Hey! KING STANDARD (D & X Pty Ltd)
Product Name
Hey! KING STANDARD
Sponsor
ARTG
289237
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Consider whether this medicine is right for you as the claims for hangover relief were not substantiated by the sponsor. Consumers should be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels
Issues related to safety
The label for the medicine may promote its use as a substitute for responsible drinking, which is inconsistent with the public health campaigns about the responsible drinking of alcohol and that minimising alcohol intake is the best way of reducing alcohol-related harm. While advertising of this nature is unacceptable, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims related to hangover relief and traditional Chinese use. The populations described in the evidence were not relevant to the target population of the medicine. The active ingredient, dose and method of ingredient preparation described in the evidence were not consistent with those for the medicine.
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Neverthless, TGA issued an educational letter to the sponsor outlining the issues with the medicine.
Additional information
This medicine was targeted to check its compliance in relation to hangover claims