The Therapeutic Goods Administration (TGA), part of the Department of Health and Aged Care, has issued an infringement notice totalling $13,320 to Sydney company JSHealth Vitamins Pty Ltd for alleged breaches of the Therapeutic Goods Act 1989.
JSHealth Vitamins supplied a complementary medicine that TGA alleges did not conform with legal requirements. The product included an ingredient extracted from fennel, Foeniculum vulgare. This ingredient is not recommended for children under 12 years and should not be taken by women who are pregnant or likely to become pregnant, or breastfeeding women.
However, the label of the medicine did not include the required warning statements advising of this nor did JSHealth Vitamins Pty Ltd have consent to supply the medicine without these warning statements on the label.
This infringement notice follows the recall of the complementary medicine by JSHealth Vitamins Pty Ltd.
If you suspect non-compliance in relation to therapeutic goods, you can online to the TGA.
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