The Therapeutic Goods Administration (TGA) has issued an infringement notice totalling $18,780 to the New South Wales based company Sun Herbal Pty Ltd, for the alleged supply of a complementary medicine that was missing a mandatory warning statement.
The medicine included the ingredient Artemisia frigida, which should not be taken by women who are pregnant or likely to become pregnant. However, the label of the medicine did not include the required warning statement advising this, nor did Sun Herbal Pty Ltd have consent to supply the medicine without this warning statement on the label. The medicine has been recalled and is no longer permitted to be supplied.
Sponsors must understand their legal obligations under the Therapeutic Goods Act 1989 prior to listing medicines in the Australian Register of Therapeutic Goods (ARTG), and must ensure that their listed medicines comply with the applicable legislative requirements at all times.
If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.
