GENRE: Email letter request
TO: Australian Federal and State Government Health Ministers, Premiers and Therapeutic Goods Administration
AUTHOR: Monica M, Qld, Australia
DATE WRITTEN: 2nd August 2013
TITLE: FOI Documents show breaches to Legislative Requirements for Fluoride Chemicals
STATUS: Awaiting response
UPDATES: Please post all updates and comments in the LEAVE A REPLY section below.
The substance of emails sent to the Therapeutic Goods Administration (TGA), both Federal and State Premiers and Ministers for Health, relate to fluoride chemicals in public water supplies.
Freedom of Information (FOI) documents clearly show that since 2002, the TGA, the Australian regulatory authority for medicines, intended to regulate substances for the purification or treatment of drinking water that made a therapeutic claim.
The TGA have not done this with fluoride chemicals as the legislative instruments require, nor following years of public complaints about their use in drinking water supplies.
Refer to FOI documents released by the Therapeutic Goods Administration on 18th April 2013 (FOI No. 156-1213) on the subject of Fluoridated water and fluoride chemicals as Excluded Therapeutic Goods.
The FOI documents back my claim that fluoride chemicals used for water fluoridation are not Excluded Goods under the legislation, because they make a therapeutic claim, ie for the prevention of tooth decay, and are advertised and endorsed as such. The TGA has not denied that a therapeutic claim is made.
The TGA advised me that they include water fluoridation chemicals as substances for use in the purification or treatment of drinking water if no claims are made for therapeutic use.
Refer to current legislation – Therapeutic Goods Act 1989 Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 Section 5 Item 10
My previous query dated 12/7/13 about the anomaly that fluorides used to fluoridate drinking water do claim a therapeutic use (ie for the prevention of tooth decay), the reply I received on 26/7/13 is that their historical records show it was their “intention” for fluoride chemicals used in drinking water to be excluded goods. This is not true.
An FOI request and documents now on the TGA website released 18/4/13 indicates that in September 2002 (particularly FOI 156-1213-19) it was clearly the TGA’s intention to regulate any substance for the purification or treatment of drinking water that made a therapeutic claim, for the following reasons:-
- would assist in protecting public health and safety by requiring TGA assessment and approval of all equipment or substances for use in the purification or treatment of drinking water where therapeutic claims are made;
- would ensure that equipment or substances for use in the purification or treatment of drinking water would be regulated by therapeutic goods legislation, including all forms of advertising and the Therapeutic Good Advertising Code, if therapeutic claims were .made about such products; and
- would promote confidence and consistency in the regulation of devices and substances where therapeutic claims are made.
Not only did the TGA have the intention to regulate all substances for use in the purification or treatment of drinking water that made a therapeutic claim, but it also undertook consultations with the following stakeholders in July and August 2002; none of whom had any objections to the proposed amendment.
Office of the NHMRC (NHMRC)
Australian Competition and Consumer Commission (ACCC)
CRC for Water Quality and Treatment (CRC)
Association of Therapeutic Goods Consultants (ATGC)
Complementary Healthcare Council of Australia (CHC)
Water Services Association of Australia (WSAA)
Australian Water Association (A W A)
Australian Self-Medication Industry (ASMI)
Direct Selling Association of Australia Inc. (DSAA)
It is proposed that the amendment should come into effect upon gazettal as:
- TGA would be seen to be protecting public health and safety and appropriately regulating products for which therapeutic claims are made;
- Amending the Order would allow enforcement action to be taken immediately against recalcitrant suppliers that have previously been warned by the Surveillance Unit about making therapeutic claims for equipment or substances for use in the purification or treatment of drinking water; and
- The affected products could continue to be sold as long as therapeutic claims were not made about them ie. the product market would still exist for these suppliers only their presentation would require amendment while any potential application was made to the TGA for registration or listing.
AS INDICATED BY THE FOI DOCUMENTS NOW ON PUBLIC RECORD, IT SEEMS INCONGRUOUS THAT THE TGA WOULD CONTINUE TO SUGGEST THAT THERE WAS SOME OTHER INTENT!
In essence, it would appear that the States, Territory and Local Government Councils have been acting illegally for making a therapeutic claim for the fluoride substances they have been putting into public drinking water supplies; advertising claims of safety and efficacy (including endorsements by government bodies, medical and dental professionals and associations); without ever having applied for listing and assessment by the TGA.
This is in direct breach of the Therapeutic Goods Act, the Regulations and the Therapeutic Goods Advertising Code.
Will the TGA be issuing an enforcement notice to those authorities to:-
- cease legislation for the mandatory inclusion of such fluorides in the drinking water?
- to cease advertising a therapeutic use for such fluoride substances?
- to apply for listing and assessment of those fluoride substances?
The FOI documents indicate no confusion as to the intent of the TGA (as outlined above) to regulate substances used to purify or treat drinking water supplies that make a therapeutic claim.
If the TGA now intends to alter the current status of fluorides used in drinking water supplies ie they are currently not Excluded Goods as per the legislative instrument because they make a therapeutic claim as well as breaches for advertising and endorsements; then the public should expect that the TGA base any decision on a full risk assessment of current research data and clinical studies to be supplied by the manufacturers of such substances.
The substances/chemicals currently used for water fluoridation in Australia include:-
fluorosilicic acid (H2SiF6);
sodium fluorosilicate (Na2SiF6);
sodium fluoride (NaF);
Sixteen Local Government Councils in Queensland have now stopped or not initiated water fluoridation. Mandatory legislation in other States prohibits other Councils and communities from doing the same.
In the public interest, and based on the above findings, I have requested that the Australian Federal Health Minister and the Therapeutic Goods Administration, as well as each State and Territory Premier and Health Minister, ensure that fluoride chemicals for human ingestion through the drinking water supply are
- withdrawn from use until they are assessed and listed as a therapeutic good, and
- not advertised or endorsed for the prevention of tooth decay, in breach of the Therapeutic Goods Advertising Code