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SUPER C 1000 (Australian Naturalcare Products Pty Ltd)
Product Name
SUPER C 1000
Date of review outcome
Date of publication
Jun-21
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Consider whether the medicine is right for you given that claims for the relief of symptoms of hayfever, allergy, or catarrh and assisting in the relief of blocked sinuses were not substantiated by the sponsor.
If you are using this medicine to assist in wound repair after surgery, seek advice from a suitably qualified health professional.
If you are using this medicine to assist in wound repair after surgery, seek advice from a suitably qualified health professional.
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
The website for the medicine contained claims that the medicine may assist wound repair especially after surgery. Surgical wounds are a serious condition that require treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to wound repair after surgery has the potential to lead consumers with this condition to delay access to timely medical advice or treatment resulting in adverse outcomes. The reference happened to be removed from the website during the course of the review.
While advertising of this nature is unacceptable, this claim has been removed and the website warned consumers to talk to their healthcare professional if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, this claim has been removed and the website warned consumers to talk to their healthcare professional if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claims related to the relief of symptoms of hayfever, allergy, or catarrh and assisting in the relief of blocked sinuses. The limitations with the evidence included that the clinical studies did not directly assess the relief of these symptoms, and therefore, the results of these studies were not relevant to the claims for 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 claims relating to relief of symptoms of hayfever, allergy, or catarrh, and relief of blocked sinuses from the ARTG record.