TGA Complaint

GENRE: Email letter

TO:  Commonwealth Ombudsman; Various email Bcc list


DATE SENT:   Tue, Apr 30, 2013 at 10:25 AM

TITLE:  TGA Complaint

STATUS: No response as yet

UPDATES:  Please post all updates and comments in the LEAVE A REPLY section below.

ATTACHMENTS: 2 x attachments      TGAReport     TGA Ethics doc

Holmes Tony <>

Dear Commonwealth Ombudsman 

I was requested by my Council (Shoalhaven Waters) to conduct an on-line survey about the quality of the water being delivered to my home.

As I had some reservations about water fluoridation, prior to conducting the survey I did some on-line research about the dangers of fluoride. Being shocked by the evidence, concerning the adverse effects of this poison, I wrote to the Council wanting to know the type of fluoride being added to my tap water. After some protracted inquiries I was informed the fluoride is an industrial grade highly hazardous fluoride waste and is being purchased from chemical companies, other than from pharmaceutical companies. These fluoride chemical waste streams come into existence in the production and manufacture of aluminium and phosphate fertilisers. As at least 97% of the fluoridated water is for non-drinking and non-cooking purposes I wrote to the Environmental Protection Authority (EPA) and was informed: Further, the POEO Act prohibits the disposal direct to waterways of fluoride waste streams that are generated from industrial or manufacturing processes.

As I have health issues, I subsequently wrote to the Therapeutic Goods Agency, wanting to know if the type of fluoride being added to my tap water has ever been tested for safety and efficacy. Again after making protracted inquiries, I was informed fluorides are listed as Schedule 6 poisons in the Schedule for Uniform Standard of Medicines and Poisons (SUSMP) and those listed in this Schedule are for uses other than human uses sic unfit for human consumption.

During the course of my inquiries, TGA advised me they would review water fluoridation and subsequently decided there is no need for controls for the ingestion of this poison. This advice is inconsistent with the guidelines set out in the TGA Human Research Ethics Committees and the Therapeutic Goods Legislation (PDF version attached) whereby it is stated in the Introduction:


The Therapeutic Goods Act, 1989 establishes a uniform, national system of regulatory controls to ensure the quality, safety, efficacy and timely availability of therapeutic goods for human use. Responsibility for the regulatory controls lies with the Therapeutic Goods Administration (TGA) as the national regulatory authority for therapeutic goods.

The TGA controls the supply of therapeutic goods through three main processes:

· the pre-market evaluation and approval of products intended for supply in Australia;

· the licensing of manufacturers; and

· post market surveillance.

Under the Act, therapeutic goods for human use that are imported, manufactured in Australia, supplied by a corporation, supplied interstate or to the Commonwealth, or exported must be included in the Australian Register of Therapeutic Goods (ARTG) unless specifically exempted.

Items which are exempt from entry on the ARTG are set out in Schedule 5 (Regulation 12(1)), Schedule 5A (Regulation 12(1A)) and Regulation 12A. These exemptions allow individuals to gain limited access to unapproved therapeutic goods through the following mechanisms:

· the Special Access Scheme (categories A and B);

· clinical trials (CTN and CTX schemes);

· authorised prescribers; and

· importation for personal use.

The TGA has informed me fluoride has been excluded from the definition of therapeutic goods and is therefor not subject to any scrutiny by that authority. Consequently I sent the attached report to TGA for comment and then had intended to forward it on to ICAC. This is because I consider TGA has failed its Public Trust and Duty of Care obligations allowing an unapproved poison to be delivered to Australians as mass medication by Councils without any controls over dosage. While TGA did respond to my email the authority did not comment on my allegations and their response is attached to the bottom on my report.

I am now aware TGA is not subject to ICAC jurisdiction and this is a matter for your office. Fluoride compounds are unapproved therapeutic goods purportedly added to town water supplies to treat dental disease.

How then is it possible TGA does not consider water fluoridation a therapeutic good that should be thoroughly tested for safety and efficacy in accordance with the Ethics Committees guidelines and the TGA legislation?

How is it possible for fluoride, an unapproved therapeutic good, to be delivered in unlimited doses without clinical trials as stipulated in the exemptions above. Furthermore water fluoridation is not for authorised prescribers or importation for personal use: is it for mass medication

Furthermore, as fluoride is currently an unapproved therapeutic good how can the TGA allow the mass medication of this drug by Councils, forcing unlimited access without the consent of the consumer? This is clearly unethical and contravenes the aims of the TGA to providea uniform, national system of regulatory controls to ensure the quality, safety, efficacy and timely availability of therapeutic goods for human use. Responsibility for the regulatory controls lies with the Therapeutic Goods Administration (TGA) as the national regulatory authority for therapeutic goods?

As the TGA is responsible for the regulatory controls of drugs why has TGA failed to test fluoride compounds that are being added to town water supplies? Clearly there needs to be some regulatory control over the dosage of this medicated water to ensure consumers do not suffer any harmful side effects from ingesting a poison (Schedule 6 of the SUSMP is the most toxic concentration for poisons). How it is then possible for the TGA to assert that no controls are needed for water fluoridation?

As I have serious health concerns with Shoalhaven Water delivering this unapproved and untested poison into my home, please use your powers to determine why the matters raised in my report have not been addressed by the TGA. Furthermore, I have serous concerns regarding the Secretary of Health deliberately excluding fluoride, a known Schedule 6 poison, from scrutiny by the TGA. There is no doubt water fluoridation is a drug and has been ruled as such by the Federal Drug Authority in America, see:

While this link confirms fluoride is a medication, it also warns about the serous side effects and concerns with overdosing. This is my main concern as discussed in my report to TGA. While promoting fluoride this link clearly contradicts the TGA claims that fluoride does not need any controls. Furthermore, this link warns levels of water fluoridation should not exceed 0.7ppm and 0.03 ppm for small children. How then is it possibly safe in Australia when the purported safe level for water fluoridation is 1.5ppm? That is more than twice the purported “safe” adult dosage and five times the “safety” level for small children, see:

I look forward to hearing from you concerning the matters I have raised in my report.

Yours faithfully

John T

Attachments x 2:

TGA Ethics doc



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