K-OS Pre-Workout Blue Gummies (Body Science International Pty Ltd)
Product Name
K-OS Pre-Workout Blue Gummies
ARTG
356382
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Do not exceed a maximum dose of 10 g per day. Seek advice from a healthcare practitioner if you have been taking 30 g per day.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record
Issues related to safety
The product contains an amount of pure caffeine that exceeds the permitted limit for listed medicines if taken at the maximum daily dose of 30 g. Ingredient limits for listed medicines are in place to ensure their safety. While exceeding this limit is unacceptable, current data indicates that the amount in the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine