Anti-Epidemic Formula 1 (Tianda Pharmaceuticals Australia Pty Ltd)
Product Name
Anti-Epidemic Formula 1
Date of review outcome
Date of publication
Jun-21
Outcome
Medicine continues to be permitted for supply. Batches released after March 2021 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Be aware that this medicine is not approved by the TGA to treat, prevent or relieve symptoms of COVID-19. Seek advice from a suitably qualified health professional if you have been or are intending on using this medicine for this purpose or other infection, or to strengthen your ability to resist infection. Be aware that the medicine may not work as expected in relation to these uses.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other)
Issues related to safety
The label and advertising for the medicine contained claims about serious forms of infectious diseases including COVID-19. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The references to COVID-19 and other infectious diseases have the potential to lead consumers with these conditions to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, current data indicate that use of the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and advertising for the medicine implied or explicitly claimed uses for preventing, treating and relieving symptoms of COVID-19 and other infections, and strengthening a consumers ability to resist infection. 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, ARTG Record and advertising for the medicine to remove the claims related to serious forms of infectious diseases and changed the name of the medicine to 'Formula 1 Granules'. The sponsor withdrew stock from distributors for the purposes of re-packaging with a corrected label.