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Better Lungs (Essam Refai Pty Ltd)

Product Name
Better Lungs
ARTG
355996
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a medical practitioner if you are or have been using this medicine for lung and breathing problems including Chronic Obstructive Pulmonary Disease (COPD), asthma, bronchitis, whooping cough, tuberculosis, and swollen breathing passages.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to antioxidant support, soothing sore throat, aiding athletic performance, free radical- scavenging, supporting multiple body systems including lungs, heart, skin and joints, avoiding seasonal issues, promoting calcium absorption, maintaining healthy bones and teeth, and detoxification of the body (including lungs).
Be aware that this medicine is not a substitute for quitting smoking/vaping.
Review scope
Targeted
Information reviewed
ARTG Record, Website
Issues related to safety
The website for this medicine contained claims specified in 'What action should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health practitioner when required, which may result in adverse outcomes.
The website for this medicine may also promote its use as a substitute for quitting smoking/vaping. This is inconsistent with the public health campaigns about reducing tobacco-related harm by quitting smoking/vaping.
While advertising of this nature is unacceptable, the website advised consumers to talk to their health professional if symptoms persist. Furthermore, the website has been removed. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this medicine contained claims specified in 'What action should consumers take?' above. 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 issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct the issues. The sponsor removed the webpage to correct the issues. The TGA also cancelled this medicine and withdrew permission for further supply due to non-payment of annual charges.
Grounds for cancellation
Cancellation for failure to pay annual charge (paragraph 30(1)(h) of the Act)

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