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Re: Boyd Haley letter about OSR

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  • andrewhallcutler
    ... And with many other issues. However, despite some technical disagreements with Dr. Haley I do not wish him ill and do not wish the FDA to do its usual
    Message 1 of 5 , Jul 1, 2010
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      --- In Autism-Mercury@yahoogroups.com, TJ Werth <tj_werth@...> wrote:
      >
      > Andy advises against OSR. It is a chelator without a known or published half-life, so it can't be dosed properly.
      > TJ

      And with many other issues.

      However, despite some technical disagreements with Dr. Haley I do not wish him ill and do not wish the FDA to do its usual thing and not let people decide what to take for themselves.

      However, the law is on the FDA's side and they are enforcing it, which is their job.

      >
      > Fwd:
      >
      > >From Boyd re OSR#1 to Chicago Tribune
      > The FDA have extended
      > our time to respond in detail until the end of July and implied that
      > they are willing to work with us on this issue.

      Good. I wish him the best of luck.

      >looking at the structure of OSR it is easily seen that it
      > contains a benzoate group (found in cranberries) and two cystamines (a
      > metabolite of cysteine and found in all mammalian cells and on the
      > terminal end of Coenzyme-A). The coupling of cystamine to benzoate is
      > through the same type of amide linkage found in connecting amino acids
      > to produce protein.
      >
      > The FDA description of a dietary supplement as extracted from their
      > letter is: To be a dietary supplement, a product must, among other
      > things, "bear [ ] or contain [ ] one or more...dietary ingredients" as
      > defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).
      > Section 20 1(11)( 1) or the Act defines "dietary ingredient" as a
      > vitamin, mineral, amino acid, herb or other botanical, or dietary
      > substance for use by man to supplement the diet by increasing the total
      > dietary intake. or a concentrate, metabolite, constituent, extract or
      > combination of any dietary ingredient from the preceding categories.
      > Using this description it is obvious to a biochemist that OSR#1 bears
      > and contains two dietary ingredients.



      Ummmmm.....

      I will be very surprised if this is legally operative. I would naively think the law applies to mixtures, not chemical combinations.

      However, I am sure the law is well defined and I wish Dr. Haley the best in his negotiations with the FDA.

      Andy

      http://www.noamalgam.com/index.html
      Amalgam Illness: Diagnosis and Treatment

      http://www.noamalgam.com/hairtestbook.html
      Hair Test Interpretation: Finding Hidden Toxicities

      http://www.noamalgam.com/nourishinghope.html
      Nourishing Hope for Autism: Nutrition Intervention for Healing Our Children

      http://www.noamalgam.com/biologicaltreatments.html
      Biological Treatments for Autism and PDD
    • truthwinsnow
      I don t care much about OSR #1 in particular. However, I am concerned that FDA is going overdrive on dietary supplements (many of them are safe) while allowing
      Message 2 of 5 , Jul 6, 2010
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        I don't care much about OSR #1 in particular.

        However, I am concerned that FDA is going overdrive on dietary supplements (many of them are safe) while allowing proven harmful drugs like Avandia. Furthermore, what can we do if FDA make ALA also a drug?

        regards,
        Ragha


        --- In Autism-Mercury@yahoogroups.com, "andrewhallcutler" <AndyCutler@...> wrote:
        >
        >
        >
        > --- In Autism-Mercury@yahoogroups.com, TJ Werth <tj_werth@> wrote:
        > >
        > > Andy advises against OSR. It is a chelator without a known or published half-life, so it can't be dosed properly.
        > > TJ
        >
        > And with many other issues.
        >
        > However, despite some technical disagreements with Dr. Haley I do not wish him ill and do not wish the FDA to do its usual thing and not let people decide what to take for themselves.
        >
        > However, the law is on the FDA's side and they are enforcing it, which is their job.
        >
        > >
        > > Fwd:
        > >
        > > >From Boyd re OSR#1 to Chicago Tribune
        > > The FDA have extended
        > > our time to respond in detail until the end of July and implied that
        > > they are willing to work with us on this issue.
        >
        > Good. I wish him the best of luck.
        >
        > >looking at the structure of OSR it is easily seen that it
        > > contains a benzoate group (found in cranberries) and two cystamines (a
        > > metabolite of cysteine and found in all mammalian cells and on the
        > > terminal end of Coenzyme-A). The coupling of cystamine to benzoate is
        > > through the same type of amide linkage found in connecting amino acids
        > > to produce protein.
        > >
        > > The FDA description of a dietary supplement as extracted from their
        > > letter is: To be a dietary supplement, a product must, among other
        > > things, "bear [ ] or contain [ ] one or more...dietary ingredients" as
        > > defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).
        > > Section 20 1(11)( 1) or the Act defines "dietary ingredient" as a
        > > vitamin, mineral, amino acid, herb or other botanical, or dietary
        > > substance for use by man to supplement the diet by increasing the total
        > > dietary intake. or a concentrate, metabolite, constituent, extract or
        > > combination of any dietary ingredient from the preceding categories.
        > > Using this description it is obvious to a biochemist that OSR#1 bears
        > > and contains two dietary ingredients.
        >
        >
        >
        > Ummmmm.....
        >
        > I will be very surprised if this is legally operative. I would naively think the law applies to mixtures, not chemical combinations.
        >
        > However, I am sure the law is well defined and I wish Dr. Haley the best in his negotiations with the FDA.
        >
        > Andy
        >
        > http://www.noamalgam.com/index.html
        > Amalgam Illness: Diagnosis and Treatment
        >
        > http://www.noamalgam.com/hairtestbook.html
        > Hair Test Interpretation: Finding Hidden Toxicities
        >
        > http://www.noamalgam.com/nourishinghope.html
        > Nourishing Hope for Autism: Nutrition Intervention for Healing Our Children
        >
        > http://www.noamalgam.com/biologicaltreatments.html
        > Biological Treatments for Autism and PDD
        >
      • nancy cook
        My sentiments exactly.  Like someone very wise once said, Why worry about the speck in your neighbors eye and miss the log in your own?   Case in point: 
        Message 3 of 5 , Jul 6, 2010
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          My sentiments exactly.  Like someone very wise once said,"Why worry about the speck in your neighbors eye and miss the log in your own?"  Case in point:  FDA

          nancy j



          a child is diagnosed with

          asd every 20 seconds

          --- On Tue, 7/6/10, truthwinsnow <raghavendrapb@...> wrote:

          From: truthwinsnow <raghavendrapb@...>
          Subject: [Autism-Mercury] Re: Boyd Haley letter about OSR
          To: Autism-Mercury@yahoogroups.com
          Date: Tuesday, July 6, 2010, 11:41 AM







           









          I don't care much about OSR #1 in particular.



          However, I am concerned that FDA is going overdrive on dietary supplements (many of them are safe) while allowing proven harmful drugs like Avandia. Furthermore, what can we do if FDA make ALA also a drug?



          regards,

          Ragha



          --- In Autism-Mercury@yahoogroups.com, "andrewhallcutler" <AndyCutler@...> wrote:

          >

          >

          >

          > --- In Autism-Mercury@yahoogroups.com, TJ Werth <tj_werth@> wrote:

          > >

          > > Andy advises against OSR. It is a chelator without a known or published half-life, so it can't be dosed properly.

          > > TJ

          >

          > And with many other issues.

          >

          > However, despite some technical disagreements with Dr. Haley I do not wish him ill and do not wish the FDA to do its usual thing and not let people decide what to take for themselves.

          >

          > However, the law is on the FDA's side and they are enforcing it, which is their job.

          >

          > >

          > > Fwd:

          > >

          > > >From Boyd re OSR#1 to Chicago Tribune

          > > The FDA have extended

          > > our time to respond in detail until the end of July and implied that

          > > they are willing to work with us on this issue.

          >

          > Good. I wish him the best of luck.

          >

          > >looking at the structure of OSR it is easily seen that it

          > > contains a benzoate group (found in cranberries) and two cystamines (a

          > > metabolite of cysteine and found in all mammalian cells and on the

          > > terminal end of Coenzyme-A). The coupling of cystamine to benzoate is

          > > through the same type of amide linkage found in connecting amino acids

          > > to produce protein.

          > >

          > > The FDA description of a dietary supplement as extracted from their

          > > letter is: To be a dietary supplement, a product must, among other

          > > things, "bear [ ] or contain [ ] one or more...dietary ingredients" as

          > > defined in section 20 I (11)( I) of the Act, 21 U.S.c.§ 321 (ff)( I).

          > > Section 20 1(11)( 1) or the Act defines "dietary ingredient" as a

          > > vitamin, mineral, amino acid, herb or other botanical, or dietary

          > > substance for use by man to supplement the diet by increasing the total

          > > dietary intake. or a concentrate, metabolite, constituent, extract or

          > > combination of any dietary ingredient from the preceding categories.

          > > Using this description it is obvious to a biochemist that OSR#1 bears

          > > and contains two dietary ingredients.

          >

          >

          >

          > Ummmmm.....

          >

          > I will be very surprised if this is legally operative. I would naively think the law applies to mixtures, not chemical combinations.

          >

          > However, I am sure the law is well defined and I wish Dr. Haley the best in his negotiations with the FDA.

          >

          > Andy

          >

          > http://www.noamalgam.com/index.html

          > Amalgam Illness: Diagnosis and Treatment

          >

          > http://www.noamalgam.com/hairtestbook.html

          > Hair Test Interpretation: Finding Hidden Toxicities

          >

          > http://www.noamalgam.com/nourishinghope.html

          > Nourishing Hope for Autism: Nutrition Intervention for Healing Our Children

          >

          > http://www.noamalgam.com/biologicaltreatments.html

          > Biological Treatments for Autism and PDD

          >

























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