For instance, they will need to state the allergen warnings for mollusc-derived ingredients, comply with new vitamin B6 dose restrictions for adults and children, and highlight pregnancy risk warnings for four additional artemisia species.
The new regulations have applied to newly listed products since 1 March.
Existing listed medicines will be given one year to implement changes until 1 March 2023.
“Suppliers of raw materials, especially proprietary ingredients, should also ensure that changes to ingredients are checked against materials.
“Suppliers need to ensure they are providing up-to-date and relevant information to sponsors or manufacturers so they can remain in compliance with their legal obligations under the Therapeutic Goods Act 1989.
“The TGA expects sponsors to obtain correct information from suppliers to meet obligations, and for suppliers to provide the necessary and correct information to sponsors, including contacting sponsors when there are changes to ingredients or requirements that may affect compliance,” said the Complementary Medicines Australia (CMA) in their technical alert announcement.
Mollusc-derived ingredients
One of the salient new requirements is to state the allergen warning “contains mollusc” or “contains mollusc products” for products containing eight examples of marine-based ingredients.
The eight samples are concentrated squid omega-3 triglycerides, green-lipped mussel, dried green-lipped mussel, green-lipped mussel oil, oyster, oyster shell, sepia and squid oil.
The objective for such a decision was to reflect an identified risk of allergenicity associated with those ingredients.
Under the new requirements, the statement “derived from seafood” is also removed from products with squid oil and concentrated squid omega-3 triglycerides.
Vitamin B6
As for Vitamin B6, the authority has stipulated dose restrictions for adults and children.
For example, the VITB6SX peripheral neuropathy warning applies if a product contains more than 10mg of pyridoxine per the maximum recommended daily dose.
The warning should be: “WARNING – Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6]”.
For dose restrictions, CMA has reduced the maximum supplemental daily intake from 200mg to 50mg a day and an extension of a warning statement for products providing between 10 to 50mg of equivalent pyridoxine.
The three vitamin B6 ingredients – pyridoxal 5-phosphate, pyridoxal 5-phosphate monohydrate and pyridoxine hydrochloride – have been adjusted in the amended requirements.
The new requirements reflect an identified risk of neuropathy associated with those ingredients.
Artemisia species
A total of four artemisinin ingredients have had pregnancy risk warnings added by the TGA.
The affected ingredients are Artemisia dracunculus, Artemisia frigida, Artemisia pallens and Artemisia vulgaris.
For example, a warning proposed for printing on the label is “Do not use if pregnant or likely to become pregnant (or words to that effect)”.
The Artemisia species have been traditionally used for gastrointestinal disorders and certain infections. It has also been highlighted as an ingredient that played a crucial role in historical pandemics. It is also used with curcumin on COVID-19 patients in a clinical trial.
However, TGA’s investigations revealed that it could potentially cause miscarriages as well. Hence, the new requirements intended to reflect an identified risk of embryotoxicity associated with those substances.
Actions to take
Overall, firms must review affected products to comply with the new requirements, whether heightened or decreased change.
Other changes discussed include benzalkonium chloride and its risk to infants from nasal use and a list of 17 inorganic magnesium salts.
