• PO Box 450 Mawson ACT, 2607 Australia

  • 02 6260 4022

Tech Alert: Clarification for Magnesium amino acid chelate

26 Aug 2021 12:27 PM | Anonymous member (Administrator)

This is a technical alert to highlight and clarify that the laxative warnings for products containing magnesium amino acid chelate are no longer required for this ingredient. The removal of these requirements is correctly reflected recently published an currently in force Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021 and its explanatory statement (Note that the laxative warnings still apply to other magnesium salts that are inorganic - as always please check the in-force Determination for each ingredient in your medicine to confirm requirements before proceeding with product decisions).

On 1 March 2021, the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021 commenced and the ingredient magnesium amino acid chelate (not an inorganic salt) incorrectly included new requirements for inorganic magnesium salts that were determined as a result of the outcome to the 2020-2021 consultation. This TGA consultations outcomes webpage will be updated shortly to reflect that the requirements will not apply to magnesium amino acid chelate.

On 12 August the TGA advised CMA of changes to the Determination through publication of version N.2 of 2021. On 13 august, CMA conveyed this information to members through a technical alert, including links to the newly published Determination which shows that the requirements do not apply. However, this technical alert also contained a table taken from the a TGA table which incorrectly displayed in the new requirements column that the requirements still applied to the ingredient - therefore, our table in this technical alert has also been updated to correctly reflect the removal of these requirements at the provided links (Word and PDF). 

The TGA is also sending an email to sponsors whom have magnesium amino acid chelate as an ingredient in an ARTG listing, to clarify the removal of the laxative warnings. To summarise, the laxative warning statements no longer apply to this ingredient, the Permissible Ingredient Determination has been correctly updated, the TGA consultation outcomes page will be updated shortly, the CMA table in the document has also been updated, and if you have this ingredient in a medicine you should also expect a clarifying email from the TGA in the near future.

Copyright © 2019 Complementary Medicines Australia. All rights reserved.

Powered by Wild Apricot Membership Software