Outcome of TGA Complaint AC-BULV1O9Q/2018, Gumby Gumby capsules: Compliance achieved? Updated 16/01/2018

https://www.facebook.com/gumbygumbygumby/ (09/01/2019)

This is the first complaint outcome reported where the TGA said compliance had been achieved after “formal action”. The complaint was received on 03/08/2018 and closed on 17/09/2018.

If you didn’t know the TGA’s complaint reference (AC-BULV1O9Q/2018) you have to trawl through 20 web pages of “complaint outcomes” to find it. No other information is provided in the TGA advertising hub.

However, a search of the main TGA web site for “Gumby gumby” does provide the Section 42DV Direction: By 7 September 2018, it directs the person responsible to cease making claims or representations for Gumby Gumby capsules outright, or in the form of testimonials (including the Gumby Gumby Australia Facebook site), that: “they have or may have an effect on cancer of any sort, location or grade; they have or may have an effect on arthritis, chronic fatigue syndrome, or skin diseases and they have or may have any other therapeutic use whatsoever while ever the capsules are not included in the Australia Register of Therapeutic Goods (ARTG)”.

To-date (11/01/2019) Gumpby Gumby is not included on the ARTG and the Gumby Gumby Australia Facebook shopping and retail site still sells the product and contains testimonials below:

https://www.facebook.com/gumbygumbygumby/ (captured 11/01/2019)

The CanSurvive (Cancer) web site also sell this product claiming, Gumby Gumby has been used in a broad range of conditions where digestive support, detoxification and immune support may be required.

https://cansurvive.org.au/product/gumby-gumby-capsules-packet-of-100-copy/ (09/01/2019)

Compliance achieved by the TGA? I don’t think so!

Update 16/01/2019:

The Facebook web page above was sent to the TGA Advertising Compliance Section on 09/01/2018 with a query as to whether compliance had been achieved.

In a response received on 11/01/2019 this query was assigned a new complaint reference AL-9M1WJCMS/2019 and it was stated it would proceed to an investigation categorised as “high” priority.

Subsequently, the TGA pointed out that that the Facebook page illustrated above was not the subject of complaint AC-BULV1O9Q/2018 for which a Directions Notice had been issued. They initiated a new case reference (AL-9M1WJCMS/2019) because this was a different advertiser .

In response, I pointed out that the Directions notice merely referred to the “Gumby Gumby Australia Facebook” and an Internet search for these words produced the page illustrated above. There would have been no confusion if the TGA had not redacted the URLs and screen shots of the relevant Face Book page on their Directions notice. Four questions arose which I have sent to the TGA:

  1. The old CRP provided both URLs and advertisement copy in their determinations; is there a legislative or other reason why the TGA does not?
  2. The TGA Advertising Complaint Outcome record for complaint AC-BULV1O9Q/2018 provides no link to the Directions notice, nor any information on any identified offences or breaches despite the fact that this case has been closed. Equally, the TGA Directions web page provided no link to the Advertising Complaint Outcome record. Why are these links not provided?
  3. Why did TGA Advertising Compliance Section miss the additional Face Book site and other sites making similar claims? I would have thought that for a critical complaint breaching s.42DM, 42DMA and other provisions of the Therapeutic Goods Act 1989, the Advertising Compliance Section would have performed an Internet search for similar prohibited claims about the same product on other web sites. Clearly, this has not been done for this case (and others I am aware of). Is there a limitation of the legislation under which you operate that prohibits the TGA from acting proactively in these cases?
  4. Why was complaint AC-BULV1O9Q/2018 accorded “critical” priority when complaint AL-9M1WJCMS/2019 (which also promotes Gumby gumby for cancer) was only accorded “high” priority?

Ken McLeod first posted concerns about the alleged cancer-curing properties of Gumby Gumby in the Skeptics in Australia Facebook Group on 15 February 2016.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Advertising, Complementary medicine, Natural Therapies, Pharmaceutical Promotion and tagged , , , , . Bookmark the permalink.

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