Rejoove (Clever Health)
Product Name
Rejoove
Sponsor
ARTG
296905
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 the medicine is right for you given that claims about assisting in the symptomatic relief of hangovers were not substantiated by the sponsor.
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 the claims related to symptomatic relief of hangover. The treatment duration, dosing and method of ingredient preparation described in the evidence were inconsistent with those for the medicine. The evidence provided by the sponsor also included review articles, textbooks 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 assisted in the symptomatic relief of hangovers, as an ‘anti-nausea’ agent, assisted in detoxification and may assist in reducing the risk of damage to the liver caused by harmful substances by acting as a powerful antioxidant. These claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
The website claimed that the medicine assisted in the symptomatic relief of hangovers, as an ‘anti-nausea’ agent, assisted in detoxification and may assist in reducing the risk of damage to the liver caused by harmful substances by acting as a powerful antioxidant. These 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 did not respond or provide the requested information to correct the issues. The TGA cancelled the medicine and withdrew permission for further supply due to non-payment of annual charges.
Additional information
This medicine was targeted to check its compliance in relation to hangover claims