Teen Mood + Anxiety (Australian Health Vitality Pty Ltd)
Product Name
Teen Mood + Anxiety
ARTG
399939
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine is no longer permitted to be supplied and has been recalled by the sponsor
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 have been taking this medicine to treat depression, ADHD or anxiety.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to promoting brain health, being anti-inflammatory, neuroprotective or an antioxidant. It may also not work as expected for supporting healthy sleep patterns, or relieving stress and sleeplessness in teenagers.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to promoting brain health, being anti-inflammatory, neuroprotective or an antioxidant. It may also not work as expected for supporting healthy sleep patterns, or relieving stress and sleeplessness in teenagers.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
The label, website, and other advertising for this medicine contained claims regarding the conditions specified in 'What actions 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 professional when required, which may result in adverse outcomes.
The website did not display the mandatory warning statement 'Always read the label and follow the directions for use'.
The website contained claims that this medicine is safe, which is not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even when it is not safe or appropriate.
While advertising of this nature and the absence of a warning statement is unacceptable, advertising for this medicine has been removed and all batches of this medicine have been recalled. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The website did not display the mandatory warning statement 'Always read the label and follow the directions for use'.
The website contained claims that this medicine is safe, which is not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even when it is not safe or appropriate.
While advertising of this nature and the absence of a warning statement is unacceptable, advertising for this medicine has been removed and all batches of this medicine have been recalled. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label, website and other advertising 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 required the sponsor to correct the issues with this medicine. The sponsor recalled all batches of this medicine from the market, cancelled this medicine, and withdrew it from further supply.