Wild Red Krill Oil Complex (Jmm International Pty Ltd)
Product Name
Wild Red Krill Oil Complex
Sponsor
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine continues to be permitted for supply. Batches released after April 2020 must carry the required seafood warning statement on the medicine label.
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains crustacean shellfish. Consider whether the medicine is right for you if you have allergies or sensitivities to this substance. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner. In addition, seek advice from a suitably qualified health professional if you are taking this medicine to relieve arthritis.
Review scope
Targeted (for presence of seafood warning)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label for the medicine did not include either of the mandatory warning statements, ‘Derived from seafood’ or ‘Contains crustacean shellfish’. As such, consumers may not be alerted to these safety risks prior to taking the medicine, which may lead to adverse outcomes. While this is unacceptable, the name of the medicine includes the animal source of the ingredient, and the label features images of crustaceans, making it unlikely someone with a known crustacean allergy will use this medicine.
The website for the medicine did not include the required statements of 'If symptoms persist, talk to your health professional' or 'if symptoms worsen or change unexpectedly, talk to your health professional' and 'Follow the directions for use' or 'Follow the instructions for use'.
The label and website of the medicine imply it can relieve arthritis, which is a serious condition that requires diagnosis, 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 arthritis has the potential to lead consumers with this condition to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label 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.
The website for the medicine did not include the required statements of 'If symptoms persist, talk to your health professional' or 'if symptoms worsen or change unexpectedly, talk to your health professional' and 'Follow the directions for use' or 'Follow the instructions for use'.
The label and website of the medicine imply it can relieve arthritis, which is a serious condition that requires diagnosis, 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 arthritis has the potential to lead consumers with this condition to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label 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 website claimed that the medicine may help to maintain healthy cholesterol and triglyceride levels, as well as relieving joint pain and inflammation associated with different forms of arthritis. 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 updated the label of the medicine to include the required warning statements and removed references to arthritis. The sponsor updated the website to remove references to arthritis and any claims not included in the ARTG listing.