MALE POWER (Tong Ji Herbal Australia Pty Ltd)
Product Name
MALE POWER
Sponsor
ARTG
127366
Date of review outcome
Date of publication
Dec-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
No, continued use is not recommended as its safety is not considered acceptable for a listed medicine
What action should consumers take?
Stop taking this medicine immediately and seek advice from a suitably qualified health practitioner
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Laboratory Results, Manufacturing Documentation, Sample
Issues related to safety
The medicine contains an amount of methoxsalen that exceeds the permitted limit for listed medicines.
The label and other advertising materials of the medicine contained claims about managing erectile dysfunction, premature ejaculation, low hormone level, small amounts of sperm, and low sperm activity. These are serious conditions that require 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. These claims have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment resulting in adverse outcomes.
The last batch [B] 1010 of the medicine expired in May 2019 and consumers should not be taking expired medicines.
The label and other advertising materials of the medicine contained claims about managing erectile dysfunction, premature ejaculation, low hormone level, small amounts of sperm, and low sperm activity. These are serious conditions that require 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. These claims have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment resulting in adverse outcomes.
The last batch [B] 1010 of the medicine expired in May 2019 and consumers should not be taking expired medicines.
Issues related to efficacy
The label and other advertising materials claimed that the medicine may help with erectile dysfunction and weakness, premature ejaculation, low male hormone level, small amount of sperm, weak immune system, memory function decline, insomnia, hearing reduction, hair loss, early growth of grey hair, dull skin, formation of wrinkles, low back pain, knee pain, dilation of blood vessels and invigoration of the blood to boost erectile function, overcome sexual dysfunction, improve male sexual function and libido, support inner organ function and general well-being, counteract the symptoms of aging by strengthening the physique and overcoming fatigue, reinforce lung and kidney function, and reducing frequent night-time urination. 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 cancelled the medicine and withdrew it from further supply.