Joint Committee on Dietary Supplements

Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866   Attachment: DS-2018-1 Enzymes - 173i75.docx Description: DS-2018-1 Enzymes - 173i75.docx Attachment: CRN ETA Best Practices Guide for Enzyme Dietary Supplement Products Supporting Docuemnt for 173i75 Enzymes.pdf Description: CRN ETA Best Practices Guide for Enzyme Dietary Supplement Products Supporting Docuemnt for 173i75 Enzymes.pdf Attachment: DS-2018-2 Protein - 173i76.docx Description: DS-2018-2 Protein - 173i76.docx Attachment: DS-2018-3 Formulation - 173i77.docx Description: DS-2018-3 Formulation - 173i77.docx Attachment: DS-2018-4 Location of tables 8.1 through 8.4 - 173i78.docx Description: DS-2018-4 Location of tables 8.1 through 8.4 - 173i78.docx

Hi, I have a concern regarding DS-2018-3. Without brushing up on naturally occurring constituents vs. added ingredients, I believe that current federal regulations provide leeway from requiring a 100% of label claim via testing for good reason. We may need some discussion about what those good reasons are. I have no concerns at the moment for the remaining three going to ballot. Thank you, Steven -- Dentali Botanical Sciences On Wed, Apr 25, 2018 at 9:13 AM, Brooker, Rachel < rbrooker@xxxxxxx > wrote: Hello Everyone,  Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.  Best Regards, Rachel  Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866 Â

?This is an older guidance and some label regs have changed. What has not changed are the rules around Class I nutrients and Class II nutrients. Vitamin C in powdered rose hip capsules would be class II because of natural variability. Vitamin C in a formulated multi-vite to which ascorbic acid has been added would be class I. Sent from my BlackBerry 10 smartphone. From: Steven D Sent: Thursday, April 26, 2018 8:55 PM To: Brooker, Rachel Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] DS JC New Issue Papers Hi, I have a concern regarding DS-2018-3. Without brushing up on naturally occurring constituents vs. added ingredients, I believe that current federal regulations provide leeway from requiring a 100% of label claim via testing for good reason. We may need some discussion about what those good reasons are. I have no concerns at the moment for the remaining three going to ballot. Thank you, Steven -- Dentali Botanical Sciences On Wed, Apr 25, 2018 at 9:13 AM, Brooker, Rachel < rbrooker@xxxxxxx > wrote: Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866   Attachment: Labeling & Nutrition _ Guidance for Industry_ Nutrition Labeling Manual - A Guide for Developing and Using Data Bases.html Description: Labeling & Nutrition _ Guidance for Industry_ Nutrition Labeling Manual - A Guide for Developing and Using Data Bases.html

Thanks for this reference, Joe!  It appears that all naturally occurring marker compounds would be Class II, so Katherine, I withdraw my previous question about the proposal.   From: ds_jc@xxxxxxxxxxxxxxxxx [mailto:ds_jc@xxxxxxxxxxxxxxxxx] On Behalf Of Betz, Joseph (NIH/OD) [E] Sent: Thursday, April 26, 2018 8:32 PM To: Steven D; Brooker, Rachel Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] DS JC New Issue Papers   ?This is an older guidance and some label regs have changed. What has not changed are the rules around Class I nutrients and Class II nutrients. Vitamin C in powdered rose hip capsules would be class II because of natural variability. Vitamin C in a formulated multi-vite to which ascorbic acid has been added would be class I.     Sent from my BlackBerry 10 smartphone. From: Steven D Sent: Thursday, April 26, 2018 8:55 PM To: Brooker, Rachel Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] DS JC New Issue Papers   Hi, I have a concern regarding DS-2018-3. Without brushing up on naturally occurring constituents vs. added ingredients, I believe that current federal regulations provide leeway from requiring a 100% of label claim via testing for good reason. We may need some discussion about what those good reasons are. I have no concerns at the moment for the remaining three going to ballot. Thank you, Steven -- Dentali Botanical Sciences     On Wed, Apr 25, 2018 at 9:13 AM, Brooker, Rachel < rbrooker@xxxxxxx > wrote: Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866  

Oops, wait, I was confused – sorry, I do NOT withdraw my question.  Like Steven, I have a concern about people being forced to consistently exceed the stated content of naturally occurring markers in order to avoid ever understating them.   From: ds_jc@xxxxxxxxxxxxxxxxx [mailto:ds_jc@xxxxxxxxxxxxxxxxx] On Behalf Of Wendy Applequist Sent: Friday, April 27, 2018 9:05 AM To: Betz, Joseph (NIH/OD) [E]; Steven D; Brooker, Rachel Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: RE: [ds_jc] DS JC New Issue Papers   Thanks for this reference, Joe!  It appears that all naturally occurring marker compounds would be Class II, so Katherine, I withdraw my previous question about the proposal.   From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Betz, Joseph (NIH/OD) [E] Sent: Thursday, April 26, 2018 8:32 PM To: Steven D; Brooker, Rachel Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] DS JC New Issue Papers   ?This is an older guidance and some label regs have changed. What has not changed are the rules around Class I nutrients and Class II nutrients. Vitamin C in powdered rose hip capsules would be class II because of natural variability. Vitamin C in a formulated multi-vite to which ascorbic acid has been added would be class I.     Sent from my BlackBerry 10 smartphone. From: Steven D Sent: Thursday, April 26, 2018 8:55 PM To: Brooker, Rachel Cc: ds_jc@xxxxxxxxxxxxxxxxx Subject: Re: [ds_jc] DS JC New Issue Papers   Hi, I have a concern regarding DS-2018-3. Without brushing up on naturally occurring constituents vs. added ingredients, I believe that current federal regulations provide leeway from requiring a 100% of label claim via testing for good reason. We may need some discussion about what those good reasons are. I have no concerns at the moment for the remaining three going to ballot. Thank you, Steven -- Dentali Botanical Sciences     On Wed, Apr 25, 2018 at 9:13 AM, Brooker, Rachel < rbrooker@xxxxxxx > wrote: Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866  

Just one caveat. If the word âstandardizedâ appears on a label, FDA would interpret that as a manipulation that would move the declared substance (e.g. hypericin) into Class
I. Joe
 

Joseph M. Betz, Ph.D.

Director, Analytical Methods and Reference Materials Program


Office of Dietary Supplements


National Institutes of Health


6100 Executive Blvd., 3B01, MSC 7517


Bethesda, MD 20892-7517 USA


Tel: (301) 435-6044 Fax: (301) 480-1845


Email:  betzj@xxxxxxxxxxxx


 


NIH...Turning Discovery Into Health 


 



âEvery passing hour brings the Solar System forty three thousand miles closer to Globular Cluster M13 in Hercules-and
still there are some misfits who insist that there is no such thing as progress.â

-- Ransom K. Fern, in Kurt Vonnegutâs âSirens of Titanâ
 



 

From: "ds_jc@xxxxxxxxxxxxxxxxx" <ds_jc@xxxxxxxxxxxxxxxxx> on behalf of Wendy Applequist <wendy.applequist@xxxxxxxxx>
Date: Friday, April 27, 2018 at 10:05 AM
To: Joseph Betz <betzj@xxxxxxxxxx>, Steven Dentali <sjdentali@xxxxxxxxx>, "Brooker, Rachel" <rbrooker@xxxxxxx>
Cc: "ds_jc@xxxxxxxxxxxxxxxxx" <ds_jc@xxxxxxxxxxxxxxxxx>
Subject: RE: [ds_jc] DS JC New Issue Papers


 

Thanks for this reference, Joe!  It appears that all naturally occurring marker compounds would be Class II, so Katherine, I withdraw
my previous question about the proposal.
 


From:
ds_jc@xxxxxxxxxxxxxxxxx [mailto:ds_jc@xxxxxxxxxxxxxxxxx] On Behalf Of Betz, Joseph (NIH/OD) [E]
Sent: Thursday, April 26, 2018 8:32 PM
To: Steven D; Brooker, Rachel
Cc: ds_jc@xxxxxxxxxxxxxxxxx
Subject: Re: [ds_jc] DS JC New Issue Papers


 

âThis is an older guidance and some label regs have changed. What has not changed are the rules around Class
I nutrients and Class II nutrients. Vitamin C in powdered rose hip capsules would be class II because of natural variability. Vitamin C in a formulated multi-vite to which ascorbic acid has been added would be class I.


 


 


Sent from my BlackBerry 10 smartphone.







From:
Steven D


Sent:
Thursday, April 26, 2018 8:55 PM


To:
Brooker, Rachel


Cc:
ds_jc@xxxxxxxxxxxxxxxxx


Subject:
Re: [ds_jc] DS JC New Issue Papers







 





Hi,

I have a concern regarding DS-2018-3. Without brushing up on naturally occurring constituents vs. added ingredients, I believe that current federal regulations provide
leeway from requiring a 100% of label claim via testing for good reason. We may need some discussion about what those good reasons are. I have no concerns at the moment for the remaining three going to ballot.

Thank you,

Steven
--


Dentali Botanical Sciences


 

 

On Wed, Apr 25, 2018 at 9:13 AM, Brooker, Rachel < rbrooker@xxxxxxx >
wrote:


Hello Everyone,
 
Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight
forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by
EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.
 
Best Regards,
Rachel

 
Rachel M. Brooker
Standards Development Liaison, Health Sciences
NSF International
ISO/TC249 US TAG Administrator
Email:
rbrooker@xxxxxxx
Phone: 734.827.6866
 

Hi all, Some initial comments: §   Re: Enzymes (DS-2018-1). It would be useful to know if the policy proposed is adopted an estimate of the percent of enzyme products in the market that are currently labeled as suggested here (and so would not need to be relabeled) versus the percent that are not now labeled as suggested (and so would be required to be relabeled. Any estimates will be appreciated. §   Re: Protein (DS-2018-2). Just to clarify – this is in section 5 (product requirements) so is not something the participating brand would be required to do but rather is something the certifier would be required to do (presumably at the expense of the brand) – is that correct? §   Re: Formulation (DS-2018-3). This appears to be non-controversial (and re: the comments by Steven Dentali and Joe Betz – FDA requires 100% of each Class 1 dietary ingredient (I know of no leeway in this) and 80% of Class 2 – just as stated in current 5.2.2). §   Re: Location of Tables (DS-2018-4). This seems entirely non-controversial if I understand correctly that there would be no changes other than the location of these within the standard.   Michael   Michael McGuffin President American Herbal Products Association www.ahpa.org 8630 Fenton Street, Suite 918 Silver Spring MD 20910 MD Phone: 301.588.1171 x201 CA Phone: 310.745.8401 UPCOMING EVENTS Dietary Supplements Regulatory Summit (5/16/2018) Day on the Hill (6/13/2018) AHPA Events at SupplySide West (11/7 -- 11/10/2018) Botanical Congress at SupplySide West (11/10/2018) 35+ years of working for you! The information contained in this communication, including attachments, may be confidential and legally privileged and its use is limited to the intended recipient. In addition, this email does not constitute legal advice. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents is strictly prohibited. If you have received this message in error please advise the sender and delete the original message and all copies from your computer system, including any attachments.   From: ds_jc@xxxxxxxxxxxxxxxxx [mailto:ds_jc@xxxxxxxxxxxxxxxxx] On Behalf Of Brooker, Rachel Sent: Wednesday, April 25, 2018 9:13 AM To: ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] DS JC New Issue Papers   Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866  

Good morning everyone,   To clarify the intent of the paper, it was my understanding that FDA allows for variability in the testing to confirm the Class I and Class II ingredients. The intention of the paper is to require finished product to be formulated (via calculation) to a minimum of 100% of the declared claims regardless if it is a Class I or Class II ingredient.   When evaluating the test results to determine if the product has met the requirements or not, we would take into account the method variability and the Class I or Class II ingredient status.     Kindest regards,   Katherine Fillinger Business Unit Manager, Dietary Supplements T +1 734-214-6269 M +1 734-707-3664  E kfillinger@xxxxxxx   NSF I n t ern a tional nsf.org   789 N. Dixboro Road, Ann Arbor, MI, 48105, U.S.A   From: ds_jc@xxxxxxxxxxxxxxxxx [mailto:ds_jc@xxxxxxxxxxxxxxxxx] On Behalf Of Michael McGuffin Sent: Thursday, April 26, 2018 11:17 PM To: Brooker, Rachel <rbrooker@xxxxxxx>; ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] RE: DS JC New Issue Papers   Hi all, Some initial comments: §   Re: Enzymes (DS-2018-1). It would be useful to know if the policy proposed is adopted an estimate of the percent of enzyme products in the market that are currently labeled as suggested here (and so would not need to be relabeled) versus the percent that are not now labeled as suggested (and so would be required to be relabeled. Any estimates will be appreciated. §   Re: Protein (DS-2018-2). Just to clarify – this is in section 5 (product requirements) so is not something the participating brand would be required to do but rather is something the certifier would be required to do (presumably at the expense of the brand) – is that correct? §   Re: Formulation (DS-2018-3). This appears to be non-controversial (and re: the comments by Steven Dentali and Joe Betz – FDA requires 100% of each Class 1 dietary ingredient (I know of no leeway in this) and 80% of Class 2 – just as stated in current 5.2.2). §   Re: Location of Tables (DS-2018-4). This seems entirely non-controversial if I understand correctly that there would be no changes other than the location of these within the standard.   Michael   Michael McGuffin President American Herbal Products Association www.ahpa.org 8630 Fenton Street, Suite 918 Silver Spring MD 20910 MD Phone: 301.588.1171 x201 CA Phone: 310.745.8401 UPCOMING EVENTS Dietary Supplements Regulatory Summit (5/16/2018) Day on the Hill (6/13/2018) AHPA Events at SupplySide West (11/7 -- 11/10/2018) Botanical Congress at SupplySide West (11/10/2018) 35+ years of working for you! The information contained in this communication, including attachments, may be confidential and legally privileged and its use is limited to the intended recipient. In addition, this email does not constitute legal advice. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents is strictly prohibited. If you have received this message in error please advise the sender and delete the original message and all copies from your computer system, including any attachments.   From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Brooker, Rachel Sent: Wednesday, April 25, 2018 9:13 AM To: ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] DS JC New Issue Papers   Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866  

§   Re: Protein (DS-2018-2). Just to clarify – this is in section 5 (product requirements) so is not something the participating brand would be required to do but rather is something the certifier would be required to do (presumably at the expense of the brand) – is that correct? That is correct.     Sylvia Laman Managing Toxicologist Dietary Supplements   NSF International 789 N. Dixboro Rd., Ann Arbor, MI 48105 USA 734-214-6213 www.nsf.org     From: ds_jc@xxxxxxxxxxxxxxxxx [mailto:ds_jc@xxxxxxxxxxxxxxxxx] On Behalf Of Michael McGuffin Sent: Thursday, April 26, 2018 11:17 PM To: Brooker, Rachel <rbrooker@xxxxxxx>; ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] RE: DS JC New Issue Papers   Hi all, Some initial comments: §   Re: Enzymes (DS-2018-1). It would be useful to know if the policy proposed is adopted an estimate of the percent of enzyme products in the market that are currently labeled as suggested here (and so would not need to be relabeled) versus the percent that are not now labeled as suggested (and so would be required to be relabeled. Any estimates will be appreciated. §   Re: Protein (DS-2018-2). Just to clarify – this is in section 5 (product requirements) so is not something the participating brand would be required to do but rather is something the certifier would be required to do (presumably at the expense of the brand) – is that correct? §   Re: Formulation (DS-2018-3). This appears to be non-controversial (and re: the comments by Steven Dentali and Joe Betz – FDA requires 100% of each Class 1 dietary ingredient (I know of no leeway in this) and 80% of Class 2 – just as stated in current 5.2.2). §   Re: Location of Tables (DS-2018-4). This seems entirely non-controversial if I understand correctly that there would be no changes other than the location of these within the standard.   Michael   Michael McGuffin President American Herbal Products Association www.ahpa.org 8630 Fenton Street, Suite 918 Silver Spring MD 20910 MD Phone: 301.588.1171 x201 CA Phone: 310.745.8401 UPCOMING EVENTS Dietary Supplements Regulatory Summit (5/16/2018) Day on the Hill (6/13/2018) AHPA Events at SupplySide West (11/7 -- 11/10/2018) Botanical Congress at SupplySide West (11/10/2018) 35+ years of working for you! The information contained in this communication, including attachments, may be confidential and legally privileged and its use is limited to the intended recipient. In addition, this email does not constitute legal advice. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents is strictly prohibited. If you have received this message in error please advise the sender and delete the original message and all copies from your computer system, including any attachments.   From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Brooker, Rachel Sent: Wednesday, April 25, 2018 9:13 AM To: ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] DS JC New Issue Papers   Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866  

Thanks Sylvia!   Michael McGuffin President American Herbal Products Association www.ahpa.org 8630 Fenton Street, Suite 918 Silver Spring MD 20910 MD Phone: 301.588.1171 x201 CA Phone: 310.745.8401 UPCOMING EVENTS Dietary Supplements Regulatory Summit (5/16/2018) Day on the Hill (6/13/2018) AHPA Events at SupplySide West (11/7 -- 11/10/2018) Botanical Congress at SupplySide West (11/10/2018) 35+ years of working for you! The information contained in this communication, including attachments, may be confidential and legally privileged and its use is limited to the intended recipient. In addition, this email does not constitute legal advice. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents is strictly prohibited. If you have received this message in error please advise the sender and delete the original message and all copies from your computer system, including any attachments.   From: Laman, Sylvia [mailto:slaman@xxxxxxx] Sent: Friday, April 27, 2018 3:57 AM To: Michael McGuffin <MMcguffin@xxxxxxxx>; Brooker, Rachel <rbrooker@xxxxxxx>; ds_jc@xxxxxxxxxxxxxxxxx Subject: RE: DS JC New Issue Papers   §   Re: Protein (DS-2018-2). Just to clarify – this is in section 5 (product requirements) so is not something the participating brand would be required to do but rather is something the certifier would be required to do (presumably at the expense of the brand) – is that correct? That is correct.     Sylvia Laman Managing Toxicologist Dietary Supplements   NSF International 789 N. Dixboro Rd., Ann Arbor, MI 48105 USA 734-214-6213 www.nsf.org     From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Michael McGuffin Sent: Thursday, April 26, 2018 11:17 PM To: Brooker, Rachel < rbrooker@xxxxxxx >; ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] RE: DS JC New Issue Papers   Hi all, Some initial comments: §   Re: Enzymes (DS-2018-1). It would be useful to know if the policy proposed is adopted an estimate of the percent of enzyme products in the market that are currently labeled as suggested here (and so would not need to be relabeled) versus the percent that are not now labeled as suggested (and so would be required to be relabeled. Any estimates will be appreciated. §   Re: Protein (DS-2018-2). Just to clarify – this is in section 5 (product requirements) so is not something the participating brand would be required to do but rather is something the certifier would be required to do (presumably at the expense of the brand) – is that correct? §   Re: Formulation (DS-2018-3). This appears to be non-controversial (and re: the comments by Steven Dentali and Joe Betz – FDA requires 100% of each Class 1 dietary ingredient (I know of no leeway in this) and 80% of Class 2 – just as stated in current 5.2.2). §   Re: Location of Tables (DS-2018-4). This seems entirely non-controversial if I understand correctly that there would be no changes other than the location of these within the standard.   Michael   Michael McGuffin President American Herbal Products Association www.ahpa.org 8630 Fenton Street, Suite 918 Silver Spring MD 20910 MD Phone: 301.588.1171 x201 CA Phone: 310.745.8401 UPCOMING EVENTS Dietary Supplements Regulatory Summit (5/16/2018) Day on the Hill (6/13/2018) AHPA Events at SupplySide West (11/7 -- 11/10/2018) Botanical Congress at SupplySide West (11/10/2018) 35+ years of working for you! The information contained in this communication, including attachments, may be confidential and legally privileged and its use is limited to the intended recipient. In addition, this email does not constitute legal advice. If the reader of this message is not the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication, or any of its contents is strictly prohibited. If you have received this message in error please advise the sender and delete the original message and all copies from your computer system, including any attachments.   From: ds_jc@xxxxxxxxxxxxxxxxx [ mailto:ds_jc@xxxxxxxxxxxxxxxxx ] On Behalf Of Brooker, Rachel Sent: Wednesday, April 25, 2018 9:13 AM To: ds_jc@xxxxxxxxxxxxxxxxx Subject: [ds_jc] DS JC New Issue Papers   Hello Everyone,   Paula has asked me to distribute four new issue papers that have come in for 173. The issue proponents feel that these are straight forward and non-controversial topics and suggest to go straight to ballot. Please review each of them and if I do not receive any comments from anyone on this JC by EOB May 9 th I will open each of them for official ballot. If you feel that they need discussion or edits then I will set up a teleconference instead of opening the ballot. Thank you.   Best Regards, Rachel   Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866   NOTICE: This email and its contents/attachments may be confidential and are intended solely for the individual to whom it is addressed.  If you are not the named addressee or if this email is otherwise received in error, please immediately notify the sender without reading it and do not take any action based on its contents or otherwise copy or disclose it to anyone. Any opinions or views expressed in  this transmission are solely of the author and do not necessarily represent those of NSF International or its affiliates.