Re: Your complaint – 2013-105268


GENRE:  Email letter; Research questions to government.

TO:  Commonwealth Ombudsman Office North

AUTHOR: John T.

DATE SENT:  Tue, Jun 11, 2013 at 3:16:21 PM

TITLE:  Re: Your complaint – 2013-105268

STATUS: Awaiting response.

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

ASWLA COMMENT: Responses to this letter cannot be disclosed, if there is a disclaimer attached. However, that does not mean ASWLA cannot disclose the essential gist of the answer. Stay tuned. This one is in the cogs.

——-Original Message——-
From: John T
Date: 11/06/2013 3:16:21 PM
To: Michael Woodhead
Subject: Re: Your complaint – 2013-105268 [SEC=UNCLASSIFIED]

Dear Mr Woodhead

Commonwealth Ombudsman Office North

Further to my previous emails and your subsequent response concerning my complaint about the Therapeutic Goods Administration (TGA) excluding fluoride as a therapeutic good.

In your letter of 24 May 2013 you have stated you will not investigate this matter unless I provide you with further reasons for making my complaint.

In my original report sent to the TGA and subsequently to your office, I alleged the TGA has breached its Public Trust obligations by excluding fluoride under the provisions of Section 6 of the Excluded Goods Order. Furthermore, in the advice I received from the TGA it is stated clearly that the Secretary of the Department of Health and Ageing had declared by way of gazette fluoridated water is excluded by virtue of Section 7 of the Therapeutic Goods Act 1989. It is apparent from these statements, the TGA and/or the Secretary has failed to apply the law as stipulated by Parliament, as follows:

7 Declaration that goods are/are not therapeutic goods

(1) Where the Secretary is satisfied that particular goods or classes of goods:

(a) are or are not therapeutic goods; or

(B) when used, advertised, or presented for supply in a particular way, are or are not therapeutic goods;

The Secretary may, by order published in the Gazette, declare that the goods, or the goods when used, advertised, or presented for supply in that way, are or are not, for the purposes of this Act, therapeutic goods.

(1A) In deciding whether particular goods or classes of goods:

(a) are therapeutic goods; or

(B) when used, advertised, or presented for supply in a particular way, are therapeutic goods;

The Secretary must disregard paragraphs (e) and (f) of the definition of therapeutic goods in subsection 3(1).

(2) The Secretary may exercise his or her powers under this section of his or her own motion or following an application made in writing to the Secretary.

(3) A declaration under this section takes effect on the day on which the declaration is published in the Gazette or on such later day as is specified in the order.

(4) If a declaration under this section:

(a) is a declaration that particular goods or classes of goods are not therapeutic goods; and

(B) applies wholly or partly to goods that, apart from this section, would be medical devices;

The goods are not medical devices, or are not medical devices when used, advertised, or presented for supply in the way specified in the declaration.

3(1) therapeutic goods means goods:

(a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:

(I) for therapeutic use; or

(ii) for use as an ingredient or component in the manufacture of therapeutic goods; or

(iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (I) or (ii); or

(B) included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);

And includes biologicals, medical devices and goods declared to be therapeutic goods under an order in force under section 7, but does not include:

(c) goods declared not to be therapeutic goods under an order in force under section 7; or

(d) goods in respect of which such an order is in force, being an order that declares the goods not to be therapeutic goods when used, advertised, or presented for supply in the way specified in the order where the goods are used, advertised, or presented for supply in that way; or

(e) goods (other than goods declared to be therapeutic goods under an order in force under section 7) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991); or

(f) goods (other than goods declared to be therapeutic goods under an order in force under section 7) which, in Australia or New Zealand, have a tradition of use as foods for humans in the form in which they are presented.

When considering these provisions the Secretary and the TGA are bound by the legislation when determining the types of goods to be excluded from scrutiny as therapeutic goods. As fluoridated water is added to the water supply to treat the consumer for a prophylactic (preventative treatment against disease, in this case dental decay) it must fall within the definition for therapeutic goods. Consequently, there is no provision under Section 7 whereby the Secretary has the power to exclude fluoridated water as a therapeutic good. The only reason for adding fluoride (fluorine compounds) to the town water supply is to prevent and delay tooth decay. And this view is consistent with legal precedent whereby the Courts have ruled that water fluoridation is a medicine. For example, the view water fluoridation is mass medication, is based on Kelberg v City of Sale, whereby in 1964 Mr Justice Gillard ruled fluoride is medication designed not to treat the water but the consumer.

This is because fluoridated water is made to a formula (i.e. 1ppm) using fluoride and its accompanying heavy metals as an ingredient to manufacture a medicine used as a prophylactic to prevent or delay tooth decay. The prescribed dosage is added to the water, not to treat the water but the consumer.

While it is clear the Secretary does not have the power to treat fluoridated water as a non-therapeutic good under the Act, the TGA now maintains it is not a therapeutic good because of the Excluded Goods Order. Originally TGA informed me (and apparently others) fluoride is covered by Item 7 of section 6 of this Order as oral hygiene products. Clearly this was a serious misinterpretation as oral hygiene products are not for ingestion, while fluoridated water is added to water for ingestion.

I now have in my possession a copy of a ministerial letter authored by the Parliamentary Secretary for Health and Ageing (The Secretary). In this letter the Secretary admits the TGA unintentionally excluded fluoride from scrutiny under the oral hygiene products provisions but intended to exclude it “as chemicals added to water for use in the purification and treatment of drinking water. Apparently this provision is Item 10 of Section 5 of the Excluded Goods Order and is subject to the condition that no claims must be made about therapeutic use.

Clearly fluoride cannot be excluded under this provision as it is added to the water to treat the consumer for a prophylactic and the State government health departments administer the fluoridation legislation encouraging Councils to fluoridate reticulated water supplies in order to purportedly treat tooth decay. Consequently, there is no way fluoride can be excluded under this provision. Fluoride is an additive as a prophylactic and under no circumstances could it ever be considered for use in the purification and treatment of drinking water. The artificial fluoride added to drinking water is

an industrial waste toxic chemical classed as a Schedule 6 Poison under the Uniform Schedule of Medicines and Poisons Standards, and not a pharmaceutical grade fluoride compound.

Artificial fluoride is a contaminant, containing highly dangerous metals (e.g. lead and arsenic) known to cause harm to humans and their environment. This view is consistent with the provisions of Section 8 of the New South Wales Code of Practice for Fluoridation of Public Water Supplies, as follows:

8 Control of fluoridating agent

8.1 Procurement of Fluoridating Agent

8.1.1 Any impurities in the fluoridating agent shall not cause health problems for consumers or result in non-compliance with the Australian Drinking Water Guidelines. Physical characteristics and variations in strength should not significantly increase risk of reliably maintaining the required fluoride concentration in the treated water.

8.1.1.1 The water utility shall develop and use a suitable chemical specification for purchasing the required fluoridating agent. The latest American Waterworks Association standard specifications for the various fluoridating agents are to be treated as a minimum requirement. Metals are the main impurities of health significance to be found in fluoride chemicals, particularly with hydrofluosilicic acid where the levels of various metals can vary significantly. The presence of moisture in powdered chemicals can lead to unreliable feeder operation. The level of insoluble matter can increase turbidity levels in the final water.

This section of the Code then goes on to state:

Water supply authorities should include the requirement for regular full chemical analysis by suppliers in supply contracts. It is also good practice to periodically obtain independent chemical analysis.

A copy of the Code is enclosed for your reference. This section allows Sodium Fluoride to be added to the water supply and my council is currently being investigated by the Energy and Water Ombudsman for adding this toxic waste without obtaining a safety certification from the supplier, stating it is safe for consumption at the level of 1ppm.

Sodium and other artificial fluorides have never been tested by the TGA.

Furthermore, no other government authority, responsible for protecting the public from harmful pollutants, have ever tested artificial fluoride for safety and efficacy.

While the TGA previously informed me fluoride is an excluded good because it is an oral hygiene product it has recanted this view when writing to the Minister, as follows:

“As reflected in our previous response, the TGA initially considered that fluorides and fluoridated reticulated drinking water are not therapeutic goods because of item 7 under section 6 of the Excluded Goods Order (being oral hygiene products). However, our records show that it was the TGA’s intention that chemicals added to water for the purposes of fluoridation should be excluded as goods under the Excluded Goods Order. The specific item that was intended to cover fluorides was an item excluding substances for use in the purification or treatment of drinking water. This currently Item 10 of Section 5 of the Excluded Goods Order and is subject to the condition that no claims must be made about therapeutic use.”

The letter to the Minister then goes on to state Fluorides whose concentrations are 15mg/kg and less are not covered by the Scheduling requirements. This matter was dealt with in my report to the TGA and I clearly demonstrated that this concentration does not apply to fluorides for ingestion, only topical use. This view is consistent with the explanation of fluoride dosage at:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e7a7e17-7538-4763-810c-7e56bd630494

This link makes it clear an ingested concentrate of 5mg/kg of fluoride or more is an acute overdose requiring medical treatment, as follows:

OVERDOSAGE

Prolonged daily ingestion of excessive fluoride will result in varying degrees of fluorosis. Accidental ingestion of large amounts of fluoride may result in acute burning in the mouth and sore tongue. Nausea, vomiting, and diarrhea may occur soon after ingestion (within 30 minutes) and are accompanied by salivation, hematemesis, and epigastric cramping abdominal pain. These symptoms may persist for 24 hours. If less than 5mg fluoride/kg body weight (i.e., less than 2.3 mg fluoride/lb body weight) have been ingested, give calcium (e.g., milk) orally to relieve gastrointestinal symptoms and observe for a few hours. If more than 5mg fluoride/kg body weight (i.e., more than 2.3 mg fluoride/lb body weight) have been ingested, induce vomiting, give orally soluble calcium (e.g., milk, 5% calcium gluconate or calcium lactate solution) and immediately seek medical assistance. For accidental ingestion of more than 15 mg fluoride/kg body weight (i.e., more than 6.9 mg fluoride/lb body weight), induce vomiting and admit immediately to a hospital facility.

This official government website provides a number of warnings about fluoride ingestion and the adverse side effects. For the TGA to advise the Minister: fluorides whose concentrations are 15mg/kg and less are not covered by the scheduling requirements is reprehensible.

The scheduling exclusion from the definition of medicines and poisons at this concentration is for topical use only. Fluorides at these concentrations are not exempted from the SUSMP and are extremely dangerous if ingested. Consequently fluorides for ingestion are necessarily covered under the scheduling for medicines and poisons and can only be classified as S6 poisons. This is the most toxic level for poisons listed in the schedules and are not suitable for human use as I was previously advised by the TGA.

Furthermore, the toxic levels of fluorides listed in the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP), is not relevant when determining whether fluoridated water is a therapeutic good for the purposes of the Excluded Goods Order.

Artificial fluoridated water is promoted by the various State and Territory Health Departments as a means of preventing and delaying tooth decay. This is the only reason for adding it to water supplies and they must fall within the definition of therapeutic goods by virtue of Section 3(1)(a)or 3(1)(I) or (ii) of the Therapeutic Goods Act 1989.

I have noted your previous comments to me about the Ombudsman respecting the role, expertise and decisions of the TGA. However, as a former Commonwealth Auditor I find these comments intriguing to say the least. Furthermore, when explaining the role of the Ombudsman you stated:

“The Ombudsman’s role is to investigate complaints about the administrative practices of government departments and agencies to ascertain whether or not the actions and decisions were consistent with the relevant legislation and administrative guidelines.”

The reason I wrote to your office was to complain about the lack of expertise demonstrated by the TGA when understanding its own legislation and statutory responsibility. The fact is the TGA is the Commonwealth agency responsible for ensuring ingredients used in medicines, including artificially fluoridated drinking water, have been tested for safety and efficacy.

All I require from the Ombudsman is the answer to the following questions:

  1. Why did the TGA advise me in writing that the Secretary had exempted water fluoride from scrutiny by way of Gazelle, when this was not the case? Clearly the Therapeutic Goods Act 1989 does not give the Secretary the power to gazette fluoride as a non-therapeutic good and this view is consistent with the TGA legislation.
  2. Why did the TGA then subsequently advise me water fluoridation was excluded under the Exempt Goods Order as an oral hygiene product when it clearly is intended for ingestion rather than topical use? Again my complaint goes to the heart of the TGA legislation and comes under the Ombudsman’s role.
  3. When I challenged the TGA concerning the exclusion of fluoride why has the TGA now informed the Minister water fluoridation chemicals are excluded under the Exempt Goods Order relating to substances for use in the purification or treatment of drinking water. This currently Item 10 of Section 5 of the Excluded Goods Order and is subject to the condition that no claims must be made about therapeutic use. Again this is a matter for the Ombudsman as it specifically concerns the TGA interpretation of its own legislation.
  4. Why does the TGA continue to maintain that fluorides at the concentration of 15mg/kg are safe for ingestion and exempted from the SUSMP when the SUSMP scheduling only exempts ingested fluorides at the level of 0.05mg/l under schedule 1of the SUSMP?

With regard to questions 1 there is no doubt the information provided to me was misleading. There is no evidence the Secretary gazetted fluoride as a non-therapeutic good under the provisions of Section 7 of the Therapeutic Goods Act 1989. Clearly this is because there is no provision enabling the Secretary to make such a decision.

With regard to question 2 again there is no doubt the information provided to me was misleading. Oral hygiene products are for topical use and are not safe to ingest. When this matter was brought to the TGA’s attention the agency has recanted and conceded water fluoridation is not excluded under Section 7 of Section 6 of the Excluded Goods Order.

With regard to question 3, it is nonsense to maintain water fluoridation is not a therapeutic good under Item 10 of Section 5 of the Excluded Goods Order. To suggest a known poison listed in the SUSMP is being added to drinking water for the purpose of purification is incomprehensible. Furthermore this provision is subject to the condition that no claims must be made about therapeutic use. To state water fluoridation is not for therapeutic use can only mean it is not safe and effective and should be banned from drinking water.

With regard to question 4, why does the TGA misinterpret the SUSMP in order to exempt fluoride from scrutiny as a poison? Fluoride is clearly a poison requiring testing for safety and efficacy when intended for ingestion. If fluoride were not a poison it would not be listed in the SUSMP and no scheduling would be required. The addition of this comment in the Minister’s letter about fluoride is misleading. It implies fluoride is safe for ingestion at the concentration of 15mg/kg. This is not the case and constitutes an acute overdose, requiring hospitalisation.

In light of the above I again request the Ombudsman investigate why the TGA considers water fluoridation is not a therapeutic good. All that is required is for the Ombudsman to obtain answers to the 4 questions outlined above. There is no disputing the fact the TGA has deliberately sought to exclude artificial fluoride from scrutiny by convoluting the therapeutic goods legislation. As you have explained in your previous letter, the Ombudsman’s role is to investigate in such circumstances.

If you still consider my complaint to be unreasonable, please provide me with your reasons. I am fully aware the Ombudsman does have some discretionary powers when it comes to complaints. This is a serous matter, affecting the majority of Australians. I am also fully aware the Ombudsman only has the power to recommend when it comes to investigations. However, as you will be aware, most recommendations by the Ombudsman are taken very seriously and acted upon as you report to Parliament.

It is also requested that the Ombudsman investigate why the TGA has a warning about fluoride tablets on its Website. The TGA has informed me water fluoridation needs no controls. Yet there is a warning pregnant women should not take fluoride tablets or drops, as follows:

Fluoride supplements

Fluoride supplements (drops, tablets) should not be taken during pregnancy.

The labelling of fluoride supplement products should include advice consistent with the following:

  • *This product should only be used on the advice of a dentist.
  • *Do not use if pregnant.

This warning may be viewed at:

http://www.tga.gov.au/industry/otc-argom-app5-03-efgh.htm#fluoride

These types of tablets and drops contain fluoride levels similar to that contained in artificial fluoridated water. In fact, the level of fluoride contained in fluoride tablets is less than the amount contained in drinking water. See:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e7a7e17-7538-4763-810c-7e56bd630494

A pregnant woman drinking one litre of fluoridated water will ingest the same amount of fluoride or more than the prescribed dose in fluoride tablets and drops.

Why has the TGA chosen to warn pregnant women about a chemical it has stated need no controls?

Furthermore, if there is the need for a warning, why is there no reference to fluoridated water, containing similar or higher levels of fluoride?

It is inconceivable to maintain it is safe to ingest fluoride from one source and claim it should not be ingested when available from another source at the same levels of concentration.

I look forward to hearing from you once you have investigated these matters that clearly fall within the Ombudsman’s role.

Yours sincerely

John T

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