The Tomato Pill Company - Ateronon XY Pro

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by The Tomato Pill Company

I, Simon Waters, Delegate of the Secretary to the Department of Health, on receipt of an application from The Tomato Pill Company, 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) are met:

1. Representations to the effect that the product identified in paragraph (b) is:
   1. Saw Palmetto is traditionally used in herbal medicine to help relieve the urologic symptoms (e.g. weak urine flow, incomplete voiding, frequent daytime and night time urination) associated with mild to moderate benign prostatic hyperplasia,
   2. Saw Palmetto used traditionally in western medicine, may help to reduce or lower urinary tract symptoms such as frequency, nocturnal urination, irritation, hesitancy, dribbling, incomplete emptying and decreased urinary flow associated with medically diagnosed benign prostatic hyperplasia in men,
   3. Saw Palmetto used traditionally for the symptomatic relief of medically diagnosed benign prostatic hyperplasia,
   4. Saw Palmetto traditionally used to assist in the management of medically diagnosed benign prostatic hyperplasia, and
   5. Saw Palmetto traditionally used in western herbal medicine for the symptomatic relief of mild prostate complaints such as:
      Frequent urination especially at night, weak or interrupted urinary flow, or the feeling of not being able to empty the bladder completely.
2. Ateronon XY Pro (AUSTL 281423) (the Medicine)
3. This approval is subject to the conditions that:
   • Restricted representations in an advertisement for the Medicine must be limited to medically diagnosed benign prostatic hyperplasia (BPH) presenting with mild to moderate symptoms.
   • Restricted representations in an advertisement for the Medicine (including a label) must be accompanied by a warning containing words to the following effect: 'Urologic symptoms may be associated with other more serious medical conditions. If you have not had your symptoms diagnosed or if you experience an increase in symptoms see a health professional'

Dated this 22nd day of August 2017

Simon Waters
Delegate of the Secretary to the Department of Health; and
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch