Flow State (The Tenth Co Pty Ltd)

The label and website for this medicine contained claims related to helping promote maternal postnatal health. This claim requires the warning statement set out under ‘What action should consumers take?’ above. However, the label and website did not include this warning statement, which is necessary to ensure the safe use of the medicine and to alert consumers to safety risks prior to taking the medicine.
The label and website also contained claims specified in 'What action should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to delay consumer access to timely advice or treatment from a suitably qualified health professional, which may result in adverse outcomes.
The website contained claims that this medicine was a substitute for good nutrition and superior to a balanced diet. Vitamin or mineral supplements are prohibited from making this claim unless permission has been given by the TGA.
While advertising of this nature is unacceptable, the labels of the affected batches have been corrected, and the claims have been removed from the label and website. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.