Blackmores - Triple Action Bone Formula / Cal-D / Total Calcium Magnesium + D3

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Blackmores Limited

I, Jane Cook, Branch Head, Post-market Surveillance Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Blackmores Limited, 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 satisfied:

1. Representations to the effect:
   1. 'May assist in the prevention of osteoporosis when dietary calcium intake is inadequate'
   2. 'A diet deficient in calcium can lead to osteoporosis in later life'
   3. 'Women’s calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention of osteoporosis'
   4. of providing accurate and balanced, evidence-based information to consumers about osteoporosis and its risk factors (including but not limited to prevalence, symptoms and guideline recommendations)
2. Triple Action Bone Formula (AUSTL 230038), Cal-D (AUSTL 179321) and Total Calcium Magnesium + D3 (AUSTL 101770).
3.  
   1. representations made pursuant to paragraph (a)(iii) may only made in conjunction with words to the effect "when dietary calcium intake is inadequate"
   2. representations made pursuant to paragraph (a)(iv) must accompany claims to the effect of assisting in the prevention of osteoporosis where dietary calcium is inadequate
   3. where the phrase "where dietary calcium intake is inadequate" or words to that effect ("the phrase"), accompanies or is part of any of the representations, the phrase must be given equal prominence to any claim about the preventative effects of the medicines with respect to osteoporosis, and for any advertisement including text, the phrase must be included in the body of the advertisement (i.e. not separated from the body of the advertisement, such as through the use of an asterisk or a 'footnote');
   4. the representations must only be made about medicines for which the recommended daily dose of calcium amounts to a minimum of 458mg of elemental calcium.

Dated this 19 day of February 2015

Jane Cook
Delegate of the Secretary to the Department of Health; and Branch Head
Post-market Surveillance Branch