Hey! King Premium (D & X Pty Ltd)
Product Name
Hey! King Premium
Sponsor
ARTG
288722
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, liver health and protection, and detoxification were not substantiated by the sponsor. Always read the label and follow the directions for use. 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, Website
Issues related to safety
The label and website 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, liver health and protection, detoxification, traditional Chinese and traditional Western/European use. The populations described in the evidence were not relevant to the target population of the medicine. The active ingredient, treatment duration, dose, frequency of dose and method of ingredient preparation described in the evidence were not consistent with those for the medicine.
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to hangover claims