Hydrodol Powder (After) (Biorevive Pty Ltd)
Product Name
Hydrodol Powder (After)
Sponsor
ARTG
297384
Date of review outcome
Date of publication
Sep-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 related to hangover relief were not substantiated by the sponsor. The medicine may also not work as expected in relation to ‘supporting and targeting the liver’, ‘therapeutic and tonic effects’, or any antioxidant claims.
Be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
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. The evidence provided by the sponsor included review articles and monographs which are insufficient in the absence of robust scientific studies such as clinical trials or systematic reviews. This is because they generally do not include sufficient detail regarding population demographic, sample size, ingredient preparation, dose and statistical analysis to allow for comparison with the medicine.
The website claimed that the medicine may help support and target the liver, its traditional herb may be used for therapeutic and tonic effects, and its antioxidants may help reduce free radical damage to body cells. However, the claims were not covered by the sponsor's certification that they held evidence to substantiate them.
The website claimed that the medicine may help support and target the liver, its traditional herb may be used for therapeutic and tonic effects, and its antioxidants may help reduce free radical damage to body cells. However, the claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The 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