Sodium Fluoride (S7 poison)


GENRE: Email Thread

TITLE: Sodium Fluoride (S7 poison)

AUTHOR: John T

TO: TGA

DATE SENT: 12th December, 2012  12:26 PMSTATUS: Waiting response

UPDATES: Any updates should be posted in the comments section below

To: info@tga.gov.au
Bcc: Various lists
 
Dear Sir/MadamAt their request, I recently conducted an on-line survey about the quality of my Council’s water supply.Before responding to the survey, I did some research on Fluoridation and on the basis on this research, I raised concerns about Sodium Fluoride (S7 poison) being added to the water.From the reply I received from the Council, my understanding is Councils are required by law to add this poison to our water. As this is a requirement of the NSW Health Department, please advise:Whether the Sodium Fluoride add to the water supply is of food grade or industrial grade quality?

Whether your Department has ever been required to test the claim that Sodium Fluoride prevents cavities?

Whether your Department has ever considered the concerns raised by the EPA in their Facts Sheets about severe dental Fluorosis, severe Skeletal Fluorosis and Skeletal fractures? See attached.

Whether your Department has collected any information concerning Sodium Fluoride poisoning (an accumulative poison) in Fluoridated communities?

Whether your Department has ever provided the NSW Health Department with any guidelines as to what constitutes a safe dosage of Sodium Fluoride and how to ensure that this dosage is not exceeded? If so, what measures were taken to enforce these recommendations?

As Sodium Fluoride is not only in the drinking water, but also in the food chain (processed foods and drinks are manufactured using tap water) and there is exposure when washing, how has it been possible to safeguard Australians from overdosing on this drug?

I would be grateful if you take these questions seriously as I do have a number of concerns about the way this poison may have affected my health over the years. I have been drinking tap water since the time it was introduced into the NSW water supply more than 50 years ago. During that time, I have had a large number of teeth cavities, requiring fillings and extractions. I was recently informed by my dentist that I have gum disease (receding gums due to calcium deficiency). As Sodium Fluoride depletes the body of calcium I am concerned this may have a lot to do with my dental health issues. Furthermore, I was diagnosed with cancer at the age of thirty (1976) and suffered a heart attack in 2010. As Sodium Fluoride has been linked to cancers and hardening of the arteries, I am also concerned this poison may have impacted adversely on my health.

Best wishes

John

——-Original Message——-From: info@tga.gov.au
Date: 17/12/2012 10:52:07 AM
To: John T
Subject: Fw: Sodium Fluoride (S7 poison) [SEC=UNCLASSIFIED]Dear JohnThank you for your enquiry of the 12 December 2012,  to the Therapeutic Goods Administration (TGA) regarding Fluoride in drinking water.We appreciate that you are concerned about the impact that fluoride in water may have had on your health. The most appropriate government agency to respond to your queries is the NSW Health Department. Their contact details are as follows:

New South Wales Ministry of Health
Phone: 02 9391 9000

Role of the TGA
The  TGA’s primary consideration of a particular product is a consideration of  whether or not it should be subject to regulation as a therapeutic good under  the provisions of the Therapeutic Goods Act 1989 (the Act). The Act provides for  the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that  are used in Australia.  The definitions provided in section 3 of the Act  are used to determine whether or not a particular product is a therapeutic good  for the purposes of regulation under the Act.


TGA’s regulatory status for fluoride in water
The Secretary of the Department of Health and Ageing may (under section 7 of the Act), 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 the Act, therapeutic goods.  In accordance with this provision  of the Act, the Secretary has declared that certain products are not therapeutic  goods for the purposes of the Act (Therapeutic Goods (Excluded Goods) Order No.  1 of 2011, available at http://www.tga.gov.au/industry/legislation-excluded-goods-order-1101.htm).  This declaration relevantly declares that oral  hygiene products for care of the teeth are not therapeutic goods if:

·        any  benefits claimed to result from use are directly related to improvements to oral  hygiene, including for the prevention of tooth decay or the use of fluoride for  the prevention of tooth decay; and
·        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.
Fluoridated water satisfies this requirement and is therefore not a therapeutic good for the purposes of the therapeutic goods regulatory scheme.


We are sorry that we are not able to assist you further.
Kind regards
Debbie
Public Contact Team
Therapeutic Goods Administration
Phone: 1800 020 653
Email: info@tga.gov.au
Therapeutic Goods Administration
Department of Health and Ageing
PO Box 100
Woden ACT 2606
——-Original Message——-
From: John T
Date: 17/12/2012 12:07:19 PM
To: info@tga.gov.au
Subject: Re: Fw: Sodium Fluoride (S7 poison) [SEC=UNCLASSIFIED]Hi  DebbieThanks for getting back to me so promptly. I have forwarded a copy of my email to the Federal Member for Health so hopefully she will be able to assist me.My understanding is that Fluoride has been added to the water supply as it is a treatment for preventing tooth decay, even though the EPA does not permit this Fluoride to be dumped into the rivers and oceans as it is considered to be an industrial grade toxic waste and has been classified as a S7 poison. Could you please advise me which Government Department would have classified it as poison?It is clear from your reply that Fluoride is not a therapeutic good (not a drug) and therefore has not been tested by the TGA for the claim that Fluoride is “safe and effective for tooth decay”.

Please confirm that my understanding in this regard is correct.

Best wishes

John

——-Original Message——-From: John T
Date: 27/12/2012 11:34:41 AM
To: info@tga.gov.au
Subject: Fw: Re: Fw: Sodium Fluoride (S7 poison) [SEC=UNCLASSIFIED]Hi DebbieI still have not heard back from you re my email below. Please respond to my request ASAP.Best wishes

John

——-Original Message——-
from:  John T
to:  info@tga.gov.au
cc:  NSW Health Department <quality@doh.health.nsw.gov.au>,
Minister.Plibersek@health.gov.au
date:  Sun, Jan 6, 2013 at 3:51 PM
subject:  Fw: Re: Fw: Sodium Fluoride (S7 poison) [SEC=UNCLASSIFIED]
Hi Debbie II still have not heard from you regarding the matters raised below.Having undertaken some more research on Fluoride, I would also like clarification on the following.In your previous email you stated:
This declaration relevantly declares that oral hygiene products for care of the teeth are not therapeutic goods if:

· any benefits claimed to result from use are directly related to improvements to oral hygiene, including for the prevention of tooth decay or the use of fluoride for the prevention of tooth decay; and

· 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.
Fluoridated water satisfies this requirement and is therefore not a therapeutic good for the purposes of the therapeutic goods regulatory scheme.
My understanding of these statements is the TGA does not have the power to determine whether fluoride is a therapeutic good. It has simply been excluded from the definition of therapeutic goods. I find this hard to understand when Sodium Fluoride is added not only to dental hygiene products but also medicines, which are therapeutic goods. My research reveals Sodium Fluoride is an active ingredient used in treating mental illness, see:
It is also used in other therapeutic goods, see:
As Sodium Fluoride is being used in therapeutic goods, how is it possible the TGA is not responsible for screening the “safety and efficacy” of this chemical?
It is clear Sodium Fluoride is a poison and has serious side effects when consumed, whether it be fluoridated drinking water, fluoridated processed foods or fluoridated medications, see:
Please advise how the TGA can satisfy its legal obligations to ensure therapeutic goods containing Sodium Fluoride are beneficial and not dangerous when prescribed for various illnesses. How can the TGA legally approve a drug containing Sodium Fluoride as a therapeutic good, when it is excluded from testing the “safety and efficacy” of this poison?
I look forward to hearing from you shortly.
Best wishes
John T
——-Original Message——-
Date: 18/01/2013 9:45:28 AM
To: John T
Subject: Re: Fw: Re: Fw: Sodium Fluoride (S7 poison) [SEC=UNCLASSIFIED]

Dear Mr Teagle

Thank you for your emails to the Therapeutic Goods Administration (TGA) and our apologies for the delay in responding.

Scheduling is a national classification system that controls how medicines and poisons are made available to the public.  Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison, required to protect public health and safety.  The Schedules are set out in the current Poisons Standard, a legislative instrument made under the Commonwealth Therapeutic Goods Act 1989.  The requirements mandated by these Schedules are generally given legal effect through State and Territory legislation.

The Poisons Standard is also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) which can be accessed through www.comlaw.gov.au.  Where a substance is included in a Schedule in the SUSMP this has the effect (the Scheduling Requirements) of restricting the labelling packaging, availability and supply of any product containing that substance.  The Scheduling Requirements for each Schedule are set out in the SUSMP.

In responding to your query, we note from your emails that your primary concern appears to be about a substance called “sodium fluoride”.  This substance is what is known as a “salt”, that is it readily dissolves into in water releasing the fluoride ion. Sodium fluoride is included in the SUSMP entries for “fluorides”.  You should also note that atomic fluorine “F” may be strongly bound into many other substances including some medicines and household products such as Teflon.  These substances are not salts and do not release fluoride ion when added to water and are therefore not considered to be fluorides or a source of fluoride.  While some of these other fluorine containing substances may have individual entries in the SUSMP, they are not included in either the entry for the parent acid or the entries for “fluorides”.  They are also not permitted additives to water.  

As noted in the SUSMP, substances are not scheduled simply on the basis of a universal scale of toxicity.  Although this is one of the factors considered, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance.  These criteria are set out in the NCCTG Scheduling Policy Framework 1 July 2010, available from the TGA website (www.tga.gov.au).

“Fluorides” for human use, that is for dental products, medicines and the like, are listed in Schedules 2, 3 and 4 of the current SUSMP.  The entries for “fluorides” in Schedules 5 and 6 are for uses other than human use.  Please note however, that although fluorides for human uses are listed in Schedules 2, 3 and 4 and conditions/requirements are specified for their supply to the public, there is a specified concentration of fluorides (15mg/kg and less), below which they are excluded from the all the scheduling requirements in the SUSMP.  Fluorides are not listed in Schedule 7 of the current SUSMP.

Fluoride scheduling was first considered in 1956 and since then fluoride has been considered on numerous occasions.  In 2007, the then National Drugs and Poisons Committee (NDPSC) decided to establish a Fluorides Working Party (FWP) to address the issues of concern in relation to contemporary human exposure to fluoride (acute toxicity in children and adults and fluorosis in children and adolescents).  The acute oral toxicity of fluoride is generally recognised as 5mg/kg and the acceptable daily intake for fluoride in children 1 to 3 years of age, in relation to the incidence of dental fluorosis, is 0.7mg.

In 2011, the National Health and Medical Research Council (NHMRC) published the latest version of the Australian Drinking Water Guidelines, which are available on the NHMRC website at http://www.nhmrc.gov.au/guidelines/publications/eh52.  The guidelines contain a specific chapter on drinking water treatment chemicals, including fluoride.  The guidelines advise that the use of fluoride is controlled by State and Territory legislation and regulations, and local regulations.  Table 8.1 provides the names of the relevant legislation and regulations, by State and Territory, under which fluoride is controlled.  It is worth noting that NHMRC’s website advises that the guidelines undergo rolling revision to ensure it represents the latest scientific evidence on good quality drinking water.  You may wish to contact the NHMRC about having your views considered in the next update of their guidelines.

I hope that this information is of assistance.

Yours sincerely

Sharon
Public Contact Team
Therapeutic Goods Administration


Phone: 1800 020 653
Email:
info@tga.gov.au

Therapeutic Goods Administration
Department of Health and Ageing
PO Box 100
Woden ACT 2606
www.tga.gov.au

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