Recoverthol (Plus Daily Ltd)
Product Name
Recoverthol
Sponsor
ARTG
Date of review outcome
Date of publication
Mar-21
Outcome
Medicine continues to be permitted for supply
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 related to hangover relief and relieving symptoms associated with occasional 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 the 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, relieving symptoms associated with occasional hangovers, and alcohol metabolism. The limitations with the evidence included that the active ingredients, dosages, duration and frequency of use described in the evidence were inconsistent with those for the medicine. In some instances the reported effects on hangover symptoms were not clinically significant or were not relevant to the medicine (e.g. looking at symptoms associated with chronic liver damage or fatty liver disease).
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the ARTG entry, label and website to remove the unsupported indications and claims.
Additional information
This medicine was targeted to check its compliance in relation to hangover claims