Medicines Board warned on illegal fluoride chemical in water

The Irish Medicines Board (IMB) was today served with an enforcement notice for its failure to act on the breach both of a European Directive and Irish Regulations governing medicinal products by Voice of Irish Concern for the Environment (VOICE), which is campaigning to end fluoridation of drinking water.

VOICE’s Robert Pocock says:
“Since hydrofluosilicic acid in drinking water, supplied by Dublin City Council and all other city and county councils, is presented by the Health Minister and other experts for preventing the disease of dental caries, it is by definition (1) a medicinal product. But this fluoridated drinking water is not an authorised product and is therefore unlawful under the EU Directive, a breach which the IMB has inexcusably failed to act on.”

The notice is addressed to the CEO of the Irish Medicines Board, Pat O’Mahony. The board is criticized for failing in the statutory duty to prohibit the presentation, advertising and supply in Ireland of an unauthorised product under the European Medicines Directive (2004/27 EC) and Irish Regulations prohibiting the promotion of medicinal substances without a medical consultation and with incorrect and inadequate labelling.

The IMB has acknowledged the public interest in the issue.

Robert Pocock continues:
“The IMB has now been requested to enforce the provisions of the Directive and Regulations in the same manner it applies itself when serving infringement notices on doctors, retail outlets, medical and health practitioners if unauthorised medicines are advertised or supplied. The regulatory agency has been granted seven days to respond, a timescale appropriate to the magnitude of the breach which affects almost three million consumers of fluoridated drinking water in Ireland.”

Added Pocock: “Failing a satisfactory response, CEO O’Mahony should step aside.” The usual enforcement sanctions for continued breach of the Directive and Regulations include fines and up to two years imprisonment.

The medicinal product, drinking water containing hydrofluosilicic acid (2), has never been approved by any regulatory agency outside Ireland either. Senior scientists involved in the UK NHS investigation into the fluoridation of drinking water in 2000 have stated of fluoridated water ‘that no drug would be licensed for safety on the present evidence’(3).

Also cited in the prohibited activity of promoting an unauthorised product (4), is the Chairman of the Expert Body on Fluorides, Prof Seamus O’Hickey who stated on February 8th 2007: “There is no problem in using tap water… at the present level to reconstitute the milk for infant feed”(5).

Sligo GP Dr Jimmy Devins is also named on the notice as a promoter of a medicinal product without medical consultation, which is forbidden by the Regulations. Devins is vice-chairman of the Joint Oireachtas Health Committee and has promoted the same medicinal product, which he states ‘has no negative side effects aside from a slight staining of the teeth in a small number of cases’ (6).

VOICE has already rejected the Health Minister’s New Regulations (S.I.42, 2007, effective July 1, 2007)) to reduce fluoride levels in drinking water as totally inadequate to deal with the risk from this illegal substance.

Most at risk are babies fed on infant formula made up with fluoridated tap water which contains 200 to 250 times more fluoride than breast milk. The American Dental Association has warned parents on using fluoridated water in infant formula (7).

No research on its wider health effects, as stipulated by the 1960 Fluoridation Act, has ever been done in Ireland because, said former Health Minister Micheál Martin, Ireland ‘is too small a country to study’(8).

Ends

For further information please contact Robert Pocock on 086 8113071.

(1) The EU Medicinal Products Directive (2004/27/EC) defines a medicine as ‘any substance ... presented as having properties for treating or preventing disease in human beings’; it came into force in Ireland on 30th October, 2005
(2) www.chemifloc.ie/msds/MSDS_Fluorosilicic_Acid.pdf
(3) Sir Iain Chalmers, Advisory Committee, UK NHS York Review in
Sunday Times letter of 18th May 2003.
(4) Irish Times Reader Response November 21st 2006. Dr O’Hickey wrote
‘on the question of reconstituting infant formula … fluoride tap water in the concentration used in water fluoridation poses no known medical problems for infants’. This is not consistent with the advice of the American Dental Association of 9th November 2007 on this subject.
(5) Oireachtas Joint Health Committee 8th February 2007
Deputy Devins: The expert body says there is no problem using tap
water here to reconstitute the milk for infant feed. Dr. O’Hickey: There is no problem at the present level.
(6) Sligo Champion. Wed April 11th 2007 Dr Jimmy Devins Vice Chair of Joint Oireachtas Health Committee

"It (water fluoridation) prevents dental caries and has no negative side effects aside from a slight staining of teeth in a small number of cases which is easily treatable."
(7) www.fluoridealert.org/infant-warning.pdf
(8) Prime Time February 22nd, 2000.