Balance Hormone Support (Whole Health Studio)
Product Name
Balance Hormone Support
Sponsor
ARTG
386661
Date of review outcome
Date of publication
Sep-2023
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?
This medicine may affect hormones and medicines such as oral contraceptives. Consult your health professional before use.
Seek advice from a suitably qualified health professional if you are or have been using this medicine to treat or relieve anxiety, endometriosis and polycystic ovary syndrome.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to reducing the emotional symptoms of PMS such as irritability, moodiness, physical symptoms such as changing appetite levels, premenstrual acne, tender breasts and low mood, being effective for painful irregular and heavy periods, enhancing energy levels, increasing the body's resistance to stress, calming and nourishing nervous system, promoting mental clarity, protecting liver, enhancing detoxification of hormones and toxins, enhancing digestion, reducing bloating, stimulating circulation, balancing sugar levels within the body, reducing sugar craving, regulating appetite, relaxing smooth muscles of the uterus, reducing prostaglandins, reducing inflammation within the digestive tract, enhancing nutrient absorption, regulating hormones, supporting the immune system, reducing inflammation, building blood, supporting liver detoxification and ovulation and being an antioxidant.
Seek advice from a suitably qualified health professional if you are or have been using this medicine to treat or relieve anxiety, endometriosis and polycystic ovary syndrome.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to reducing the emotional symptoms of PMS such as irritability, moodiness, physical symptoms such as changing appetite levels, premenstrual acne, tender breasts and low mood, being effective for painful irregular and heavy periods, enhancing energy levels, increasing the body's resistance to stress, calming and nourishing nervous system, promoting mental clarity, protecting liver, enhancing detoxification of hormones and toxins, enhancing digestion, reducing bloating, stimulating circulation, balancing sugar levels within the body, reducing sugar craving, regulating appetite, relaxing smooth muscles of the uterus, reducing prostaglandins, reducing inflammation within the digestive tract, enhancing nutrient absorption, regulating hormones, supporting the immune system, reducing inflammation, building blood, supporting liver detoxification and ovulation and being an antioxidant.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
This medicine contains the herbal ingredient Vitex agnus-castus, which may affect hormones and medicines such as oral contraceptives. However, the website for this medicine claimed that it could be taken with oral contraceptive pills. This claim has the potential to mislead consumers about the proper use of this medicine. While advertising of this nature is unacceptable, the above claim has been removed and the label advised consumers to see a health professional before use.
In addition, the website claimed that this medicine can relieve anxiety, endometriosis and polycystic ovary syndrome. 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 suitability qualified health professional when required, which may result in adverse outcomes. However, the website also advised consumers to see a healthcare practitioner if symptoms persist.
As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
In addition, the website claimed that this medicine can relieve anxiety, endometriosis and polycystic ovary syndrome. 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 suitability qualified health professional when required, which may result in adverse outcomes. However, the website also advised consumers to see a healthcare practitioner if symptoms persist.
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 required the sponsor to correct the issues with this medicine. The sponsor updated the website to remove the unsupported indications and claims. The sponsor cancelled this medicine and withdrew it from further supply.