Hydrodol Powder (Before & After) (Biorevive Pty Ltd)
Product Name
Hydrodol Powder (Before & After)
Sponsor
ARTG
297598
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 the liver’.
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 active ingredients, dosages, duration and frequency of use described in the evidence were inconsistent with those for the medicine.
An unpublished clinical study was provided to support the hangover relief claim. The limitations of the evidence included a lack of peer-review and declaration of conflicts of interest; reported effects on hangover were not clinically significant and possibly not due to the trial medicine alone; inadequately controlled variables (such as type of alcoholic beverages taken); and poor or unjustified relevance to the sponsor’s medicine (e.g. symptoms that showed significant differences were not commonly associated with hangover; the formulation, dosages and dosage regimens described in the study were different or not justified as being relevant to those for the medicine on the ARTG).
Symptoms and claims described in other pieces of evidence were not relevant or not justified to support the hangover relief claim.
Additionally, the label of the medicine advertised a claim related to supporting the liver. However, the claim was not covered by the sponsor’s certification that they held evidence to substantiate it.
An unpublished clinical study was provided to support the hangover relief claim. The limitations of the evidence included a lack of peer-review and declaration of conflicts of interest; reported effects on hangover were not clinically significant and possibly not due to the trial medicine alone; inadequately controlled variables (such as type of alcoholic beverages taken); and poor or unjustified relevance to the sponsor’s medicine (e.g. symptoms that showed significant differences were not commonly associated with hangover; the formulation, dosages and dosage regimens described in the study were different or not justified as being relevant to those for the medicine on the ARTG).
Symptoms and claims described in other pieces of evidence were not relevant or not justified to support the hangover relief claim.
Additionally, the label of the medicine advertised a claim related to supporting the liver. However, the claim was not covered by the sponsor’s certification that they held evidence to substantiate it.
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