Sanofi-Aventis Healthcare - Nature's Own Glucosamine Sulfate Complex 1000 and Nature's Own Joint Enhance

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Sanofi-Aventis Healthcare Pty Ltd t/a Sanofi Consumer Healthcare

I, Leanne McCauley, Director, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraphs (a) and (b) below for use in advertisements directed to consumers, for the product identified in paragraph (c), provided the condition identified in paragraph (d) 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 (c):
3. may provide symptomatic relief of osteoarthritis;
4. may relieve joint pain caused by osteoarthritis; and
5. may help increase joint mobility associated with osteoarthritis.
6. Nature's Own Glucosamine Sulfate Complex 1000 (AUSTL 101721) and Nature's Own Joint Enhance (AUSTL 200649)
7. Information about the different types of arthritis (as approved in paragraph (a)) 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 18th day of November 2016

Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director
Regulatory Practice, Education and Compliance Branch