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Changes to Permissible Ingredients - June 2018
Subject to the approval of the Delegate of the Minister of Health, this page outlines changes that will be made to the Therapeutic Goods (Permissible Ingredients) Determination in June 2018.
Please note that this list is not definitive, as other changes may be processed in the interim, depending on the progress of applications and reviews. The TGA will endeavour to provide updates as far in advance as possible.
1. Transition arrangements
In February 2018, the Complementary and OTC Medicines Branch (COMB) communicated about the upcoming changes to the Determination scheduled for inclusion in the June 2018 update subject to the Delegate's approval. A number of these changes are an outcome of TGA initiated safety reviews for several ingredients that are currently used in listed medicines. COMB has established transition arrangements for products affected by amendments that do not pose an immediate safety risk to consumers as detailed below.
We recommend that sponsors take steps to comply with the requirements ahead of the transition period as the safety of a medicine is the sponsor's responsibility, and to ensure that sponsors are compliant by the end of the transition period.
Any new listings from the date that the Determination is in force (expected to be 1 July 2018) will need to comply immediately with the new requirements. Where applicable, transition arrangements will be specified in the Determination.
2. Clarification of SUSMP requirements for arbutin
Ingredients known to contain arbutin will have arbutin listed as a mandatory component with associated specific requirements in line with the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The affected ingredients will be:
- Achillea millefolium
- Arctostaphylos uva-ursi (leaf)
- Chimaphila umbellata
- Kalmia latifolia
- Ledum palustre
- Origanum majorana
- Pyrus communis
- Pyrus pyrifolia
- Rhododendron ferrugineum
- Turnera diffusa
- Vaccinium vitis-idaea (leaf)
The update for arbutin is to bring the Determination into alignment with requirements of the SUSMP. There is no transition period for these changes.
3. New specific requirements for poliglusam
Following the safety review of poliglusam, a new restriction on maximum daily dosage of 1750 mg will apply. A specific requirement will also apply to the minimum average molecular mass, with poliglusam requiring an average molecular mass greater than 2 kilodaltons. This is due to a considerable difference in the safety profile between larger and small molecular mass poliglusam.
Listed medicines already on the ARTG containing poliglusam will have until January 2020 to comply with the new requirements.
4. New specific requirements for cysteine
As a result of a safety review, more restrictive requirements will be applied to cysteine, its salts and cystine. The new maximum daily dosages will be:
- cysteine - no more than 450 mg
- cysteine hydrochloride - no more than 585 mg
- cysteine hydrochloride monohydrate - no more than 652 mg
- cystine - no more than 450 mg
Listed medicines already on the ARTG containing cysteine, cysteine salts and cystine will have until January 2020 to comply with the new requirements.
5. Proposed restrictions for caffeine - Delay of implementation
In February 2018 TGA proposed that the maximum daily dose for caffeine as a component of herbal ingredients and as an individual ingredient was not to be more than 600mg, with divided preparations for oral use to contain no more than 100 mg per dosage unit.
In response to feedback received from industry stakeholders regarding the need for additional requirements for caffeine, we will further review the appropriate restrictions that apply to caffeine. Consequently, the proposed amendments for caffeine will not be included in the June 2018 update of the Determination, and will be reconsidered before inclusion in a future update.
6. New therapeutic purpose and specific requirements for methyl salicylate
Following a safety alert issued by the US Food and Drug Administration, the Complementary and OTC Medicines Branch and Toxicology Section of the Scientific Evaluation Branch carried out an assessment of the safety of methyl salicylate in listed medicines.
As a result of the review, the TGA will expand the purpose of methyl salicylate to include use as an active ingredient for both topical and oral administration. Additionally, medicines containing methyl salicylate will have additional specific requirements. All such medicines will be required to declare methyl salicylate on the label. Topical medicines containing methyl salicylate will be required to include a number of warning statements on the label, and must not contain a methyl salicylate concentration of more than 25%.
The herbal ingredients that are affected include:
- Betula lenta
- Betula nigra
- Betula pendula
- birch leaf dry
- Filipendula ulmaria
- Gaultheria procumbens
- meadowsweet herb dry
- Nyctanthes arbor-tristis
- wintergreen oil
Listed medicines already on the ARTG containing methyl salicylate will have until January 2020 to comply with the new specific requirements.
7. Addition of new therapeutic purposes for menthol
The TGA has recently conducted a review of menthol safety and as a result will make the requirements applying to menthol less restrictive by expanding its use from only permitted as an active ingredient in medicated lozenges and medicated space sprays to permitted as an active ingredient for both topical (not more than 5%) and oral administration (not more than 1 gram maximum recommended daily dose). In addition, warning statements will apply when the ingredient is for topical use.
Menthol will be added as a mandatory component of the following ingredients (and the same specific requirements and warning statements will apply):
- Mentha aquatica
- Mentha arvensis
- Mentha arvensis leaf oil
- Mentha arvensis oil
- Mentha haplocalyx
- Mentha pulegium
- Mentha spicata
- Mentha x cardiaca
- Mentha x piperita
- mint oil dementholised
- peppermint leaf dry
- peppermint leaf powder
- peppermint oil
- peppermint oil terpeneless
- peppermint oil terpenes and terpenoids
- spearmint oil
- spearmint oil terpeneless
Listed medicines already on the ARTG will have until January 2020 to comply with the new specific requirements.
The TGA has been provided with further information on the safety of menthol in listed medicines, and determined that the risks associated with topical menthol exposure at higher concentrations of 5-25% can be mitigated by an additional warning statement. The Determination will be amended accordingly in June 2019.
8. Ingredient name changes
The names of the following ingredients will be changed:
- Astragalus membranaceus will change to Astragalus mongholicus (as per MPNS).
The TGA has reviewed further information on the taxonomical classification of Astragalus species, and has noted that Astragalus membranaceus and Astragalus mongholicus are considered to be separate species. The Determination will be amended in September 2018 for this ingredient to remain as Astragalus membranaceus.
- Poria cocos will change to Wolfiporia cocos (as per Species Fungorum).
Listed medicines already on the ARTG will have until January 2020 to comply with the new ingredient names.
9. Microbial preservative warning statements
As Therapeutic Goods Orders No. 69 & 92 for medicine labels requires any ingredients used as microbial preservatives to be named on the medicine label, listed medicines should comply with the relevant requirements in the appropriate labelling order. Consequently, the equivalent requirements within the Determination will be removed for:
- benzethonium chloride
- benzyl alcohol
- chlorobutanol hemihydrate
- dehydroacetic acid
- diazolidinyl urea
- phenethyl alcohol
10. Minor amendments
- dimeticone 1.5 & dimeticone 2: Allowable concentration in medicine increased.
- potassium iodide: specific requirement on internal use limits re-instated.
- isojasmone: approved for flavour use in proprietary ingredients.
- ubidecarenone: warning statement requirements clarified.
- calcium folinate, folic acid, levomefolate calcium & levomefolate glucosamine: Requirements on products with a combination of these ingredients clarified.
11. New ingredients
- PEG-9 polydimethylsiloxyethyl dimeticone
- sucrose tristearate
- Tinospora cordifolia
12. Removed ingredients
- meadowsweet herb powder
Timeframes and processes
Other proposed changes may be outlined as the TGA completes ongoing applications and reviews.
Changes made to the Determination are published on the Regulatory decisions and notices (complementary medicines) webpage.