TGA fails to act on the promotion and sale of unapproved therapeutic goods

Products not regulated by the TGA represent, “a serious risk” says the regulator in, “Buying medicines and medical devices“.

“These items have a high chance of being counterfeit, containing the wrong amount of active ingredient, being contaminated with toxic chemicals, containing undisclosed or dangerous ingredients and/or being past their use by date”.

The TGA has recently issued infringement notices for the alleged importation of unapproved therapeutic goods used in cosmetic procedures.

But they have taken no action on the following six complaints about the advertising of therapeutic goods that have not been listed, registered or included on the Australian Register of Therapeutic Goods (ARTG). The companies involved have broken the law.

The critique by Commissioner Haynes on the financial services industry and their regulators is equally applicable to the complementary medicine industry and the TGA.      A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.

  1.  2016/10/027 Nature’s Goodness Bioactivated Resveratrol

In September 2016 the Complaints Resolution Panel (CRP) received a complaint about advertisements for Nature’s Goodness Bioactivated Resveratrol which appeared on the sponsor’s and retailer websites.

The Panel referred this complaint to the TGA in October 2016 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods) and/or possible food interface issues.

No action appears to have been taken by the TGA on this referral. Over 2-years after the original complaint, the promotion of this product continues at https://naturesgoodness.com.au/products/bioactivated-resveratrol-red-grape-antioxidants-capsules-500mg-60s.

Why has Nature’s Goodness Pty Ltd (Prosolution Group Pty Ltd, ABN 096725370) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?

  1.  2016/10/028 Jay Cutler Elite Series Big T

In September 2016 the Complaints Resolution Panel (CRP) received the complaint about an advertisement for Jay Cutler Elite Series Big T

The Panel referred this complaint to the TGA on October 2016 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods).

No action appears to have been taken by the TGA on this referral. Over 2-years after the original complaint the promotion of this product continues, at various Australian outlets including: https://www.sportitude.com.au/shop/product/jay-cutler-elite-series-big-t-androgenic-testosterone-booster-285g and http://csaactive.com.au/starter/products/jay-cutler-elite-series-big-t/.

Why have these web sites not received an infringement notice for the promotion and sale of unapproved therapeutic goods?

  1.  2016/10/026 ProSolution Plus

In September 2016 the Complaints Resolution Panel (CRP) received a complaint about advertisements for ProSolution Plus which appeared on the sponsor’s web site.

The Panel referred this complaint to the TGA on October 2016 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods).

No action appears to have been taken by the TGA on this referral. Over 2-years after the original complaint, the promotion of this product continues at: https://www.prosolutionpills.com.au/

Why has this company (Prosolution Group, ABN 096725370) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?

  1.  2017/12/002 Ayurda Livgood

The Complaints Resolution Panel (CRP) received the complaint about an advertisement for Ayurda Livgood which appeared on the sponsor’s web site on 20 November 2017

The Panel referred this complaint to the TGA in December 2017 because of the possible breach of section 42DL(1)(g) of the Act (the product may not be entered in the Australian Register of Therapeutic Goods) and/or possible food interface issues.

No action appears to have been taken by the TGA on this referral, and 12 months after the original complaint the promotion of this product continues: https://suryaayurveda.com.au/index.php?route=product/product&product_id=297&search=Livgood

Why has this company (Surya Ayurveda Pty Ltd, ABN 32 156 368 811) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?

  1.  2018/03/015 AusLabs SAMS, STACKS, PCT &   SUPPORT, PEPTIDES

The Complaints Resolution Panel (CRP) received the complaint about an advertisement for AusLabs SAMS, STACKS, PCT & SUPPORT, PEPTIDES which appeared on the sponsor’s web site and Facebook on 29 March 2018.

The Panel referred this complaint to the TGA because of the possible breaches of section 42DL(1)(g) of the Act (the products may not be entered in the Australian Register of Therapeutic Goods).

No action appears to have been taken by the TGA on this referral (and many others), and 12 months after the original complaint the promotion of this product continues: https://www.auslabs.co/

Why has this company (AusLabs Co, ABN: (35 603 534 541) not received an infringement notice for the promotion and sale of unapproved therapeutic goods?

  1.  AC-JJPZUJ0G/201 (Doctor’s Best Extra Strength Ginkgo)

In correspondence dated 29 November 2018 the TGA categorised the promotion of companies named in this complaint as follows:

Aussie Well – CM:0017193 – Categorisation Low
Lean Machine – CM:0017194 – Categorisation Medium
Mega Vitamins – CM:0017195 – Categorisation Low
Rewardia – CM:0017196 – Categorisation Low
Trusted Health Supplies – CM:0017197 Categorisation Medium

I do not understand how the TGA arrived at these different priorities when the advertising of all the companies cited contained the same serious breaches of the Therapeutic Goods Act and Code.

All these company web sites promote and sell a product, “Doctor’s Best Extra Strength Ginkgo” (and many others) that appears to have been imported direct from the U.S.A. without being listed on the ARTG.

Thus, all web sites breach the Therapeutic Goods Act 1989 42DL(g) and 22(5) and the Therapeutic Goods Advertising Code 2015, s.4(1)(a).

For this reason, I suggested this complaint should be categorised as “critical”. Yet the TGA prioritised individual components as “low” or “medium” priority.

Why have infringement notices for the alleged importation of unapproved therapeutic goods not been issued to the companies highlighted in my complaint, e.g. LeanMachine (ABN 55 293 601 285), Trusted Health Supplies (ABN 92 046 652 410), Rewardia (ABN 24 64419354) and AussieWell (ABN 15 036 836769)?

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About Dr Ken Harvey

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

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