Versa 1 in PCT

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  1. Quote Originally Posted by USPlabsRep View Post
    That's new draft GUIDANCE dumbass...Do you know the meaning of "draft"....That's new draft GUIDANCE dumbass...Do you know the meaning of "draft"....As a supplement consumer and you seem like a bright ****er, you would understand that if the DRAFT guidance was passed the supplement industry is dead.Are you in favor of that?
    My statement was based on current letter of law revisions to the FDCA made by DSHEA. Requirements being that a product meet one of the two following requirements:
    1. The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
    2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
    Hence my questions over whether you have found Aegeline in Bael Tree *Fruits*, as that is the only part of the plant that the USDA records as being found in the US food supply, and Aegeline was only found at ~2000 ppm in the *leaves* of Aegle Marmelos. And again, just as with the letter you got over DMAA, the FDA would certainly not consider synthetic Aegeline to fit into the definition of dietary ingredient.

    Also, how does citicoline meet ingredient requirements?

    It looks like you're going for satisfying requirement one which is where it seems that you fall short if the FDA were to actually take notice and investigate you.

    You could probably file an NDI on the ingredient and be totally fine if you elected to go for requirement two and you used safety data citing all of your human testing to show that Aegeline on its own does not show any of the negative effects possible with Aegle Marmelos leaves as a whole.

    ---

    As for the draft guidance for NDIs, the FDA certainly overstretched a lot, but that was probably tactical on their part so they can come out with a more reasonable but still more restrictive than current law notice later this year (the revision is in progress...not sure on an ETA for release). But that's sort of my point in all of this. The FDA doesn't have to convince all of us in the fitness world that what they are doing is best. They just have to be able to show the general public 'hey look at these shady supplement companies putting you in danger, what we're doing is totally justified'


  2. Your work for the FDA or something?
    Black Lion Representative
    I'm a Brooklyn boy I may take some gettin' use to
    •   
       


  3. Quote Originally Posted by halfhuman View Post
    Your work for the FDA or something?
    Was thinking this myself.
    PEScience Representative
    http://www.pescience.com/insider
    Instagram: kylebayne23

  4. Quote Originally Posted by halfhuman View Post
    Your work for the FDA or something?
    lol right? why would someone care that much unless you're affiliated with the supplement industry
    Controlled Labs Board Rep
    [email protected]
    CONTROLLED LABS products are produced in a GMP for Sport certified facility.

  5. Quote Originally Posted by De__eB View Post
    My statement was based on current letter of law revisions to the FDCA made by DSHEA. Requirements being that a product meet one of the two following requirements:

    Hence my questions over whether you have found Aegeline in Bael Tree *Fruits*, as that is the only part of the plant that the USDA records as being found in the US food supply, and Aegeline was only found at ~2000 ppm in the *leaves* of Aegle Marmelos. And again, just as with the letter you got over DMAA, the FDA would certainly not consider synthetic Aegeline to fit into the definition of dietary ingredient.

    Also, how does citicoline meet ingredient requirements?

    It looks like you're going for satisfying requirement one which is where it seems that you fall short if the FDA were to actually take notice and investigate you.

    You could probably file an NDI on the ingredient and be totally fine if you elected to go for requirement two and you used safety data citing all of your human testing to show that Aegeline on its own does not show any of the negative effects possible with Aegle Marmelos leaves as a whole.

    ---

    As for the draft guidance for NDIs, the FDA certainly overstretched a lot, but that was probably tactical on their part so they can come out with a more reasonable but still more restrictive than current law notice later this year (the revision is in progress...not sure on an ETA for release). But that's sort of my point in all of this. The FDA doesn't have to convince all of us in the fitness world that what they are doing is best. They just have to be able to show the general public 'hey look at these shady supplement companies putting you in danger, what we're doing is totally justified'
    Well you said it...

    The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered;

    exactly!

  6. Quote Originally Posted by kbayne View Post
    Was thinking this myself.

    Well he did say he emailed the FDA about this...pretty low if you ask me.

    What do they say in streets....Snitches get _____?

    Nothing worst then a snitch....

  7. Lets get him! I'm from Brooklyn. We don't that lightly son
    Black Lion Representative
    I'm a Brooklyn boy I may take some gettin' use to

  8. Quote Originally Posted by USPlabsRep View Post
    Well he did say he emailed the FDA about this...pretty low if you ask me.

    What do they say in streets....Snitches get _____?

    Nothing worst then a snitch....
    I only emailed the FDAs docket reading room in Maryland, just to ask if they had received an NDI, since there is some backlog to when they post notices to the federal register.

    It's not like I emailed Novitzky and asked him to give you the FDA raid treatment.

  9. Quote Originally Posted by De__eB View Post

    I only emailed the FDAs docket reading room in Maryland, just to ask if they had received an NDI, since there is some backlog to when they post notices to the federal register.

    It's not like I emailed Novitzky and asked him to give you the FDA raid treatment.
    Dude, just give it up.
    PEScience Representative
    http://www.pescience.com/insider
    Instagram: kylebayne23

  10. Quote Originally Posted by kbayne View Post
    Dude, just give it up.
    Were you planning to contribute anything to the conversation at some point or would that require you to think too much?
    •   
       


  11. Quote Originally Posted by De__eB View Post

    Were you planning to contribute anything to the conversation at some point or would that require you to think too much?
    Not my job to bud. Just trying to say you are attacking companies. You just did to PES also. And I don't see anyone else on your side.
    PEScience Representative
    http://www.pescience.com/insider
    Instagram: kylebayne23
  

  
 

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