Caruso's Natural Health - ProstateEZE Max

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Caruso's Natural Health Pty Ltd

I, Jane Cook, Head, Office of Product Review, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Caruso's Natural Health Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b), provided the conditions identified in paragraph (c) is met:

1.  
   1. May assist in the management of mild to moderate symptoms of medically diagnosed benign prostatic hypertrophy;
   2. For the symptomatic relief of medically diagnosed benign prostatic hypertrophy, where symptoms are mild to moderate;
   3. Pygeum africana may provide support for the symptomatic relief [of] nocturia, nocturnal frequency, difficult in starting micturition, incomplete emptying of the bladder, daytime frequency, weak stream, after-dribbling, hesitation and interruption of flow when such symptoms are associated with medically diagnosed benign prostatic hypertrophy; and
   4. Representations regarding the prevalence of benign prostatic hypertrophy, including the increase in prevalence with age
2. ProstateEZE Max (AUST L 177351)
3.  
   1. Restricted representations about use of the Medicine must be limited to medically diagnosed benign prostatic hypertrophy presenting with mild to moderate symptoms.
   2. Restricted representations in any advertisement for the Medicine (including a label) must be accompanied by a warning containing words to the following effect: 'If you have not had your symptoms diagnosed or if you experience an increase in symptoms see a health professional'.
   3. Restricted representations about the prevalence of benign prostatic hypertrophy must reflect the body of contemporary knowledge about benign prostatic hypertrophy and must be used in such a manner so as not to cause fear or distress.

Dated this 27th day of October 2014

Dr Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Office of Product Review