Is fluoridated water a medicine?

One of the predictable claims made by anti-fluoridationists is that fluoridated water is a medicine and therefore should not be imposed on the public.

It’s all semantics, of course, but some anti-fluoridationist get pretty dogmatic about it. So the people who run the Fluoride in Water* Facebook page decided to check it out with Medsafe – the New Zealand Medicines and Medical Devices Safety Authority.

Medsafe-Logo

Here’s the guts of the reply they got from the Medsafe Pharmacovigilance Team:


“A medicine is defined in S3 of the Medicines Act as:

a substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally for

a) administering to one or more human beings for a therapeutic purpose

b) use as an ingredient in the preparation of any substance or article that is to be administered to one or more human beings for a therapeutic purpose,

  • where it is so used- in a pharmacy or a hospital; or
  • by a practitioner, or registered midwife or designated prescriber, or in accordance with a standing order; or
  • in the course of any business that consists of or includes the retail sale, or supply in circumstances corresponding to retail sale, of herbal remedies;

c) use as a pregnancy test.

S4 defines the term therapeutic purpose as:

  • treating or preventing disease
  • diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition
  • and several other non-pertinent activities.

“However, Medsafe has never considered the fluoridation of water to lead to the creation of a medicine. Fluoride is found naturally in water at varying concentrations and water is not supplied for a therapeutic purpose. We consider that the principal use of water and foodstuffs (which contain minerals or fluoride) is dietary and not therapeutic. We therefore do not consider the addition of substances such as chlorine or fluoride, or alum to water to be under the remit of the Medicines Act but rather under the control of other public health and water quality legislation. A similar argument can be used in relation to quinine. While quinine is a medicinal substance, the quinine contained in a gin and tonic, no matter how therapeutic we might think consuming one may be, does not make tonic water (or gin) a medicine. This pragmatic approach to the legislation is clearly what was intended by parliament. Too rigid an interpretation quickly makes everything a potential medicine. After all we drink water to prevent dehydration which is a symptom of a disease state. This kind of over-interpretation of the wording of the legislation is not, and has never been the intention of parliament.

“Finally while we must accept that fluoride in certain concentrations and formulations is scheduled as a medicine in several schedules within the Medicines Act, the concentrations of fluoride in drinking water are well below the threshold for consideration as a medicine and so would be considered to fall within the controls of other legislation, such as water quality control etc. Fluoride is also an element and it is naturally found in a great many places, the presence of fluoride, or any other element or mineral in an item does not make the item a medicine. After all, lithium can be used as a medicine, but its presence in a lithium battery, or a paint, does not make that product a medicine.”

via Why fluoride water is not classed as a medicine under the Medicines Act – Medsafe.


* Follow that Facebook page if fluoridation interests you – it’s one of the few trying to give good scientific information and counter the misinformation that seems to be common on social communication sites like Facebook and Twitter.

For further articles on fluoridation look at the links on the Fluoridation page.
See also: Fluoridation

28 responses to “Is fluoridated water a medicine?

  1. Still censoring, I see.

    Have a look at s4 (f) of the medicines act

    4 Meaning of therapeutic purpose In this Act, unless the context otherwise requires, the term therapeutic purpose means (a) Treating or preventing disease; or (b) Diagnosing disease or ascertaining the existence, degree, or extent of a physiological condition; or (c) Effecting contraception; or (d) Inducing anaesthesia; or (e) Altering the shape, structure, size, or weight of the human body; or (f) Otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating or reducing or postponing, or increasing or accelerating, the operation of that function, or in any other way;

    Medsafe just call (f) ‘non-pertinant.’

    I’ve been to many meetings with Medsafe Officials… they quite openly admit in private that what they say publicly is for PR purposes. Just as anyone wanting to sell drinks with ‘topped up levels of minerals.’… they are required to meet dietary supplement regulation standards… if they make any claims they get hit as being medicines.

    Ron

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  2. Thanks for sharing the page Ken. I’m also trying get a similar reply from the FDA.

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  3. Yes, Ron. And I will continue to do so. The filters I have placed on your comments have radically reduced dishonest comments aimed purely at disruption by childishly repeating assertions on issues already thoroughly dealt with.

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  4. I’ve been to many meetings with Medsafe Officials… they quite openly admit in private that what they say publicly is for PR purposes.

    Names and dates or it didn’t happen.

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  5. Pingback: The Daily Blog Watch Friday 19 July « The Daily Blog

  6. I’ve been to many meetings with NASA Officials… they quite openly admit in private that what they say publicly about the moon landings is for PR purposes.
    I’ve been to many meetings with Biologists… they quite openly admit in private that what they say publicly about the “theory” of evolution is for PR purposes.
    I’ve been to many meetings with Climatologists… they quite openly admit in private that what they say publicly about global warming is for PR purposes.

    I’ve been to many meetings with geologists… they quite openly admit in private that what they say publicly about the Earth being billions of years old is for PR purposes.

    (…giggle…)

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  7. Semantics indeed. Medical ethics do not hinge on the definition of a “medicine” in NZ statutes. The justification for the addition of fluorides to drinking water is that it has therapeutic benefits – what other justification could there be? Therefore it is a medical intervention, and subject to medical ethics, which include a fundamental right to refuse treatment. Thus, fluoridation of drinking water is a violation of human rights, and should stop immediately.

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  8. Strypey, if fluoridation of water supplies is a violation of human rights then do something about it. Oh, yes, the Human Rights Commission rejects that argument. So take a court case.

    Now if we lived in one those geological zones where the source water had excess F would you consider treatment to remove the excess was a violation of your human rights? Do you consider the treatment of Hamilton’s water supply to remove excess As a violation of human rights?

    In reality the only thing that counts is public approval. If sufficient Hamilton citizens agree with your they will vote against fluoridation in the referendum. If not they will vote for it.

    It’s a democratic issue.

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  9. We’ve already been through that argument here Strypley.
    Interventions in foodstuffs and water supplies justified in terms of public health and safety are widespread and most are not regarded as medications.

    Thus, fluoridation of drinking water is a violation of human rights, and should stop immediately.

    Yeah right, along with filtration and chlorination.

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  10. “In reality the only thing that counts is public approval. If sufficient Hamilton citizens agree with your they will vote against fluoridation in the referendum. If not they will vote for it.”

    Does that mean that if a majority of Hamilton citizens vote to add LSD in the drinking water, the minority have to accept that result as “democracy”? Democracy is not majority rule. Democracy is the radical idea that no government (local, national, or global) has a right to force decisions on people without their consent. No consent, no fluoridation.

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  11. Strypey. None is suggesting (apart from you) that we add LSD to drinking water. simply that we reinstate the previous practice of correcting a deficiency of F.

    If you oppose that then get out and campaign against it.or do you prefer to take up arms and impose your own beliefs in the community?

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  12. @Ken
    The Human Rights Commission last reported on the ethical issues surrounding fluoridation in 1980, before the passage of the Bill of Rights Act, more than 30 years ago. That report is merely a 3 page summary of the pro-fluoridation position. It’s long past time for the HRC to conduct a thorough and neutral investigation into whether the claimed benefits of fluoride overrule the recognised human right to refuse medical treatment.

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  13. OK Strypey, you contact the HRC and let us know how you get on.

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  14. @Ken
    You are misrepresenting the situation with the propaganda phrase “correcting a deficiency”. Claiming that I am correcting a deficiency of LSD in the drinking water does not change the fact that I am artifically adding something that naturally is not there.

    People in Hamilton did get out and campaign against it, and won. Now central government is being called in to overrule the elected local representatives. I think you’ll find the people behind that strategy are the ones who think its ok to “impose your own beliefs in the community”.

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  15. Strypey, F is already present in our source water – it’s just there at deficient levels.

    Most Hamiltonians were completely unaware if what our Council was up to – hence the opposition to the decision and the agitation for a referendum.

    Far from imposing our views in the community supporters of the referendum were successful in their bid to give the community a say.

    I have no idea where you got the idea this has anything to do with central government – although the council did admit they did not have the skills to make such a decision and expressed their wish for it to be the responsibility of central government. However, that is just not the case at the moment.

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  16. @Ken
    “F is already present in our source water – it’s just there at deficient levels.”
    You are welcome to that view, and to address the perceived “deficient levels” of fluoride in your own drinking water using fluoridated toothpaste or fluoride tablets. You have no right to impose your opinion about the correct level of fluoride in the water on me, or anyone else, by having it artifically added to drinking water at source. It doesn’t matter that you believe that higher levels of fluoride are “for your own good”, any more than it matters if I believe a dose of LSD would be “for your own good”. You don’t have the right to impose your beliefs on others in the community any more than I do.

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  17. You don’t have the right to impose your beliefs…

    Science is not a religion.
    Nothing to do with belief.

    …any more than it matters if I believe a dose of LSD…

    Nobody is talking about LSD except you. It’s silly.

    The “Straw Man” Fallacy

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  18. Cedric:
    “Science is not a religion. Nothing to do with belief.”

    While studying science at university, I was taught that honest scientists acknowledge they are human, and thus subject to confirmation bias. When any position – such as drinking water having “deficient levels” of fluoride – is presented as an inviolable truth, this is “science” as religion. Using select scientific findings as justification does not make such dogma scientific, any more than it does when Intelligent Design folks do it.

    Most philosophers of science now acknowledge that science cannot prove things, only disprove them (by the law of non-contradiction). Thus science cannot prove that fluoridation is useless or harmful, any more than it can prove it is beneficial or safe. It can disprove any of these propositions, merely by presenting evidence of an observation that does not fit the theory (confirming the null hypothesis).

    Thus, anti-fluoridation scientists like chemistry professor Paul Connett do not need to produce a larger volume of studies than their well-funded pro-fluoridation opponents, they simply need to provide one irrefutable study showing a lack of beneficial effect, or a illness not present in non-fluoridated areas. Which they have done many times over. Science, understood properly and practiced correctly, is not a religion. Pro-fluoridation which shouts down disconfirming evidence of its dogma is religion.

    By the way Cedric, an analogy is not the same as a strawman. Let me explain. One can prove by empirical observation that the level of fluoride is lower or higher in one sample of water in comparison with another sample, and with sufficient sampling, make an educated extrapolation to the water source as a whole. On the other hand, whether higher levels are “pollution” or lower levels “deficiency” is a matter of opinion, not a self-evident fact. When considered in combination with the point above, it’s more reasonable to characterize high fluoride levels as “pollution” but it remains an opinion.

    Finally, on the subject of the Human Rights Commission, this is a body with a specific scope, and limited funding. I checked the range of matters they investigate. Medical ethics are not among them. Therefore, by bring the HRC into the discssion, it is Ken who is slaughtering a strawman:
    http://www.hrc.co.nz/enquiries-and-complaints-guide/what-can-i-complain-about/disability

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  19. Danyl, read a few of my articles in my blog and you will see that I often discuss the fact that scientists are human, just as prone to confirmation bias as other people. But I do argue that interaction with reality, testing ideas and hypotheses against reality, together with sceptical consideration of colleagues, helps to overcome (but never completely of course) confirmation bias.

    Who the hell is presenting anything as inviolable truth around here – certainly not me – check my comments about testing against reality? You are just creating a straw man – an inappropriate one.

    You are completely wrong to claim that all it takes is “one irrefutable study showing a lack of beneficial effect” – although I guess the key word is “irrefutable.” And that’s the problem because by cherry picking its easy to find studies which can be used to claim no beneficial effect. The anti-fluoridationists are doing it all the time.

    And Connett is not seen as reputable or even a careful scientists. Just have a look at this refutation of his simplistic arguments Response to a list of “50 Reasons to Oppose Fluoridation”

    compiled by Dr Connett* – http://www.health.govt.nz/system/files/documents/pages/response-50-reasons-oppose-fluoridation.pdf

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  20. “Thus, intelligent design scientists from the Discovery Institute such as Charles B Thaxton do not need to produce a larger volume of studies than their well-funded pro-evolution opponents, they simply need to provide one irrefutable study showing a missing link, or a species with no known progenitor.”

    You’re dead right Cedric, it’s child’s play.

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  21. @Richard
    There are a number of facts which are not explained by the current model of evolution (dependent as it is on the dogma of genetic determinism which has also been disconfirmed by many studies), but “intelligent design” responds to this with a ‘black and white fallacy’, pretending that if the current model of evolution is in any way incomplete, then creationism – a theory disconfirmed by *most* of the available evidence – must therefore be true. This is equivalent to responding to the observations that led to relativity and quantam mechanics by returning to the Earth-centric solar system, and abandoning Newtownian mechanics. The appropriate scientific approach, is to begin work on a new theory, which explains *both* the repeatable observations that gave rise to the traditional theory, and those which disconfirm with it.

    Ken:
    >> And that’s the problem because by cherry picking its easy to find studies which can be used to claim no beneficial effect. <<

    This sentence illustrates exactly the problem I describe in my response to Cedric. If there is one study, free from methodological flaws (eg small sample size, inconsistent testing, failure to account for uncontrollable variables etc), which shows the same number of caries across otherwise similar fluoridated and non-fluoridated populations, then it disconfirms the hypothesis that fluoridation is effective at reducing caries. Regardless of how many other studies have been constructed to confirm that hypothesis.

    My point is that it is not the *volume* of studies that is important. It is whether or not a testable and repeatable observation has been recorded in any study, which cannot be explained by the theory. Reviews like those you linked (none of which reference any studies less than 10 years old) use creative statistics to explain away observable evidence of fluoride-related harm, and evidence of non-fluoridated populations experiencing the same reduction in caries as fluoridated areas. They then conclude that the 'weight of evidence' supports fluoridation as a practice, and leave it to the blogopshere to assasinate the character of anyone who challenges this conclusion or the methodology it's based on. This is poor public policy based on poor science.

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  22. Strypey, this is an old post.

    Nevertheless, you are wrong about evolution. Evolutionary science does not depend on “genetic determinism” at all.

    All theories have areas where they are incomplete – it’s part of the provisional nature of scientific knowledge. It also keeps scientists in a job. Perfectly normal and we don’t throw theories out because of it – we usually improve them as we find more details and obtain new knowledge.

    You are also completely wrong about the idea of a single study overturning the results of all others, just because it fits your own biases. You are just attempting to justify you anti-science, anti-fluoridation, position and resistance to objective and verified information with a bit of naive mental gymnastics.

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  23. “While studying science at university, I was taught that honest scientists acknowledge they are human, and thus subject to confirmation bias. When any position – such as NASA putting men on the moon – is presented as an inviolable truth, this is “science” as religion. Using select scientific findings as justification does not make such dogma scientific, any more than it does when Intelligent Design folks do it.”

    “If there is one study, free from methodological flaws (eg small sample size, inconsistent testing, failure to account for uncontrollable variables etc), which shows that the Earth is flat, then it disconfirms the hypothesis that the Earht is round. Regardless of how many other studies have been constructed to confirm that hypothesis.”

    Thus, anti-fluoridation scientists like chemistry professor Paul Connett…

    No, stop it.
    I don’t give a dry turd about Connett.
    Your ham-fisted name dropping will not work.
    A Chemistry Professor? Why heavens to Betsy!!!
    (…fart…)
    Science is not about personalites.
    I don’t care about Duesberg or Wakefied or Bill Kaysing or Jim Berkland or Duane Gish either.
    Reality is not your friend.

    Moon Landing Hoax – Wires Footage

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  24. @Ken
    “Strypey, this is an old post.”

    It takes time to carry on a debate that goes beyond merely presenting ideological positions. We are just starting to discuss methods and definitions, and then perhaps we can proceed to evidence. Are you telling me you consider the debate over before it has even begun in earnest?

    “You are also completely wrong about the idea of a single study overturning the results of all others, just because it fits your own biases”

    If I’d argued that I would certainly be wrong, but I didn’t and you are slaughtering strawmen. Let me explain by analogy. If my waterproof coat leaks once, that conclusively proves it is not waterproof. It doesn’t matter how many times it has not leaked in the past. This single study would overturn the results of all others. I can’t demand that you prove it *is* waterproof before I buy it from you – that’s not possible – but I can return it after getting wet and demand my money back, because I have falsified your claim, and I can prove it by letting you or a neutral third party feel the wet inside of the coat.

    “All theories have areas where they are incomplete – it’s part of the provisional nature of scientific knowledge. It also keeps scientists in a job. Perfectly normal and we don’t throw theories out because of it – we usually improve them as we find more details and obtain new knowledge.”

    Yes, this is precisely what I am saying. But part of this process, as documented by Thomas Kuhn in “The Structure of Scientific Revolutions” is the paradigm shift, when the improved version of the theory, adapted to the new observations, is ignored and shouted down for a generation because it is so different from the old theory, which every knows is what “science says”. Sound familiar?

    You may remember that this was the process by which, for example, climate science gradually came around to the idea of the weather as a chaotic system, and carbon/greenhouse induced climate change as a real phenomenon. Turns out the hippies were right on that one. Who would have thought?

    Calling people who challenge current scientific theory “anti-science” is analagous to calling USAmercians who criticize their government “anti-democratic”. In each case the criticism is being made by someone who profoundly misunderstands the cherished thing they are defending.

    Oh and BTW
    @Cedric
    “…just because it fits your own biases. You are just attempting to justify you anti-science, pro-fluoridation, position and resistance to objective and verified information with a bit of naive mental gymnastics.”

    Two can play at ‘twisting the other person’s words around’ rhetoric games. It doesn’t really contribute much to a scientific debate though.

    Thanks for the exchange of opinions. I’ll be sure to turn out lights out on my way out…

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  25. Let me explain by analogy.

    Please don’t.
    Arguments from analogy when done by creationists are so very boring and stupid. You are not going to fare any better.
    Stick to the science.

    But part of this process, as documented by Thomas Kuhn in “The St..

    Oh do fuck off. Spare me the cliches. If I had a dollar for every idiot dressing up their anti-science opinion by using the word “Quantum” or invoking Kuhn or Einstien or whoever, I’d be quite a lot richer.
    Stick to the science. Never mind the name dropping.
    All the re-examining of what science “really” is won’t help you at all.
    You have shit.
    You pontificate because you can’t defend your position on fluoride.

    @Cedric
    “…just because it fits your own…

    That was Ken, you halfwit.

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  26. If Fluoride is a medication and no one prescribed to me (that it is added in tap water), it is a CRIME. I did say to the government but no answer.
    The majority of people don’t have option of correct dosage!
    “The individual is handicapped by coming face with a conspiracy so monstrous; he cannot believe it exists.” — J. Edgar Hoover, Former Head of FBI

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  27. Did you not read the article, Avanti.

    Fluoride is not a medicine – any more than iodine, selenium iron, etc., etc. These are beneficial elements. Iodine, selenium and iron are not prescribed to you either.

    While there a recommended minimum and maximum intakes – there is no question of “dose.” Provided intake is within the recommended limits (as is also the case for ion, selenium, iodine, etc.) things are OK.

    Only the ideologically and commercially motivated anti-fluoride campaigners are resorting to describing community water fluoridation as a medicine. It isn’t.

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  28. David Fierstien

    I found this while exploring the internet:

    “Disclaimer: This drug has not been found by FDA to be safe and effective . . ”

    A drug? Unapproved by the FDA? Not found to be safe? Where have I heard this before? We are, of course, talking about oxygen. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5c319c6e-c089-49ec-9470-2126d2a99962&type=display

    Like

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