Therapeutic Goods Act 1989
Approval under section 42DF for use of restricted representations by Blackmores Ltd
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 Blackmores 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 product identified in paragraph (b):
- Relief of pain, swelling, stiffness and restricted joint mobility associated with osteoarthritis of the knee in conjunction with the statement: 'If symptoms persist for 3 weeks, see your healthcare professional';
- Representations that refer to relief of the symptoms (relief of pain, swelling, stiffness and restricted joint mobility) of osteoarthritis as shown in a clinic trial[1] of osteoarthritis of the knee in conjunction with the statement: 'If symptoms persist for 3 weeks, see your healthcare professional';
- Representations that refer to Flexagil being an effective alternative treatment to topical diclofenac for ankle sprains and strains[2] in conjunction with the statement: 'If symptoms persist for 7 days, see your healthcare professional';
- Relief of mild to moderate pain and restricted movement associated with upper and lower back pain in conjunction with the statement: 'If symptoms persist for 7 days, see your healthcare professional';
- Relief of mild pain, swelling, tenderness and impaired movement in acute sporting injuries such as ankle strains and sprains and minor tendon and ligament or muscle injuries in conjunction with the statement: 'If symptoms persist for 7 days, see your healthcare professional'; and
- Relief of the pain of mild soft tissue injury e.g. tennis elbow in conjunction with the statement: 'If symptoms persist for 7 days, see your healthcare professional'.
- Flexagil Pain Relief cream tube (AUST R 178341)
Dated this 13th day of September 2016
Signed electronically
Leanne McCauley
Delegate of the Secretary to the Department of Health; and
Director, Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch
Footnotes
- Noting that section 4(4) of the Therapeutic Advertising Code 2015 requires that: "...Publication of research results must identify the researcher and financial sponsor of the research."
- While many ankle sprains and strains are likely to resolve without the need to seek health professional advice, consumers may infer this claim to mean that the Medicine is effective for the same indications as topical diclofenac medicines, which include approved indications that refer to 'osteoarthritis' (a restricted representation).