Caruso's Kids Eye Care (Caruso's Natural Health Pty Ltd)
Product Name
Caruso's Kids Eye Care
Sponsor
ARTG
278173
Date of review outcome
Date of publication
Mar-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 based on particular claims for the medicine being unable to be substantiated by the sponsor. These claims are related to optimal motor skill and visual acuity development, effects on cellular membranes and neurotransmission, learning and behaviour, blue light protection, protection from eye damage, assistance with eye strain and fatigue, improvements in glare recovery and contrast sensitivity, protection of the brain, macula, retina, lens and associated tissue, the improvement of macula pigment density, mood maintenance, antioxidant activity, reduction in cellular damage, improvements or enhancements at the cellular level, the support of macula and retina health, brain and nervous system development and maintenance, effects on rod vision and eye development and function.
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the advertised claims detailed in 'What action should consumers take?' above. The evidence held by the sponsor were either not relevant to or did not support the claims. The dosages and dosage forms of ingredients in the evidence provided were not applicable to the medicine. The populations described in the evidence (adults) were not applicable to the target population of the medicine (children).
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor provided additional evidence and updated the label of the medicine, website and ARTG listing to remove some of the unsupported claims. TGA cancelled the medicine and moved to withdraw permission for further supply. The sponsor cancelled the medicine and withdrew it from further supply prior to TGA’s cancellation taking effect.