And I believe this is precisely what was meant when we voted to replace the word drug “where necessary” – what was meant was “wherever it happens to occur.” I do not believe we intended to have the discussion over again for each instance where the word came up; that would be silly and would negate the purpose of taking the vote in the first place. So I believe this is a settled matter that has already been voted on, globally for wherever “drug” occurs in the AHP monographs, and the TG does not need to decide on a case by case basis what “where necessary” means. Cortex Scientific Botanicals PO Box 3316 Central Point, OR 97502 541-973-2252 office 805-459-0616 cell This email transmission, and any documents, files, and previous or subsequent e-mail messages attached to it may contain information that is confidential and/or legally privileged. Unless you are the intended recipient or authorized to receive for the intended recipient and recognized as such by the sender, you may not read, print, retain, use, copy, distribute or disclose to anyone the message or any information contained in the message. If you have received this message in error, please advise the sender by reply e-mail, and destroy the original message and all copies, including any attachments. From: Staci - CSB [mailto:staci@xxxxxxxxxxxxxxxxxxxx] Sent: Monday, February 20, 2017 6:59 AM To: 'Brooker, Rachel' <rbrooker@xxxxxxx>; 'Sidney Sudberg' <sidney@xxxxxxxxxxxx>; 'Susan Ulery' <susan.ulery@xxxxxxxxx>; 'Snider, Jason' <jsnider@xxxxxxx> Cc: 'ds_jc@xxxxxxxxxxxxxxxxx' <ds_jc@xxxxxxxxxxxxxxxxx> Subject: RE: [ds_jc] Groups - NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) uploaded Regarding use of the word “drug” - This issue of terminology has been discussed extensively in the past at these meetings and it has always been decided to remove “drug” and replace it with “powdered root” in the case of a powdered root. (I note that “herb” is not a clear description to use as a replacement for “drug” since “herb” is commonly understood to refer to aerial parts.) Most users of this monograph are not going to understand goldenseal to be a “drug.” In addition, by law and regulation it is not factually a “drug” at least in the US and Canada, although it may be a “drug” in the EU. So for clarity and to avoid factual inaccuracy it has always been decided, in every prior conversation on this topic, to remove “drug” universally and replace it with the accurate descriptors. I sincerely hope the same decision will be made in this case. Cortex Scientific Botanicals PO Box 3316 Central Point, OR 97502 541-973-2252 office 805-459-0616 cell This email transmission, and any documents, files, and previous or subsequent e-mail messages attached to it may contain information that is confidential and/or legally privileged. Unless you are the intended recipient or authorized to receive for the intended recipient and recognized as such by the sender, you may not read, print, retain, use, copy, distribute or disclose to anyone the message or any information contained in the message. If you have received this message in error, please advise the sender by reply e-mail, and destroy the original message and all copies, including any attachments. From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Brooker, Rachel Sent: Monday, February 20, 2017 5:25 AM To: Sidney Sudberg < sidney@xxxxxxxxxxxx >; Susan Ulery < susan.ulery@xxxxxxxxx >; Snider, Jason < jsnider@xxxxxxx > Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: RE: [ds_jc] Groups - NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) uploaded Good Morning Sidney, The JC voted in the last meeting to make this change where it is necessary. Part of this TG is to determine where it is necessary. Thanks, Rachel From: Sidney Sudberg [ mailto:sidney@xxxxxxxxxxxx ] Sent: Saturday, February 18, 2017 7:14 PM To: Brooker, Rachel; Susan Ulery; Snider, Jason Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] Groups - NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) uploaded Dear Rachel & Susan; Has it been agreed to change the reference to 'powdered drug' unanimously or is this under consideration? It is not uncommon, historically speaking, to use that terminology, pharmacognostically speaking, as far as I know. So, I am not sure that it should or needs to be changed, unless it is the consensus of the committee, that it should because it is what the DS Industry feels is more 'accurate'? I have one other comment, regarding the section 4.2.1 as well: "4.2.1 Sample preparation In a test tube, 0.25 g of powdered drug is extracted in an ultrasonic bath at room temperature for 30 minutes with 4 mL of a methanol and water mixture (80:20). The suspension is filtered and the residue washed twice with 2 mL methanol. The filtrate and washings are combined and brought up to volume with methanol in a 20 mL volumetric flask. One mL of the solution is transferred into a small sample vial. This is the test solution. The solution is sensitive to light and heat and shall be stored in the refrigerator in an amber vial. Hydro alcohol extracts can be applied to the plate directly. Dried extracts can be dissolved in an appropriate solvent (e.g. methanol) and stirred and applied to the plate directly." I find the use of a 20 mL volumetric flask to be an uncommon size to find & use, which could make performing this procedure difficult to reproduce exactly as written. My question is, is it necessary to reproduce exactly as written or is it acceptable to modify accordingly to accomplish the same goal? If not, then I wonder if it should be changed to something like a 25 mL vf & adjust the quantities to accomplish the same or similar concentration? Just thought I would point this out but it is certainly not a show stopper & since this is a qualitative method, it really shouldn't matter that much? Any comments? Sidney From: ds_jc@xxxxxxxxxxxxxxxxx < ds_jc@xxxxxxxxxxxxxxxxx > on behalf of Brooker, Rachel < rbrooker@xxxxxxx > Sent: Thursday, February 16, 2017 10:20:38 AM To: Susan Ulery; Snider, Jason Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: RE: [ds_jc] Groups - NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) uploaded Hi Susan, We did discuss and agree to change that in the standard at the meeting. The original ballot to approve of this version did pass and we due to ANSI’s deadline (we actually were already past it!) we had to publish the standard that passed the ballot. Now we have time to make the change from the meeting. I will be setting up a meeting to go over all the places that this change needs to happen. Thanks, Rachel From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Susan Ulery Sent: Thursday, February 16, 2017 1:07 PM To: Snider, Jason Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] Groups - NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) uploaded Hi Jason, Thanks for sending this. I noted in 4.2.1 use of "drug" to describe goldenseal, but shouldn't that be "herb"? 4.2.1 Sample preparation In a test tube, 0.25 g of powdered drug is extracted... ? Susan Ulery ? Susan H. Ulery, CEO Ph: 970-589-2707
www.assureconsulting.us On Thu, Feb 16, 2017 at 10:59 AM, Jason Snider < jsnider@xxxxxxx > wrote: Submitter's message Please note that this new document has just been published. NSF employees will be able to view this document in AESOP; others can use the link below. Thank you for your contributions to this document! -- Jason Snider Document Name : NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) Description NSF/ANSI 321-2016: Goldenseal Root (Hydrastis canadensis) Download Latest Revision Submitter : Jason Snider Group : Joint Committee on Dietary Supplements Folder : Standards Date submitted : 2017-02-16 09:59:35 Revision : 1