GENRE: Email letter
TO: Ms Sharon Woods – TGA Australia; Varous government departments
AUTHOR: John T
DATE SENT: Wed, Jan 23, 2013 at 4:36 PM
TITLE: Sodium Fluoride 2
STATUS: Awaiting response
UPDATES: Any updates should be posted in the comments section below
|cc:|| NSW Health Department <email@example.com>,
Ms Sharon Woods
Public Contact Team
Therapeutic Goods Agency
Thank your for your email of 18th January 2013, explaining the subtle differences between Sodium Fluoride (apparently this is a S6 poison, not a S7 poison as you have pointed out which is a salt) and Fluorine (which is not a salt), as follows:
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).
While your legislation uses the generic term, “Fluoride”, presumably you know I am concerned about the industrial grade highly hazardous chemical waste, when I used the term, “Sodium Fluoride”. My understanding of your response is that it is legal to add this type of Sodium Fluoride, with it’s accompanying heavy metals as an additive to water, while it is illegal to add Fluorine as an additive to water. Is my understanding correct in this regard?
The type of Sodium Fluoride I am talking about is explained at:
Your email then goes on to state:
“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.
My understanding of these statements is that Sodium Fluoride (and I am talking about the highly hazardous chemical waste) is a S6 poison and the TGA maintains it is not for human use. In other words it is a poison and should not be ingested. Is my understanding correct?
Clearly this is consistent with your statement about fluorides being used for dental products are listed poisons and necessarily carry warnings about the dangers of ingesting these products and the need to seek medical help in such cases. With regard to the dosage of those Fluorides used in dental hygiene, etc, I note you have stipulated different “safety” level for adults and children when applying these products topically. As the TGA is the Agency responsible to approving these products, what human studies has it undertaken to ensure these “safety” levels can be applied to all those using the products? Clearly consumers are all different when it comes to health matters, and I fail to see how “one size fits all”.
I have also noted your further comments as follows;
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 have written to the NHMRC about my concerns and am still awaiting a response.
What I really need from you in plain English is the following answers:
Sodium Fluoride is an S6 poison and is not for human use, i.e. it should not be ingested?
Does the TGA have the power to determine whether Sodium Fluoride (the industrial grade highly hazardous chemical waste) is of a food grade quality?
With regard to the levels of Sodium Fluoride being approved by the TGA in medicines, what human studies has it undertaken to ensure its safety and efficacy?
In your response you have stated,
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. This implies there is constant testing to ensure the safe and efficacious ingestion of these scheduled poisons, including Sodium Fluoride. What do these tests consist of and how are consumers monitored to satisfy these requirements?
Whether the TGA considers it is safe to use Sodium Fluoride as an additive to water?
What tests are undertaken by the TGA to determine the level of Sodium Fluoride Poisoning in Australia due to this poison being added to dental products, medicines, drinking water and fruit juices, agricultural produce treated with phosphates, processed foods, and as a food additive? See:
What human studies has the TGA undertaken to ascertain the accumulative harmful effects of Sodium Fluoride?
Are you aware the drug Cipro and similar drugs (presumably approved by the TGA) has been linked to chronic fatigue syndrome, as it contains Sodium Fluoride? See:
As the TGA is approving drugs that are ingested containing Sodium Fluoride, resulting in Sodium Fluoride Poisoning, I ask again, how can the TGA approve these drugs and not have the power to test the safety and efficacy of this S6 poison?
Clearly from your advice, it is not possible to determine the amount of Sodium Fluoride being ingested by consumers. You mention acute oral toxicity of fluoride as having safety levels. As Sodium Fluoride is in drinking water, soft drinks and juices, processed foods, agricultural produce treated with phosphates, medicines, etc., how are consumers able to monitor the amount they are ingesting each day, let alone know what the purported safe levels are? As Sodium Fluoride is accumulative, there can be no safe levels, see:
I thank you once again for getting back to me and look forward to further clarification about my concerns with Sodium Fluoride.