A local woman is challenging the legality of using hydrofluorosilic acid to fluoridate Waterloo’s drinking water by filing a complaint with Health Canada.

Carole Clinch, research coordinator for People for Safe Drinking water, said under the new Natural Health Products Regulations, under the Food and Drug Act enacted in 2006, all substances claiming to have a therapeutic effect have to be regulated for use by Health Canada.

Any approval would have to follow a review by Health Canada for the product’s safety, efficacy and quality. “They (the fluoride producers) would have to obtain a market authorization, product license and a site license in order to be sold,” said Clinch.

She said that due to a backlog of requests from manufacturers for regulatory approval that Health Canada provided a moratorium for manufacturers of fluoridation products until Jan. 1, 2010. That moratorium was extended to March 31 of this year.

That deadline has since come and gone.

But when Clinch went to find any evidence that the importers or producers of hydrofluorosilicic acid had complied with the new standard, including producing any new research to back up its claims of reducing dental caries without causing any health harms, she was told they hadn’t even applied for approval.

“I have a statement from Health Canada after I asked them if any manufacturer or importer has made a submission for the approval process?” said Clinch. “They said ‘No’ — not one manufacturer or importer has applied.”

That makes artificial water fluoridation products unregulated, unapproved, uncontrolled and illegal under the new Health Canada standard. Clinch called on the federal government body charged with protecting Canadians health to stop the importation of hydrofluorosilicic acid, or the production of the water additive.

She filed a formal complaint with Health Canada just before the end of the deadline and received confirmation of its receipt from Tom Barker, supervisor of Health Canada’s Drug Compliance and Verification and Investigation Unit. He said the matter would be forwarded to an inspector for appropriate action.

“Thank you for bringing this potential violation of the Food and Drugs Act to our attention,” said Baker in a letter obtained by the Chronicle. “Such information helps us to meet our mission which is, ‘To ensure that the drugs, medical devices and other therapeutic products available in Canada are safe, effective and of high quality.”

The Chronicle called Barker for confirmation of the complaint about hydrofluorosilicic, and about the process Health Canada’s Drug Compliance and Verification unit would follow, but he has not returned the calls.

Without that approval Clinch said that it puts the “lie” to claims by dentists and various other health authorities that hydrofluorosilicic acid is safe because it is certified.

“The onus is on the manufacturer to be in compliance with Canadian law,” said Clinch. “They are not in compliance with Canadian law.”

This development has already caused a stir in several Quebec jurisdictions that use hydrofluorosilicic acid, and led to a call to stop using it immediately, said Clinch.

She’s calling on the Region of Waterloo to follow suit and stop putting hydrofluorosilicic acid into Waterloo’s water.

“The onus is on the Region of Waterloo to make sure the product they’re buying and putting into our drinking water is legally being sold in Canada,” said Clinch. “This is now a legal requirement under the Natural Health Products Regulations which is a subset of the new Food and Drug Act.

“The citizens of Waterloo deserve better than this, and they should be protected by this regulatory approval process by the highest health authority in the country, Health Canada.”

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