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Caruso's Kids Calm and Behaviour (Caruso's Natural Health Pty Ltd)
Product Name
Caruso's Kids Calm and Behaviour
Sponsor
ARTG
234012
Date of review outcome
Date of publication
Dec-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that the claims about decreasing free radical damage to body cells, reducing the symptoms of stress and mild anxiety, stimulating a healthy immune system, improving skin repair, antispasmodic effects, relieving restlessness, promoting nerve transmission, calming nerves, promoting relaxation, wound healing and promoting connective tissue health in kids were unable to be substantiated.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claims detailed in ‘What action should consumers take?’ above.The evidence provided was insufficient as the subjects tested did not reflect the target population for the medicine. This included using populations with diagnosed disorders as well as using subjects of age groups not reflected by the usage instructions.
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.