On 11/10/2011 9:45 AM, Pouta wrote:
> Dr. Bornfeld, first I would like to thank you for your contributions
> to this forum, they are greatly appreciated.
>
>
>>> ok, I thought maybe he was referring to CloSYS...
>>
>> I couldn't find any information about their ingredients on
>> their website -- even next to a note about "ingredients".
>
>
http://www.closys.com/our_products/ingredients.html
>
> and, from a bottle that I have :
>
> purified water, trisodium phosphate, stabilized chlorine dioxide,
> citric acid.
>
> the additional dropper of "flavor control" contains: natural mineral
> oil, peppermint oil.
>
>
>> However, it happens that at some time in the past
>> we received a sample of their rinse and toothpaste.
>> The apparent active ingredient is chlorine dioxide.
>
> when the solid phase of a compound is not stable at room temperature,
> it has to be prepared in such a way, with proper solvents, so that it
> is stable at room temperature... it is "stabilized"... so with their
> stabilized ClO2, there is something else in addition to the ClO2 that
> they are not telling us about... their formulation is patent-
> protected, which is why they won't disclose.
Actually, if it's protected there is no reason to hide the
ingredients--and to my mind significant liability if any of the
undisclosed ingredients cause any kind of adverse reactions.
When a pharmaceutical enters the approval process with the FDA, all
materials active and otherwise, solvents and excipients must be
disclosed. Once the approval process is completed disclosure of
contents is required.
If this company is not classified as a pharmaceutical it of course has
a lower regulatory burden.
>
>
>> You've got to know that since there is no specific
>> therapeutic claim, it does not require the same
>> burden of demonstrable safety and effectiveness
>> as do pharmaceuticals.
>
> "...kills 99.9% of harmful bacteria in 10 seconds..."
I'm no legal expert, so I don't know if this can be considered a
therapeutic claim. I do know that there is pending legislation to
increase regulation of all new ingredients in OTC supplements.
Specifically as to the claim of 99.9% kill of harmful bacteria, I would
love to see the specifics of how that data point was reached. There are
several intraoral antimicrobials in rinses and mouthwashes. Their
effectiveness is variable, and the whole concept of routine use of
topical antimicrobials has been called into question.
>
>
>> I have seen no research on either the safety or effectiveness
>> of chlorine dioxide when taken internally.
>
> does rinsing (without swallowing) equate to "taken internally"...?
Naturally, the amount of any substance placed in the mouth that is
actually ingested or otherwise absorbed will vary from time to time, by
use and application, and from person to person. So I don't think asking
for evidence of safety is an unfair burden.
>
>
>> I would guess (based on my rapidly diminishing residual store of
>> knowledge from my chemistry degree) that chlorine dioxide would not be
>> terribly stable. I have no reason to believe it would remain in the
>> mouth long enough to keep sulfurous compounds at bay (though meticulous
>> oral hygiene might).
>
> as an aside, similar doubts are popping up regarding alcohol in
> mouthwashes. Professor Michael McCullough (chair of the ADA's
> therapeutics committee, and associate professor of oral medicine at
> the University of Melbourne), has said that alcohol-containing
> mouthwash should be reclassified as prescription-only, and carry
> written health warnings.
>
> Prof McCullough is calling on the ADA to urgently re-assess its seal
> of approval on mouthwashes containing alcohol. "We see people with
> oral cancer, who have no other risk factors than the use of alcohol-
> containing mouthwash, so what we've done in this study is review all
> the evidence that's out there,'' he said. "If it was a facial cream
> that had the effect of reducing acne, but had a four- to five-fold
> increased risk of skin cancer, no one would be recommending it.''
This is a very old story. Alcohol has long been known to potentiate
the carcinogenic properties of tobacco in the mouth. Whether it is
carcinogenic by itself is a bit more controversial, but I agree that
there is no good reason to use an alcohol-based mouthwash.
>
>
>> Personally, I wouldn't put chlorine dioxide in my mouth.
>
> I wonder if the term "stabilized chlorine dioxide" is a misnomer,
> referring simply to sodium chlorite, not chlorine dioxide.
I wouldn't think so--that would be clearly deceptive, and would imply to
me a much greater level of risk.
There are indications for the use of sodium hypochlorite during root
canal treatment, but this is in a much more controlled environment than
an OTC rinse. Even then, there has been trouble on occasion.
Steve