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Nature's Own Lysine 1000mg (previously Nature's Own Double Strength Cold Sore Relief) (Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare)
Product Name
Nature's Own Lysine 1000mg (previously Nature's Own Double Strength Cold Sore Relief)
ARTG details
Date of review outcome
Date of publication
Jun-2025
Outcome
Medicine continues to be permitted for supply
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 claims for helping reduce the occurrence and symptoms of facial cold sores were 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 claims outlined in 'What action should consumers take?' above. However, the sponsor did not hold sufficient evidence to support these claims. The limitations with the evidence included the dosage 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 ARTG record, label and website to remove the unsupported claims.
Additional information
This medicine was targeted to check its compliance in relation to cold sore management claims