Natural Life Squalene 1000 mg (Lifetime Health Products Pty Ltd)
Product Name
Natural Life Squalene 1000 mg
Sponsor
ARTG
94402
Date of review outcome
Date of publication
Dec-20
Outcome
Medicine continues to be permitted for supply. Batches released from 15 January 2021 must carry a corrected label with claims related to maintaining immune system function, general wellbeing and healthy skin removed.
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 suitably qualified health professional if you are or have been taking this medicine to relieve arthritic pain and joint inflammation. Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to maintaining immune system function, general wellbeing and healthy skin.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website of the medicine states it can relieve joint inflammation and arthritic pain. Arthritis can be a serious condition that requires diagnosis, treatment or supervision by a suitably qualified health professional. Reference to arthritis without specifying mild forms of the condition is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to arthritic pain has the potential to lead consumers with arthritis to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the website also warns consumers to see a healthcare practitioner if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and/or website claimed that the medicine may help to maintain immune system function, general wellbeing and healthy skin. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor removed the claims related to maintaining immune system function, general wellbeing, healthy skin, relief of arthritic pain and joint inflammation from the medicine label and/or website.