METAGENICS META ZINC WITH VITAMIN C ORANGE (Metagenics (Aust) Pty Ltd)
Product Name
METAGENICS META ZINC WITH VITAMIN C ORANGE
Sponsor
ARTG details
Date of review outcome
Date of publication
Jun-21
Outcome
Medicine continues to be permitted for supply. Batches released from 1 September 2021 must carry a corrected label.
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that claims related to the management of mild acne, reducing the severity of common colds, maintaining/supporting healthy cognitive function in children, treatment of zinc deficiency, preventing dietary zinc deficiency in children and reducing common cold duration in children were not substantiated by the sponsor
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
The sponsor did not demonstrate that the amount of a flavour component contained in the medicine is below the maximum daily limit permitted for listed medicines. Ingredient limits for listed medicines are in place to ensure their safety. However, available information suggests that the amount contained in the medicine is unlikely to pose a risk to consumer health and safety.
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 limitations with the evidence included that the doses, dosage forms and study population were not relevant to the medicine.
Actions taken during the review
The TGA issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct the identified issues. The sponsor removed the unsupported claims from the label and website for the medicine, and modified the wording of other claims to better reflect their evidence. The sponsor also removed the claim that the medicine is absorbed with 'little side effects' from the website.