For this ingredient, common names have been included in the list of synonyms in the Ingredients Table for clarity.
Herbal component names (HCNs)
Herbal Component Names (HCNs) are used to identify a component or group of components within parent herbal ingredients. These names are also in the Ingredients Table.
A HCN is not an ingredient in its own right. It can only be used in conjunction with an AHN or AHS.
How HCNs are used
Some HCNs must be declared in listed medicine applications due to specifications for the parent ingredient in the Therapeutic Goods (Permissible Ingredients) Determination or requirements in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP). These 'mandatory' components must be declared in the medicine application, but may not be required to be declared on the medicine label.
In the past, TGA approved new HCNs for non-mandatory components, however this process has been discontinued and you cannot apply for a new HCN.
New HCNs are only created when a legislative requirement comes into force. In this situation, the TGA will consider whether an existing approved name should be linked as an equivalent to the parent AHN or if a new HCN is needed.
Claims for listed medicines
Listed medicines may make claims on their labels about herbal components without pre-market evaluation of HCNs as long as they are true and the labels comply with regulatory requirements. Sponsors are required to hold evidence to support any claims that they make about herbal components. This evidence can be reviewed as part of a post-market compliance review.
Standardised herbal ingredients
When submitting a listing application, extracts can only be identified as being standardised if the standardised component has an AAN or HCN. If there isn't an approved name for the component, a non-standardised plant preparation type should be used to describe the extract. For example, use 'ext. dry conc.' instead of 'ext. dry conc. stand'.
Sponsors may make claims on their labels about herbal components without declaring this information on the medicine application. Any such statement must be true and comply with regulatory requirements.
Principles for herbal component naming
The following principles apply to the naming of new mandatory HCNs by the TGA.
HCNs for simple, well-characterised components
For a simple and well-characterised component, e.g. 'menthol', the HCN only includes the name of the chemical entity (i.e. not the name of the parent AHN), for example:
- 'arbutin', rather than 'arbutin (of Achillea millefolium)'
The HCN is linked in TGA's Business Systems as a mandatory equivalent component to the parent AHN (e.g. arbutin will be linked to the parent Achillea millefolium).
HCNs for complex components
The naming of complex components is assessed on a case-by-case basis. In some instances, it may be appropriate to include the parent plant species in the HCN. For example, 'purine alkaloids calculated as caffeine (of Paullinia cupana)'.
Examples include chemical groups that are unique to the plant species or may not be easy to characterise.
- 'fucoidan (of Fucus vesiculosus)' and 'fucoidan (of Undaria pinnatifida)'.
Note: In this instance, the component fucoidan represents a mixture of polymeric constituents, the composition of which varies between fucoidan-containing species. Therefore, each of these HCNs includes the parent AHN.
Additional information on medicine labels
Extra information about herbal ingredients, such as common names, can be included on medicine labels if:
- complete approved name is present
- all other information required under the legislation is present
- the additional information is both correct and unlikely to mislead consumers.
Common names must reflect common usage and understanding in Australia, e.g. black cohosh is the common name for Actaea racemosa.