ETHICAL NUTRIENTS LYSINE COLD SORE DEFENCE (Metagenics (Aust) Pty Ltd)
Product Name
ETHICAL NUTRIENTS LYSINE COLD SORE DEFENCE
Sponsor
ARTG details
Date of review outcome
Date of publication
Jun-2025
Outcome
Medicine continues to be permitted for supply. However, from 7 May 2025, no additional batches of this medicine must be released into the market.
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?
Consider whether this medicine is right for you given the claim for helping reduce the occurrence of facial cold sores was not substantiated by the sponsor
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The name, label and website for this medicine contained the claim outlined in 'What action should consumers take?' above. However, the sponsor did not hold sufficient evidence to support this claim. The limitations with the evidence included the dosage, study population and the results of some studies not being relevant to this medicine. The evidence provided was not of sufficient quality.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor updated the website to remove the unsupported claim and responded with more information about this medicine. The TGA imposed a condition on this medicine requiring that no further batches are released into the market with the unsupported claim.
Additional information
This medicine was targeted to check its compliance in relation to cold sore management claims