Please note our corrections to this misleading letter.
Dear Councillors
I write to you about the important issue of community water fluoridation.
The National Health and Medical Research Council (NHMRC) is Australia’s leading expert body supporting health and medical research; developing health advice for the Australian community, health professionals and governments; and providing advice on ethical behaviour in health care and in the conduct of health and medical research. ♦
We are aware that some members of the community are raising concerns about health implications of water fluoridation. NHMRC recently reviewed the scientific evidence that reported any health effects of water fluoridation and checked if they are relevant to Australia. NHMRC found no reliable evidence that community water fluoridation at current Australian levels causes health problems. In particular, NHMRC found no links between water fluoridation and lowered IQ, – [Jundong Wang ] ← cognitive dysfunction, cancer, Down syndrome or hip fracture. NHMRC also found no reliable evidence of a link between water fluoridation and thyroid problems, chronic kidney disease, kidney stones, high blood pressure, musculoskeletal pain or osteoporosis.
Most of the evidence on possible harms to humans is from areas with higher levels of fluoride than we use in Australia. This is important as we cannot compare our situation with such countries. Confidence in the conclusions of these studies is also affected by the small number of studies and how they were carried out. Many did not control for factors that could affect the results and their interpretation, such as taking into consideration consumption of fluoride from other sources, exposure to other factors such as iodine, and socio-economic status of study participants. [Pollution]
Some people ask if there is a cumulative effect of consuming fluoride over a lifetime. The toxicologists on our expert committee advised that fluoride is excreted regularly by the kidneys to achieve a ‘steady state’ that is safe for humans. This is different to lead which accumulates in the body.
The findings from the latest review are summarised in the Information Paper – water fluoridation: dental and other human health outcomes (the Information Paper), on the NHMRC website at https://www.nhmrc.gov.au/guidelines-publications/eh43-0. NHMRC ensured that the ethics of community water fluoridation were considered during this review, as we were aware of some community concern, including the issue of informed consent. The expert committee had two members with expertise in ethics, and a discussion paper was considered by the committee prior to the issue being discussed by the Australian Health Ethics Committee. The result is a section in the Information Paper that focuses on ethical considerations (pg. 55-57).
The expert committee tasked with guiding the development of this evaluation of the evidence on the health effects of water fluoridation was selected to ensure appropriate expertise in the key areas of science and review methodology, in order to undertake a transparent and rigorous evidence-based assessment. It comprised highly-regarded experts in the fields of public health, oral health, epidemiology, child health, toxicology, cancer, bone biology, neurodevelopment, Aboriginal and Torres Strait Islander health, [ MORE ] water management and health ethics.
Australia has a long history of community water fluoridation to help reduce tooth decay. Tooth decay is one of the most common health issues in Australia, affecting five out of ten children and nine out of ten adults. It can cause pain, difficulty eating and sleeping as well as costly dental treatments. The Council of NHMRC is made up of the Chief Health Officers from all of Australia’s states and territories, and they repeatedly assure me of the value of community water fluoridation [See “Extract” below] as a broad-reaching and equitable public health measure. NHMRC is not alone in our support for water fluoridation; it is supported by a wide range of public health and dental health organisations in Australia and around the world.
The latest evidence builds on past research and is clear – community water fluoridation helps to reduce tooth decay across the population. NHMRC’s recently released Public Statement further summarises this information and the new Questions and Answers resource can answer queries your constituents may have. You can find these documents on the NHMRC website at https://www.nhmrc.gov.au/guidelines- publications/e44-0.
Yours sincerely
Professor Anne Kelso AO Chief Executive Officer
8 March 2018
See our previous criteque 2016 → HERE
♦ Your lack knowledge on the issue of fluoridation, undermines our confidence
in your policies and knowledge of other medical and ethical maters.
‘
SARAC-HEATH, Joy
From: Tony Gill
Sent: Monday, 5 August 2013 3:38 PM
To: TGA Info
Subject: Re: Fw: Your reply to enquiry dated 26/7/13 [DLM=For-Official-Use-Only]
Cara
Happy for this initial response to go. T hanks
T ony
Dr Tony Gill IMBBS MPH FAFPHM AFACHSM ISenior Medical Adviser IOffice of Scientific Evaluation I Therapeutic Goods Administration I PO Box 100, WODEN ACT 26061 Ph: 02 6232 83951 Fax: 02 6232 82391Mob: 0432 758 162 I Email: anthony.gill@tqa.gov.au
From: Tony Gill
Sent: Monday, 5 August 2013 3:38 PM
To: TGA Info
Subject: Re: Fw: Your reply to enquiry dated 26/7/13 [DLM=For-Official-Use-Only]
Cara
Happy for this initial response to go. T hanks
T ony
Dr Tony Gill IMBBS MPH FAFPHM AFACHSM ISenior Medical Adviser IOffice of Scientific Evaluation I Therapeutic Goods Administration I PO Box 100, WODEN ACT 26061 Ph: 02 6232 83951 Fax: 02 6232 82391Mob: 0432 758 162 I Email: anthony.gill@tqa.gov.au
From: To: Date: Subject: Sent by:
Dear Dr Gill
Dear Dr Gill
TGA Info/TGA/Health
Anthony Gill/TGA/Health@TTRA
05/08/2013 02:57 PM
Fw: Your reply to enquiry dated 26/7/13 [DLM=For-Official-Use-Only) Cara-Lee Rake
Anthony Gill/TGA/Health@TTRA
05/08/2013 02:57 PM
Fw: Your reply to enquiry dated 26/7/13 [DLM=For-Official-Use-Only) Cara-Lee Rake
Please find attached a draft response to equest.
Your consideration/ clearance would be greatly appreciated.
Many thanks Cara
Dear-
Thank you for your email of 30 June 2013 to the TGA.
Please find attached the copies of the Excluded Goods Order publications as requested.
Your subsequent email has been forwarded to the relevant area of the TGA for response.
I hope that this information is useful.
Yours sincerely
Cara
Public Contact Team Therapeutic Goods Administration
Phone: 1800 020 653 Email: info@tga.gov.au
TherapeuticGoods Administration Department of Health and Ageing PO Box 100
Woden ACT 2606 www.tga.gov.au
Your consideration/ clearance would be greatly appreciated.
Many thanks Cara
Dear-
Thank you for your email of 30 June 2013 to the TGA.
Please find attached the copies of the Excluded Goods Order publications as requested.
Your subsequent email has been forwarded to the relevant area of the TGA for response.
I hope that this information is useful.
Yours sincerely
Cara
Public Contact Team Therapeutic Goods Administration
Phone: 1800 020 653 Email: info@tga.gov.au
TherapeuticGoods Administration Department of Health and Ageing PO Box 100
Woden ACT 2606 www.tga.gov.au
1
[attachment “EGO 2002-1.pdr’ deleted by Anthony Gill/TGNHealth] [attachment “EGO 2004-1.pdf’ deleted by Anthony Gill/TGNHealth] (attachment “EGO 2005-1.pdf’ deleted by Anthony Gill/TGNHealth]
From :
T o: Date· SubJect:
T o: Date· SubJect:
<info@tga.gov.au> 30/07/2013 12:25 PM
RE: Your reply to enquiry dated 26/7/13
RE: Your reply to enquiry dated 26/7/13
HiCindy- TGA
Thanks for your reply. With regard to some information you supplied. I’ve tried to locate the Excluded Goods Orders
No. 1 of 2002, No. 1 of 2004 and No. 1 of 2005 through the TGA website but they’re not coming up. I wonder whether you could give me the link to these documents or provide me with a copy. Thanks a lot.
—–Original Message—
From: cindy.chan@tga.gov.au [mailto:cindy.chan@tqa.qov.au] On Behalf Of info@tga.gov.au Sen~ ly 2013 11:49 AM
To: . . . . . .
Subject: Re: Fluorides put into potable drinking water supplies [SEC=UNCLASSIAED]
Dear –
Thank you for your email of 12 July 2013 to the Therapeutic Goods Administration (TGA).
The Secretary of the Department of Health and Ageing, or her delegate, has the power under section 7 of the Therapeutic Goods ACT, 1989 (the Act) to declare some products not to be therapeutic goods. Once a product is declared not to be therapeutic goods, that product is no longer regulated under the Act. The Therapeutic Goods (Excluded Goods) Order 2011 (Excluded Goods Order) is the most current written instrument under Section 7 of the Act.
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 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 is 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. Regulation of reticulated drinking water, including its fluoridation, has always been the jurisdiction of the states, territories and local councils. It is the legislation in these jurisdictions that sets out which chemicals may be used in the water supply and the standards of purity that must be met by those chemicals.
To allay any more confusion about the regulation of substances for fluoridation of water or fluoridated water, the TGA agrees that the Excluded Goods Order or any other appropriate legislative instrument under the Act should make it clear that these substances and products are not therapeutic goods.
Another form of regulation which is set out in the Act is scheduling of medicines and poisons. Scheduling is a national classification system that controls how medicines and poisons are made available to the public. The Schedules and the list of substances per Schedule are set out in the current Poisons Standard (also known as the Standard for the Uniform Scheduling of Medicines and Poison) which is accessible on the Comlaw website.
The requirements mandated by the Schedules are generally given legal effect through state and territory legislation. The listing of a substance in a particular Schedule is determined according to the
Thanks for your reply. With regard to some information you supplied. I’ve tried to locate the Excluded Goods Orders
No. 1 of 2002, No. 1 of 2004 and No. 1 of 2005 through the TGA website but they’re not coming up. I wonder whether you could give me the link to these documents or provide me with a copy. Thanks a lot.
—–Original Message—
From: cindy.chan@tga.gov.au [mailto:cindy.chan@tqa.qov.au] On Behalf Of info@tga.gov.au Sen~ ly 2013 11:49 AM
To: . . . . . .
Subject: Re: Fluorides put into potable drinking water supplies [SEC=UNCLASSIAED]
Dear –
Thank you for your email of 12 July 2013 to the Therapeutic Goods Administration (TGA).
The Secretary of the Department of Health and Ageing, or her delegate, has the power under section 7 of the Therapeutic Goods ACT, 1989 (the Act) to declare some products not to be therapeutic goods. Once a product is declared not to be therapeutic goods, that product is no longer regulated under the Act. The Therapeutic Goods (Excluded Goods) Order 2011 (Excluded Goods Order) is the most current written instrument under Section 7 of the Act.
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 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 is 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. Regulation of reticulated drinking water, including its fluoridation, has always been the jurisdiction of the states, territories and local councils. It is the legislation in these jurisdictions that sets out which chemicals may be used in the water supply and the standards of purity that must be met by those chemicals.
To allay any more confusion about the regulation of substances for fluoridation of water or fluoridated water, the TGA agrees that the Excluded Goods Order or any other appropriate legislative instrument under the Act should make it clear that these substances and products are not therapeutic goods.
Another form of regulation which is set out in the Act is scheduling of medicines and poisons. Scheduling is a national classification system that controls how medicines and poisons are made available to the public. The Schedules and the list of substances per Schedule are set out in the current Poisons Standard (also known as the Standard for the Uniform Scheduling of Medicines and Poison) which is accessible on the Comlaw website.
The requirements mandated by the Schedules are generally given legal effect through state and territory legislation. The listing of a substance in a particular Schedule is determined according to the
2
level of regulatory control over the availability of the medicine or poison required to protect public health and safety. The listing of a substance in a particular Schedule takes into account a number of factors such as the toxicity of the substance, the purpose of the use, potential for abuse, safety in use and the need for the substance. Information in relation to these criteria can be accessed from the TGA website.
‘Fluorides’ for human use, which are for dental products, medicines and the like, are listed in Schedules 2,3 and 4. Fluorides whose concentrations are 15mg/kg and less are not covered by the scheduling requirements and are not classified as Poisons at or below this concentration.
Fluoride scheduling was first considered in 1956 and since then fluoride has been considered on numerous occasions. In 2007, a Fluorides Working Party was established to address the issues of concern in relation to contemporary human exposure to fluoride (acute toxicity in children and adults and fluoride in children and adolescents). The acute oral toxicity of fluoride is generally recognised as Smg/kg and the acceptable daily intake for fluoride in children one to three years of age, in relation to the incidence of dental fluorosis, is 0.7mg.
In 2011, the National Health and Medical Research Council (NMHRC) published the latest version of the Australian Drinking Water Guidelines which can be accessed on the NHMRC website. The Guidelines contain a specific chapter on drinking water treatment chemicals, including fluoride. The NHMRC’s website advises that the Guidelines undergo rolling revision to ensure it represents t11e latest scientific evidence on good quality drinking water.
I hope that this information is useful. Yours sincerely
Cindy Chan Public Contact Team
Therapeutic Goods Administration Phone: 1800 020 653
Email; jnfo@tqa.qov.au
Therapeutic Goods Administration Department of Health and Ageing PO Box 100
Woden ACT 2606 www.tga.gov.au
‘Fluorides’ for human use, which are for dental products, medicines and the like, are listed in Schedules 2,3 and 4. Fluorides whose concentrations are 15mg/kg and less are not covered by the scheduling requirements and are not classified as Poisons at or below this concentration.
Fluoride scheduling was first considered in 1956 and since then fluoride has been considered on numerous occasions. In 2007, a Fluorides Working Party was established to address the issues of concern in relation to contemporary human exposure to fluoride (acute toxicity in children and adults and fluoride in children and adolescents). The acute oral toxicity of fluoride is generally recognised as Smg/kg and the acceptable daily intake for fluoride in children one to three years of age, in relation to the incidence of dental fluorosis, is 0.7mg.
In 2011, the National Health and Medical Research Council (NMHRC) published the latest version of the Australian Drinking Water Guidelines which can be accessed on the NHMRC website. The Guidelines contain a specific chapter on drinking water treatment chemicals, including fluoride. The NHMRC’s website advises that the Guidelines undergo rolling revision to ensure it represents t11e latest scientific evidence on good quality drinking water.
I hope that this information is useful. Yours sincerely
Cindy Chan Public Contact Team
Therapeutic Goods Administration Phone: 1800 020 653
Email; jnfo@tqa.qov.au
Therapeutic Goods Administration Department of Health and Ageing PO Box 100
Woden ACT 2606 www.tga.gov.au
From· To: Date: Subject:
<info@tga.gov.au> 12/07/2013 08:29 PM
Fluorides put into potable drinking water supplies
Fluorides put into potable drinking water supplies
Dear Sir/Madam,
Fluoride is listed by the Therapeutic Goods Administration (TGA) under “Substances that may be used in listed medicines” (Dec 2007). used as a “component” and with the following restrictions:- “ln dental products, the concentration from all ingredients must not exceed 15 mg/kg or 15 mg/Lor 0.0015%. In other products, the concentration from all ingredients must not exceed 1000 mg/kg or 1000 mg/Lor 0.1%”
This TGA document also states “Importantly, as a result of a safety concern, substances may be subject to new restrictions or may be removed from the list.” (page 3).
Fluoride is listed by the Therapeutic Goods Administration (TGA) under “Substances that may be used in listed medicines” (Dec 2007). used as a “component” and with the following restrictions:- “ln dental products, the concentration from all ingredients must not exceed 15 mg/kg or 15 mg/Lor 0.0015%. In other products, the concentration from all ingredients must not exceed 1000 mg/kg or 1000 mg/Lor 0.1%”
This TGA document also states “Importantly, as a result of a safety concern, substances may be subject to new restrictions or may be removed from the list.” (page 3).
3
The TGA definition of 111edici11e means:
(a) therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic
means in or on the body of a human or animal; and
(b) any other therapeutic goods declared by the Secretary, for the purpose ofthe definition oftherapeutic device, not to be therapeutic devices.
By the TGA’s own definition it still has not listed the “fluorides” put into public potable water supplies as a medicine when there is a therapeutic use proclaimed for its inclusion in the water supply ie to prevent tooth decay.
I have searched the Excluded Goods Order No. I of2011 and can find no relevant category that would cover these “fluorides” being excluded from TGA assessment.
Table I Item 10 refers to Substances used for the purification or treatment ofdrinking water but are restricted to those substances which claim no therapeutic use.
As the “fluorides” put into drinking water are there to treat the body and not the water and as a thereaputic use is intended, this Section does not apply.
Table 2 Item 7 refers to Oral hygiene products for care of the teeth and the mouth (e.g. dentrifices, mouth washes and breath fresheners) If:
a. any benefits claimed to result from use are directly related to improvements to oral hygiene, including for the prevention oftooth decay or the use offluoride for the prevention oftooth decay; and
b. other benefits in relation to diseases or ailments, e.g. gum or other oral disease or periodontal conditions are not claimed to result from use.
This section appears to cover “over-the-counter” products one might find at a supermarket for example, but does not cover the “fluorides” in public potable drinking water supplies.
Could you please clarify:-
Why would the TGA not require a risk assessment of the “fluorides” put into the drinking water supply as they are listed as Poisons, are not pharmaceutical grade and as far as I know have never been tested for human consumption, yet the authorities including these substances do so by claiming a therapeutic use?
Individuals consuming these “fluorides” are not under the supervision ofany clinician or dentist; there is no dose to weight or age relationship; no advice on potential overdosing, no contra-indications; or who should not be taking these “fluorides”, yet the TGA on its own website has the following guidance:-
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:
(a) therapeutic goods that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic
means in or on the body of a human or animal; and
(b) any other therapeutic goods declared by the Secretary, for the purpose ofthe definition oftherapeutic device, not to be therapeutic devices.
By the TGA’s own definition it still has not listed the “fluorides” put into public potable water supplies as a medicine when there is a therapeutic use proclaimed for its inclusion in the water supply ie to prevent tooth decay.
I have searched the Excluded Goods Order No. I of2011 and can find no relevant category that would cover these “fluorides” being excluded from TGA assessment.
Table I Item 10 refers to Substances used for the purification or treatment ofdrinking water but are restricted to those substances which claim no therapeutic use.
As the “fluorides” put into drinking water are there to treat the body and not the water and as a thereaputic use is intended, this Section does not apply.
Table 2 Item 7 refers to Oral hygiene products for care of the teeth and the mouth (e.g. dentrifices, mouth washes and breath fresheners) If:
a. any benefits claimed to result from use are directly related to improvements to oral hygiene, including for the prevention oftooth decay or the use offluoride for the prevention oftooth decay; and
b. other benefits in relation to diseases or ailments, e.g. gum or other oral disease or periodontal conditions are not claimed to result from use.
This section appears to cover “over-the-counter” products one might find at a supermarket for example, but does not cover the “fluorides” in public potable drinking water supplies.
Could you please clarify:-
Why would the TGA not require a risk assessment of the “fluorides” put into the drinking water supply as they are listed as Poisons, are not pharmaceutical grade and as far as I know have never been tested for human consumption, yet the authorities including these substances do so by claiming a therapeutic use?
Individuals consuming these “fluorides” are not under the supervision ofany clinician or dentist; there is no dose to weight or age relationship; no advice on potential overdosing, no contra-indications; or who should not be taking these “fluorides”, yet the TGA on its own website has the following guidance:-
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 ofa dentist.
- *Do not use ifpregnant.
4
What guidance does the TGA have for pregnant woment drinking the ”fluorides” in the public potable water supply?
Why is it that fluorides put into the drinking water supply are not reguded as a therapeutic good when other oral hygiene products with the same or lower dosage of Fluoride are listed on the ARTG?
What manner of risk assessment is carried out to differentiate what is or is not a therapeutic good or an excluded good?
Based on the above findings, “Fluorides” included in the public potable water supply are not Excluded Goods by any TOA definition, but by definition are a therapeutic good., and as the regulatory authority I believe the TGA has a duty ofcare to the public to assess the safety ofthese “fluorides” for human consumption..
I would very much appreciate your response at your earliest opportunity.
Yours faithfully,
Why is it that fluorides put into the drinking water supply are not reguded as a therapeutic good when other oral hygiene products with the same or lower dosage of Fluoride are listed on the ARTG?
What manner of risk assessment is carried out to differentiate what is or is not a therapeutic good or an excluded good?
Based on the above findings, “Fluorides” included in the public potable water supply are not Excluded Goods by any TOA definition, but by definition are a therapeutic good., and as the regulatory authority I believe the TGA has a duty ofcare to the public to assess the safety ofthese “fluorides” for human consumption..
I would very much appreciate your response at your earliest opportunity.
Yours faithfully,
Email:
Pb:
“Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information and has been sent in accordance with the TGA security policy.
If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author lmilledlatety and delete all copies of this transmission.”
[attachment “EGO 2002-l.pdf’ deleted by Anthony Gill/TOA/Health] [attachment “EGO 2005-1.pd:C’ deleted by Anthony Gill/TOA/Health] [attachment “EGO 2004-1.pdf’ deleted by Anthony Gill/TOA/Health]
Pb:
“Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information and has been sent in accordance with the TGA security policy.
If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author lmilledlatety and delete all copies of this transmission.”
[attachment “EGO 2002-l.pdf’ deleted by Anthony Gill/TOA/Health] [attachment “EGO 2005-1.pd:C’ deleted by Anthony Gill/TOA/Health] [attachment “EGO 2004-1.pdf’ deleted by Anthony Gill/TOA/Health]
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Water Fluoridation Is Illegal
These corrections undertaken by:
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