Blackmores - Various products

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations byBlackmores Ltd

I, Jane Cook, Head, Pharmacovigilance and Special Product Access Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health, on receipt of an application from Blackmores Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraphs (a), (b) and (c) below for use in advertisements directed to consumers, for the products identified in paragraph (d), provided the condition identified in paragraph (e) is met:

1. Representations that refer to "arthritis", "osteoarthritis" and "rheumatoid arthritis" to the effect of providing accurate, balanced and contemporary information, the purpose of which is to inform consumers that there are different types of arthritis and to describe their key features.
2. Representations that refer to "osteoarthritis" to the effect that the products identified in paragraph (d):
   • may provide symptomatic relief of osteoarthritis;
   • may relieve joint pain caused by osteoarthritis;
   • may increase joint mobility and reduce joint stiffness associated with osteoarthritis; and
   • may protect joint cartilage in osteoarthritis.
3. Representations that refer to "arthritis" in the context:
   • "arthritis pain relief" and/or "effective for arthritis pain" only where "arthritis" is qualified by "osteoarthritis".
4. Blackmores Glucosamine Sulphate 1500 one-a-day (ARTG No. 189845)
   Blackmores Joint Formula with Glucosamine and Chondroitin (ARTG No. 163884)
   Blackmores Joint Formula Advanced (ARTG No. 164270)
   Blackmores Joint Formula Advanced Glucosamine & Chondroitin with MSM Booster (ARTG No. 170426)
   Blackmores Glucosamine + High Strength Fish Oil (ARTG No. 196009)
   Blackmores Glucosamine + Fish Oil (ARTG No. 178720)
   Blackmores Glucosamine Sulfate Complex 1000 (ARTG No. 231341, 180950)
   Blackmores Vegetarian Glucosamine Sulfate Complex 1000 (ARTG No. 182257)
5. Information about the different types of arthritis must merely distinguish the types of arthritis and their key features. This must be both the purpose of the information and its likely consequence. That is, any information about the different types of arthritis must in no way state or imply that the medicines being advertised are being promoted for any condition other than osteoarthritis.

Dated this 9 day of September 2015

Jane Cook
Delegate of the Secretary to the Department of Health; and
Head
Pharmacovigilance and Special Product Access Branch