Hangover Relief (Body Armour Pty Ltd)
Product Name
Hangover Relief
Sponsor
ARTG
304293
Date of review outcome
Date cancellation takes effect
Date of publication
Jun-2024
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Do not use this medicine if you are pregnant or breastfeeding. Seek advice from a suitably qualified health practitioner if you have been taking this medicine under these circumstances.
Seek advice from a medical practitioner if you have been using this medicine for anti-cancer, antidiabetic, anti-obesity, chemoprotective, or osteoporotic effects; treatment of liver disorders or liver damage; or regulating blood acidity or blood pressure.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to maintaining/supporting liver health or healthy liver function, protecting the liver, relieving digestive discomfort, antioxidant activity, or reducing/decreasing free radical formation in the body or damage to body cells.
Be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
Seek advice from a medical practitioner if you have been using this medicine for anti-cancer, antidiabetic, anti-obesity, chemoprotective, or osteoporotic effects; treatment of liver disorders or liver damage; or regulating blood acidity or blood pressure.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to maintaining/supporting liver health or healthy liver function, protecting the liver, relieving digestive discomfort, antioxidant activity, or reducing/decreasing free radical formation in the body or damage to body cells.
Be aware that consumption of this medicine is not a substitute for responsible drinking or for reducing the consumption of alcohol.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The website for this medicine contained claims specified in 'What action should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitability qualified health professional when required, which may result in adverse outcomes.
The website also claimed that this medicine 'posed no risk'. This claim is not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even when it is not safe or appropriate.
Additionally, the label and website may promote the use of this medicine 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 was of reducing alcohol-related harm.
While advertising of this nature is unacceptable, supply of this medicine has ceased, the above claims have been removed, and this medicine in unlikely to pose an immediate risk to consumer health and safety.
The website also claimed that this medicine 'posed no risk'. This claim is not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even when it is not safe or appropriate.
Additionally, the label and website may promote the use of this medicine 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 was of reducing alcohol-related harm.
While advertising of this nature is unacceptable, supply of this medicine has ceased, the above claims have been removed, and this medicine in unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and website for this medicine contained claims specified in 'What action should consumers take?' above. However, 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 this medicine. The sponsor did not sufficiently address all the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (paragraph 30(2)(c) of the Act).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act)
The goods do not comply with an applicable provision of the Therapeutic Goods Advertising Code, and/or any other requirement relating to advertising applicable under Part 5 1 or the regulations (paragraph 30(2)(ea) of the Act).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act)
The goods do not comply with an applicable provision of the Therapeutic Goods Advertising Code, and/or any other requirement relating to advertising applicable under Part 5 1 or the regulations (paragraph 30(2)(ea) of the Act).