MOOD (CP Laboratories Pty Ltd)
Product Name
MOOD
Sponsor
ARTG
396374
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a medical practitioner if you have been using this medicine to treat major depressive disorder, complex mental illness, depression, and anxiety.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the above conditions as well as for reducing the occurrence of symptoms of mild anxiety, enhancing mood, supporting mental wellbeing, decreasing muscle tiredness, improving exercise performance, boosting healthy skin, balancing brain-gut interactions, supporting healthy inner microbial environment, supporting or boosting immunity/immune system, and assisting in the wellbeing of healthy cholesterol levels.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to the above conditions as well as for reducing the occurrence of symptoms of mild anxiety, enhancing mood, supporting mental wellbeing, decreasing muscle tiredness, improving exercise performance, boosting healthy skin, balancing brain-gut interactions, supporting healthy inner microbial environment, supporting or boosting immunity/immune system, and assisting in the wellbeing of healthy cholesterol levels.
Review scope
Targeted
Information reviewed
ARTG Record, 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 suitably qualified health professional when required, which may result in adverse outcomes. However, given this medicine was never marketed, it does not pose an immediate risk to consumer health and safety.
Issues related to efficacy
The 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 issued a warning letter to the sponsor outlining issues with this medicine. In addition, the TGA required the sponsor to correct the issues with this medicine. The sponsor did not sufficiently address the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
The goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 or the regulations (paragraph 30(2)(ea) of the Act).
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).
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).