BergaMet Sport (DOJS Holdings Pty Ltd)
Product Name
BergaMet Sport
Sponsor
ARTG
280002
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Do not exceed a maximum dose of 1 tablet per day.
Consider whether this medicine is right for you given that the claim for maintaining or supporting muscle performance, endurance or stamina was not substantiated by the sponsor.
Consider whether this medicine is right for you given that the claim for maintaining or supporting muscle performance, endurance or stamina was not substantiated by the sponsor.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels
Issues related to safety
This medicine contains an amount of the herbal ingredient Lepidium meyenii (commonly known as Maca or Peruvian ginseng) that exceeds the permitted limit for listed medicines if taken at the labelled maximum daily dose of 2 tablets. Ingredient limits for listed medicines are in place to ensure their safety.
While exceeding this limit is unacceptable, current data indicates that the amount of Lepidium meyenii in this medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, supply of this medicine was ceased in July 2022.
While exceeding this limit is unacceptable, current data indicates that the amount of Lepidium meyenii in this medicine is unlikely to pose an immediate risk to consumer health and safety. Additionally, supply of this medicine was ceased in July 2022.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claim outlined in 'What action should consumers take?' above. The limitations with the evidence included the study population, active ingredient, dosage and the results of some studies not being relevant to this medicine. Some evidence provided was not of sufficient quality.
Actions taken during the review
The sponsor cancelled this medicine after receiving the TGA's request for information and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.
Additional information
This medicine was targeted to check its compliance in relation to claims about exercise, muscle, or physical performance