In this end of year edition, we provide an overview of some of the key regulatory occurrences in 2019.
Complementary medicines (‘Dietary supplements’)
The TGA’s agenda this year was wide-ranging and major regulatory headline changes include:
- The new Advertising Code (no. 2 of 2018) became effective, while in March enhanced penalties for addressing non-compliant advertising were introduced;
- TGO 101 Standard for tablets, capsules and pills commenced;
- New restrictions on caffeine content implemented;
- Guidance on using ‘natural’ and related claims when advertising to the public released;
- Launch of the new online new substance application and exclusivity period;
- November saw the start of advertising applications in any specified media being lodged with Consumer Healthcare Products Australia using an updated form;
- The TGA approved terminology for therapeutic goods updated;
- ‘TGA assessed’ claim introduced on product labels; and
- The TGA is seeking comments on a proposal to declare certain sports supplements therapeutic goods. Closing date: 3 December.
Navigating 2020 and beyond - key dates for your listed medicine products:
- 30th April the transition to move to the updated list of ingredient names ends;
- 1st September period to transitions labels to TGO 92 Standard for labels of non-prescription medicines and all labels must comply;
- 5th March 2021 end of the phase in period for the permissible indications list, to avoid cancellation any AUST L products must only use indications included in the list of pre-approved 'permitted indications'.
- 2019 saw the federal government commission an independent five year review into the health star ratings;
- In the yearly Failing Food Report of particular note are the number of foods ‘failing’ due to the illegal presence of added or non-permitted vitamins and certain herbs considered to be a health risk;
- A full review of Standard 2.9.4 – Formulated supplementary sports foods is being undertaken;
- There is a proposal to prohibit the retail sale of pure and highly concentrated caffeine products; and
- Imported Food Control Regulations 1993 were sunsetted on 1st October and the Imported Food Control Regulations 2019 introduced.
- Industrial Chemicals Act 2019 (AICIS) introduced which replaces NICNAS and creates a new regulatory scheme for the importation and manufacture of industrial chemicals;
- Annual reports no longer required for permits and self-assessed assessment certificates;
- Polymers of low concern (PLC) can now be introduced without notification;
- New criteria for PLCs which mean more polymers will meet the definition of a PLC and greater number exempt from notification;
- The definition of new synthetic polymer has changed. References to 'at least 2%' in the current definition have been amended to read 'greater than 2%'. This provides greater international alignment with the USA and Canada;
- Safety Data Sheets and labels no longer have to be provided if the cosmetic is introduced under the 'no unreasonable risk' category in volumes greater than 10kg per annum.
Key dates for 2020:
- 1st July AICIS will replace NICNAS (further guidance expected 2020); and
- 1st July ban on the use of new animal test data for ingredients solely used in cosmetics.
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