Bioglan Ashwagandha (Natural Bio Pty Limited)
Product Name
Bioglan Ashwagandha
Sponsor
ARTG
289121
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that the claims about the medicine were not substantiated. These claims related to the traditional use of the medicine in the Ayurvedic tradition as a rejuvenative tonic, an anti-inflammatory, an aphrodisiac and sleep aid, to calm the mind, relieve nervous tension, irritability and mild anxiety, support the nervous system, support cognitive function, memory and mental concentration, support immune and adrenal gland health, assist with recovery from illness, pacify and relieve Kapha and Vata, help the body adapt to stress and support longevity.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the advertised claims in relation to the traditional Ayurvedic use of the medicine, detailed in ‘What action should consumers take?’ above. The evidence was not sufficient because the traditional methods of preparing the ingredients did not align with that used in the medicine. In some cases, scientific evidence was used inappropriately to support advertised claims based on a tradition of use in Ayurvedic medicine.
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.