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Gnosis's Extrafolate products (Thorne): misinformation and mislabeling.

Discussion in 'Detox: Methylation; B12; Glutathione; Chelation' started by Xara, Mar 26, 2013.

  1. Xara

    Xara Senior Member

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    Gnosis has been ordered by the US District Court for the Southern District of New York to correct previous mislabeling and misinformation.

    "Extrafolate is not a substantially Pure 6S Isomer Product."

    The Extrafolate products (Extrafolate-S and Extrafolate) turn out to be a Mixture product that consists of appr. 50% of the 6R and 50% of the 6S isomers of methyltetrahydrofolate. 6S is the active isomer, 6R is an unnatural isomer that provides no nutritional benefit.
    See for yourself what the CEO of Gnosis said (dated March 4, 2013):
    http://www.gnosis-bio.com/pdf/Letter_Engredia_2013 04-03-2013.pdf

    As far as I know Gnosis's Extrafolate-S is used in Thornes 5-MTHF 1 mg.

    Perhaps it's not such a good idea to use that product:

    Folate racemic MTHFR and folinic may be dangerous, according to the writer of this blog:
    "The 6R type of folates do NOT occur in our bodies naturally and are stored in the liver. They INHIBIT natural folate (the 6S type of MTHF is inhibted by the 6R type and BOTH types are stored in the liver when taking these racemic supplements. The 6R type appears to be HARDER for the body to dispose of and there appears to be NO known function to it..but it DOES inhibit by blocking the real folate (the 6S type) from being used."
    Source:
    http://tealady-health.blog.co.uk/20...-mthfr-and-folinic-may-be-dangerous-11203372/

    I got that last link via MTHFR.net:
    http://mthfr.net/forums/topic/5-mthf-vs-l-5-mthf/
    Dr. Ben Lynch, about the link to that article on racemic forms of methylfolate:
    "I merely am showing it to you as it may actually be useful – or it may be totally worthless."

    Since this all isn't exactly my area of expertise, I'd like to second that.
    alex3619 and Valentijn like this.
  2. dbkita

    dbkita Senior Member

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    I would personally avoid a racemic mixture. Given the Merck patent on methylfolate, the Gnosis stuff always seemed fishy to me.
  3. ahmo

    ahmo Senior Member

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    Thank you Xara. Happily I'm using Nutricology, but I'll have to look into this now.
  4. adreno

    adreno 3% neanderthal

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    Well, there differences between their Extrafolate, Extrafolate-S and Quatrefolic:

    http://www.gnosis-bio.com/reduced-folates.php
  5. dbkita

    dbkita Senior Member

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    You are right. There is a distinction. And guess what the marketing when I originally looked before was so confusing I did not even know that :)

    The FDA has granted permission for quatrefolic as a novel entity since it is a different salted version of the S-enantiomer. So I guess that is how they got around the patent. Patent busting is actually not uncommon in the pharmaceutical (i.e. sadly my) industry. The FDA grants a lot of things nowadays that are very similar in therapeutic effect and chemical makeup. Not surprising since the number of novel clinical entities has dropped and plateaued the lst decade due to various bottlenecks.


    That being the company said they claim improved stability and solubility and I honestly never took time to investigate those claims. Seemed to me though the other existing variants were sufficient. Again my initial reaction was skeptical only in that I know for some compounds isolating the specific enantiomer is a pain in the you know what. Merck solved it for a different salted variant, had the patent and others who licensed it simply repeated the steps. Even though they may seem 'evil' as a big pharma, I trust the medicinal chemistry and formulation at a big pharma. That is their bread and butter.

    Looks like my concerns were at least justified in the Extrafolate variants. I am sure we all have had challenges making decisions on which brand or which company when deciding to purchase. Sometimes it comes down to gut instinct which is just as often wrong as it was right.

    How have people's reaction been to Quatrefolic? Anyone tried it who wants to comment?
  6. adreno

    adreno 3% neanderthal

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    I have tried quatrefolic, though it is hard for me to discern differences. I would say that metafolin feels more calming, whereas quatrefolic makes me more hyper, unstable or hypokalemic. Perhaps it is placebo. Or perhaps quatrefolic is really more potent. Also, I'm taking the metafolin sublingually, so there might be a difference there.
  7. dbkita

    dbkita Senior Member

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    I wonder how much of the metafolin you are taking as a sublingual actually gets through the oral cavity lining or instead slowly crawls down through the endothelial tissues lining the esophagus and gut. I bet you absorb the whole thing. No doubt. I just wonder if you are turning it into a sort of slower release process? But you are right the more hypokalemic suggests it may be more stable. Not sure why the solubility was big deal though. The Metafolin type variants are supposed to be well absorbed (provided you don't collide with ascorbic acid for example).
  8. dbkita

    dbkita Senior Member

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    One thing bugs me though.

    Check this link:
    http://www.pureformulas.com/best-fu...les-by-doctors-best.html#sthash.hFFGOzg3.dpbs

    Notice the following on the label:

    "Amount Per Serving %DV
    (6S)-5-MethylTetraHydroFolate (MTHF) 400mcg 100%
    (elemental, as 800 mcg [6S]-5-Methyltetrahydrofolic acid, glucosamine salt"

    My concern is they say 400 mcg elemental as 800 mcg ([6S]-5-Methyltetrahydrofolic acid, glucosamine salt).


    I added the parentheses for clarification. But the molecular masses of the left and right molecules in parentheses are not equal. Nor are they a whole number ratio. Ergo even if more than one glucosamine per molecule why the exact factor of two drop in amount? Maybe Doctor's best mislabeled. Little peculiar. Probably bears some investigation down the road.

    And yes you are right Extrafolate S should be ok.
  9. adreno

    adreno 3% neanderthal

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    Yeah, the Thorne product contains Extrafolate-S, so this should be ok. But since Extrafolate-S in an S isomer calcium salt, how is it different from Metafolin?
  10. dbkita

    dbkita Senior Member

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    Probably isn't. Depends only on manufacturing standards really (i.e. could only tell difference in an HPLC or mass spectrometer). There multiple outfits that rebrand the the Merck calcium salted variant.
  11. cph13

    cph13 Senior Member

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    8-} OK U genius's. I take Solgar but it seems Dr.'s Best is cheaper sooooooooooo.....can I switch? Gosh you people are just brilliant and MOSTLY "over my head"
    Happy Healing and
    Hugs
  12. cph13

    cph13 Senior Member

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    Xara thanks for all your careful "watching out for us". It gets the rest of the genius's going.
  13. Xara

    Xara Senior Member

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    You're welcome, ahmo! How are you doing lately by the way?
  14. Xara

    Xara Senior Member

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    adreno
    If you ask me, the letter of Gnosis applies to Extrafolate AND Extrafolate-S.
    When you look at the page
    http://www.gnosis-bio.com/reduced-folates.php
    and you click on Quatrefolic, on Extrafolate and on Extrafolate-S, you'll see that both Extrafolate and Extrafolat-S contain this message:

    "Please click here to see an important notice about Gnosis's EXTRAFOLATE Products"
    Quatrefolic does not have that message.

    When clicking, you'll get the letter.
    In the letter Gnosis says that between 2006 and 2009 they improperly used the terms [6S]-5-methyltetrahydrofolate and L-5-Methyltetrahydrofolate to describe its Mixture Product.

    So having a Thorne label on a website that says L-5-Methyltetrahydrofolate (Extrafolate-S) does not quite convince me.

    cph13,
    based on the announcement of Gnosis, Gnosis's letter, I think the Quatrefolic is ok, so Dr's Best Quatrefolic should be ok, but since the label seems to be awkard to a well-known local genius I'm glad I'm using Solgar... :)
    cph13 likes this.
  15. adreno

    adreno 3% neanderthal

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    As I understand it, Gnosis mislabeled Extrafolate as a non-racemic mix, whereas only Extrafolate-S is non-racemic. Where that leaves Gnosis' credibility I don't know. I would personally stick to either Metafolin or Quatrefolic.

    And thank you for the kind words. I wish a was actually a genius, though ;)
    cph13 likes this.
  16. Xara

    Xara Senior Member

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    Umm, I guess these thanks are directed cph13...
    If not they should be! *sternly like a school teacher*

    Me, I was only referring to that OTHER (yes, now I HAVE included you!) well-known local genius. :)
    Cheerio adreno.
    cph13 likes this.
  17. adreno

    adreno 3% neanderthal

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    Yeah, dbkita knows his stuff :)
  18. cph13

    cph13 Senior Member

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    I will stick with what I'm taking....no reason to upset the applecart for a few bucks. It does get expensive though.
  19. Freddd

    Freddd Senior Member

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    This has been educational, thank you all. I had been bothered by all these things on labels others mention so I have not yet considered a trial. Right now while CNS healing is on I certainly would not do anything that might interrupt it in any case. I would of course be interested in hearing of results. One of the requirements of Merck in regard to their Metafolin product is that they require the vitamin Metafolin to meet all the standards of the prescription product except for dose per pill. So one can be sure of pharmacokinetics etc. matching that claimed in the Deplin etc. studies.
  20. Lotus97

    Lotus97 Senior Member

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    The person who wrote that blog revised their original stance of folinic acid possibly being bad:

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