Original Lung Detox (Nature's Care Manufacture Pty Limited)
Product Name
Original Lung Detox
ARTG
243133
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-21
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been taking this medicine for supporting long term lung health affected by air pollution and smoking. Consider whether the medicine is right for you given that claims related to lung detox, inflammation relief, antioxidant action, reduction of free radical damage to body cells and lung health support were not substantiated by the sponsor.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The label and website for the medicine referred to long term lung health effects from air pollution and smoking, which implies use of the medicine for the prevention of serious forms of respiratory disorders or diseases, such as pneumonia, chronic obstructive airways disease (COAD), chronic obstructive pulmonary disease (COPD) and asthma. Claims implying prevention of serious forms of lung disease are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Use of the medicine, without involvement of a suitably qualified health professional, may lead to inappropriate use of this medicine by consumers and delay access to timely medical advice, which may result in adverse outcomes.However, the medicine is unlikely to pose an immediate risk to consumer health and safety, as the medicine's label warns consumers to consult a healthcare professional if coughing and other symptoms persist. Additionally, the supply of the medicine ceased in July 2021.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims related to lung detox, inflammation relief, antioxidant action, reduction of free radical damage to body cells and lung health support. The limitations with the evidence included that the populations described in the evidence were not relevant to the target population of the medicine. Additionally, the active ingredients, dose, and ingredient preparation described in the evidence were not consistent with those for the medicine. The remaining evidence included review articles, animal studies and in-vitro laboratory studies. These types of evidence are insufficient in the absence of robust scientific studies, such as clinical trials or systematic reviews, to support these claims. This is because they generally do not include sufficient detail regarding population demographics, sample size, ingredient preparation, dose and statistical analysis to allow for comparison with the medicine.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor did not provide sufficient information to address all the issues. The TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
The presentation of the listed goods is unacceptable (paragraph 30(2)(aa) of the Act).The certification under paragraph 26A(2)(ja) of the Act is incorrect (paragraph 30(2)(ba) of the Act).