TO: Various email Bcc list
DATE SENT: Aug 20, 2013 at 10:50 PM
TITLE: AFIN Memo #574 Open Letter to Councillors – Tuesday, 20 Aug 2013
STATUS: No response required.
UPDATES: Please post all updates and comments in the LEAVE A REPLY section below.
EXTERNAL LINKS: http://www.tga.gov.au/about/foi-documents-released-2012-2013.htm
AFIN Memo – Tuesday, 20 Aug 2013
Hereunder is Monica M’s Open letter to councillors  to which Monica has added a paragraph for better understanding since the letter was included in AFIN Memo 570. Monica views this letter as a template: e.g. people could send it to councillors ‘as is’ or modify it as deemed appropriate. Those in Victoria who are fluoridated ‘courtesy’ of their water boards – not by their councillors – might potentially consider addressing it to their water board CEO and board members but note, first, that the word ‘Council’ is imbedded in the text and that would need altering.
It might be wise to leave the disclaimer attached. If sending, please detach this message and any link to AFIN.
The Therapeutic Goods Administration (TGA) is the government body that regulates medicines and any products that make or advertise a therapeutic claim for human use. In other words, if you are making a therapeutic claim for a product or substance, then the TGA will be looking at assessing the product and your claims to see if it falls under the “Schedules” for classifying medicines.
Fluorides used for water fluoridation do make the claim that they “prevent tooth decay” (which the TGA has determined is a therapeutic claim) and therefore come under the regulation of the TGA. Substances are only permitted to be put into drinking water that do not make a therapeutic claim. If they do, they are required to be assessed and regulated by the TGA.
QUOTE: The Therapeutic Goods Administration (TGA) include fluorides used for water fluoridation under specific legislation Therapeutic Goods Act 1989, Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 Section 5 Item 10:-
“Substances for use in the purification or treatment of drinking water if no claims are made for therapeutic use” UNQUOTE
It has been the TGA’s intention to regulate the above substances that made a therapeutic claim since 2002 (Refer to FOI document 156-1213-19 released 18/4/13) at http://www.tga.gov.au/about/foi-documents-released-2012-2013.htm)
With this notice, I would respectfully ask that Council confirm the current legislation, as noted above, and CEASE WATER FLUORIDATION UNTIL SUCH FLUORIDES COMPLY WITH THE THERAPEUTIC GOODS ACT.
Likewise, any therapeutic claims (eg for the prevention of tooth decay) and any other such advertising claiming a therapeutic use (see definition below) are not permitted under the Therapeutic Goods Advertising Code 2007.
Therapeutic use is defined in the Therapeutic Goods Act 1989 as meaning use in or in connection with:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons or animals; or
(b) influencing, inhibiting or modifying a physiological process in persons or animals; or …
In the event that I do not receive a reply within 28 days, I shall take it that the Council intends to comply with the current legislation noted above.
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