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NUTRA-LIFE ESTER-C 1000MG + BIOFLAVONOIDS (Vitaco Health Australia Pty Ltd)
Product Name
NUTRA-LIFE ESTER-C 1000MG + BIOFLAVONOIDS
Sponsor
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine continues to be permitted for supply. Batches released from 16 March 2020 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a health professional if symptoms persist, worsen or change unexpectedly.
Review scope
Random
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website of the medicine was missing a mandatory warning statement to ‘seek advice from a health professional if symptoms persist, worsen or change unexpectedly.’ This warning is required for claims relating to the treatment of the common cold or related symptoms. As such, the absence of the warning could imply to a consumer that a persistent common cold may be adequately managed by using the advertised medicine. This may result in a delay in seeking medical attention for proper treatment or management of the condition when appropriate.
Issues related to efficacy
The label claimed that the vitamin C ingredient (Ester-C®) contained in the medicine may be retained in the body for longer than other forms of vitamin C. However, the label of the medicine did not clearly convey that this claim is only in relation to non-smokers in the general population. The presentation of this claim on the label may have led to misrepresentations about the efficacy of the medicine.
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor updated the labels, website and ARTG listing of the medicine to correct these issues.