Nutricia Australia - Profutura products

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Nutricia Australia 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 Nutricia Australia 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 products identified in paragraph (b), provided the conditions identified in paragraph (c) are met:

1.  
   1. May help to relieve or reduce breast pain and discomfort associated with mastitis
   2. May reduce the recurrence of mastitis. Use at the first signs of mastitis
   3. Mastitis relief - during breastfeeding
   4. May be used in conjunction with conventional treatment- under direction of your health care professional
2. 'Profutura Pregnancy and Breast Feeding Multi + Probiotic' (AUST L 227779) and 'Profutura Mastitis Relief' (AUST L 228818)
3.  
   1. The use of the restricted representations on a label must be accompanied by a warning, prominently displayed or communicated, i.e. standing out so as to be easily read from a normal viewing distance, which advises consumers to seek medical advice if symptoms persist.
   2. The use of the representation 'mastitis relief' must only be in conjunction with representation (a)(i) above.

Signed electronically on: 11 December 2014

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