What’s the problem, TGA?

Earlier this week I submitted a complaint about the EKEN PowerBand, a product that is reported to give its users increased Endurance, Balance, Strength, and Flexibility.

To my surprise, I got a reply from the TGACRP that essentially meant that they had no control over them – because the product was not on the Australian Register of Therapeutic Goods.

Oddly enough, they were able to take action against PowerBalance late last year.
So, I responded with some clarification of what was in my complaint (as it appeared the referenced legislation was not investigated sufficiently).

Thank you for your response.

I refer to your E-Mail response to my complaint about the EKEN PowerBand, and the finding that because the product is not on the ARTG it does not fall under the jurisdiction of the CRP.

I refer back to the legislation specified within the complaint, Section 42DL(1)(g) of the Act that prohibits the publications of advertisements for therapeutic goods that are not included in the register.

Therapeutic Goods Act 1989 – Sect 42DL
(1) A person must not publish or broadcast an advertisement about therapeutic goods:
(g) that are not entered in the Register; or

Therefore, according to the Therapeutic Goods Act, does indeed fall within the jurisdiction of the TGACRP.

If you feel I am incorrect in my interpretation of the 42DL(1)(g), please advise on what grounds the TGACRP acknowledged the legitimacy of the complaint about PowerBalance (a similar product in design, claimed mechanism, and claimed benefit) for my reference.

For clear precedence of this legislation in practice, I refer to the recent findings of the TGACRP:
http://www.tgacrp.com.au/index.cfm?pageID=13&special=complaint_single&complaintID=1650

32. Section 42DL(1)(g) of the Act prohibits the publication of advertisements for therapeutic goods that are not included in the Register. The advertiser acknowledged that the wrist band product is not included in the Register and the Panel was of the view that the product was promoted for therapeutic use. The advertisements therefore breached section 42DL(1)(g) of the Act and the Panel found this aspect of the complaint justified.

Please advise me on the outcome of any further inquiry you may make.

Sincerely,

Bayani Mills

So, hopefully this time we’ll make some headway on having this product removed.

I eagerly await.

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