The TGA have announced a consultation on proposed changes to the Permissible Indications Determination low-negligible risk ingredients, closing 15 September 2021.

The Proposed changes relate to:

- Peripheral neuropathy associated with lower dose vitamin B6 - a proposed reduction of maximum supplemental daily intake from 200mg/day to 50mg/day; and extension of a warning statement for products providing between 10 – 50 mg of equivalent pyridoxine.

- Artemisinin and pregnancy risk - proposed new label requirements for artemisinin containing products, which may also affect products that have artemisinin in a flavour or fragrance. These changes were anticipated following the ongoing review of Artemisinin containing medicines and pregnancy risk by the TGA.

- Allergen statement for mollusc-derived ingredients - proposal for ingredients on the Permissible Ingredients Determination that are derived from a marine mollusc (substances derived from squid, oyster, green lipped mussel or homeopathic Sepia) be updated to include the warning statement “Contains mollusc” or “Contains mollusc products”, in alignment with FSANZ allergen warnings.

Please read today’s full technical alert for more information